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Baricitinib - Eli Lilly and Company/Incyte Corporation

Drug Profile

Baricitinib - Eli Lilly and Company/Incyte Corporation

Alternative Names: INCB 028050; INCB 28050; LY 3009104; Olumiant

Latest Information Update: 12 Oct 2021

At a glance

  • Originator Incyte Corporation
  • Developer Eli Lilly; Eli Lilly and Company; Incyte Corporation; Natco Pharma
  • Class Acetonitriles; Anti-inflammatories; Antipsoriatics; Antirheumatics; Azetidines; Eye disorder therapies; Pyrazoles; Pyrimidines; Pyrroles; Skin disorder therapies; Small molecules
  • Mechanism of Action Janus kinase 1 inhibitors; Janus kinase-2 inhibitors; TYK2 kinase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Systemic lupus erythematosus
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Atopic dermatitis; Rheumatoid arthritis
  • Registered COVID 2019 infections
  • Preregistration Alopecia areata
  • Phase III Juvenile rheumatoid arthritis; Systemic lupus erythematosus; Uveitis
  • Phase II/III Aicardi-Goutieres syndrome; Hereditary autoinflammatory diseases
  • Phase II Giant cell arteritis; Myositis; Polymyalgia rheumatica; Primary biliary cirrhosis
  • Discontinued Diabetic nephropathies; Psoriasis; Psoriatic arthritis

Most Recent Events

  • 30 Sep 2021 Efficacy and adverse events data from BRAVE-AA1 and BRAVE-AA2 clinical trials in Alopecia areata released by Eli Lilly and Company
  • 27 Sep 2021 Phase-III clinical trials in COVID-2019 infections (In infants, In children, In adults, In adolescents) in Belgium (PO) (EudraCT2021-001338-21)
  • 13 Sep 2021 Biomarkers information updated

Development Overview

Introduction

Baricitinib is an orally-administered, small-molecule, janus kinase (JAK) inhibitor being developed by Eli Lilly and Incyte Corporation, for the treatment of rheumatoid arthritis (RA), atopic dermatitis, alopecia areata, giant cell arteritis, psoriatic arthritis, uveitis and systemic lupus erythematosus (SLE), hereditary autoinflammatory diseases, polymyalgia rheumatica and COVID-2019 infections. It inhibits JAK1 and JAK2 subtypes, which mediate the signalling of several important drivers of inflammatory diseases, myeloproliferative disorders and malignancies. The drug has greater potency of inhibition against JAK1, JAK2 and TYK2 than JAK3. It also has the potential to disrupt cytokine-mediated activity. The drug is launched and approved in several countries for atopic dermatitis, COVID-2019 infections and rheumatoid arthritis worldwide. The drug is launched in Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Japan, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, the US, the UK for rheumatoid arthritis. Baricitinib is available in Japan and in the EU, and under regulatory review in the US for atopic dermatitis. The drug is approved in Kuwait and India for the treatment of rheumatoid arthritis. The drug is also approved as monotherapy and in combination with remdesivir, for emergency use in the US for COVID-2019 infections. The drug is also approved as monotherapy and in combination with remdesivir, for emergency use in India for treatment of COVID-2019 infections. The product is approved in Japan for the treatment of pneumonia associated with COVID-2019 infections. The drug is under regulatory review in the EU for COVID-2019 infections. It is also under regulatory review for the treatment of alopecia areata in the EU and Japan. Clinical development is underway in various countries for the treatment of atopic dermatitis, juvenile rheumatoid arthritis, alopecia areata, giant cell arteritis, psoriatic arthritis, primary biliary cirrhosis, uveitis, systemic lupus erythematosus, idiopathic inflammatory myopathies, hereditary autoinflammatory diseases, Aicardi-Goutières syndrome, polymyalgia rheumatica and COVID-2019 infections.

Baricitinib was under phase II development for the treatment of diabetic nephropathies, in the US, Mexico, Japan and Puerto Rico, and for the treatment of psoriasis, in the US, Canada, Japan and Puerto Rico. However, development in these indications was discontinued. Phase II development for rheumatoid arthritis was underway in Ukraine. However no recent reports of development have been identified.

Baricitinib is a follow-on compound to ruxolitinib [see Adis Insight Drug profile 800026694], which has entered clinical development.

Company Agreements

In May 2021, Natco Pharma entered into a royalty-free, non-exclusive voluntary licensing agreement with Eli Lilly to manufacture and commercialise baricitinib in India. The financial terms of the agreement are not disclosed. [1]

In May 2021, Dr. Reddy’s Laboratories entered into a royalty-free, non-exclusive voluntary licensing agreement with Eli Lilly to manufacture and commercialise baricitinib in India. Financial terms of the agreement are not disclosed. [2]

In May 2021, Lupin signed a royalty-free, limited, non-exclusive voluntary licensing agreement with Eli Lilly and Company (Lilly) for manufacturing and selling of Lilly’s drug baricitinib in combination with remdesivir for the treatment of suspect or laboratory-confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) in India. [3]

In May 2021, Cipla entered into an royalty-free, non-exclusive voluntary licensing agreement with Eli Lilly and Company, to manufacture and market baricitinib for treatment of COVID-2019 infections in India. Financial terms regarding the agreement were not disclosed. [4]

In May 2021, Sun pharmaceutical Industries entered into a royalty-free, non-exclusive voluntary licensing agreement with Eli Lilly and Company to manufacture and distribute baricitinib in India. The drug will be used to alleviate burden on COVID-19 in combination with remdesivir. Financial terms from the deal were not disclosed. [5]

In April 2020, Eli Lilly and Company entered into a research and development agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study baricitinib as an arm in NIAID's Adaptive COVID-19 treatment trial. [6]

In April 2019, Incyte elected to no longer co-fund the development of baricitinib, as a result of which, Eli Lilly and Company will solely fund all future development of baricitinib and pay a lower royalty rate to Incyte on future sales. Earlier, in December 2009, Incyte entered into an exclusive worldwide license and collaboration agreement with Eli Lilly and Company for the development and commercialisation of baricitinib and certain follow-on compounds, for inflammatory autoimmune diseases. Eli Lilly and Company was granted worldwide rights to develop and commercialise baricitinib as an oral treatment for all inflammatory conditions. In exchange for these rights, Incyte received an initial payment of $US90 million and became eligible for up to $US665 million in additional potential development, regulatory and commercialisation milestones, as well as tiered, double-digit royalty payments on future global sales. Incyte will retain the option to co-develop its JAK1/JAK2 inhibitors with Lilly on a compound-by-compound and indication-by-indication basis, beginning at the initiation of phase IIb development. Additionally, Incyte has the option to co-promote products in the US. Development of the JAK1/JAK2 inhibitors will be governed by a joint development committee. Incyte exercised its option to co-develop baricitinib with Eli Lilly and Company during the third quarter of 2010. Incyte will be responsible for funding 30% of the associated global development costs through regulatory approval in rheumatoid arthritis, and the company's royalty rate will increase across all tiers, up to the high twenties on potential future global sales. [7] [8] [9]

Key Development Milestones

Rheumatoid arthritis (RA)

In September 2017, Eli Lilly and Company announced that it has launched baricitinib 2mg and 4mg for the treatment of rheumatoid arthritis, including the prevention of structural injury of joints, in patients with an inadequate response to standard-of-care regimens [10] . The Japanese Ministry of Health, Labor and Welfare approved the drug in July 2017. The approval was based on the development programme of baricitinib, including the four phase III studies. Eli Lilly and Company had submitted the application with the Pharmaceuticals and Medical Devices Agency, in the first quarter of 2016. The approval triggers a $US15 million milestone payment from Eli Lilly and Company to Incyte Corporation [11] [12] . Data from a 24 week post marketing safety surveillance study did not demonstrate any new safety signals [13] .

In June 2018, the US FDA approved the 2-mg dose of baricitinib for the treatment of patients with moderate to severe rheumatoid arthritis, who have responded inadequately to one or more tumor necrosis factor (TNF) inhibitor therapies. The approval was based on the phase III trial. As part of the approval, the companies have agreed to conduct a randomized controlled clinical trial to evaluate the long-term safety of baricitinib in patients with rheumatoid arthritis. Incyte is now eligible to receive an $US100 million milestone payment from Lilly as a result of baricitinib approval [14] . Baricitinib 4mg and 2mg once-daily tablet was approved by the European Commission in February 2017, for the treatment of patients with moderate to severe rheumatoid arthritis, who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Approval of the MAA will trigger $US65 million milestone payment to Incyte [15] . Earlier in December 2016, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion, recommending the approval. The committee’s positive opinion was based on five phase III studies of baricitinib (RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON and RA-BEYOND) [see below]. The product may be used as a monotherapy or in combination with methotrexate. Eli Lilly had submitted the MAA to the EMA in February 2016. The MAA submission triggered a milestone payment of $US20 million and approval resulted in $US65 million milestone from Lilly to Incyte [16] [12] [17] .

In January 2018, baricitinib was approved in Australia for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately, or who are intolerant, to one or more disease modifying anti-rheumatic drugs (DMARDs). The drug can be used as monotherapy or in combination with cDMARDs, including methotrexate (MTX) [18] .

Baricitinib was approved in Kuwait and Switzerland in June 2017, for the treatment of patients with rheumatoid arthritis [11]

In April 2018, Eli Lilly and Company and Incyte reported that the US FDA's Arthritis Advisory Committee recommended approval of the once daily 2mg dose of baricitinib, and did not recommend approval of the 4mg dose of baricitinib, for the treatment of moderately-to-severely active rheumatoid arthritis, for adult patients, who have had an inadequate response or intolerance to methotrexate. The decision was taken based on the adequacy of the safety and benefit-risk profiles. The FDA also convened the Committee to discuss on the resubmitted NDA [19] [20] . In January 2018, the US FDA had accepted the resubmission of NDA. The NDA was originally filed in January 2016 [21] [22] [23] . However, in April 2017, in a complete response letter for the NDA, the FDA had indicated that additional clinical data were needed to determine the most appropriate doses and characterise safety concerns across the treatment arms [24] . The NDA was filed in January 2016. Incyte will receive a milestone payment of $US35 million from Lilly related to the NDA submission. Incyte will also receive a milestone payment of $US100 million from Lilly, if baricitinib is granted approval in the US. Lilly will lead launch and global commercialisation efforts for baricitinib in RA, if approved [25] [26] [27] .

The phase III programme for RA consists of four pivotal controlled trials. Upon the initiation of the phase III RA programme in November 2012, Incyte earned a $US50 million milestone payment from Eli Lilly and Company [28] [29] .

In November 2016, pooled analyses data from phase II and III studies, which evaluated the effect of baricitinib and statin therapy on lipid profile in patients with moderately to severely active rheumatoid arthritis, were presented at the 80th American College of Rheumatology and the 51st Annual Meeting of the Association of Rheumatology and Health Professionals (ACR/ARHP-2016) [30] .

In May 2017, Eli Lilly and Company completed a randomised, double-blind, placebo-controlled phase III trial that evaluated the efficacy and safety of baricitinib in patients with moderate to severe RA who have had an inadequate response to methotrexate (14875; I4V-CR-JAGS; NCT02265705). Patients continued on background methotrexate, and the primary endpoint was the proportion of patients who achieved ACR20 improvement at 12 weeks. The trial was initiated in October 2014 and enrolled 288 patients in Argentina, Brazil and China. Results from the trial were presented at the 19th Annual Congress of the European League Against Rheumatism (EULAR-2018), in June 2018. Data from the trial were released by the company in June 2020 [31] [32] [33] .

In October 2020, Eli Lilly and Company completed a long-term phase III extension trial for patients with RA who have participated in a previous trial of baricitinib (RA-BEYOND; 14060; I4V-MC-JADY; NCT01885078; EudraCT2012-003686-17; 14908; CCRN2341; CTRI2014-07-004736; JapicCTI142405). The randomised, double-blind, placebo-controlled trial was initiated in June 2013 and enrolled 2089 patients in Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, the United Kingdom, the US. Data from the long-term extension trial was presented at the 17th Annual Congress of the European League Against Rheumatism (EULAR-2016) [34] [35] .

In June 2016, Eli Lilly and Company in collaboration with Incyte Corporation reported statistically significant 52 and 24 weeks data of the phase III RA-BEGIN and RA-BEAM trials. The analysis of the trials demonstrated that in each study, patients treated with baricitinib achieved less impairment in work productivity and daily activities compared to patients taking the comparator (methotrexate or adalimumab), including significant improvements in pain, physical function, tiredness and morning joint stiffness, which were observed as early as one week after initial treatment with baricitinib. The data was presented at the 17th Annual Congress of the European League Against Rheumatism (EULAR - 2016) [36] .

In November 2015, Eli Lilly and Company presented detailed results from the RA-BEAM phase III trial at the 79th American College of Rheumatology and the 50th Annual Meeting of the Association of Rheumatology and Health Professionals (ACR/ARHP-2015) and in November 2016, Eli Lilly and Company and Incyte presented efficacy and safety data from the trial at the 80th American College of Rheumatology and the 51st Annual Meeting of the Association of Rheumatology and Health Professionals (ACR/ARH-2016). The data demonstrated statistical superiority of baricitinib in improvement of all seven ACR response rates in comparison with adalimumab [see Adis Insight Drug profile 800008414]. The study met its primary endpoints thereby demonstrating superior ACR20 responses in baricitinib treatment group relative to the placebo group as per top line results released by Eli Lilly and Company and Incyte Corporation in October 2015 and February 2017 (NCT01710358; EudraCT2012-002322-73). The company initiated the trial in October 2012 in patients with moderate to severe RA who have had an inadequate response to methotrexate. Patients were randomised to receive baricitinib, adalimumab or placebo, while continuing on background methotrexate. Enrolment of approximately 1280 patients was completed in May 2015 in the US, Canada, Puerto Rico, Argentina, Mexico, South Africa, the UK, Belgium, Netherlands, Croatia, Czech Republic, France, Germany, Greece, Hungary, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Switzerland, Russia, China, Japan, South Korea and Taiwan; the study was completed in September 2015 [37] [38] [39] [40] [41] [42] [43] . In June 2019, the company presented the efficacy results of this study at the 20th Annual Congress of the European League Against Rheumatism (EULAR-2019) [44] . In June 2021, the company presented additional efficacy data from the trial at the 22nd Annual Congress of the European League Against Rheumatism (EULAR-2021) [45] .

Eli Lilly and Company, in September 2015, released results from the phase III RA-BEGIN trial wherein, the trial met its primary endpoints and baricitinib monotherapy was found to be non-inferior to methotrexate monotherapy based on ACR20 response rate after 24 weeks of treatment. Additionally, baricitinib was superior to methotrexate based on ACR20 response. A majority of patients completing the RA-BEGIN trial opted to enrol for the long term extension trial. Eli Lilly and Company had initiated a double-blind, placebo-controlled phase III trial in November 2012 in patients with moderate to severe RA who had limited or no prior treatment with methotrexate, and are naive to other conventional or biologic DMARDs (RA-BEGIN; NCT01711359; EudraCT2012-002324-32). Patients had been randomised to receive baricitinib alone, methotrexate alone, or a combination of the two. The primary endpoint is the proportion of patients who achieve ACR20 improvement at 24 weeks. Enrolment of 600 patients was completed in May 2015 in the US, Canada, Mexico, Argentina, Brazil, Puerto Rico, the UK, Austria, Belgium, Germany, Greece, Italy, Portugal, Sweden, South Africa, Japan, South Korea, Russia and India8. Baricitinib plus methotrexate indicated significant inhibition of progressive radiographic joint damage, versus methotrexate alone [46] [47] [48] . Data demonstrating that compared with methotrexate, baricitinib was not associated with an increase in number of patients with reduction in NK cells. However, treatment with methotrexate and baricitinib was associated with an increase in the number of patients with with low NK cell count, were presented at the 18th Annual Congress of the European League Against Rheumatism (EULAR-2017). In October 2018, the company presented additional data from the trial at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting (ACR/ARHP-2018) [49] [50] . In June 2019, the company presented efficacy data at the 20th Annual Congress of the European League Against Rheumatism (EULAR-2019) [51] .

In December 2014, Eli Lilly and Company completed a randomised, double-blind, placebo-controlled phase III trial, which assessed the efficacy and safety of baricitinib (4 mg/daily) in patients with moderate to severe RA who have had inadequate response to or are intolerant to conventional DMARDs and who have not received a biologic DMARD (RA-BUILD; 14059; I4V-MC-JADX; NCT01721057; EudraCT2012-002339-27). The global trial enrolled 684 patients in the US, Argentina, Australia, Belgium, Canada, Croatia, Czech Republic, Mexico, Germany, Hungary, Italy, India, Japan, Puerto Rico, Portugal, Poland, Romania, Russia, Slovakia, Spain, South Korea and Taiwan and the UK [52] . In June 2015, the company presented data from the trial at the 16th Annual Congress of the European League Against Rheumatism [53] . In February 2015, the company reported that baricitinib effectively reduced rheumatoid arthritis disease activity, compared with placebo. The study also met its primary endpoint, which was an improved American College of Rheumatology 20% (ACR 20) response rate compared with placebo at 12 weeks [54] .

In September 2014, Eli Lilly and Company completed the global phase III RA-BEACON trial to assess the efficacy and safety of baricitinib (2mg or 4mg daily) in patients with moderate to severe RA who have had an inadequate response to a TNF inhibitor, despite ongoing treatment with conventional DMARDs (RA-BEACON; NCT01721044; EudraCT2012-002323-15). The randomised, double-blind, placebo-controlled trial enrolled 527 patients in the US, Canada, Argentina, Mexico, Puerto Rico, Australia, Japan, South Korea, the UK, Austria, Belgium, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, South Africa, Spain, Switzerland, Turkey, Israel and India [55] . In June 2015, the company presented data from the trial at the 16th Annual Congress of the European League Against Rheumatism [53] . According to top-line results reported in December 2014, the trial met its primary endpoint of improved ACR20 response at 12 weeks [56] . In November 2019, Eli Lilly presented the efficacy data from a phase III RA-BEACON trial in rheumatoid arthritis at the 83rd American College of Rheumatology and the 54th Association of Rheumatology Health Professionals Annual Scientific Meeting (ACR/ARHP-2019) [57] .

A phase IIb randomised clinical trial of baricitinib was initiated in October 2010, in 301 patients with active RA on background methotrexate therapy in the US, Europe, Ukraine, South America and India (NCT01185353; EudraCT2010-022504-42) [58] . The trial was conducted by Eli Lilly and Company in collaboration with Incyte and was completed in April 2012. Results for the primary endpoint (ACR20 response rate at 12 weeks) were released in June 2012 [59] . The trial achieved its primary endpoint, and 12-week data have been reported [42] . Patients, who completed the 12-week portion of the trial continued in the open-label extension of the trial. Results from the 52-week open-label extension portion of the trial were presented at the 14th Annual Congress of the European League Against Rheumatism (EULAR-2013) [60] . The initiation of this trial triggered a milestone payment of $US19 million from Eli Lilly and Company to Incyte [61] . As of October 2015, no further development has been reported in Ukraine.

In December 2013, Eli Lilly and Company completed a phase II clinical trial to assess baricitinib in patients with active RA on background methotrexate therapy. The trial enrolled 144 patients in Japan (NCT01469013) [62] .

Incyte completed a 6-month, double-blind, placebo-controlled, phase II trial of baricitinib in RA in July 2010, and positive results have been reported (NCT00902486; EudraCT2009-011206-42) [63] . The trial enrolled 127 patients from the US and the Czech Republic with RA who had inadequate response to any DMARD therapy [64] [65] [66] .

In October 2018, Eli Lilly and Company presented data from pooled analysis of clinical studies conducted in patients with rheumatoid arthritis at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting (ACR/ARHP-2018) [67] .

Atopic dermatitis

In December 2020, the Ministry of Health, Labour and Welfare approved baricitinib (Olumiant®, 2mg and 4mg tablets) for the treatment of atopic dermatitis in adult patients who have inadequate response to conventional therapies. The product was launched subsequently. Regulatory application seeking approval was submitted in January 2020 [68] [69] [70] .

Prior to October 2020, The European Commission approved baricitinib (Olumiant®) for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. In September 2020, Eli Lilly and Incyte announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for baricitinib as a treatment of adult patients with moderate to severe atopic dermatitis (AD). The positive opinion is based on Lilly's phase III BREEZE-AD clinical development programme [see below] for baricitinib evaluating its potential to treat atopic dermatitis [71] [72] . Eli Lilly had submitted a regulatory application in the EU seeking approval for the use of baricitinib as a treatment for patients with moderate to severe atopic dermatitis in January 2020 [69] [73] .

In July 2021, Eli Lilly and Company and Incyte reported that the US FDA will not be able to meet the Prescription Drug User Fee Act (PDUFA) target date and complete the review of the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD). earlier in April 2021, the FDA had extended the review period for the sNDA. The sNDA was submitted to the US FDA in the second quarter of 2020 [74] [75] [76] .

In July 2019, the EMA accepted the modification of an agreed paediatric investigation plan for baricitinib for the treatment of atopic dermatitis [77] .

In March 2020, Eli Lily and Company presented the pooled efficacy data from a phase III BREEZE-AD1 and BREEZE-AD2 trial in atopic dermatitis at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (2020) [78] .

In August 2021, Eli Lilly and Company and Incyte Corporation completed the phase III BREEZE-AD5 trial that evaluated the efficacy and safety of 1 mg and 2 mg doses of baricitinib monotherpay in adult patients with moderate to severe atopic dermatitis (I4V-MC-JAIW; 17049; NCT03435081). The randomised, double-blind, placebo-controlled was initiated in February 2018 and recruited 450 patients in the US Canada and Puerto Rico. In January 2020, Eli Lilly and Incyte released topline results from its phase III BREEZE-AD5 trial demonstrating the meeting of primary endpoint of proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) at week 16 along with secondary endpoints [79] [80] .

In January 2019, Eli Lily and Company initiated the phase III BREEZE-AD-PEDS trial to assess the pharmacokinetics, efficacy and safety of baricitinib in paediatric patients with moderate to severe atopic dermatitis (I4V-MC-JAIP; EudraCT2018-000349-38; NCT03952559).The randomised, double-blind trial intends to enrol 465 patients aged 2-17 years in Argentina, Germany, Poland, Spain and United Kingdom and will expand to Australia, Austria, Brazil, Czech Republic, France, Greece, Hungary, Israel, Mexico, Russia, Switzerland, Taiwan, Ukraine and the US [81] .

In August 2019, the phase III BREEZE-AD7 met its primary endpoint compared with the placebo, at week 16, as defined by the Investigator's Global Assessment for AD (IGA) score of clear or almost clear (IGA 0,1). In August 2019, Eli Lilly and Company completed the trial which was designed to assess the efficacy and safety of baricitinib in combination with topical corticosteroids in adult patients with moderate to severe atopic dermatitis (I4V-MC-JAIY; JapicCTI184198; NCT03733301; EudraCT2018-001726-26). The double-blind, randomised study, initiated in November 2018, enrolled 329 patients in Spain, Argentina, Australia, Austria, Germany, Japan, South Korea, Italy, Taiwan and Poland [82] . In August 2019, efficacy and safety data from the trial were released by Eli Lilly and Company [83] .

In January 2020, Eli Lilly and Company announced that the phase III BREEZE-AD4, study in patients with moderate to severe atopic dermatitis met its primary endpoint of at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) at week 16. The trial also met its key secondary end points including Global Assessment of 0 (clear) or 1 (almost clear) and 4-point improvement in Itch Numeric Rating Scale at week 16. In May 2018, Eli Lilly and Company and Incyte Corporation initiated the phase III BREEZE-AD4 trial to evaluate the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine (NCT03428100; EudraCT2017-004574-34; 16841; I4V-MC-JAIN; JapicCTI183961). The double-blind, parallel, prospective, randomised trial is enrolling approximately 500 patients in the UK, the Netherlands, Austria, Poland, Spain, Belgium, Brazil, Finland, France, Germany, Italy, Japan, Russia and Switzerland. In January 2020, efficacy and safety data from the trial were released by Eli Lilly and Company [73] [84] .

In March 2018, Eli Lilly and Company and Incyte Corporation initiated the phase III BREEZE-AD3 trial to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis (I4V-MC-JAHN; I4V-MC-JAHN-a; 16587; NCT03334435; EudraCT 2017-000873-35). The double-blind, parallel, prospective, randomised study is enrolling approximately 1 500 patients in Argentina, Australia, Austria, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Swaziland, Switzerland and Taiwan. In October 2020, the company released the results from the trial [85] [86] .

In July 2018, Eli Lilly and Company initiated the phase III BREEZE-AD6 trial valuate the long-term efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis, who have completed participation in study BREEZE-AD5/Study JAIW (I4V-MC-JAIX; NCT03559270; 17064). The open label trial is enrolling 300 patients by invitation in the US [87] .

In August 2019, Eli Lilly and Company in collaboration with Incyte Corporation completed the phase III BREEZE-AD1 trial that evaluated the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis (16580; I4V-MC-JAHL; EudraCT2017-000870-12; NCT03334396). Evaluation of the proportion of participants achieving IGA of 0 or 1 with a ≥ 2 point improvement was the defined primary endpoint of the trial. The randomised, double-blind, placebo-controlled trial, initiated in November 2017, enrolled 624 patients in Czech Republic, Denmark, France, Germany, India, Italy, Japan, Mexico, Russia, Taiwan. In February 2019, Eli Lilly and Company announced the top line results of the phase III BREEZE-AD1 study. In the study, significant number of patients who received baricitinib, achieved the primary endpoint, compared with placebo, at week 16, as defined by the Investigator's Global Assessment for AD (IGA) score of clear or almost clear (IGA 0,1) [88] [89] .

Eli Lilly and Company announced the top line results of the phase III in February 2019, which demonstrated that a significant population of patients treated with baricitinib achieved the primary endpoint, compared with the placebo, at week 16, as defined by the Investigator's Global Assessment for AD (IGA) score of clear or almost clear (IGA 0,1) [88] . In December 2018, Eli Lilly and Company completed the BREEZE-AD2 phase III trial that evaluated the efficacy and safety of baricitinib, as monotherapy, in participants with moderate to severe atopic dermatitis (16581; I4V-MC-JAHM; EudraCT2017-000871-10; NCT03334422; JapicCTI183825). Evaluation of the proportion of participants achieving IGA of 0 or 1 with a ≥ 2 point improvement was the defined primary endpoint of the trial. The randomised, double-blind, placebo-controlled trial was initiated in November 2017 and enrolled 750 patients in Argentina, Australia, Austria, Hungary, Israel, Japan, Poland, South Korea, Switzerland and Spain [90] .

Eli Lilly and Company, in March 2017, completed a phase IIa trial that evaluated the safety and efficacy of orally administered baricitinib od versus placebo in patients with moderate-to-severe atopic dermatitis (16284; I4V-MC-JAHG; NCT02576938). Treatment with triamcinolone 0.1% topical was optional in both the arms. The primary endpoint was the proportion of patients with a ≥ 50% reduction in the eczema area and severity index (EASI 50), assessed at week 16. The randomised, double-blind trial was initiated in February 2016 and enrolled 124 subjects in the US and Japan (Incyte corporation form 10-k, March 2017). In September 2017, Eli Lilly and Company released safety and efficacy results from the trial [91] [92] .

COVID-2019 infections

In July 2021, Eli Lilly and Company and Incyte announced that the US FDA has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. The EUA provided based on data from the phase III COV-BARRIER study, for the use of baricitinib for treatment of COVID-19 in hospitalised adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) [93] .

In November 2020, the US FDA, as part of its Coronavirus Treatment Acceleration Program (CTAP), issued an emergency use authorisation (EUA) for the usage of baricitinib, to be administered as a combination therapy with remdesivir [see Adis Insight Drug profile 800043325]. The drug is authorised for use for the treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-2019) infections, in hospitalised adults and pediatric patients, aged two years or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The recommended dose for this EUA is baricitinib 4 mg once daily for 14 days or until hospital discharge. The EUA decision was based on data from the ACTT-2 trial [see below]. Earlier, in October 2020, Eli Lilly and Incyte Corporation had submitted an initial request to the FDA for EUA, based on favourable data displaying that the combination therapy reduced time to recovery and improved clinical outcomes for patients with COVID-19 infections compared with remdesivir [94] [71] [95] . The company intends to make baricitinib available through commercial channels and will work with hospitals and governments to ensure patient access [96] .
In April 2021, the Ministry of Health, Labour and Welfare of Japan approved the baricitinib tablets of 1mg, 2mg and 4mg strengths (Olumiant) for the treatment of pneumonia associated with COVID-2019 in hospitalised adult patients [97] [98] .

In May 2021, Natco Pharma received emergency use approval for baricitinib tablets of 1mg, 2mg and 4mg strengths, in combination with remdesivir, from Central Drugs Standard Control Organization (CDSCO), for the treatment of patients with COVID-2019 infections in India. Natco intends to apply for a Compulsory License based on the emergency use approval [99] . In May 2021, Eli Lilly and Company received approval for restricted emergency use of baricitinib tablets from Central Drugs Standard Control Organization, for baricitinib (2 mg and 4 mg) in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) [100] .

In April 2021, EMA has started evaluating an application to extend the use of baricitinib (Olumiant) to include treatment of COVID-19 in hospitalised patients from 10 years of age who require supplemental oxygen. EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Olumiant, including results from 2 large randomised studies in patients hospitalised with COVID-19, in order to recommend as soon as possible whether or not the extension of indication should be authorised [101] .

In September 2021, Eli Lilly and Company initiated a phase III COV-BARRIER-PEDS trial to characterise the pharmacokinetics (PK) of baricitinib in pediatric patients with COVID-19 (EudraCT-2021-001338-21; I4V-MC-KHAB). The open-label trial intends to enrol approximately 24 patients in Belgium.

In November 2020, National Institute of Allergy and Infectious Diseases (NIAID) initiated a phase III ACTT-4 trial to evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir (NCT04640168; 20-0006 ACTT-4). The randomised trial intends to enrol approximately 1,010 patients in the US, Japan, South Korea, Mexico, Singapore [102]

In December 2020, Eli Lilly and Company initiated a phase III COV-BARRIER Sub-Study to assess the efficacy and safety of baricitinib versus placebo when added to standard of care which included corticosteroids (86% of the patients) in patients hospitalized with COVID-19 requiring invasive mechanical ventilation or ECMO at baseline. A total of 101 patients were randomized to baricitinib or placebo with 51 receiving baricitinib and 50 receiving placebo. In August 2021, data from the trial were released by company [103]

In June 2021, Eli Lilly and Company and Incyte completed a phase III COV-BARRIER trial. The trial did not meet statistical significance on primary endpoint of the difference in the proportion progression to non-invasive ventilation or invasive mechanical ventilation or death by day 28 (NCT04421027; 17830; I4V-MC-KHAA, EudraCT2020-001517-21). The randomised, double-blinded trial was initiated in April 2021 and enrolled 1585 patients in US, Argentina, Brazil, Germany, Italy, Japan, Mexico, Russia, Spain, the UK, India, Puerto Rico and South Korea [104] [105] [106] [107] [108] .

In September 2020, the phase III ACTT-2 trial met the primary endpoint of reduction of time to recovery with oral baricitinib and remdesivir combination therapy, in hospitalised patients with COVID-2019 infections, when compared with remdesivir. In July 2020, National Institute of Allergy and Infectious Diseases (NIAID) completed the phase III ACTT-2 trial designed to assess the safety and efficacy of oral baricitinib and remdesivir combination therapy for the treatment of COVID-19 in hospitalized adults (ACTT-2) (20-0006ACTT2; NCT04401579). The randomised, double blind trial, initiated in May 2020, completed enrolment of 1 033 patients in the US, Japan, Denmark, South Korea, Mexico, Singapore, Spain, the UK [109] . In April 2020, Eli Lilly and Company entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study baricitinib as an arm in NIAID's Adaptive COVID-19 treatment trial [6] [69] [110] . In September 2020, Eli Lilly released results of this trial [96] [111] . In October and November 2020, Eli Lilly and Company released results from the trial [112] [113] . In December 2020, Eli Lilly and NIAID released updated results of this trial [114] [115] .

A phase II/III trial was planned by Eli Lilly and Company to evaluate the safety and efficacy of baricitinib in patients with COVID-2019 infections (NCT04340232; 20-0738). The open label trial was designed to enrol approximately 80 patients in the US. However in March 2021, the study was withdrawn prior to enrolment as the company could not make FDA required changes [116] .

Alopecia areata

As of October 2021, baricitinib is included in the draft agenda for the meeting of Committee for medicinal products for human use (CHMP) of the European Medicines Agency (EMA), for extension of indication of the drug to include treatment of severe alopecia areata in adult patients [117] [118] .

As of July 2021, Eli Lilly announced the submission of regulatory application to MHLW for the approval of baricitinib in the treatment of alopecia areata [118] .

In March 2020, the US FDA granted Breakthrough Therapy designation to baricitinib for the treatment of alopecia areata. The designation was based on the results from the BRAVE-AA1 study [see below] [119] .

In Sepetmber 2021 and April 2021, pooled efficacy and safety data from BRAVE-AA1 and BRAVE-AA2 trial were released by Eli Lilly and Company [120] [121] .

In July 2019, Eli Lilly and Company and Incyte Corporation initiated the phase III BRAVE-AA2 trial to test if baricitinib is safe and effective in adults with severe or very severe alopecia areata (16978; I4V-MC-JAIR; NCT03899259). The double-blind, randomised trial is enrolling approximately 476 patients in the US, Japan, Puerto Rico, Taiwan, China, Argentina, Australia, Brazil, Israel and South Korea. Efficacy and adverse events data from the trial released by Eli Lilly and Company [122] [123] . In April 2021, efficacy data from the trial were released by Eli Lilly and Company [120] .

In September 2018, Eli Lilly and Company and Incyte Corporation initiated the phase II/III BRAVE-AA1 trial to select up to two doses of baricitinib and assess their efficacy and safety for the treatment of severe or very severe alopecia areata (NCT03570749; 16582; I4V-MC-JAHO). The double-blind, randomised trial is enrolling approximately 725 patients in the US, Japan, South korea, Mexico and Puerto Rico [124] . In November 2020, Eli Lilly and Company and Incyte Corporation released the efficacy and safety results from the trial, indicating that proportion of patients achieving the primary endpoint of Severity of Alopecia Tool (SALT) score of 20 was significantly greater in baricitinib treated groups [125] . In April 2021, efficacy data from the trial were released by Eli Lilly and Company [120] .

Idiopathic Inflammatory Myopathies (Myositis in development table)

In March 2020, University of Manchester in collaboration with Eli Lilly initiated phase II trial to evaluate efficacy of baricitinib in adult patients with idiopathic inflammatory myopathy (EudraCT2019-003868-42). The randomised trial intends to enrol 25 patients in the UK [126] .

Juvenile rheumatoid arthritis

In February 2020, Eli Lilly and Company initiated a phase III trial to evaluate the safety and efficacy of baricitinib in in the treatment of Juvenile Idiopathic Arthritis (JIA) in participants ages 1 to 17 (16275; I4V-MC-JAHU; EudraCT2017-004495-60; NCT04088396). The randomised, double-blind, placebo-controlled trial intends to enrol approximately 103 patients in Argentina, Austria, Belgium, Brazil, Czech Republic, Denmark, France, Germany, India, Israel, Italy, Japan, Mexico, Poland, Russia, Spain, Turkey and UK [127] .

In April 2019, Eli Lilly and Company initiated the phase III JUVE-X trial to evaluate the safety and efficacy of baricitinib in the treatment of Juvenile Idiopathic Arthritis (JIA) in participants ages 1 to 17 (16278; EudraCT2017-004471-31; I4V-MC-JAHX; P157-2018; NCT03773965). The open-label trial is enrolling approximately 236 patients in Argentina, Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Israel, Italy, Japan, Mexico, Poland, Russia, Spain, Turkey and UK [128] .

In December 2018, Eli Lilly and Company initiated the phase III JUVE-BASIS trial to evaluate the safety and efficacy of baricitinib for the treatment of patients with juvenile rheumatoid arthritis (2 to 18 years of age) (16276; I4V-MC-JAHV; EudraCT-2017-004518-24; NCT03773978). The randomised, double-blind, placebo-controlled study is intended to enrol approximately 197 patients in the US, and will expand to several other countries [129] .

Polymyalgia rheumatica

In December 2020, University Hospital, Brest in collaboration with Eli Lilly and Company initiated the phase II trial BACHELOR trial to evaluate the healing effect of baricitinib in early polymyalgia rheumatica patients (BACHELOR29BRC18-0144; NCT04027101). The randomised, double-blind trial intends to enrol approximately 34 patients in France [130] .

Primary biliary cirrhosis

In September 2019, Eli Lilly and Company terminated a phase II trial due to enrollment futility (NCT03742973; 17039; I4V-MC-JAIV; EudraCT2018-003365-34). The trial evaluated the safety and efficacy of baricitinib in participants with primary biliary cholangitis (PBC) who do not respond or are unable to take ursodeoxycholic acid (UDCA). The double-blind, randomised trial, initiated in March 2019, enrolled 2 patients in the US, the UK and Puerto Rico [131] .

Systemic lupus erythematosus

The US FDA in December 2018, granted a fast track designation to baricitinib, for the treatment of systemic lupus erythematosus (SLE). The designation was granted from the positive results of a phase II trial that evaluated the efficacy and safety of baricitinib [see below] [132] [133] .

In February 2017, the US FDA granted orphan drug designation to baricitinib for the treatment of paediatric systemic lupus erythematosus [134] .

Incyte Corporation and Eli Lilly and Company, in April 2019, initiated the phase III SLE-BRAVE-X trial to explore the long term safety and efficacy of baricitinib, in patients with systemic lupus erythematosus (NCT03843125; EudraCT2017-005028-11; I4V-MC-JAIM; 16832). The randomised, double-blinded trial has initiated enrolment in the US, Spain, Hungary, Czech Republic and intends to expand in Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, South Korea, Mexico, the Netherlands, Philippines, Poland, Romania, Russia, Serbia, South Africa, Switzerland, Taiwan and in the UK, to enrol a total of approximately 1100 patients. The trial includes patients who completed treatment in the phase III I4V-MC-JAHZ and I4V-MC-JAIA trials [see below] [135] .

In August 2018, Eli Lilly and Company initiated the phase III BRAVE II trial to evaluate the safety and efficacy of baricitinib in participants with systemic lupus erythematosus (SLE) (16677; I4V-MC-JAIA; NCT03616964). The double-blind, randomised trial is enrolling approximately 750 patients in the US [136] .

In August 2018, Eli Lilly and Company, in collaboration with Incyte Corporation, initiated the phase III BRAVE I trial of baricitinib, in patients with systemic lupus erythematosus (16676; I4V-MC-JAHZ; NCT03616912; EudraCT2017-005026-37). The randomised, double-blind, placebo-controlled study intends to enrol approximately 809 patients in the US, Australia, Austria, Belgium, Brazil, China, Czech Republic, Germany, Greece, Hungary, Israel, Mexico, the Netherlands, Russia, Switzerland, Taiwan and the UK [137] .

In November 2017, Eli Lilly and Company completed the randomised, double-blind, parallel, placebo-controlled, phase II JAHH trial that evaluated the efficacy and safety of baricitinib, in patients with systemic lupus erythematosus (6270; I4V-MC-JAHH; EudraCT2015-004404-35; NCT02708095). The trial was initiated in May 2016, and enrolled 314 patients in the US, Argentina, Austria, France, Japan, South Korea, Mexico, Poland, Puerto Rico, Romania, Spain, Taiwan and Japan [138] [139] . Safety and efficacy data from the trial were presented at the 19th Annual Congress of the European League Against Rheumatism (EULAR-2018) [140] . Updated safety data were released by the company in July 2018 [141] . In June 2019, the company presented efficacy data at the 20th Annual Congress of the European League Against Rheumatism (EULAR-2019) [142] . In June 2020, the company presented updated results from this trial at the 21st Annual Congress of the European League Against Rheumatism (EULAR-2020). In June 2021, updated efficacy data were presented at the 22nd Annual Congress of the European League Against Rheumatism (EULAR-2021) [143] [144] .

Uveitis

In June 2020, Eli Lilly and Company reinitiated enrollment in a phase III trial in patients with active juvenile idiopathic arthritis-associated uveitis or chronic anterior antinuclear antibody-positive uveitis (NCT04088409; EudraCT2019-000119-10; I4V-MC-JAHW; 16277). The trial was suspended for enrollment in April 2020 due to the COVID-19 pandemic. The trial was earlier initiated in October 2019 and was designed to evaluate the safety and efficacy of baricitinib.The open-label, active-controlled trial intended to enroll approximately 40 patients in Germany, France, the UK, Spain and Italy [145] .

Giant cell arteritis (GCA)

In April 2021, Mayo Clinic and Eli Lilly and Company completed a phase II trial that evaluated the efficacy, safety and tolerability of baricitinib tablet in addition to a standardised glucocorticoid taper in patients with relapsing giant-cell-arteritis (GCA) (16-008993; NCT03026504). The open-label, pilot trial was initiated in March 2017 and enrolled 15 patients in the US [146] .

Herditary autoinflammatory diseases

In October 2020, Eli Lilly and Company initiated a phase II/III trial to evaluate the efficacy and safety of baricitinib in adult and pediatric patients with nakajo-nishimura syndrome/chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature (NNS/CANDLE), STING-associated vasculopathy with onset during infancy (SAVI), and aicardi-goutières syndrome (AGS) (NCT04517253; I4V-JE-JAJE). The open-label study is design to enroll 5 patients in Japan [147] .

Compassionate use

As of September 2018, the compassionate study (expanded access) of baricitinib appears to completed and there is no information available. Earlier in November 2012, Eli Lilly and Company initiated the trial for the treatment of patients with chronic atypical neutrophilic dermatosis with lipodystrophy, juvenile dermatomyositis, stimulator of interferon genes (STING)-associated vasculopathy with onset during infancy (SAVI) and Aicardi-Goutières Syndrome (EudraCT2015-003424-31; NCT01724580). The trial was conducted in the US and the UK [148] .

Other trials

In November 2017, Eli Lilly and Company completed a phase I bioequivalence trial of baricitinib, in healthy volunteers(14934; I4V-MC-JAGU; NCT03212638). The randomised, open label trial was initiated in June 2017, and enrolled 44 volunteers in Singapore [149] .

In July 2016, Eli Lilly and Company completed a phase I trial, which assesed the pharmacokinetics, safety and tolerability of a single and multiple dose of baricitinib in healthy volunteers (14778; I4V-GH-JAGR; NCT02758613). The randomised, double-blind, parallel, placebo-controlled trial was initiated in May 2016 and enrolled 40 volunteers in China [150] . In June 2019, the company presented safety and pharmacokinetics data at the 20th Annual Congress of the European League Against Rheumatism (EULAR-2019) [151] .

Eli Lilly and Company has a number of completed, ongoing or planned drug-interaction trials in healthy volunteers, in the UK. The company completed a phase I trial in October 2013, which evaluated the effect of multiple doses of baricitinib on the pharmacokinetics of a single dose of the oral contraceptive, ethinylestradiol/levonorgestrel (Microgynon®) [see RDI profile 800012198](NCT01896726) [152] . Additionally, in October 2013, Eli Lilly and Company completed a phase I trial that investigated the effect of CYP3A induction by rifampicin on the pharmacokinetics of baricitinib in healthy volunteers (NCT01910311). The trial enrolled 18 subjects in the UK [153] . A phase I drug-interaction study that evaluated the pharmacokinetics of baricitinib when given in combination with probenecid was completed in September 2013 (NCT01937026) [154] . Another phase I trial was completed in August 2013, which assessed the effects of baricitinib on the pharmacokinetics of digoxin, and the tolerability of baricitinib when given in combination with digoxin (NCT01859078) [155] . Eli Lilly and Company has additionally completed a phase I trial to evaluate the effect of ciclosporin on the pharmacokinetics of baricitinib (NCT01968057) [156] . A phase I trial to assess the effect of omeprazole on the pharmacokinetics of baricitinib was initiated in the UK in October 2013 and was completed in November 2013 (NCT01925144) [157] . Another phase I trial to assess the effect of ketoconazole or fluconazole on baricitinib is was completed in November 2013 (NCT01924299) [158] . A completed phase I trial investigated the pharmacokinetics, safety and tolerability of multiple doses of baricitinib in combination with simvastatin versus simvastatin alone in approximately 40 healthy subjects in the United Kingdom (NCT01960140) [159] .

In February 2015, Eli Lilly and Company completed a phase I trial, initiated in January 2015, to determine the relative bioavailability of a single dose of baricitinib tablet and baricitinib intravenous infusion in healthy volunteers (NCT02340104). The trial enrolled 8 volunteers in the UK [160] .

In December 2014, Eli Lilly and Company completed a phase I trial that determined the relative bioavailability of the baricitinib commercial tablet compared to the phase II tablets and to determine the effect of food on the bioavailability of the commercial tablet in healthy volunteers (14612; I4V-MC-JAGO; NCT02263911; JapicCTI142687). The randomised, open-label trial was initiated in November 2014 and enrolled 16 volunteers in Japan [161] .

Eli Lilly and Company has completed a pharmacokinetic phase I trial of baricitinib in participants with normal hepatic function and those with hepatic dysfunction in the US (NCT01870388) [162] .

Eli Lilly and Company and InCyte completed a phase I clinical trial that evaluated the effect of baricitinib on the electrical activity of the heart, compared with placebo and moxifloxacin, following a single oral dose in healthy volunteers (NCT01536951). The trial enrolled 69 subjects in the US and was completed in May 2013 [163] .

In September 2011, Eli Lilly and Company completed a phase I trial to assess the effect of three formulations of baricitinib on relative bioavailability in healthy volunteers (NCT01398475). The randomised, crossover assignment, open-label trial enrolled 16 patients in Singapore [164] .

The disposition of radio-labelled [14C]-baricitinib in six healthy male volunteers was investigated in a phase I trial (NCT01299285) [165] .

In May 2011, Eli Lilly and Company completed a phase I trial which investigated the tolerability and pharmacokinetics of single and multiple doses of baricitinib in healthy Japanese volunteers (NCT01247350). This randomised, double-blind, placebo-controlled trial involved 34 subjects and was completed in the US [166] .

Incyte completed a single dose escalation phase I trial in healthy volunteers during the second quarter of 2008. The agent was well-tolerated and demonstrated appropriate pharmacodynamic and pharmacokinetic properties to begin a multiple dose escalation trial [167] [168] .

In October 2020, St Vincent's Institute of Medical Research in collaboration with Juvenile Diabetes Research Foundation initiated a phase II BANDIT trial to investigate the efficacy of baricitinib in new onset type 1 diabetes mellitus (SVI-BARI-01; NCT04774224). The randomised, placebo controlled trial intends to enrol approximately 83 patients in Australia [169] .

Diabetic nephropathies

Baricitinib is no longer listed on the Eli Lilly and Company's pipeline for the treatment of diabetic nephropathies and its development appears to be discontinued for this indication (Eli Lilly pipeline and Company, December 2016).

In November 2014, Eli Lilly and Company and Incyte completed a phase II trial to investigate the safety and efficacy of baricitinib in patients with diabetic nephropathies (I4V-MC-JAGQ; NCT01683409). The randomised, double-blind trial was initiated in August 2012 and enrolment of 129 patients was completed in April 2014 in the US, Mexico, Puerto Rico and Japan. In April 2015, positive proof-of-concept data was presented at the scientific sessions of the American Diabetes Association [53] [170] .

Psoriasis

Baricitinib is no longer listed on the Eli Lilly and Company's pipeline for the treatment of psoriasis and its development appears to be discontinued for this indication (Eli Lilly and Company pipeline, December 2016).

In August 2014, Eli Lilly and Company completed a phase IIb trial of baricitinib in patients with moderate to severe psoriasis (14455; I4V-MC-JADP; NCT01490632). The randomised, double-blind trial was initiated in December 2011 and enrolled 238 patients in the US, Japan, Canada and Puerto Rico [171] [42] .

Psoriatic arthritis

As of April 2019, Eli Lilly and Company announced that, the company has no plans to initiate phase III development of baricitinib for psoriatic arthritis [172] . In August 2017, Eli Lilly and Company reported that, it intends to initiate a phase III trial to evaluate safety and efficacy of baricitinib in patients with psoriatic arthritis (I4V-MC-JAHA; EudraCT2016-004675-52) in 2018. The randomised, double-blind trial intends to enrol approximately 622 patients in Spain, Germany and Hungary [22] [173] [25] [174] .

Labeling information

Baricitinib carries a boxed warning for the risk of serious infections, malignancies and thrombosis [14] .

Patent Information

In February 2015, Incyte announced that it holds certain patents and has pending patent applications in the US, the EU and Japan for baricitinib. The granted patents and the pending applications, if issued, will expire in 2029 (Incyte 10-K, February 2015).

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation Capsule, Suspension, Tablet, unspecified
  • Class Acetonitriles, Anti-inflammatories, Antipsoriatics, Antirheumatics, Azetidines, Eye disorder therapies, Pyrazoles, Pyrimidines, Pyrroles, Skin disorder therapies, Small molecules
  • Target Janus kinase 1; Janus kinase-2; TYK2 kinase
  • Mechanism of Action Janus kinase 1 inhibitors; Janus kinase-2 inhibitors; TYK2 kinase inhibitors
  • WHO ATC code

    L04A-A37 (Baricitinib)

  • EPhMRA code

    L4 (Immunosuppressants)

  • Chemical name 2-[1-ethylsulfonyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)pyrazol-1-yl]azetidin-3-yl]acetonitrile
  • Molecular formula C16 H17 N7 O2 S
  • SMILES C(CC1(CN(C1)S(=O)(=O)CC)N1N=CC(=C1)C1=C2C(=NC=N1)NC=C2)#N
  • Chemical Structure
  • CAS Registry Number 1187594-09-7

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

aicardi-Goutieres syndrome

Brief Title

transmembrane protein 173

salvador family WW domain containing protein 1

1

1

aicardi-Goutieres syndrome

Official Title

transmembrane protein 173

salvador family WW domain containing protein 1

1

1

autoimmune disorders

Eligibility Criteria

C-reactive protein (CRP)

1

autoimmune disorders

Official Title

transmembrane protein 173

salvador family WW domain containing protein 1

Janus kinase 1 (JAK1)

1

1

1

cOVID 2019 infections

Outcome Measure

Vascular endothelial growth factor A (VEGF)

Tumor necrosis factor alpha (TNF-alpha)

Interleukin-8 (IL-8)

Interleukin-6 (IL-6)

Interleukin-21 (IL-21)

Interleukin-2 (IL-2)

Interleukin-17 (IL-17)

Interleukin-10 (IL-10)

interleukin 11

Interleukin 1 Beta (IL-1β)

Interleukin 1 alpha (IL-1α)

Interferon Gamma (IFNg)

IL31

Ferritin

D-dimer

C-reactive protein (CRP)

1

3

1

3

1

1

1

1

1

1

1

1

1

1

2

4

cOVID 2019 infections

Arm Group Description

Interleukin-6 (IL-6)

Ferritin

D-dimer

1

1

1

cOVID 2019 infections

Detailed Description

Tumor necrosis factor alpha (TNF-alpha)

Interleukin-6 (IL-6)

Fibrinogen

Ferritin

D-dimer

C-reactive protein (CRP)

1

2

1

1

1

2

cOVID 2019 infections

Eligibility Criteria

Lactate dehydrogenase (LDH)

Interleukin-6 (IL-6)

Ferritin

D-dimer

C-reactive protein (CRP)

1

1

3

2

3

cOVID 2019 infections

Official Title

Janus kinase 1 (JAK1)

1

COVID-19 pneumonia

Detailed Description

Interleukin-6 (IL-6)

Fibrinogen

Ferritin

D-dimer

Creatinine

C-reactive protein (CRP)

Bilirubin

2

2

2

2

1

2

1

COVID-19 pneumonia

Outcome Measure

Ferritin

D-dimer

C-reactive protein (CRP)

2

2

2

COVID-19 respiratory infection

Outcome Measure

Ferritin

D-dimer

C-reactive protein (CRP)

1

1

1

cystic fibrosis

Official Title

cytochrome P450 family 2 subfamily B member 6

1

dermatomyositis

Brief Summary

Janus kinase 1 (JAK1)

Interferon Gamma (IFNg)

Interferon alpha (IFN-alpha)

1

1

1

dermatomyositis

Detailed Description

Janus kinase 1 (JAK1)

Interferon Gamma (IFNg)

Interferon alpha (IFN-alpha)

1

1

1

dermatomyositis

Eligibility Criteria

solute carrier family 22 member 8

C-reactive protein (CRP)

1

1

dermatomyositis

Official Title

transmembrane protein 173

salvador family WW domain containing protein 1

Janus kinase 1 (JAK1)

1

1

1

diabetic cardiomyopathy

Official Title

cytochrome P450 family 2 subfamily B member 6

1

diabetic nephropathies

Arm Group Description

Estradiol-17beta 3-sulfate

1

diabetic nephropathies

Eligibility Criteria

peptidylprolyl isomerase G

Gonadotropin releasing hormone

FSH

Estradiol-17beta 3-sulfate

cytochrome P450 family 2 subfamily B member 6

1

1

2

1

1

diabetic nephropathies

Official Title

solute carrier family 22 member 8

cytochrome P450 family 2 subfamily B member 6

1

1

diabetic nephropathies

Outcome Measure

Monocyte chemoattractant protein-1 (MCP-1/CCL2)

Creatinine

1

1

diabetic neuropathies

Eligibility Criteria

FSH

1

diabetic neuropathies

Official Title

CYP3A4

1

encephalopathy

Brief Summary

jagged 1

1

encephalopathy

Eligibility Criteria

Thyroxine (T4)

Tetrahydrobiopterin

T-cell surface antigen CD4

T-cell receptor T3 delta chain (CD3d)

T-cell receptor CD3-epsilon (CD3e)

Neopterin

jagged 1

CD3 gamma chain (CD3G)

1

1

1

1

1

1

1

1

encephalopathy

Outcome Measure

Interferon Gamma (IFNg)

Interferon alpha (IFN-alpha)

1

1

giant cell arteritis

Eligibility Criteria

grancalcin

Estrogen receptor alpha (ER alpha)

C-reactive protein (CRP)

1

1

1

gout

Eligibility Criteria

peptidylprolyl isomerase G

cytochrome P450 family 2 subfamily B member 6

1

1

gout

Official Title

solute carrier family 22 member 8

1

graft-versus-host disease

Brief Title

Janus kinase 1 (JAK1)

1

graft-versus-host disease

Detailed Description

L-Aspartic acid

ALT

1

1

graft-versus-host disease

Official Title

Janus kinase 1 (JAK1)

1

hereditary autoinflammatory diseases

Brief Title

transmembrane protein 173

salvador family WW domain containing protein 1

1

1

hereditary autoinflammatory diseases

Official Title

transmembrane protein 173

salvador family WW domain containing protein 1

1

1

hypercholesterolaemia

Official Title

cytochrome P450 family 2 subfamily B member 6

1

inflammation

Eligibility Criteria

FSH

1

juvenile rheumatoid arthritis

Eligibility Criteria

Rheumatoid factor

1

leukoencephalopathies

Brief Summary

jagged 1

1

leukoencephalopathies

Eligibility Criteria

Thyroxine (T4)

Tetrahydrobiopterin

T-cell surface antigen CD4

T-cell receptor T3 delta chain (CD3d)

T-cell receptor CD3-epsilon (CD3e)

Neopterin

jagged 1

CD3 gamma chain (CD3G)

1

1

1

1

1

1

1

1

leukoencephalopathies

Outcome Measure

Interferon Gamma (IFNg)

Interferon alpha (IFN-alpha)

1

1

low HDL cholesterol

Official Title

cytochrome P450 family 2 subfamily B member 6

1

myositis

Brief Title

Janus kinase 1 (JAK1)

1

myositis

Eligibility Criteria

WNT1 inducible signaling pathway protein 3

visual system homeobox 1

urocortin 2

SUMO1 activating enzyme subunit 1

RNA binding region (RNP1, RRM) containing 3

MORC family CW-type zinc finger 3

interferon induced with helicase C domain 1

B-lymphocyte antigen CD19

argonaute 2, RISC catalytic component

4-hydroxyphenylpyruvate dioxygenase

3-hydroxy-3-methylglutaryl-CoA reductase

1

1

1

1

1

1

1

1

1

1

1

myositis

Official Title

Janus kinase 1 (JAK1)

1

neurological disorders

Brief Summary

jagged 1

1

neurological disorders

Eligibility Criteria

Thyroxine (T4)

Tetrahydrobiopterin

T-cell surface antigen CD4

T-cell receptor T3 delta chain (CD3d)

T-cell receptor CD3-epsilon (CD3e)

Neopterin

jagged 1

CD3 gamma chain (CD3G)

1

1

1

1

1

1

1

1

neurological disorders

Outcome Measure

Interferon Gamma (IFNg)

Interferon alpha (IFN-alpha)

1

1

plaque psoriasis

Outcome Measure

Poly-g-D-glutamate

Folic acid

1

1

pneumonia

Eligibility Criteria

Ferritin

C-reactive protein (CRP)

1

1

pneumonia

Official Title

Janus kinase 1 (JAK1)

1

pneumonia

Outcome Measure

Vascular endothelial growth factor A (VEGF)

Tumor necrosis factor alpha (TNF-alpha)

Interleukin-8 (IL-8)

Interleukin-6 (IL-6)

Interleukin-21 (IL-21)

Interleukin-2 (IL-2)

Interleukin-17 (IL-17)

Interleukin-10 (IL-10)

interleukin 11

Interleukin 1 Beta (IL-1β)

Interleukin 1 alpha (IL-1α)

Interferon Gamma (IFNg)

IL31

1

1

1

1

1

1

1

1

1

1

1

1

1

polymyalgia rheumatica

Brief Summary

group-specific component (vitamin D binding protein)

1

polymyalgia rheumatica

Outcome Measure

C-reactive protein (CRP)

1

pregnancy

Arm Group Description

Estradiol-17beta 3-sulfate

1

pregnancy

Eligibility Criteria

Gonadotropin releasing hormone

Estradiol-17beta 3-sulfate

1

1

psoriasis

Arm Group Description

Estradiol-17beta 3-sulfate

1

psoriasis

Eligibility Criteria

peptidylprolyl isomerase G

Gonadotropin releasing hormone

FSH

Estradiol-17beta 3-sulfate

cytochrome P450 family 2 subfamily B member 6

1

1

3

1

1

psoriasis

Official Title

solute carrier family 22 member 8

cytochrome P450 family 2 subfamily B member 6

CYP3A4

1

1

1

respiratory tract infections

Outcome Measure

Tumor necrosis factor alpha (TNF-alpha)

Interleukin-6 (IL-6)

C-reactive protein (CRP)

1

1

1

rheumatoid arthritis

Arm Group Label

Tumor necrosis factor alpha (TNF-alpha)

2

rheumatoid arthritis

Outcome Measure

Z-DNA binding protein 1

Survivin

Poly-g-D-glutamate

Folic acid

Estrogen receptor alpha (ER alpha)

C-reactive protein (CRP)

acrosin

1

1

1

1

5

12

4

rheumatoid arthritis

Brief Title

Survivin

1

rheumatoid arthritis

Arm Group Description

Tumor necrosis factor alpha (TNF-alpha)

Estradiol-17beta 3-sulfate

1

1

rheumatoid arthritis

Detailed Description

Survivin

1

rheumatoid arthritis

Eligibility Criteria

Tumor necrosis factor alpha (TNF-alpha)

Rheumatoid factor

peptidylprolyl isomerase G

metaxin 1

Interleukin-6 (IL-6)

Interleukin 1 Beta (IL-1β)

Interleukin 1 alpha (IL-1α)

Gonadotropin releasing hormone

FSH

Estrogen receptor alpha (ER alpha)

Estradiol-17beta 3-sulfate

cytochrome P450 family 2 subfamily B member 6

crystallin, gamma D

CCP antibodies

C-reactive protein (CRP)

acrosin

1

2

1

3

1

1

1

1

4

1

1

1

1

1

8

1

rheumatoid arthritis

Official Title

Survivin

solute carrier family 22 member 8

cytochrome P450 family 2 subfamily B member 6

CYP3A4

1

1

1

1

rheumatoid arthritis

Brief Summary

Survivin

1

SARS-CoV-2 acute respiratory disease

Detailed Description

Interleukin-6 (IL-6)

Fibrinogen

Ferritin

D-dimer

Creatinine

C-reactive protein (CRP)

Bilirubin

1

1

1

1

1

1

1

SARS-CoV-2 acute respiratory disease

Outcome Measure

Ferritin

D-dimer

C-reactive protein (CRP)

1

3

3

Sjogren's syndrome

Brief Summary

C-reactive protein (CRP)

acrosin

1

1

Sjogren's syndrome

Eligibility Criteria

WNT1 inducible signaling pathway protein 3

visual system homeobox 1

Thyroxine (T4)

Thyroid stimulating hormone beta (TSH)

Rheumatoid factor

C-reactive protein (CRP)

BTNL2

argonaute 2, RISC catalytic component

acrosin

4-hydroxyphenylpyruvate dioxygenase

1

1

1

1

1

2

1

1

1

1

Sjogren's syndrome

Outcome Measure

Rheumatoid factor

LDL receptor related protein 8

C-reactive protein (CRP)

1

1

1

skin disorders

Eligibility Criteria

C-reactive protein (CRP)

1

skin disorders

Official Title

transmembrane protein 173

salvador family WW domain containing protein 1

Janus kinase 1 (JAK1)

1

1

1

systemic lupus erythematosus

Outcome Measure

sorcin

dsDNA Auto-antibodies

4

1

type 1 diabetes mellitus

Arm Group Description

Tyrosine kinase JAK2

Stearic acid

Janus kinase 1 (JAK1)

1

1

1

type 1 diabetes mellitus

Brief Summary

C-peptide

1

type 1 diabetes mellitus

Eligibility Criteria

Insulin Auto-antibodies

Insulin

Imidazoleacetic acid

C-peptide

1

1

1

1

type 1 diabetes mellitus

Outcome Measure

Insulin

C-peptide

1

1

vitiligo

Outcome Measure

Tumor necrosis factor alpha (TNF-alpha)

SDF-1 alpha (CXCL12)

PF4

Interleukin-5 (IL-5)

Interleukin-4 (IL-4)

Interleukin-23 (IL-23)

Interleukin-22 (IL-22)

Interleukin-17 (IL-17)

Interleukin-15 (IL-15)

Interleukin-13 (IL-13)

Interleukin-12B (IL-12p40)

Interleukin-12A (IL-12p35)

interleukin 37

interleukin 33

Interferon Gamma (IFNg)

IFN-alpha 2

Heat shock protein 70 (HSP70)

CXCL9

CXCL16

Chemokine IFN-γ-inducible protein 10 (IP-10/CXCL10)

C-X-C motif chemokine ligand 11

C-C motif chemokine ligand 20

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

Biomarker

Drug Name Biomarker Name Biomarker Function
Baricitinib - Eli Lilly and Company/Incyte Corporation 3-hydroxy-3-methylglutaryl-CoA reductase Eligibility Criteria
4-hydroxyphenylpyruvate dioxygenase Eligibility Criteria
acrosin Brief Summary, Eligibility Criteria, Outcome Measure
ALT Detailed Description
argonaute 2, RISC catalytic component Eligibility Criteria
B-lymphocyte antigen CD19 Eligibility Criteria
Bilirubin Detailed Description
BTNL2 Eligibility Criteria
C-C motif chemokine ligand 20 Outcome Measure
C-peptide Brief Summary, Eligibility Criteria, Outcome Measure
C-reactive protein (CRP) Arm Group Description, Brief Summary, Detailed Description, Eligibility Criteria, Outcome Measure
C-X-C motif chemokine ligand 11 Outcome Measure
Cardiac Troponin I Eligibility Criteria
Cardiac Troponin T Outcome Measure
CCP antibodies Eligibility Criteria
CD3 gamma chain (CD3G) Eligibility Criteria
Chemokine IFN-γ-inducible protein 10 (IP-10/CXCL10) Outcome Measure
Creatinine Detailed Description, Outcome Measure
crystallin, gamma D Eligibility Criteria
CXCL16 Outcome Measure
CXCL9 Outcome Measure
CYP3A4 Official Title
cytochrome P450 family 2 subfamily B member 6 Eligibility Criteria, Official Title
D-dimer Arm Group Description, Detailed Description, Eligibility Criteria, Outcome Measure
dsDNA Auto-antibodies Outcome Measure
Estradiol-17beta 3-sulfate Arm Group Description, Eligibility Criteria
Estrogen receptor alpha (ER alpha) Eligibility Criteria, Outcome Measure
Ferritin Arm Group Description, Detailed Description, Eligibility Criteria, Outcome Measure
Fibrinogen Detailed Description, Eligibility Criteria
Folic acid Outcome Measure
FSH Eligibility Criteria
Gonadotropin releasing hormone Eligibility Criteria
grancalcin Eligibility Criteria
group-specific component (vitamin D binding protein) Brief Summary
Heat shock protein 70 (HSP70) Outcome Measure, Outcome Measure
Heat shock protein 70 (HSP70) Outcome Measure, Outcome Measure
IFN-alpha 2 Outcome Measure
IL31 Outcome Measure
Imidazoleacetic acid Eligibility Criteria
Insulin Eligibility Criteria, Outcome Measure
Insulin Auto-antibodies Eligibility Criteria
Interferon alpha (IFN-alpha) Brief Summary, Detailed Description, Outcome Measure
Interferon Gamma (IFNg) Brief Summary, Detailed Description, Outcome Measure
interferon induced with helicase C domain 1 Eligibility Criteria
Interleukin 1 alpha (IL-1α) Eligibility Criteria, Outcome Measure
Interleukin 1 Beta (IL-1β) Eligibility Criteria, Outcome Measure
interleukin 11 Outcome Measure
interleukin 33 Outcome Measure
interleukin 37 Outcome Measure
Interleukin-10 (IL-10) Outcome Measure
Interleukin-12A (IL-12p35) Outcome Measure
Interleukin-12B (IL-12p40) Outcome Measure
Interleukin-13 (IL-13) Outcome Measure
Interleukin-15 (IL-15) Outcome Measure
Interleukin-17 (IL-17) Outcome Measure
Interleukin-2 (IL-2) Outcome Measure
Interleukin-21 (IL-21) Outcome Measure
Interleukin-22 (IL-22) Outcome Measure
Interleukin-23 (IL-23) Outcome Measure
Interleukin-4 (IL-4) Outcome Measure
Interleukin-5 (IL-5) Outcome Measure
Interleukin-6 (IL-6) Arm Group Description, Detailed Description, Eligibility Criteria, Outcome Measure
Interleukin-8 (IL-8) Outcome Measure
jagged 1 Brief Summary, Eligibility Criteria
Janus kinase 1 (JAK1) Arm Group Description, Brief Summary, Brief Title, Detailed Description, Official Title
L-Aspartic acid Detailed Description
Lactate dehydrogenase (LDH) Eligibility Criteria
LDL receptor related protein 8 Outcome Measure
metaxin 1 Eligibility Criteria
Monocyte chemoattractant protein-1 (MCP-1/CCL2) Outcome Measure
MORC family CW-type zinc finger 3 Eligibility Criteria
Neopterin Eligibility Criteria
peptidylprolyl isomerase G Eligibility Criteria
PF4 Outcome Measure
Poly-g-D-glutamate Outcome Measure
Rheumatoid factor Eligibility Criteria, Outcome Measure
RNA binding region (RNP1, RRM) containing 3 Eligibility Criteria
salvador family WW domain containing protein 1 Brief Title, Official Title
SDF-1 alpha (CXCL12) Outcome Measure
solute carrier family 22 member 8 Eligibility Criteria, Official Title
sorcin Outcome Measure
Stearic acid Arm Group Description
SUMO1 activating enzyme subunit 1 Eligibility Criteria
Survivin Brief Summary, Brief Title, Detailed Description, Official Title, Outcome Measure
T-cell receptor CD3-epsilon (CD3e) Eligibility Criteria
T-cell receptor T3 delta chain (CD3d) Eligibility Criteria
T-cell surface antigen CD4 Eligibility Criteria
Tetrahydrobiopterin Eligibility Criteria
Thyroid stimulating hormone beta (TSH) Eligibility Criteria
Thyroxine (T4) Eligibility Criteria
transmembrane protein 173 Brief Title, Official Title
Tumor necrosis factor alpha (TNF-alpha) Arm Group Description, Arm Group Label, Detailed Description, Eligibility Criteria, Outcome Measure
Tyrosine kinase JAK2 Arm Group Description
urocortin 2 Eligibility Criteria
Vascular endothelial growth factor A (VEGF) Outcome Measure
visual system homeobox 1 Eligibility Criteria
WNT1 inducible signaling pathway protein 3 Eligibility Criteria
Z-DNA binding protein 1 Outcome Measure
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Aicardi-Goutieres syndrome - In adolescents, In adults, In children, In infants, In the elderly Phase II/III Japan PO / Tablet Eli Lilly and Company 27 Oct 2020
Aicardi-Goutieres syndrome - In adolescents, In adults, In children, In infants, In the elderly Phase II/III Japan PO / Suspension Eli Lilly and Company 27 Oct 2020
Alopecia areata - - Preregistration Japan PO / Tablet Eli Lilly and Company, Incyte Corporation 30 Jul 2021
Alopecia areata - - Preregistration European Union PO / Tablet Eli Lilly and Company 11 Oct 2021
Alopecia areata - - Phase III Puerto Rico, Taiwan, USA PO / Tablet Eli Lilly and Company, Incyte Corporation 08 Jul 2019
Alopecia areata - - Phase III Argentina, Australia, Brazil, China, Israel, South Korea PO / Tablet Eli Lilly and Company 08 Jul 2019
Alopecia areata - - Phase II/III Mexico PO / Tablet Eli Lilly and Company 24 Sep 2018
Atopic dermatitis moderate to severe atopic dermatitis Combination therapy, Treatment-experienced Marketed Austria, Belgium, Finland, Germany, Greece, Hungary, Ireland, Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom PO / unspecified Eli Lilly and Company, Incyte Corporation 16 Dec 2020
Atopic dermatitis moderate to severe atopic dermatitis Treatment-experienced Marketed Japan PO / Tablet Eli Lilly and Company, Incyte Corporation 26 Dec 2020
Atopic dermatitis moderate to severe atopic dermatitis Combination therapy, Treatment-experienced Registered European Union, Iceland, Liechtenstein PO / unspecified Eli Lilly and Company, Incyte Corporation 27 Oct 2020
Atopic dermatitis - Treatment-experienced Preregistration USA PO / unspecified Eli Lilly and Company, Incyte Corporation 06 Apr 2021
Atopic dermatitis moderate to severe atopic dermatitis Combination therapy, Treatment-experienced Phase III Argentina, Australia, Brazil, South Korea, Taiwan PO / unspecified Eli Lilly and Company, Incyte Corporation 16 Nov 2018
Atopic dermatitis - In adolescents, In children Phase III Albania, Argentina, Germany, Poland, Spain, United Kingdom PO / Tablet Eli Lilly and Company 01 Jan 2019
Atopic dermatitis - - Phase III Japan PO / Tablet Eli Lilly and Company 26 Nov 2017
Atopic dermatitis - Treatment-experienced Phase III Canada, Czech Republic, Denmark, France, Germany, India, Italy, Mexico, Russia, Taiwan PO / Tablet Eli Lilly and Company, Incyte Corporation 20 Feb 2018
Atopic dermatitis - Treatment-experienced Phase III Canada, Puerto Rico PO / unspecified Eli Lilly and Company, Incyte Corporation 20 Feb 2018
Atopic dermatitis - - Phase III Argentina, Australia, Austria, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Mexico, Poland, Russia, South Korea, Spain, Swaziland, Switzerland, Taiwan PO / Tablet Eli Lilly and Company, Incyte Corporation 16 Mar 2018
COVID 2019 infections emergency use authorisation in patients 2 years and older Combination therapy, In adolescents, In adults, In children Registered USA PO / Tablet Eli Lilly and Company, Incyte Corporation 19 Nov 2020
COVID 2019 infections in combination with remdesivir, approved under EUA Combination therapy Registered India PO / unspecified Eli Lilly and Company 04 May 2021
COVID 2019 infections pneumonia associated with COVID-2019 in hospitalised patients - Registered Japan PO / Tablet Eli Lilly and Company 23 Apr 2021
COVID 2019 infections Emergency Use approval - Registered India PO / Tablet Natco Pharma 03 May 2021
COVID 2019 infections emergency use authorisation in patients 2 years and older In adolescents, In adults, In children, In the elderly, Monotherapy Registered USA PO / Tablet Eli Lilly and Company, Incyte Corporation 02 Aug 2021
COVID 2019 infections treatment of COVID-19 in hospitalised patients from 10 years of age who require supplemental oxygen In adolescents, In adults, In children Preregistration European Union PO / Tablet Eli Lilly and Company 29 Apr 2021
COVID 2019 infections - Combination therapy Phase III Denmark, Japan, Mexico, Singapore, South Korea, Spain, United Kingdom PO / Tablet Eli Lilly and Company, Incyte Corporation 08 May 2020
COVID 2019 infections - In adolescents, In adults, In children, In infants Phase III Belgium PO / Suspension Eli Lilly and Company 27 Sep 2021
COVID 2019 infections - - Phase III Argentina, Brazil, Mexico, Puerto Rico, Russia, South Korea, USA, United Kingdom PO / Tablet Eli Lilly and Company 15 Jun 2020
Diabetic nephropathies - - Discontinued (II) Japan, Mexico, Puerto Rico, USA PO / Tablet Eli Lilly, Incyte Corporation 22 Dec 2016
Giant cell arteritis - Adjunctive treatment Phase II USA PO / Tablet Eli Lilly and Company 09 Mar 2017
Hereditary autoinflammatory diseases - In adolescents, In adults, In children, In infants, In the elderly Phase II/III Japan PO / Suspension Eli Lilly and Company 27 Oct 2020
Hereditary autoinflammatory diseases - In adolescents, In adults, In children, In infants, In the elderly Phase II/III Japan PO / Tablet Eli Lilly and Company 27 Oct 2020
Juvenile rheumatoid arthritis - In adolescents, In children, In infants Phase III Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, France, Germany, India, Israel, Italy, Japan, Mexico, Poland, Russia, Spain, Turkey, United Kingdom PO / unspecified Eli Lilly and Company 12 Feb 2020
Juvenile rheumatoid arthritis - In adolescents, In children, Treatment-experienced Phase III Japan PO / unspecified Eli Lilly and Company 17 Dec 2018
Myositis Idiopathic inflammatory myopathy - Phase II United Kingdom PO / unspecified Eli Lilly and Company 10 Mar 2020
Polymyalgia rheumatica - - Phase II France PO / Tablet Eli Lilly and Company 01 Dec 2020
Primary biliary cirrhosis - - Phase II Puerto Rico, USA, United Kingdom PO / Tablet Eli Lilly and Company 28 Mar 2019
Psoriasis - - Discontinued (II) Canada, Japan, Puerto Rico, USA PO / Capsule Eli Lilly and Company 22 Dec 2016
Psoriatic arthritis phase III trial planned - Discontinued (Clinical) USA PO / Tablet Eli Lilly and Company, Incyte Corporation 30 Apr 2019
Rheumatoid arthritis combination with cDMARDs, including methotrexate Combination therapy, Treatment-experienced Marketed Australia PO / Tablet Eli Lilly and Company 16 Dec 2020
Rheumatoid arthritis - Monotherapy, Treatment-experienced Marketed Australia PO / Tablet Eli Lilly and Company 16 Dec 2020
Rheumatoid arthritis - Treatment-experienced, Treatment-naive Marketed Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Netherlands, Norway, Poland, Portugal, Spain, Sweden, USA, United Kingdom PO / Tablet Eli Lilly and Company 16 Dec 2020
Rheumatoid arthritis - Treatment-experienced Marketed India, Japan, Switzerland PO / Tablet Eli Lilly and Company 16 Dec 2020
Rheumatoid arthritis - - Registered Kuwait PO / Tablet Eli Lilly and Company 01 Jun 2017
Rheumatoid arthritis - Treatment-experienced, Treatment-naive Registered European Union, Iceland, Liechtenstein PO / Tablet Eli Lilly and Company 13 Feb 2017
Rheumatoid arthritis - Treatment-naive Preregistration Japan PO / Tablet Eli Lilly and Company, Incyte Corporation 31 Mar 2016
Rheumatoid arthritis - Treatment-experienced Phase III Japan PO / Capsule Eli Lilly and Company 31 Jan 2013
Rheumatoid arthritis Patients with limited or no prior treatment with methotrexate Treatment-naive Phase III Argentina, Brazil, Canada, India, Mexico, Puerto Rico, Russia, South Africa, South Korea PO / Tablet Eli Lilly and Company 31 Dec 2014
Rheumatoid arthritis - Treatment-experienced Phase III Argentina, Brazil, Canada, China, Israel, Mexico, Puerto Rico, Russia, South Africa, South Korea, Taiwan, Turkey PO / Tablet Eli Lilly and Company 01 Oct 2014
Rheumatoid arthritis - - No development reported (II) Ukraine PO / Capsule Eli Lilly and Company, Incyte Corporation 09 Oct 2015
Rheumatoid arthritis - Treatment-experienced Discontinued (II) Czech Republic, USA PO / Capsule Incyte Corporation 01 Jul 2013
Rheumatoid arthritis - In volunteers Discontinued (I) Singapore PO / Tablet Eli Lilly and Company 21 Dec 2016
Rheumatoid arthritis - In volunteers Discontinued (I) Singapore PO / Capsule Eli Lilly 21 Dec 2016
Systemic lupus erythematosus - In adults, In the elderly, Treatment-experienced Phase III Australia, Austria, Belgium, Brazil, China, Czech Republic, Germany, Greece, Hungary, Israel, Mexico, Netherlands, Russia, Spain, Swaziland, Taiwan, USA (fast track), United Kingdom PO / Tablet Eli Lilly and Company, Incyte Corporation 08 Apr 2019
Systemic lupus erythematosus - - Phase II Argentina, Austria, France, Japan, Mexico, Poland, Puerto Rico, Romania, South Korea, Taiwan PO / Tablet Eli Lilly and Company 23 May 2016
Uveitis - In adolescents, In children, In infants, Treatment-experienced Phase III France, Germany, Italy, Spain, United Kingdom PO / unspecified Eli Lilly and Company 16 Oct 2019

Priority Development Status

Type Region Indication
Fast Track USA Systemic lupus erythematosus
BTT USA Alopecia areata

Orphan Status

Indication Patient Segment Country Organisation Event Date
Systemic lupus erythematosus In children USA Eli Lilly and Company 11 Feb 2017

Commercial Information

Involved Organisations

Organisation Involvement Countries
Incyte Corporation Originator USA
Incyte Corporation Owner USA
Sun Pharmaceutical Industries Market Licensee India
Cipla Market Licensee India
Dr Reddys Laboratories Market Licensee India
Lupin Market Licensee India
Natco Pharma Market Licensee India
Natco Pharma Licensee India
Eli Lilly and Company Licensee World
BenevolentAI Collaborator United-Kingdom
National Institute of Allergy and Infectious Diseases Collaborator USA

Brand Names

Brand Name Organisations Indications Countries
Olumiant Eli Lilly and Company Rheumatoid arthritis, Atopic dermatitis European Union, Japan

Credit Suisse Market Status

Indication Region Company Phase Expected Launch Year Probability of Success% Patent Expiry Year Expected Generic Entry Last Update
Rheumatoid Arthritis ex US Eli Lilly, Inc., Incyte Genomics Marketed 2017 100 2029 01 Jun 2029 01 Feb 2021
Rheumatoid Arthritis US Eli Lilly, Inc., Incyte Genomics Marketed 2018 100 2030 06 Aug 2030 01 Feb 2021

Credit Suisse Financial Forecast

Indication Region 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 Last Update
Rheumatoid Arthritis ex US 0 46 196 385 463 578 688 790 880 960 01 Feb 2021
Rheumatoid Arthritis US 0 0 7 42 70 105 140 169 197 226 01 Feb 2021
Total 0 46 203 427 533 683 828 959 1077 1186

Scientific Summary

  • Adverse Events Occasional: Diarrhoea; Headache; Nasopharyngitis; Respiratory tract infections; Tuberculosis

Pharmacokinetics

After administration of baricitinib to rodents, a free drug fraction of approximately 50%, oral bioavailability of 53% and an elimination half-life of approximately 5 hours were noted [181] .

In a phase I trial, baricitinib administration in healthy volunteers, rapidly declined the plasma concentrations following attainment of peak concentrations, with a mean terminal half-life of 5.7 to 7.3 hours. Steady state plasma concentrations was achieved after the second day of QD dosing, with minimal accumulation of baricitinib in plasma (up to 10%) during 7 days of QD oral doses of 2 to 10mg baricitinib. Single-and multiple dose mean values for AUC (0-∞) and C max resulted in increase in an approximately dose-proportional manner across the dose range [151] [150] .

Adverse Events

Phase III

In the phase III BREEZE-AD1 and BREEZE-AD2 trial, at week 16, the treatment-emergent adverse events and serious adverse events were similar to that of placebo, in patients with moderate to severe atopic dermatitis who received baricitinib. Nasopharyngitis and headache were observed to be the most common treatment-emergent adverse events. No venous thromboembolic events (VTEs), major adverse cardiovascular events (MACE), or deaths were reported [88] [89] [90] .

Compared with methotrexate, baricitinib monotherapy was associated with lower rates of liver abnormalities, lymphopaenia and adverse events leading to interruption. Interim results from the phase III RA-BEGIN trial demonstrated that the incidence of treatment-emergent adverse events and serious adverse events was similar across all treatment groups. No reports of cases of tuberculosis or gastrointestinal perforation cases were found during the study and the most common adverse events observed were consistent with previous studies of baricitinib in RA. Patients receiving the combination of baricitinib plus methotrexate demonstrated more discontinuations due to adverse events. The randomised, double-blind, placebo-controlled trial enrolled 581 patients who received 4mg baricitinib, administered orally, once daily for 52 weeks, with rescue with methotrexate (4mg) for non-responders at week 24 [46] [47] .

In the phase III RA-BALANCE trial, during weeks 0-24, treatment emergent adverse events and infections were seen in 74.5% and 42.1% of baricitinib patients and 62.1% and 28.3% of placebo patients, respectively. Across the groups, serious adverse events were reported in 2.8% of patients. One non serious oesophageal candidiasis case was observed in the baricitinib group for week 0-24. Three and one herpes zoster events were reported for week 0-24, in the drug and placebo-treated groups, respectively. Major cardiovascular events, deaths, tuberculosis, venous thromboembolic events or malignancies were not reported in the study through week 52 for the drug and through week 24 for placebo group. Unexpected safety signals were not observed [32] [33] .

Baricitinib was generally well tolerated during the RA-BEYOND phase III trial. The incidence of treatment-emergent adverse events, serious adverse events and discontinuation or interruption in treatment were similar between baricitinib and placebo. The long-term extension trial enrolled 2600 patients with rheumatoid arthritis [34] .

Baricitinib 4mg, administered orally, once daily for 24 weeks in patients with moderate to severe rheumatoid arthritis who had an inadequate response to at least one disease-modifying antirheumatic drug (cDMARD) exhibited incidence of treatment-emergent and serious adverse events including serious infections that were similar to placebo, in phase III RA-BUILD study. No opportunistic or gastrointestinal perforations were observed in the study. A patient was reported with tuberculosis after receiving baricitinib. Discontinuation rates due to adverse events were found to be similar between the treatment groups [54] .

Treatment with baricitinib in a phase III RA-BEACON trial was observed to be safe and well tolerated in patients with rheumatoid arthritis (RA) up to 8.4 years. The rate of treatment-emergent adverse events was higher for baricitinib 4mg (77%) and baricitinib 2mg (71%) than for placebo (64%). The incidence of serious adverse events were 10% in 4mg arm, 4% in 2mg arm of baricitinib and 7% for placebo. One death was reported due to stroke in the baricitinib 4mg arm. There were no cases of opportunistic infections, tuberculosis or gastrointestinal perforations. The most commonly reported adverse events in patients on baricitinib were headache, upper respiratory tract infection and nasopharyngitis. The trial enrolled 527 patients with moderate to severe RA who had an inadequate response to a TNF inhibitor, despite ongoing treatment with conventional DMARDs. Baricitinib was dosed at 2mg or 4mg daily for 6 months [31] [178] [179] [56] [55] .

In the RA-BEAM phase III trial, a once-daily, oral baricitinib (4mg) demonstrated similar serious adverse events (SAEs) compared with placebo, and lower SAEs in adalimumab treatment arm (40 mg/biweekly). Serious infection rates were found to be similar across all groups. No gastrointestinal perforations were reported. One event of tuberculosis was reported in each of the baricitinib and adalimumab arms. Five deaths were reported; one in the placebo arm, two in the baricitinib arm, one in the adalimumab arm and one placebo rescued to baricitinib. The rates of treatment emergent adverse events (TEAEs) including, infections were higher for baricitinib and adalimumab arms compared with placebo. Two potential opportunistic infections were reported in the baricitinib arm; neither was reported serious. The most common adverse events reported in baricitinib treatment arm were nasopharyngitis and bronchitis with no cases of gastrointestinal perforations reported. Rates of discontinuations due to AEs were similar across all arms. Specifically, through week 24, 3%, 5% and 2% of patients stopped the therapy due to adverse events in placebo, baricitinib and adalimumab groups, respectively. Serious adverse event rates through 24 weeks were similar with placebo and baricitinib (5% each) and lower with adalimumab (2%). Through week 52, 7% and 4% patients stopping therapy due to AEs for baricitinib and adalimumab groups, respectively. Serious adverse event rates were 8% for baricitinib and 4% for adalimumab. Major adverse cardiovascular events were reported in < 1% of patients in both the baricitinib and adalimumab groups (baseline through 52 weeks). The study evaluated baricitinib, adalimumab or placebo in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to methotrexate [37] [38] [39] [40] [43] .

Results from the phase III BREEZE-AD3 trial in moderate to severe atopic dermatitis (AD) demonstrated a safety profile consistent with the known safety findings of baricitinib in previous 16-week, placebo-controlled AD studies [85] [86] .

Results from the phase III BREEZE-AD4, study in patients with moderate to severe atopic dermatitis showed that the safety profile of baricitinib was consistent with the known safety findings baricitinib. Nasopharyngitis, headache, and influenza were the most common treatment-emergent adverse events (TEAEs) reported. No venous thromboembolic events (VTEs) or deaths were reported in the trial. The trial is enrolling 500 patients [73] [84] .

Safety data of the phase III BREEZE-AD7 trial in patients with moderate to severe atopic dermatitis were consistent with the known safety profile of baricitinib. Nasopharyngitis, upper respiratory tract infection and folliculitis were the most common treatment-emergent adverse events reported. One case of pulmonary embolism and one opportunistic infection were reported in the baricitinib and placebo group, respectively. No malignancies, major adverse cardiovascular events (MACE), or deaths were reported in the study. The trial is enrolling 300 patients [83] [82] .

In phase III COV-BARRIER sub-study, by day 28, the frequency of adverse events, serious adverse events and serious infections were similar in the baricitinib group (88%, 50% and 44%, respectively) compared to placebo (95.9%, 71.4% and 53.1%, respectively). Venous thromboembolic events were reported in six percent of patients treated with baricitinib and 6.1 percent of patients treated with placebo. No new safety signals were identified [103]

In the phase III BREEZE-AD5 trial in patients in moderate to severe atopic dermatitis, baricitinib exhibited a consistent safety profile with the known safety findings. The most common treatment-emergent adverse events (TEAEs)reported were upper respiratory tract infections, nasopharyngitis, and diarrhea. There were no venous thromboembolic events (VTEs) or deaths were reported in the trial [79] [80]

Treatment with once-daily baricitinib in a phase III BRAVE-AA2 study was observed to be safe and well tolerated in adults with severe alopecia areata. No deaths or major adverse cardiovascular events (MACE) or venous thromboembolic events (VTEs) were reported from the study [123] [122]

Results from a phase III COV-BARRIER demonstrated that, the frequency of adverse events and serious adverse events were generally similar in the baricitinib (44.5% and 14.7%, respectively) and placebo (44.4% and 18.0%, respectively) groups. Serious infections and venous thromboembolism (VTE) occurred in 8.5 percent and 2.7 percent of patients treated with baricitinib, respectively, versus 9.8 percent and 2.5 percent of patients treated with placebo. No new safety signals potentially related to the use of baricitinib were identified [104] [106] .

Phase II/III:

The results from the phase II/III BRAVE-AA1 trial in patients with alopecia areata showed that baricitinib was well tolerated. There were no serious adverse events reported in the study for a period of up to 36 weeks. The treatment-emergent adverse events (TEAEs) observed were mild or moderate and the most common included upper respiratory tract infections, nasopharyngitis and acne. Interim results from phase II/III BRAVE-AA1 trial in patients with severe or very severe alopecia areata demonstrated that at week 36, the most common adverse event was upper respiratory tract infection which occurred in 11.1% and 22.2% of patients in the 2 mg and 4 mg treated groups respectively, as compared with 17.9% patients in the placebo group. No serious adverse events, deaths, thrombotic events or new safety concerns were reported. The double-blind, randomised trial enrolled approximately 725 patients [119] [125] [124] .

Phase II:

Baricitinib was well tolerated in a phase II study conducted in patients with moderate-to-severe atopic dermatitis. In topical corticosteroid (TCS) alone arm, 49% patients showed treatment-emergent adverse events (TEAE), while it was 46% and 71% in 2mg and 4mg baricitinib arms, respectively. The most common TEAE were upper respiratory tract infections and nasopharyngitis, headache, and increases in asymptomatic laboratory changes, namely increases in creatine phosphokinase were the most common TEAE in 4mg baricitinib with TCS arm. A randomised, double-blind, placebo-controlled study was carried out in 124 patients [91] [92] .

The most frequently reported adverse events associated with baricitinib (1mg, 2mg, 4mg and 8mg) or placebo administered for 12 weeks were infections. The rate of infection was similar between the baricitinib and placebo groups (12%) in the phase IIb JADA trial in 301 patients with rheumatoid arthritis. There were no deaths or opportunistic infections in all baricitinib groups. Seven serious adverse events were reported in six patients (two events in the placebo group, four and one in the 2mg and 8mg baricitinib groups, respectively). Dose-dependent changes in laboratory parameters were also observed; these were more pronounced in the 8mg baricitinib group [59] . 24-week outcomes were similar to those observed in the first 12 weeks, with no opportunistic infections or deaths over the study period [180] . Following the 52-week open-label extension portion of the trial, treatment-emergent adverse events occurred in 53% of patients receiving 4mg baricitinib, serious adverse events in 10%, infections in 31% and serious infections in 4%. Among patients receiving the 8mg dose, treatment-emergent adverse events occurred in 63%, serious adverse events in 9%, infections in 40% and serious infections in 2%. No opportunistic infections or cases of tuberculosis were reported. One death occurred in the 8mg dose group due to a suspected myocardial infarction [60] .

Once-daily, oral baricitinib (4, 7 and 10 mg) was well tolerated in 12-week results from a phase II trial of the drug in patients with inadequately controlled rheumatoid arthritis. All doses of baricitinib were generally well tolerated in this study. Most adverse events (AEs) were mild-to-moderate in intensity with a frequency similar to that observed in the placebo group. One unrelated serious AE (a gastrointestinal bleed) was observed. There were no cases of thrombocytopenia, and haemoglobin and haematocrit levels remained steady in patients treated with baricitinib at 4 or 7 mg/day, whilst the 10 mg dose of the drug showed a modest decrease in these parameters over time [65] . In final results from this trial, The frequency of treatment-emergent adverse events in placebo, and baricitinib 4mg, 7mg and 10mg groups was 61.3%, 48.4%, 59.4% and 74.2%, respectively, with headache (10.6% vs. 6.5% for placebo), upper respiratory tract infection (5.3% vs. 9.7% for placebo) and diarrhoea (5.3% vs. 6.5% for placebo) being the most frequently reported. One subject reported an unrelated serious AE (GI bleed). At week 12, two cases of herpes zoster were reported (2.1% vs. 0% for placebo). Increases were observed in HDL and LDL, and HDL:LDL ratios tended to increase with therapy (10.06% vs. 0.41% for placebo). The rates of malignancy, serious infection and herpes zoster did not increase over time including long-term observations [36] .

In a phase II trial conducted in patients with systemic lupus erythematosus, rates of adverse events leading to treatment discontinuation and serious AEs were higher for both baricitinib dose groups compared with placebo. Treatment emergent adverse events (TEAEs) were reported in 68 (64.8%), 75 (71.4%) and 76 (73.1%) patients in the placebo, 2 mg and 4 mg arms, respectively. The most common TEAEs in the baricitinib group were upper respiratory tract infections, including viral upper respiratory infections, and urinary tract infections. Serious adverse events were reported in 5 (4.8%), 11 (10.5%) and 10 (9.6%) patients in the placebo, 2 mg and 4 mg arms, respectively. Serious infections were reported in 1 (1%), 2 (1.9%) and 6 (5.8%) patients in the placebo, 2 mg and 4 mg arms, respectively. The percentage of patients who discontinued the therapy through 24-week period was 21%, 18% and 17% in the placebo, 2mg and 4mg dosing arms of baricitinib, respectively. There were no deaths, malignancies, major adverse cardiovascular events, tuberculosis, or serious herpes zoster infections; one SAE of deep vein thrombosis was reported in a patient with risk factors in the 4mg group. The trial was conducted in 314 patients [141] [140] [139] .

In a phase I trial, baricitinib administration reported incidence of treatment-emergent AEs (TEAEs) in 33.3% of healthy volunteers with mild severity. No serious AEs were reported with no withdrawn due to AEs. An apparent increase in the incidence of drug-related TEAEs was reported over the 2 to 10mg dose range, with a comparable incidence same as placebo at the 10mg dose [151] [150] .

Pooled analysis

Results from a post-hoc analysis of the phase III RA-BUILD and RA-BEAM studies demonstrated similar rates of adverse events, serious adverse events and serious infections between patients treated with placebo and baricitinib in patients younger than 65 years and patients 65 years or older [177] [43] [52] .

Pooled data from clinical studies conducted in 3 492 patients with rheumatoid arthritis demonstrated that for arterial thrombotic events (ATE) and major adverse cardiovascular events (MACE), the frequency of reported events and incidence rates (IR) were low, comparable across treatments and analysis sets, and did not increase with prolonged exposure. For deep vein thrombosis and/or pulmonary embolism (DVT/PE), events (n = 6) were reported for baricitinib 4 mg but not placebo during the 24-week placebo-controlled period. This imbalance was not replicated during 24 weeks after switch to baricitinib 4-mg from placebo (N = 928, one event) or active comparator (N = 451, zero events). DVT/PE IRs were comparable between baricitinib 2- and 4-mg doses at longer exposure, and the frequency of permanent discontinuation following a DVT/PE event was low (n = 5; 0.1%; IR = 0.06) [67] .

In a post hoc analysis of a long-term study of baricitinib in patients with active rheumatoid arthritis who were inadequate responders to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) or biologic DMARDs (bDMARD), non new safety concerns were observed through 2.3 years of treatment [13] .

In a pooled analysis of nine trials including 3 770 patients with rheumatoid arthritis who had received a total of 13 148 patient years of exposure with time on treatment ranging to a maximum of 8.4 years (median 4.2 years), no new safety concerns were reported [13] .

Updated results of the phase III ACTT-2 trial demonstrated that the combination of baricitinib and remdesivir had slightly fewer serious adverse effects in patients (n = 1 033) with hospitalised COVID-2019 infections [114] [115] . Interim results showed that adverse events and serious adverse events were reported in 41% and 15% of patients treated with baricitinib in combination with remdesivir, respectively, vs. 48% and 20% in patients treated with remdesivir. Infections and venous thromboembolism (VTE) occurred in 6% and 4% of patients treated with baricitinib in combination with remdesivir, respectively, vs. 10% and 3% of patients treated with remdesivir. No new safety signals were identified for baricitinib-treated patients [112] [109] .

Pooled data from the BRAVE-AA1 and BRAVE-AA2 trials of baricitinib in patients with alopecia areata, the commonly reported treatment-emergent adverse events (TEAEs) were included upper respiratory tract infections, headache and acne. No deaths or venous thromboembolic events (VTEs) were reported in the trials. The safety profile of baricitinib in the studies was consistent with its known safety profile in patients with rheumatoid arthritis (RA) and atopic dermatitis (AD) [123] [124] [120] .

Pharmacodynamics

Summary

Results of the randomised, double-blind, parallel, placebo-controlled, phase II JAHH trial in patients (n = 270) with systemic lupus erythematosus showed that baricitinib 4 mg treatment was associated with statistically significant decreases of serum IL-12/23p40 and IL-6 at week 12 which continued through week 24. Serum IFN-α or IFN-γ were not reduced with baricitinib treatment. At week 0, serum IL-17A, IL-12/23p40, IL-6, IFN-γ and IFN-α were readily detectable. The IL-12/23p40 was detectable in 100% of patients versus 100% of controls, IFN-γ in 89% of patients versus 66% of controls, IL-6 in 53% of patients versus. 12% of controls and in IFN-α 41% of patients versus 2% of controls. Detection of serum IL-2, GM-CSF, IL-5, IL-10 and IL-17A was variable. At baseline (week 0), IL-12/23p40 was positively correlated with SLEDAI and IFN gene signature and negatively correlated with serum C4. The IL-6 was positively correlated with joint swelling, joint tenderness, IFN-γ and C3. Serum IFN-α was positively correlated with serum IFN-γ, anti-Sm and anti-RNP, and the IFN gene signature. Treatment with baricitinib 4 mg significantly decreased serum IL12/23p40 and IL-6 cytokine levels at week 12 (p < 0.05) but not serum IFN-α or IFN-γ levels [144] [139] .

Pooled analyses data from phase II and III studies, conducted in patients with moderately to severely active rheumatoid arthritis, showed that baricitinib 4mg od was associated with increased LDL-C, HDL-C, and TG levels, with a stable LDL-C/HDL-C ratio. The lipid elevation plateaued after week 12. By nuclear magnetic resonance, baricitinib did not significantly affect total LDL particle number while the small, dense potentially more atherogenic LDL particle numbers decreased. Baricitinib significantly increased HDL-C, the total number of HDL particles, all HDL subfractions, and TG-rich lipoproteins. The magnitude of lipid change was not significantly different between baseline statin users and nonusers. In patients who initiated statin therapy before week 24, the elevation in total cholesterol (n = 18), LDL-C and TG decreased to pretreatment levels in response to statin therapy, while HDL-C remained elevated with statin therapy. Similar results in lipids changes and response to initiation of statin therapy were observed for apolipoprotein A1 and apolipoprotein B corresponding to HDL-C and LDL-C [30] .

Janus kinases JAK1 and JAK2 were inhibited by baricitinib 0.3 nmol/L in vitro. This inhibition was selective, relative to > 26 other kinases including JAK3. The signalling of multiple pro-inflammatory cytokines, including interleukin (IL)-6 and IL-23, was inhibited by baricitinib at concentrations of < 50 nmol/L. Cytochrome P450 enzymes were not inhibited by baricitinib [181] .

In rats with adjuvant-induced arthritis, the clinical score and histological signs of disease improved after daily administration of baricitinib at doses of ≤2 mg/kg [181] .

Antimicrobial Activity

Summary

Therapeutic Trials

In a phase II trial conducted in patients with systemic lupus erythematosus, a significantly greater proportion of patients receiving baricitinib 4-mg achieved resolution of SLEDAI-2K arthritis or rash, compared with placebo (67% vs 53%, p<0.05); and SRI-4 response (64% vs 48%, p < 0.05) at week 24. At week 24, the proportion of patients achieving flare reduction (SELENA-SLEDAI Flare Index [SFI]), Lupus Low Disease Activity State (LLDAS), and tender joint count (TJC) change from baseline were also significantly improved for baricitinib 4-mg compared with placebo. No statistically significant differences were observed between baricitinib 2-mg and placebo in any of the endpoints. Treatment-induced changes were reported in the bari 4-mg versus PBO group at early time points (Wks 2 and 4; bari 4-mg > 2-mg). No changes were observed in the serum cytokine levels at 4 mg dose of baricitinib. Statistically significant changes were reported for type I and II IFN responsive genes, and in the JAK/signal transducer and activator of transcription (STAT) canonical and noncanonical signaling pathways, in the bari 4-mg versus PBO group comparisons. A decrease in gene expression from BL was reported with bari, compared to PBO, for interleukin (IL)-3, -5, -6, -7, and granulocyte macrophage colony-stimulating factor pathways, which attributed to inhibition of JAK/STAT signaling. Among patients who were anti-dsDNA positive at baseline, significant decreases of anti-dsDNA antibodies were observed for BARI 2-mg and 4-mg compared to placebo beginning at weeks 2 and 4, respectively, and continuing through week 24. Moreover, reductions of IgG levels were found for BARI-treated patients including significant decreases for BARI 4-mg compared to placebo at weeks 12 and 24. Among patients who had low levels of C3 and C4 at baseline, no significant differences in median change from baseline were observed over time with BARI compared to placebo. For patients who were anti-dsDNA positive at baseline, no relationship in SRI-4 responder rate was observed for those who stayed positive or achieved normal levels by week 24, possibly due to the limited sample size [143] [142] [140] [139] .

Phase III

Updated results of the phase III RA-BEAM trial of baricitinib 4mg over 52 weeks in patients (n = 487) with rheumatoid arthritis (RA) and an inadequate response to methotrexate showed that majority of patients achieved low disease activity (LDA) and had no structural progression. Patients with high baseline disease activity were associated with longer time to achieve LDA. Patients with higher baseline structural damage in addition to high disease activity were less likely to achieve LDA, but consistent with the other groups, had similar low rate of joint damage progression. Long-term maintenance and continued improvement in Clinical Disease Activity Index (CDAI) were observed with baricitinib treatment. Baricitinib 4mg treated patients were classified into three groups based on their CDAI trajectory patterns, group 1 (n = 344, 71%), group 2 (n = 56, 11%), and group 3 (n = 87, 18%). Group 1 had lower baseline CDAI (34), achieved CDAI≤10 (LDA) rapidly and maintained LDA up to 52 weeks. Group 2 had higher CDAI at baseline (48), responded quickly, and although patients took longer to attain LDA, they continued to show CDAI improvement. Group 3 had similar baseline CDAI values (48) to Group 2 but higher baseline damage (mean total Sharp score [mTSS] of 50, versus 41 for Groups 1 and 2). Most Group 3 patients did not achieve LDA but continued to show improvement over time. The majority of patients had no radiographic progression with the highest proportion in Group 1. The trajectories of average pain VAS, Health Assessment Questionnaire–Disability Index (HAQ-DI), tender joint count 28, and swollen joint count 28 were consistent in all three groups [44] . Additional results from the trial reported statistically significant improvements (P<0.05) with baricitinib and adalimumab versus placebo were reported as early as week 1 for pain, MJS severity, HAQ-DI, and PtGA and at week 4 for FACIT-F and SF-36 PCS scores. Statistically significantly larger improvements (P<0.05) were reported as early as week 2 for pain, PtGA, week 3 for MJS severity, and week 4 for HAQ-DI and SF-36 PCS scores. These improvements were maintained to week 12 [45] . Interim results of the RA-BEAM trial of once-daily, oral baricitinib (4mg) met its primary objective by demonstrating superiority over adalimumab and placebo arm after 12 weeks of treatment based on ACR20 response. A significantly higher proportion of patients taking baricitinib showed low disease activity, assessed by the 28-joint Disease Activity Score (using high-sensitivity C reactive protein [DAS28-CRP]), Simplified Disease Activity Index (SDAI) and CDAI scores, as compared with adalimumab at weeks 12 and 52. Baricitinib significantly improved joint pain, severity of morning joint stiffness and tiredness, compared to placebo, as early as day 3 and significantly improved duration of morning joint stiffness by day 5. Improvements were significantly greater in the baricitinib arm compared with the adalimumab arm by day 17 (joint pain), day 19 (severity of morning joint stiffness) and day 21 (tiredness). At 12 weeks, 75% of patients treated with baricitinib reported clinically meaningful improvement in physical function versus 71% of patients treated with adalimumab (p = 0.302). At 24 weeks, 73% of patients treated with baricitinib reported clinically meaningful improvement in physical function compared with 64% of patients treated with adalimumab (p < 0.05) and at 52 weeks, 68% of patients treated with baricitinib reported clinically meaningful improvement in physical function compared with 58% of patients treated with adalimumab (p < 0.01). Also, at 52 weeks, the treatment with baricitinib was associated with significant improvement in pain, and the physical health components of quality of life, including clinically meaningful improvement in fatigue compared with patients treated with adalimumab. Improvements in ACR50 and ACR70 responses were statistically significant as compared with adalimumab at weeks 12, 20, 28, 32 and 40. At week 52, baricitinib treatment significantly improved all seven components of the American College of Rheumatology (ACR) composite score, including ACR20, ACR50 and ACR70 response rates as compared with injectable adalimumab (40 mg/biweekly), although only ACR 50 was statistically significant. At 52 weeks, baricitinib significantly improved the mean number of swollen and tender joints, physical function, and reduction in pain versus adalimumab. Additionally, significant improvement in the structural changes in the joints were observed in both baricitinib and adalimumab arms compared with placebo. Baricitinib exhibited improved ACR20 response rate versus adalimumab arm after 12 weeks of treatment, and prevented progressive radiographic structural joint damage followed by 24 weeks of treatment, compared with the placebo group. The baricitinib treatment related benefits observed at 12 and 24 weeks of study were consistent through 52 weeks of therapy. The 52-week study evaluated 1 305 patients who had active, moderate-to-severe RA and were undergoing methotrexate treatment. The patients were divided into two groups of baricitinib (n = 487) and placebo (n = 488) or adalimumab (n = 330)treatment [37] [38] [36] [39] [40] [43] .

Once daily baricitinib resulted in low rates of radiographic progression of structural joint damage, for up to a period of two years, in the phase III long term extension RA-BEYOND trial in subjects with rheumatoid arthritis. The 4 mg dose was associated with the most robust benefit. Among DMARD-naive subjects, rates were significantly lower for patients who received initial baricitinib, compared with those initially treated with methotrexate. For subjects with an inadequate response to the methotrexate/conventional synthetic DMARD regimen, rates of progression were significantly lower in the initial baricitinib cohort versus the initial placebo cohort, and comparable with the initial adalimumab cohort. Previously reported data demonstrated superior efficacy with baricitinib, through 48 weeks. The long-term extension trial enrolled 2600 patients with rheumatoid arthritis [176] [34] [35] .

In the phase III RA-BALANCE trial, a significantly greater primary ACR20 response was displayed by baricitinib-treated patients, as compared with placebo, wherein the respective values for the two groups were 58.6% and 28.3%, (p≤0.001). ACR20/50/70, DAS28-hsCRP, CDAI low disease activity and SDAI low disease activity values significantly improvemed in patients receiving baricitinib versus placebo at weeks 12 and 24, many as early as by week 1. Significantly less radiographic progression was seen in patients receiving baricitinib, as compared with placebo at week 16, with numerical improvement seen at week 24. In the twelfth week, significant improvement in HAQ-DI minimum clinically important difference ≥0.3 (physical function), duration of morning joint stiffness, severity of morning joint stiffness numeric rating scale (NRS), worst tiredness NRS and reduced pain (0-100mm VAS) were observed in patients receiving baricitinib, as compared with placebo. In addition, 52% of patients initially treated with baricitinib were observed to be in the state of low disease activity (LDA) at week 24 and maintained up to week 148 [31] [32] [33] .

In the RA-BEGIN phase III trial, 81% of patients receiving baricitinib (bari) monotherapy and 79% of patients receiving baricitinib plus methotrexate achieved clinically meaningful improvement in physical function versus 70% among those receiving methotrexate alone therapy (p < 0.05), at 24weeks. At 52 weeks, 68% of patients on baricitinib monotherapy and 72% of patients on baricitinib in combination with methotrexate achieved clinically meaningful improvements in physical function compared to 57% of those treated with methotrexate alone (p < 0.05). LDA and remission response rates in the delayed-start group resulted in an increase from 60% to 78% and 18% to 31%, respectively, within 4 weeks after switching to bari 4-mg. Remission rates reached 47% within 1 year after switching, but were not different from the group that initiated bari. The delayed-start group showed a rapid improvement in HAQ-DI. Reduction in the rate of structural damage was reported in initiating bari, whereas delayed initiation of bari for 1 year resulted in numerically higher mTSS [51] . Baricitinib (as monotherapy or in combination with methotrexate) was also associated with significant improvement in pain and the physical health components of the quality of life assessment, including clinically meaningful improvement in fatigue compared with methotrexate alone treatment, at 24 as well as 52 weeks treatment. All of the improvements with baricitinib were statistically significant at week 24 and week 52, compared to methotrexate alone. Updated results showed that the mean baseline pain VAS ranged from 58.7 to 65.2 with a 6-month mean change in pain of -28.3 to -33.5 for the methotrexate arm. Similar HAQ-DI and changes in HAQ-DI for the methotrexate arm were observed. At week 24, baricitinib showed numerically greater improvement over methotrexate in pain, than that for tocilizumab, adalimumab and tofacitinib. Patients treated with baricitinib showed significantly greater improvement in HAQ-DI at week 24 than tocilizumab and adalimumab, but not tofacitinib. The 52-week study evaluated baricitinib used as monotherapy or in combination with methotrexate versus methotrexate alone treatment in patients with rheumatoid arthritis, who had limited or no previous treatment with any disease-modifying antirheumatic drugs (DMARDs) [49] [49] [36] [48] .

Baricitinib 4mg, administered orally, once daily at 24 weeks demonstrated statistically significant improvement in rheumatoid arthritis disease activity in comparison with placebo in the second consecutive study of phase III RA-BUILD trial in patients with moderate to severe rheumatoid arthritis who showed inadequate response to at least one disease-modifying antirheumatic drug (cDMARD) [54] .

Pooled analysis

Results from a post-hoc analysis of the phase III RA-BUILD and RA-BEAM studies demonstrated that efficacy of baricitinib was not affected by the age of the patients. At week 12, 67% patients younger than 65 and 68% older than 65 years achieved ACR20 and 20% improvement across various aspects of RA, whereas ACR20 was achieved by 40% of patients younger than 65 years and 43% older than 65 years of age. Proportion of patients in the low, middle and high BMI groups who achieved an ACR20 response were 68.4%, 68% and 64.7%, respectively. At week 12, in the baricitinib 4 mg groups, 67.9%, 67.3% and 66.9% of patients achieved an ACR20 response, and previously used methotrexate alone, methotrexate + 1 csDMARD and methotrexate + ≥2 csDMARDs, respectively. ACR50 responses were also similar across the groups (42.5%, 42.9% and 39.2%, respectively) and ACR70 responses were 21.4%, 19.5% and 13.3% respectively [177] [43] .

Results from a phase III long-term extension study showed that that 4 mg once daily was the most efficacious dose of baricitinib for patients with rheumatoid arthritis (RA); increases in disease activity were consistently seen with dose reduction from 4 mg to 2 mg in well-controlled patients. Among patients who achieved sustained disease control with baricitinib 4 mg, dose reduction to 2 mg resulted in significant increases in disease activity at 12, 24, and 48 weeks; however, the majority of patients in both groups maintained the state of low-dose activity (LDA) or remission. Rescue rates were 7.3% for baricitinib 4 mg, 17.1% for baricitinib 2 mg. Most rescued patients could regain LDA or remission [182] [43] [55] [52] .

The randomised, double-blind phase III RA-BEACON trial of baricitinib in patients with rheumatoid arthritis (RA) met its primary endpoint of improved ACR20 response at 12 weeks, compared to placebo. Updated results from phase III trial showed that the baricitinib 2mg treated patients was classified into three groups based on their CDAI trajectory patterns, group 1 (n = 90, 52%), group 2 (n =29, 17%), and group 3 (n = 55, 32%). Group 1 had lower baseline CDAI (34), achieved 53% improvement in group mean of CDAI at week 4 and 64% improvement at week 12, maintained similar improvement till week 24. Group 2 had higher CDAI at baseline (51), 32% improvement in group mean of CDAI at week 4 and higher improvement at week 12 (52%) and week 24 (66%). Group 3 had similar baseline CDAI values (48) to Group 2 but smaller improvement in CDAI and 18% at week 24. The majority of patients had no radiographic progression with the highest proportion in Group 1. The trajectories of average pain VAS, Health Assessment Questionnaire–Disability Index (HAQ-DI), tender joint count, and swollen joint count showed a trajectory similar to corresponding 3 groups were consistent in all three groups. As compared to group 1 and 2, group 3 had more pain, worse physical function and large proportion of patients at baseline [57] . At week 12, ACR20 response rates were 53%, 49% and 32% for 4mg, 2mg and placebo, respectively (p ≤ 0.001) and were 45%, 39% and 21% for 4mg, 2mg and placebo, respectively (p ≤ 0.001), at week 24. Improvement in physical component score of SF-36 was statistically significant in patients treated with baricitinib compared with placebo at week 4, which was sustained through week 24. Baricitinib also significantly improved fatigue and reduced the duration of morning joint stiffness, as early as week 4, compared with placebo; this effect was maintained throughout the study. There were also significant improvements in physical functioning and pain in the baricitinib-treated groups at week 12 and week 24, compared with placebo. A significantly greater proportion of patients treated with baricitinib also achieved a DAS28-CRP score below 2.6 and HAQ-DI of 0.3 at week 12. Significant improvements in ACR response rates, DAS28-CRP and HAQ-DI with baricitinib compared with placebo at week 12 were maintained through week 24. The trial enrolled 527 patients with moderate to severe RA who had an inadequate response to a TNF inhibitor, despite ongoing treatment with conventional DMARDs. Baricitinib was dosed at 2mg or 4mg daily for 6 months [178] [179] [56] [55] .

Phase II

Treatment with baricitinib resulted in a significantly greater difference in the ACR20 response between the combined 4mg and 8mg groups compared with placebo at 12 weeks (76% vs 41%, p < 0.001), the primary endpoint of the phase IIb JADA trial in rheumatoid arthritis (RA). Significant improvement was observed as early as 2 weeks after the start of therapy and was maintained through week 12. There were significant improvements in response rates for the ACR20, ACR50 and ACR70 criteria for all baricitinib dose groups, compared with placebo. Results from week 24 showed that in patients who continued to receive baricitinib 2mg, 4mg or 8mg, improvements in the ACR20, 50 and 70 response rates were maintained over this time. Improvements observed at week 24 were sustained through week 52 in the extension portion of the trial. In this randomised, double-blind, dose ranging trial, 301 patients with active disease, inadequately controlled on methotrexate, received once daily baricitinib 1mg, 2mg, 4mg and 8mg or placebo for 12 weeks [60] [59] . Data from an MRI substudy in patients with erosive RA (n = 154) demonstrated that significant improvements in the Total Inflammation Score and the Total Joint Damage score were achieved in the baricitinib 4mg and 8mg groups at 12 weeks, compared with the placebo group, an effect that was maintained through to 24 weeks [180] .

Positive three-month results from a phase II trial of baricitinib showed that all three once-daily, oral doses of the product were associated with rapid increases in ACR scores, in patients with rheumatoid arthritis (RA). In this trial, patients with inadequately controlled disease by any DMARD therapy, were randomised to receive one of three dose levels of baricitinib (4, 7 or 10 mg) or placebo, once-daily. After three months, ACR scores were shown to have improved rapidly for all three doses of baricitinib, compared with baseline; all doses of the drug were approximately equally effective at this time point. In the baricitinib groups, ACR20, 50 and 70 scores at 12 weeks included response rates of up to 60%, 36% and 16%, respectively; the corresponding response rates for the placebo group were 32%, 13% and 3%, respectively. Baricitinib was also demonstrated to be as effective in patients previously treated with biologics (mostly anti-TNF therapies) as in patients previously treated with traditional DMARDs (mostly methotrexate) [65] . In final results from this trial, ACR20 responses for biologic experienced subjects was 33% for placebo and 53%, 73% and 43% for baricitinib 4mg, 7mg and 10mg, respectively. ACR50 responses for biologic experienced subjects was 11% for placebo and 33%, 45% and 29% for baricitinib 4mg, 7mg and 10mg, respectively [64] .

In a post hoc analysis of a long term efficacy study in patients with active rheumatoid arthritis who were inadequate responders to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) or biologic DMARDs (bDMARD), low disease activity at week 120 was observed in 27.5% and 18.4% of subjects in the csDMARD-IR and bDMARD-IR cohorts, respectively, in a non-responder imputation analysis. For subjects remaining on treatment, low disease activity was maintained at 2.3 years in 85% and 86% of subjects in the csDMARD-IR and bDMARD-IR cohorts, respectively [13] .

In a pooled analysis of phase III trials assessing baricitinib 4 mg od as monotherapy or in combination with methotrexate or other synthetic DMARDs and baricitinib 2 mg od in combination with other synthetic DMARDs in patients who were either DMARD-naïve or inadequate responders to synthetic DMARD and methotrexate, low rates of radiographic progression, assessed by the van der Heijde modified Total Sharp Score, were maintained for up to 5 years [13] .

Phase III:

Results from the phase III BREEZE-AD7 trial in patients with moderate to severe atopic dermatitis showed that baricitinib in combination with topical corticosteroids significantly improved severity of the disease at week 16. The validated Investigator's Global Assessment for AD (vIGA) score of "clear or almost clear" skin (vIGA 0, 1) was reported in 23.9%, 30.6% (p ≤ 0.01) and 14.7% of patients treated with baricitinib 2mg, baricitinib 4mg and placebo, respectively. At week 16, about 43.1% (p ≤ 0.01) of baricitinib 2mg patients, 47.7% (p ≤ 0.001) of baricitinib 4mg patients and 22.9% of placebo patients achieved Eczema Area and Severity Index 75 (EASI75). A 4-point improvement in Itch NRS at Week 16 was seen in 38.1% (p ≤ 0.01), 44% (p ≤ 0.01) and 20.2% of patients treated with baricitinib 2mg, baricitinib 4mg and placebo, respectively. The trial is enrolling 300 patients [83] [82] .

Results from the phase III BREEZE-AD3 trial in moderate to severe atopic dermatitis (AD) showed 45.7% of responders and partial responders on 4-mg of baricitinib had a vIGA-AD score of 0 or 1, while 40% had a validated Investigator Global Assessment score of "clear or almost clear" skin (vIGA-AD) score of 0 or 1 after 68 weeks of continuous therapy. At the start of BREEZE-AD3 46.3% of responders and partial responders on 2-mg of baricitinib had a vIGA-AD score of 0 or 1, while 50% had a vIGA-AD score of 0 or 1 after 68 weeks of continuous therapy. Baricitinib 4-mg and 2-mg dose groups were able to maintain clear or almost clear skin response rates through the 68-week treatment period [85] [86] .

Phase II/III:

In a phase II/III BRAVE-AA1 trial of baricitinib in patients with alopecia areata achieved its primary endpoint of hair regrowth across the two dosing regimens at week 36. The results showed that the proportion of patients reaching 80% or more scalp hair coverage was achieved by 35% (p ≤ 0.001) of patients treated with baricitinib 4 mg/day, 22% (p ≤ 0.001) of patients treated with baricitinib 2 mg/day and 5% of patients in the placebo group at week 36.Interim results from phase II/III BRAVE-AA1 trial in patients with severe or very severe alopecia areata and Severity of Alopecia Tool (SALT) score of 50 demonstrated that significantly greater proportion of patients achieved the primary endpoint of Severity of Alopecia Tool (SALT) score of 20. At week 36, SALT score of 20 defined as having 20% or less of scalp hair loss and considered as clinically meaningful improvement, was significantly greater in patients treated with baricitinib (2 mg) (33.3%, p=0.016), and (4 mg) (51.9%, p=0.001) as compared with placebo (3.6%). At week 36, the treated groups also showed no hair loss or limited hair loss on the patient-reported outcomes (PRO) for scalp hair assessment (p<0.05). Patients who were treated with 4 mg dose improved the growth of eyebrows and eyelashes, as assessed by the clinician-reported outcome and PRO measures (p<0.05 vs placebo). The double-blind, randomised trial enrolled approximately 725 patients [121] [120] [125] [124] .

Results from the phase III BREEZE-AD5 trial in patients with moderate to severe atopic dermatitis demonstrated that 2 mg dose of baricitinib monothrapy met the primary endpoint of proportion of participants achieving Eczema Area and Severity Index (EASI75) at week 16. The EASI75 was reported in 43 (29.5%) and 19 (12.9%) of the patients treated with baricitinib 1mg and baricitinib 2mg doses respectively as compared to placebo 12 (8.2%). The validated Investigator's Global Assessment for atopic dermatitis (AD) (vIGA) score of clear or almost clear skin (vIGA 0, 1) was reported in 35 24.0% and 19 (12.9%) of the patients treated with baricitinib 1mg and baricitinib 2mg doses as compared to placebo 8 (5.4%). A 4-point improvement in Itch NRS at week 16 was seen in the 33 (25.2 %) and 21 (15.9%) of the patients treated with baricitinib 1mg and baricitinib 2mg doses as compared to placebo 7 (5.7%) respectively. Key secondary endpoints including measure of skin inflammation defined by clear or almost clear skin and at least 2 points on the validated Investigator's Global Assessment for AD (vIGA 0 or 1 at week 16) was also reported along with the reduction in the itch severity [79] [80] .

Phase II:

Results from a phase II study conducted in patients with moderate-to-severe atopic dermatitis demonstrated significantly improved signs and symptoms with baricitinib in combination with a mid-potency topical corticosteroid (TCS) than TCS alone. After 16 weeks of treatment, 50% or greater reduction in overall disease severity, measured by the Eczema Area and Severity Index (EASI-50), was noted in 61% patients treated with 4mg baricitinib in combination with TCS (n=38), than 37% with TCS alone (n=49), (P < 0.05). 57% patients in 2mg baricitinib in combination with TCS (n=37) arm achieved EASI-50, however results observed were not statistically different compared to treatment with TCS alone (P=0.065). After four weeks of treatment, EASI-50 was achieved by 68% patients treated with 4mg baricitinib in combination with TCS and 62% patients with 2mg of baricitinib in combination with TCS. The patient percentage was restricted 16% in TCS alone arm (P < 0.001). A randomised, double-blind, placebo-controlled study was carried out in 124 patients [91] [92] .

Results from the phase III BREEZE-AD4, study in patients with moderate to severe atopic dermatitis showed that the trial met its primary endpoint of at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) at week 16. The 4mg dose of baricitinib plus TCS met the primary end point in the study, with EASI75 achieved by 31.5% of patients treated with that dose compared with 17.2% of patients in the placebo plus TCS group (p ≤ 0.05). Among patients treated with 1mg and 2mg of baricitinib, 22.6% and 27.6% of patients, respectively achieved EASI75, though not statistically significant. Additionally, the 4mg dose of baricitinib plus TCS met key secondary end point of Investigator’s Global Assessment (vIGAa) of 0 (clear) or 1 (almost clear) in 21.7% patients compared with 9.7% of placebo patients (p ≤ 0.05). About 12.9% of patients in 1mg baricitinib group and 15.1% patients in the 2mg group achieved vIGAa at week 16. A 4-point improvement in Itch Numeric Rating Scale at week 16 was also reported in 38.2% of patients in the 4mg dose of baricitinib plus TCS compared with 8.2% of placebo patients (P ≤ 0.001). About 23.1% (p ≤ 0.05) and 22.9% (p ≤ 0.01) of baricitinib patients in the 1mg and 2mg group, respectively met the 4-point improvement in Itch Numeric Rating Scale at week 16. The trial is enrolling 500 patients [73] [84] .

In the phase III BREEZE-AD1 and BREEZE-AD2 trial, at week 16, among patients with atopic comorbidities, significantly more patients in the baricitinib-treated groups (4 mg, 2 mg, and 1 mg, respectively) against placebo had Investigator’s Global Assessment (IGA) rated mild or less (IGA < 2) (29.8%, 25.0%, and 18.6% vs. 9.8%) or EASI 50 (32.7%, 29.0%, and 20.3%, vs. 11.5%), p < 0.01 for all comparisons. Patients with atopic comorbidities experienced improvement in itch (> 4 points) with baricitinib 4 mg (21.6%), 2 mg (16.6%), and 1 mg (10.1%) against placebo (4.4%; p < 0.05 for all). No significant treatment related effect differences observed in patients with or without atopic comorbidities [78] [89] [90] ..

A phase III BRAVE-AA2 trial of baricitinib in patients with alopecia areata, achieved its primary endpoint of hair regrowth across the two dosing regimens at week 36. The results showed that the proportion of patients reaching 80% or more scalp hair coverage was achieved by 33% (p ≤ 0.001) of patients treated with baricitinib 4 mg/day, 17% (p ≤ 0.001) of patients treated with baricitinib 2 mg/day and 3% of patients in the placebo group, at week 36 [121] [120] [122] [123] .

Pooled data from the BRAVE-AA1 and BRAVE-AA2 trials in patients with alopecia areata showed that the trials achieved the primary endpoint of hair regrowth across the two dosing regimens at week 36. Across both studies, the proportion of patients self-reporting at least 80 percent scalp hair coverage was significantly greater in the 2-mg and 4-mg groups compared to placebo (p ≤ 0.001) by Week 36. In both the studies, over the nine-month treatment period, patients with severe alopecia areata treated with baricitinib 2mg and 4mg doses experienced significantly greater scalp hair regrowth compared to patients treated with placebo [121] [123] [124] [120] .

COVID-2019 infections

Phase III

Updated results of the phase III ACTT-2 trial demonstrated that the combination of baricitinib and remdesivir reduced median time to recovery in hospitalised COVID-2019 patients (n = 1 033) from eight days to seven days. Patients who required high-flow oxygen or non-invasive ventilation during their hospitalisation showed that their median time to recovery was shortened from 18 days to 10 days. The patient's conditions at day 15 of the study (as measured by an eight-category ordinal scale which ranked the severity of their condition) was significantly improved with the combination therapy [114] [115] . Interim results showed that the ACTT-2 trial met the primary endpoint, where the overall patient population treated with baricitinib in combination with remdesivir improved their median time to recovery from 8 to 7 days in comparison to remdesivir, a 12.5% improvement (incidence rate ratio: 1.16; 95% CI: 1.01, 1.32; p = 0.04). The treatment with baricitinib plus remdesivir showed statistically significant reduction in the time to recovery for patients in comparison with remdesivir alone, observed in hospitalised adult patients requiring supplemental oxygen (grade 5 on the eight-point ordinal scale) and those who required high-flow oxygen/non-invasive ventilation (grade 6) at baseline. The study also met a pre-specified secondary endpoint. Using the ordinal scale that ranged from recovered to death, the odds of improvement in clinical status at Day 15 were 30% greater in patients being treated with baricitinib in combination with remdesivir compared with remdesivir (odds ratio 1.3; 95% CI: 1.0, 1.6; p = 0.04). The proportion of patients who progressed to ventilation (non-invasive or invasive) or died by day 29 was lower in baricitinib in combination with remdesivir (23%) compared to remdesivir alone (28%) [odds ratio: 0.74; 95% CI: 0.56, 0.99; p = 0.039]. A numerical decrease in death (35%) through Day 29 was observed in patients treated with baricitinib in combination with remdesivir compared to remdesivir in the overall population (5.1% vs 7.8%, respectively; hazard ratio: 0.65; 95% CI: 0.39, 1.08; p = 0.09). The reduction in mortality was more pronounced for patients receiving oxygen, as mortality at Day 29 was 60% lower and 43% lower for the OS5 and OS6 subgroups respectively [112] [113] [96] [111] [109] .

In phase III COV-BARRIER sub-study, patients with COVID-19 on mechanical ventilation or extracorporeal membrane oxygenation (ECMO) who received baricitinib plus standard of care were 46% less likely to die by day 28 compared to patients who received placebo plus standard of care (nominal p-value = 0.0296; hazard ratio [HR] [95% CI] = 0.54 [0.31, 0.96]; analysis not adjusted for multiplicity). The cumulative proportion of patients who died by Day 28 was 39.2% (n/N: 20/51) in the baricitinib arm versus 58% in the placebo arm (n/N: 29/50). Similar mortality benefit was observed by day 60 (HR [96% CI] = 0.56 [0.33, 0.97]) with a cumulative proportion of death of 45.1% (n/N: 23/51) for baricitinib compared to 62.0% for placebo (n/N: 31/50). These findings are consistent with the reduction in mortality observed in the overall COV-BARRIER patient population [103]

Results from a phase III COV-BARRIER demonstrated that, the trial did not met statistical significance on the primary endpoint of the difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation or invasive mechanical ventilation or death by day 28. Baricitinib-treated patients were 2.7 percent less likely than those receiving standard of care (SoC) to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI; 0.67, 1.08; p=0.1800). Treatment with baricitinib in addition to SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) resulted in a significant reduction (nominal p-value=0.0018) in death from any cause by 38 percent (n/N: 62/764 [8.1%] baricitinib, 100/761 [13.1%] placebo; hazard ratio [HR]: 0.57; 95% CI: 0.41, 0.78) by Day 28. A numerical reduction in mortality was observed for all baseline severity subgroups of baricitinib-treated patients and was most pronounced for patients receiving non-invasive mechanical ventilation at baseline (17.5% versus 29.4% for baricitinib plus SoC versus SoC; hazard ratio [HR]: 0.52; 95% CI: 0.33, 0.80; nominal p-value=0.0065). A reduction in mortality was also seen for the pre-specified subgroups of patients being treated with or without corticosteroids at baseline [104] [106] .

Future Events

Expected Date Event Type Description Updated
31 Dec 2021 Regulatory Status Eli Lilly and Company announces intention to submit sNDA to US FDA for alopecia areata in USA, in the H2 2021 (9337408) [120] 12 Oct 2021
31 Jul 2021 Regulatory Status EMA will communicate on the outcome of its evaluation of application for COVID-2019 infections (In adolescents, In children, In adults) by July 2021 [101] 09 May 2021
01 May 2021 Trial Update University Hospital of Bordeaux plans a phase II trial for non-segmental Vitiligo (Combination therapy) in France (NCT04822584) 16 Apr 2021
31 Dec 2020 Regulatory Status Eli Lilly and Company announces intention to submit regulatory applications for approval in the US for Atopic dermatitis in 2020 [73] 10 May 2020
03 Sep 2020 Trial Update Eli Lilly and Company plans a phase II/III trial in Herditary autoinflammatory diseases (In infants, In children, In adolescents, In adults, In the elderly) in Japan in September 2020 (PO. Tablet) (PO, Liquid) (NCT04517253) (700326832) 01 Dec 2020
30 Apr 2020 Trial Update Eli Lilly and Company in collaboration with National Institute of Allergy and Infectious Diseases plans a clinical trial for COVID-2019 infections in the USA (PO) in April 2020 (700320690) [6] 10 May 2020
30 Aug 2019 Trial Update Eli Lilly and Incyte Corporation plans the phase III SLE-BRAVE-X trial for Systemic lupus erythematosus in the US (NCT03843125) 25 Sep 2019
24 Jun 2019 Trial Update Eli Lilly and Incyte plan the phase III BRAVE-AA2 trial for Alopecia areata in Argentina, Australia, Brazil, Israel, Japan, taiwan and USA (PO) (NCT03899259) 24 Jul 2019
15 Mar 2019 Trial Update Eli Lilly and Company plans the phase III JUVE-X trial for Juvenile rheumatoid arthritis (In infants, In children, In adolescents) in Argentina, Brazil, Japan and Mexico (PO, Tablet) (NCT03773965) (EudraCT2017-004471-31) 08 May 2019
01 Feb 2019 Trial Update Eli Lilly and Company plans a phase II trial for Primary biliary cirrhosis in USA and Puerto Rico (PO) (700301776) (NCT03742973) 08 May 2019
31 Dec 2018 Trial Update Eli Lilly plans to initiate the phase III programme for Psoriatic arthritis in 2018 [175] 18 Sep 2020
24 Sep 2018 Trial Update Eli Lilly and Incyte Corporation plans the phase II/III BRAVE-AA1 trial for Alopecia areata in September 2018 (PO) (NCT03570749) (700297193) 10 Oct 2018
30 Jun 2018 Regulatory Status Eli Lilly plans to launch baricitinib in USA in second quarter of 2018 [14] 16 Dec 2020
27 Jun 2018 Trial Update Eli Lilly plans a phase III trial for Atopic Dermatitis(second-line therapy or greater)(NCT03559270) 13 Jul 2018
01 Jun 2018 Regulatory Status The US FDA assigns PDUFA action date of 01/06/2018 for baricitinib for Rheumatoid arthritis [19] 13 Jul 2018
16 May 2018 Trial Update Eli Lilly in collaboration with Incyte Corporation plans the BREEZE-AD4 phase III trial for Atopic Dermatitis (Combination therapy, Treatment-experienced) in May 2018 (700293018), (NCT03428100) 06 Jun 2018
06 Mar 2018 Trial Update Eli Lilly plans the phase III BREEZE-AD3 trial in Atopic dermatitis (PO) (NCT03334435) (700290169) 23 Apr 2018
20 Feb 2018 Trial Update Eli Lilly plans the BREEZE-AD5 phase III trial for Atopic Dermatitis in February 2018 (700293201), (NCT03435081) 13 Mar 2018
31 Jan 2018 Regulatory Status Incyte Corporation and Eli Lilly announces intention to resubmit NDA to US FDA for Rheumatoid arthritis before the end of January 2018 [22] 04 May 2018
13 Nov 2017 Trial Update Eli Lilly plans the phase III BREEZE-AD2 trial in Atopic dermatitis (NCT03334422) (700290167) 19 Dec 2017

Development History

Event Date Update Type Comment
11 Oct 2021 Phase Change - Preregistration Preregistration for Alopecia areata in European Union, prior to October 2021 (PO) [117] Updated 12 Oct 2021
30 Sep 2021 Scientific Update Efficacy and adverse events data from BRAVE-AA1 and BRAVE-AA2 clinical trials in Alopecia areata released by Eli Lilly and Company [121] Updated 12 Oct 2021
27 Sep 2021 Phase Change - III Phase-III clinical trials in COVID-2019 infections (In infants, In children, In adults, In adolescents) in Belgium (PO) (EudraCT2021-001338-21) Updated 07 Oct 2021
13 Sep 2021 Biomarker Update Biomarkers information updated Updated 17 Sep 2021
16 Aug 2021 Trial Update Eli Lilly and Company and Incyte Corporation completes BREEZE-AD5 phase III trial in Atopic dermatitis (Treatment-experienced) in USA, Canada, Puerto Rico (PO) (NCT03435081) Updated 31 Aug 2021
03 Aug 2021 Scientific Update Efficacy and safety data from phase III COV-BARRIER sub-study in COVID-2019 infections released by Eli Lilly and Company [103] Updated 06 Aug 2021
02 Aug 2021 Phase Change - Registered Registered for COVID-2019 infections (Monotherapy, In adolescents, In children, In adults, In the elderly) in USA (PO) [93] Updated 02 Aug 2021
30 Jul 2021 Phase Change - Preregistration Preregistration for Alopecia areata in Japan prior to July 2021 (PO) [118] Updated 08 Oct 2021
29 Jul 2021 Phase Change - Preregistration Preregistration for COVID-2019 infections (Monotherapy, In adolescents, In children, In adults, In the elderly) in USA (PO), prior to July 2021 [93] Updated 02 Aug 2021
16 Jul 2021 Regulatory Status PDUFA action date extended by US FDA for sNDA for Atopic dermatitis [74] Updated 20 Jul 2021
10 Jun 2021 Trial Update Eli Lilly and Company completes a COV-BARRIER in COVID-2019 infections in United Kingdom, Spain, Russia, Mexico, Mexico, Japan, Italy, Germany, Brazil, Argentina, USA, India, South Korea, Puerto Rico (NCT04421027) Updated 12 Jul 2021
02 Jun 2021 Scientific Update Additional efficacy data from the phase III RA-BEAM trial in Rheumatoid Arthritis presented at the 22nd Annual Congress of the European League Against Rheumatism (EULAR-2021) [45] Updated 06 Jul 2021
02 Jun 2021 Scientific Update Efficacy data from a phase II trial in Systemic lupus erythematosus presented at the 22nd Annual Congress of the European League Against Rheumatism (EULAR-2021) [143] Updated 27 Jun 2021
18 May 2021 Licensing Status Baricitinib non-exclusively licensed to Sun Pharmaceutical Industries in India [5] Updated 18 May 2021
17 May 2021 Licensing Status Baricitinib non-exclusively licensed to Natco Pharma in India [1] Updated 23 May 2021
11 May 2021 Licensing Status Baricitinib non-exclusively licensed to Dr. Reddy's Laboratories in India [2] Updated 19 May 2021
10 May 2021 Licensing Status Baricitinib non-exclusively licensed to Lupin in India [3] Updated 19 May 2021
10 May 2021 Licensing Status Baricitinib non-exclusively licensed to Cipla in India [4] Updated 13 May 2021
04 May 2021 Phase Change - Registered Registered for COVID-2019 infections (Combination therapy) in India (PO) for the Emergency Use Authorisation [100] Updated 09 May 2021
03 May 2021 Phase Change - Registered Registered for COVID-2019 infections in India under emergency use approval (PO) [99] Updated 07 May 2021
03 May 2021 Regulatory Status Natco Pharma announces intentions to submit compulsory license application to CDSCO for COVID-2019 infections [99] Updated 07 May 2021
29 Apr 2021 Regulatory Status EMA starts evaluation of an application to extend the use of baricitinib for COVID-2019 infections (In adolescents, In adults, In children) [101] Updated 21 May 2021
29 Apr 2021 Regulatory Status EMA will communicate on the outcome of its evaluation of application for COVID-2019 infections (In adolescents, In children, In adults) by July 2021 [101] Updated 09 May 2021
29 Apr 2021 Phase Change - Preregistration Preregistration for COVID-2019 infections (In adolescents, In children, In adults) in European Union (PO) [101] Updated 06 May 2021
23 Apr 2021 Phase Change - Preregistration Preregistration for COVID-2019 infections in Japan (PO) before April 2021 [97] [98] Updated 08 May 2021
23 Apr 2021 Phase Change - Registered Registered for COVID-2019 infections in Japan (PO) [97] [98] Updated 08 May 2021
21 Apr 2021 Regulatory Status Eli Lilly and Company announces intention to submit regulatory applications for Alopecia areata, Worldwide [120] Updated 22 Apr 2021
20 Apr 2021 Regulatory Status Eli Lilly and Company announces intention to submit sNDA to US FDA for alopecia areata in USA, in the H2 2021 [121] [120] Updated 12 Oct 2021
20 Apr 2021 Scientific Update Efficacy data from a phase II/III BRAVE-AA1 clinical trial in Alopecia areata released by Eli Lilly and Company [120] Updated 22 Apr 2021
20 Apr 2021 Scientific Update Efficacy data from a phase III BRAVE-AA2 clinical trial in Alopecia areata released by Eli Lilly and Company [120] Updated 22 Apr 2021
20 Apr 2021 Scientific Update Pooled efficacy and adverse events data from BRAVE-AA1 and BRAVE-AA2 clinical trials in Alopecia areata released by Eli Lilly and Company [120] Updated 22 Apr 2021
12 Apr 2021 Trial Update Mayo Clinic and Eli Lilly and Company completes a phase-II clinical trial in Giant cell arteritis (Adjunctive treatment) in USA (PO) (NCT03026504) Updated 13 Jul 2021
09 Apr 2021 Scientific Update Efficacy and adverse events data from a phase III COV-BARRIER trial in COVID-19 infections released by Eli Lilly and Company and Incyte [104] Updated 12 Apr 2021
30 Mar 2021 Trial Update University Hospital of Bordeaux plans a phase II trial for non-segmental Vitiligo (Combination therapy) in France (NCT04822584) Updated 16 Apr 2021
08 Mar 2021 Trial Update Eli Lilly and Company withdraws a phase II/III trial in COVID-2019 infections in the USA (NCT04340232) Updated 19 Mar 2021
03 Mar 2021 Scientific Update Efficacy and adverse events data from a phase III clinical trials in Alopecia areata released by Eli Lilly and Company [122] Updated 05 Mar 2021
01 Feb 2021 Financial Update Credit Suisse financial data update Updated 14 Mar 2021
31 Dec 2020 Trial Update Eli Lilly and Company initiates a phase III COV-BARRIER sub-study in COVID-2019 infections [103] Updated 06 Aug 2021
26 Dec 2020 Phase Change - Marketed Launched for Atopic dermatitis (Treatment-experienced) in Japan (PO) [70] Updated 12 Apr 2021
25 Dec 2020 Phase Change - Registered Registered for Atopic dermatitis (Treatment-experienced) in Japan (PO) [70] Updated 11 Feb 2021
16 Dec 2020 Phase Change - Marketed Launched for Atopic dermatitis (Combination therapy, Treatment-experienced) in Austria, Spain, Poland, Hungary, Netherlands, Belgium, United Kingdom, Greece, Ireland, Portugal, Finland, Germany, Sweden, Norway (PO) before December 2020 Updated 16 Dec 2020
16 Dec 2020 Phase Change - Marketed Launched for Rheumatoid arthritis (Combination therapy, Treatment-experienced) in Australia (PO) before December 2020 Updated 16 Dec 2020
16 Dec 2020 Phase Change - Marketed Launched for Rheumatoid arthritis (Monotherapy, Treatment-experienced) in Australia (PO) before December 2020 Updated 16 Dec 2020
16 Dec 2020 Phase Change - Marketed Launched for Rheumatoid arthritis (Treatment-experienced) in Switzerland (PO) before December 2020 Updated 16 Dec 2020
16 Dec 2020 Phase Change - Marketed Launched for Rheumatoid arthritis (Treatment-naive, Treatment-experienced) in Ireland, Portugal, Finland, Germany, Sweden, Denmark, France, Hungary, Netherlands, Belgium, United Kingdom, Greece, Poland, Austria, Spain, Norway (PO) before December 2020 Updated 16 Dec 2020
11 Dec 2020 Scientific Update Interim efficacy and adverse events data from a phase III ACTT-2trial in COVID-2019 infections released by Eli Lilly and Company and National Institute of Allergy and Infectious Diseases [114] [115] Updated 16 Dec 2020
01 Dec 2020 Phase Change - II Phase-II clinical trials in Polymyalgia rheumatica in France (PO, Tablet) (NCT04027101) Updated 14 Dec 2020
24 Nov 2020 Trial Update National Institute of Allergy and Infectious Diseases initiates a phase III ACTT-4 trial in COVID-2091 infections (Combination therapy) USA, Japan, South Korea, Mexico, Singapore (NCT04640168) Updated 30 May 2021
19 Nov 2020 Phase Change - Registered Registered (emergency use authorisation) for COVID-2019 infections (Combination therapy, In adolescents, In children, In adults) in USA (PO) [94] Updated 16 Dec 2020
19 Nov 2020 Regulatory Status The US FDA issues emergency use authorisation (EUA) for COVID-2019 infections (Combination therapy, In children, In adolescents, In adults) under the Coronavirus Treatment Acceleration Program (CTAP) [94] Updated 24 Nov 2020
19 Nov 2020 Scientific Update Efficacy and safety data from the phase III ACTT-II trial for COVID-2019 infections released by Eli Lilly [112] Updated 24 Nov 2020
02 Nov 2020 Scientific Update Efficacy and adverse events data from a post hoc analysis of a long term trial in Rheumatoid arthritis released by Eli Lilly [13] Updated 06 Nov 2020
02 Nov 2020 Scientific Update Pooled adverse events data from trials in Rheumatoid arthritis released by Eli Lilly [13] Updated 06 Nov 2020
02 Nov 2020 Scientific Update Pooled efficacy data from phase III trials in Rheumatoid arthritis released by Eli Lilly [13] Updated 06 Nov 2020
31 Oct 2020 Scientific Update Safety and efficacy data from the phase III BREEZE-AD3 trial in Atopic dermatitis released by Eli Lilly and Company [85] Updated 03 Nov 2020
30 Oct 2020 Scientific Update Updated interim efficacy and adverse events data from a phase II/III BRAVE-AA1 trial in Alopecia areata released by Eli Lilly and Company and Incyte Corporation [125] Updated 03 Nov 2020
27 Oct 2020 Phase Change - II/III Phase-II/III clinical trials in Aicardi-Goutieres-syndrome (In infants, In children, In adolescents, In adults, In the elderly) in Japan (PO, Suspension) (NCT04517253) Updated 06 May 2021
27 Oct 2020 Phase Change - II/III Phase-II/III clinical trials in Aicardi-Goutieres-syndrome (In infants, In children, In adolescents, In adults, In the elderly) in Japan (PO, Tablet) (NCT04517253) Updated 06 May 2021
27 Oct 2020 Phase Change - Preregistration Preregistration for COVID-2019 infections (Combination therapy, In children, In adolescents, In adults) in USA (PO) before October 2020 [71] Updated 16 Dec 2020
27 Oct 2020 Phase Change - II/III Phase-II/III clinical trials in Hereditary autoinflammatory diseases (In infants, In children, In adults, In adolescents, In the elderly) in Japan (PO, Tablet) (NCT04517253) Updated 01 Dec 2020
27 Oct 2020 Phase Change - II/III Phase-II/III clinical trials in Hereditary autoinflammatory diseases (In infants, In children, In adults, In the elderly, In adolescents) in Japan (PO, Suspension) (NCT04517253) Updated 01 Dec 2020
27 Oct 2020 Phase Change - Registered Registered for Atopic dermatitis (Combination therapy, Treatment-experienced) in Liechtenstein, Iceland, Norway, European Union (PO) before October 2020 [71] Updated 30 Oct 2020
27 Oct 2020 Regulatory Status Eli Lilly and Company files initial request for emergency use authorization (EUA) for COVID-2019 infections (Combination therapy, In children, In adolescents, In adults) in USA before October 2020 [71] Updated 30 Oct 2020
21 Oct 2020 Trial Update Eli Lilly and Company completes phase III clinical trials in Rheumatoid arthritis in Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, the United Kingdom, USA (PO, Tablet) (NCT01885078) Updated 18 Nov 2020
09 Oct 2020 Scientific Update Efficacy data from the phase III ACTT-II trial in COVID-2019 infections released by Eli Lilly [113] Updated 13 Oct 2020
18 Sep 2020 Regulatory Status Committee for Medicinal Products for Human Use (CHMP) issues positive opinion for approval of baricitinib for Atopic dermatitis in the European Union [72] Updated 21 Sep 2020
14 Sep 2020 Regulatory Status Eli Lilly announces intention to submit regulatory application to the US FDA for emergency use authorisation in COVID-2019 infections in USA [96] Updated 18 Sep 2020
14 Sep 2020 Scientific Update Efficacy data from the phase III ACTT-II trial in COVID-2019 infections released by Eli Lilly [111] [96] Updated 16 Sep 2020
18 Aug 2020 Trial Update Eli Lilly and Company plans a phase II/III trial in Herditary autoinflammatory diseases (In infants, In children, In adolescents, In adults, In the elderly) in Japan in September 2020 (PO. Tablet) (PO, Liquid) (NCT04517253) Updated 01 Dec 2020
31 Jul 2020 Trial Update National Institute of Allergy and Infectious Diseases completes phase III ACTT-2 trial in COVID-2019 infections (Combination therapy) in United Kingdom, Spain, Singapore, Mexico, South Korea, Denmark, Japan (PO) (NCT04401579) Updated 16 Dec 2020
15 Jul 2020 Trial Update National Institute of Allergy and Infectious Diseases completes enrolment in its phase III trial in COVID-2019 infections (Combination therapy) in United Kingdom, Spain, Singapore, Mexico, South Korea, Denmark, Japan (PO) (NCT04401579) Updated 18 Sep 2020
07 Jul 2020 Scientific Update Efficacy data from a clinical trial in COVID-19 infections released by Eli Lilly [107] Updated 12 Jul 2020
30 Jun 2020 Phase Change - Preregistration Preregistration for Atopic dermatitis (Treatment-experienced) in USA (PO) [75] Updated 13 Apr 2021
15 Jun 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections in India, South Korea, Puerto Rico (PO) (NCT04421027) Updated 16 Dec 2020
15 Jun 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections in USA (PO) (NCT04421027) [105] Updated 18 Jun 2020
12 Jun 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections in United Kingdom, Spain, Russia, Mexico, Mexico, Japan, Italy, Germany, Brazil and Argentina (PO) after June 2020 (NCT04421027) (EudraCT2020-001517-21) Updated 18 Sep 2020
11 Jun 2020 Trial Update Eli Lilly plans the COV-BARRIER phase III trial for COVID-19 Infection in USA, Germany, Mexico, and Spain, in May 2020 (NCT04421027) Updated 11 Jun 2020
10 Jun 2020 Scientific Update Efficacy and adverse events data from a phase III trial in Rheumatoid arthritis released by Eli Lilly and Company [31] Updated 15 Jun 2020
05 Jun 2020 Trial Update Eli Lilly and Company reinitiates a phase III trial in Uveitis (In infants, In adolescents, In children, Treatment experienced) in Spain, United Kingdom, France, Germany and Italy (PO) (NCT04088409) (EudraCT2019-000119-10) Updated 15 Jun 2020
03 Jun 2020 Scientific Update Interim efficacy and adverse events data from a phase II trial in systemic lupus erythematosus presented at the 21st Annual Congress of the European League Against Rheumatism (EULAR-2020) [144] Updated 12 Jul 2020
08 May 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Combination therapy) in United Kingdom, Spain, Singapore, Mexico, South Korea, Denmark, Japan (PO) (NCT04401579) Updated 16 Sep 2020
08 May 2020 Phase Change - II Phase II trials in COVID-2019 infections (Combination therapy) in USA (PO) [110] [69] (NCT04401579) Updated 10 May 2020
28 Apr 2020 Trial Update Eli Lilly and Company suspends the phase III trial in Uveitis (In infants, In adolescents, In children, Treatment experienced) in Spain, United Kingdom, France, Germany and Italy, due to the COVID-19 pandemic (PO) (NCT04088409) (EudraCT2019-000119-10) Updated 06 May 2020
10 Apr 2020 Trial Update Eli Lilly and Company in collaboration with National Institute of Allergy and Infectious Diseases plans a clinical trial for COVID-2019 infections in the USA (PO) in April 2020 [6] Updated 10 May 2020
10 Apr 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (PO) [6] Updated 14 Apr 2020
16 Mar 2020 Regulatory Status Baricitinib - Eli Lilly and Company/Incyte Corporation receives Breakthrough Therapy status for Alopecia areata in USA [119] Updated 19 Mar 2020
16 Mar 2020 Scientific Update Adverse events data from the phase II BRAVE-AA1 trial in Alopecia aerata released by Eli Lilly and Company [119] Updated 19 Mar 2020
13 Mar 2020 Scientific Update Pooled efficacy data from a phase III BREEZE-AD1 and BREEZE-AD2 trial in Atopic dermatitis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology [78] Updated 06 May 2020
10 Mar 2020 Phase Change - II Phase-II clinical trials in Myositis in United Kingdom (PO) (EudraCT2019-003868-42) Updated 16 Jun 2020
12 Feb 2020 Phase Change - III Phase-III clinical trials in Juvenile rheumatoid arthritis (In infants, In children, In adolescents) in Austria, Belgium, Brazil, Czech Republic, Denmark, France, Germany, India, Israel, Italy, Mexico, Poland, Russia, Spain, Turkey, United Kingdom (PO) (EudraCT2017-004495-60) (NCT04088396) Updated 13 Mar 2020
12 Feb 2020 Trial Update Eli Lilly initiates a phase III trial for Juvenile idiopathic arthritis (In infants, In children, In adolescents) in Argentina and Japan (PO) (EudraCT017-004495-60) (NCT04088396) Updated 13 Mar 2020
31 Jan 2020 Phase Change - Preregistration Preregistration for Atopic dermatitis (Combination therapy, Treatment-experienced) in Japan (PO) [69] Updated 10 May 2020
30 Jan 2020 Scientific Update Efficacy and adverse events data from the phase III BREEZE-AD5 trial in Atopic dermatitis released by Eli Lilly and Incyte [80] Updated 04 Feb 2020
27 Jan 2020 Regulatory Status Eli Lilly and Company announces intention to submit regulatory applications for approval in the US for Atopic dermatitis in 2020 [73] Updated 10 May 2020
27 Jan 2020 Phase Change - Preregistration Preregistration for Atopic dermatitis (Combination therapy, Treatment-experienced) in European Union (PO) [73] Updated 31 Jan 2020
27 Jan 2020 Scientific Update Efficacy and adverse events data from the phase III BREEZE-AD4 trial in Atopic dermatitis released by Eli Lilly and Company [73] Updated 29 Jan 2020
08 Nov 2019 Scientific Update Efficacy data from a phase III RA-BEACON trial in Rheumatoid arthritis presented at the 83rd American College of Rheumatology and the 54th Association of Rheumatology Health Professionals Annual Scientific Meeting (ACR/ARHP-2019) [57] Updated 11 Feb 2020
16 Oct 2019 Phase Change - III Phase-III clinical trials in Uveitis (In adolescents, In children, In infants, Treatment-experienced) in Italy (PO) (NCT04088409) Updated 06 May 2020
16 Oct 2019 Phase Change - III Phase-III clinical trials in Uveitis (In infants, In adolescents, In children, Treatment experienced) in Spain, United Kingdom, France, Germany (PO) (NCT04088409) (EudraCT2019-000119-10) Updated 29 Nov 2019
26 Sep 2019 Trial Update Eli Lilly and Company terminates a phase-II trial in in Primary biliary cirrhosis in Puerto Rico, USA, United Kingdom due to enrollment futility (PO) (NCT03742973) (EudraCT2018-003365-34) Updated 20 Oct 2020
17 Sep 2019 Trial Update Eli Lilly plans the phase III JUVE-BRIGHT trial for Juvenile rheumatoid arthritis (In children, In adolescents, Treatment-experienced) or Uveitis (In children, In adolescents, Treatment-experienced) in Germany (PO) (EudraCT2019-000119-10) (NCT04088409) Updated 08 Aug 2019
09 Sep 2019 Trial Update Eli Lilly initiates enrolment in the phase III SLE-BRAVE-X trial for Systemic lupus erythematosus (In adults, In the elderly, Treatment-experienced) in the USA (PO) (NCT03843125) Updated 25 Sep 2019
29 Aug 2019 Trial Update Eli Lilly and Incyte Corporation complete the phase III BREEZE-AD7 trial for Atopic dermatitis (Combination therapy, Treatment-experienced) in Argentina, Australia, Austria, Germany, Italy, Japan, Poland, South Korea, Spain and Taiwan (PO) (NCT03733301) Updated 30 Sep 2019
23 Aug 2019 Scientific Update Efficacy and adverse events data from the phase III BREEZE-AD7 trial in Atopic dermatitis released by Eli Lilly [83] Updated 27 Aug 2019
16 Aug 2019 Trial Update Eli Lilly and Company completes the phase-III BREEZE-AD1 trial in Atopic dermatitis (Treatment-experienced) in Czech Republic, Denmark, France, Germany, India, Italy, Japan, Mexico, Russia, Taiwan (NCT03334396) Updated 14 Oct 2019
14 Aug 2019 Trial Update Eli Lilly plans a phase III trial for Juvenile idiopathic arthritis (In infants, In children, In adolescents) in Germany and Belgium (PO) (EudraCT017-004495-60) Updated 20 Aug 2019
16 Jul 2019 Regulatory Status EMA approves Paediatric Investigation Plan (PIP) for baricitinib for Atopic dermatitis [77] Updated 03 Feb 2020
08 Jul 2019 Phase Change - III Phase-III clinical trials in Alopecia areata in Argentina, Australia, Brazil, China, Israel, South Korea (PO) (NCT03899259) Updated 27 Mar 2020
08 Jul 2019 Phase Change - III Phase-III clinical trials in Alopecia areata in USA, Taiwan, Puerto Rico, Japan (PO) (NCT03899259) Updated 24 Jul 2019
12 Jun 2019 Scientific Update Efficacy data from a phase II trial in Systemic lupus erythematosus presented at the 20th Annual Congress of the European League Against Rheumatism (EULAR-2019) [142] Updated 22 Jun 2019
12 Jun 2019 Scientific Update Efficacy data from the phase III RA-BEGIN trial in Rheumatoid arthritis presented at the 20th Annual Congress of the European League Against Rheumatism (EULAR-2019) [51] Updated 22 Jun 2019
12 Jun 2019 Scientific Update Interim efficacy data from a phase III RA-BEAM trial in rheumatoid arthritis were presented at the 20th Annual Congress of the European League Against Rheumatism (EULAR-2019) [44] Updated 22 Jun 2019
12 Jun 2019 Scientific Update Pharmacokinetics and safety data from a phase I trial in healthy volunteers presented at the 20th Annual Congress of the European League Against Rheumatism (EULAR-2019) [151] Updated 22 Jun 2019
30 Apr 2019 Licensing Status Incyte elects to no longer co-fund the development of baricitinib [9] Updated 07 May 2019
30 Apr 2019 Phase Change - Discontinued(Clinical) Discontinued - Clinical-Phase-Unknown for Psoriatic arthritis in USA (PO) [172] Updated 07 May 2019
08 Apr 2019 Phase Change - III Phase-III clinical trials in Systemic lupus erythematosus (In adults, In the elderly, Treatment-experienced) in Czech Republic (PO) after April 2019 (EudraCT2017-005028-11) Updated 25 Jul 2019
08 Apr 2019 Phase Change - III Phase-III clinical trials in Systemic lupus erythematosus (In adults, In the elderly, Treatment-experienced) in Hungary, Spain (PO) (EudraCT2017-005028-11) (NCT03843125) Updated 15 Jul 2019
05 Apr 2019 Phase Change - III Phase-III clinical trials in Juvenile rheumatoid arthritis (In infants, In children, In adolescents) in Australia, China (PO) after April 2019 (EudraCT2017-004471-31) (NCT03773965) Updated 13 Mar 2020
05 Apr 2019 Trial Update Eli Lilly and Company plans the phase III JUVE-X trial for Juvenile rheumatoid arthritis (In infants, In children, In adolescents) in Austria, Belgium, Czech Republic, Denmark, France, Germany, Israel, Italy, Mexico, Poland, Russia, Spain, Turkey and UK (PO) after April 2019 (NCT03773965) (EudraCT2017-004471-31) Updated 13 Mar 2020
05 Apr 2019 Phase Change - III Phase-III clinical trials in Juvenile rheumatoid arthritis (In adolescents, In children, In infants) in Argentina, Japan (PO) (NCT03773965) Updated 08 May 2019
04 Apr 2019 Trial Update Eli Lilly and Incyte plan the phase III BRAVE-AA2 trial for Alopecia areata in Argentina, Australia, Brazil, Israel, Japan, taiwan and USA (PO) (NCT03899259) Updated 24 Jul 2019
28 Mar 2019 Phase Change - II Phase-II clinical trials in Primary biliary cirrhosis in United Kingdom (PO) (EudraCT 2018-003365-34) Updated 01 Nov 2019
28 Mar 2019 Phase Change - II Phase-II clinical trials in Primary biliary cirrhosis in Puerto Rico, USA (PO) (NCT03742973) Updated 08 May 2019
19 Feb 2019 Trial Update Eli Lilly and Incyte Corporation plans the phase III SLE-BRAVE-X trial for Systemic lupus erythematosus in the US (NCT03843125) Updated 25 Sep 2019
05 Feb 2019 Scientific Update Topline adverse events data from the phase-III BREEZE-AD1 and BREEZE-AD2 trial in Atopic dermatitis released by Eli Lilly [88] Updated 06 Feb 2019
01 Jan 2019 Phase Change - III Phase-III clinical trials in Atopic dermatitis (In adolescents, In children) in United Kingdom, Argentina, Germany, Poland, Albania (PO) (NCT03952559) (EudraCT2018-000349-38) Updated 13 Jun 2019
01 Jan 2019 Phase Change - III Phase-III clinical trials in Atopic dermatitis (In children, In adolescents) in Spain (PO) (EudraCT2018-000349-38) (NCT03952559) Updated 19 Feb 2019
17 Dec 2018 Phase Change - III Phase-III clinical trials in Juvenile rheumatoid arthritis (In children, In adolescents, Treatment-experienced) in Japan (PO) (NCT03773978) Updated 22 Jan 2019
17 Dec 2018 Trial Update Eli Lilly and Company plans the JUVE-BASIS phase III trial for Juvenile Idiopathic Arthritis in Brazil, Germany, Japan, Mexico and Russia , (NCT03773978) Updated 21 Dec 2018
14 Dec 2018 Regulatory Status Baricitinib receives Fast Track designation for Systemic lupus erythematosus [PO] in USA [132] Updated 18 Dec 2018
12 Dec 2018 Trial Update Eli Lilly and Company plans the phase III JUVE-X trial for Juvenile rheumatoid arthritis (In infants, In children, In adolescents) in Argentina, Brazil, Japan and Mexico (PO, Tablet) (NCT03773965) (EudraCT2017-004471-31) Updated 08 May 2019
12 Dec 2018 Trial Update Eli Lilly completes a phase III trial in Atopic dermatitis in Argentina, Australia, Austria, Hungary, Israel, Japan, Poland, South Korea, Spain and Switzerland (PO) (NCT03334422) Updated 01 Feb 2019
10 Dec 2018 Phase Change - Marketed Launched for Rheumatoid arthritis (Treatment-experienced) in India (PO) Updated 16 Dec 2020
16 Nov 2018 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Combination therapy, Treatment-experienced) in Italy and Taiwan (PO) (NCT03733301) Updated 27 Aug 2019
16 Nov 2018 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Combination therapy, Treatment-experienced) in South Korea, Japan, Germany, Australia, Argentina (PO) (NCT03733301) (EudraCT2018-001726-26) Updated 07 Dec 2018
16 Nov 2018 Trial Update Eli Lilly and Company in collaboration with Incyte Corporation initiates enrolment in the BREEZE-AD7 trial for Atopic dermatitis (Combination therapy, Treatment-experienced) in Austria and Poland (NCT03733301) (EudraCT2018-001726-26) Updated 07 Dec 2018
15 Nov 2018 Trial Update Eli Lilly and Company plans a phase II trial for Primary biliary cirrhosis in USA and Puerto Rico (PO) (NCT03742973) Updated 08 May 2019
15 Nov 2018 Phase Change - Preclinical Preclinical trials in Primary biliary cirrhosis in Puerto Rico, USA (PO) (NCT03742973) Updated 23 Nov 2018
19 Oct 2018 Scientific Update Efficacy data from phase III RA-BEGIN trial in Rheumatoid arthritis presented at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting (ACR/ARHP-2018) [49] Updated 20 Nov 2018
19 Oct 2018 Scientific Update Adverse events data from pooled analysis in Rheumatoid arthritis presented at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting (ACR/ARHP-2018) [67] Updated 19 Nov 2018
25 Sep 2018 Trial Update Eli Lilly initiates enrolment in a phase III trial for Atopic dermatitis (Combination therapy) in Spain (EudraCT2018-001726-26) Updated 05 Oct 2018
24 Sep 2018 Phase Change - II/III Phase-II/III clinical trials in Alopecia areata in Mexico, South Korea (PO) (NCT03570749) Updated 27 Mar 2020
24 Sep 2018 Phase Change - II/III Phase-II/III clinical trials in Alopecia areata in USA, Japan, Puerto Rico (PO) (NCT03570749) Updated 11 Oct 2018
06 Sep 2018 Trial Update Eli Lilly and Company completes a compassionate use trial in Chronic atypical neutrophilic dermatosis with lipodystrophy, Juvenile dermatomyositis, Stimulator of interferon genes associated vasculopathy with onset during infancy and Aicardi-Goutières Syndromein USA and the UK as expanded of baricitinib is no longer available (NCT01724580) Updated 07 Feb 2020
02 Aug 2018 Phase Change - III Phase-III clinical trials in Systemic lupus erythematosus (In the elderly, Treatment-experienced, In adults) in United Kingdom, Taiwan, Russia, Swaziland, Netherlands, Mexico, Israel, Greece, Germany, Brazil, Belgium, China, Australia, and Austria (PO) (NCT03616912) Updated 19 Nov 2020
02 Aug 2018 Trial Update Eli Lilly and Company and Incyte Corporation initiate enrolment in the phase III BRAVE I trial for Systemic lupus erythematosus (In adults, In the elderly, Treatment-experienced) in Czech Republic and Hungary (PO) (NCT03616912) Updated 19 Nov 2020
02 Aug 2018 Trial Update Eli Lilly and Incyte Corporation initiates the phase III BRAVE II trial for Systemic lupus erythematosus in USA (PO) (NCT03616964) Updated 29 Aug 2018
02 Aug 2018 Phase Change - III Phase-III clinical trials in Systemic lupus erythematosus (In adults, In the elderly, Treatment-experienced) in USA (PO) (NCT03616912) Updated 22 Aug 2018
19 Jul 2018 Scientific Update Updated safety data from a phase II trial in Systemic lupur erythematosus released by Eli Lilly [141] Updated 23 Jul 2018
06 Jul 2018 Trial Update Eli Lilly initiates the phase III BREEZE-AD6 trial for Atopics dermatitis in USA (NCT03559270) Updated 13 Jul 2018
05 Jul 2018 Trial Update Eli Lilly and Incyte Corporation plans the phase II/III BRAVE-AA1 trial for Alopecia areata in September 2018 (PO) (NCT03570749) Updated 10 Oct 2018
30 Jun 2018 Phase Change - Marketed Launched for Rheumatoid arthritis (Treatment-naive, Treatment-experienced) in USA (PO) Updated 16 Dec 2020
25 Jun 2018 Trial Update Eli Lilly plans a phase III trial for Atopic Dermatitis(second-line therapy or greater)(NCT03559270) Updated 13 Jul 2018
13 Jun 2018 Scientific Update Efficacy and adverse events data from the phase III RA-BALANCE trial in Rheumatoid arthritis presented at the 19th Annual Congress of the European League Against Rheumatism (EULAR-2018) [32] Updated 10 Jul 2018
12 Jun 2018 Scientific Update Safety and efficacy data from a phase II trial in Systemic lupur erythematosus presented at the 19th Annual Congress of the European League Against Rheumatism (EULAR-2018) [140] Updated 13 Jul 2018
01 Jun 2018 Regulatory Status Eli Lilly plans to launch baricitinib in USA in second quarter of 2018 [14] Updated 16 Dec 2020
01 Jun 2018 Regulatory Status Baricitinib carries a boxed warning for the risk of serious infections, malignancies and thrombosis [14] Updated 13 Jul 2018
01 Jun 2018 Phase Change - Registered Registered for Rheumatoid arthritis (Treatment-naive, Treatment-experienced) in USA (PO) [14] Updated 05 Jun 2018
01 Jun 2018 Trial Update Eli Lilly/Incyte Corporation plans to conduct a randomised controlled clinical trial for Rheumatoid arthritis [14] Updated 05 Jun 2018
15 May 2018 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Combination therapy, Treatment-experienced) in Switzerland, France and in Finland (PO) after May 2018 (NCT03428100) Updated 31 Jan 2020
15 May 2018 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Combination therapy, Treatment-experienced) in Brazil, Belgium, Spain, Poland, Austria, Netherlands, United Kingdom (PO) (NCT03428100) (EudraCT2017-004574-34) Updated 06 Jun 2018
01 May 2018 Regulatory Status The US FDA assigns PDUFA action date of 01/06/2018 for baricitinib for Rheumatoid arthritis [19] Updated 13 Jul 2018
23 Apr 2018 Regulatory Status The US FDA's Arthritis Advisory Committee did not recommend approval of the 4mg dose of baricitinib for the treatment of Rheumatoid arthritis [20] Updated 30 Apr 2018
23 Apr 2018 Regulatory Status The US FDA's Arthritis Advisory Committee recommends approval of the 2mg dose of baricitinib for the treatment of Rheumatoid arthritis [20] Updated 30 Apr 2018
16 Mar 2018 Phase Change - III Phase-III clinical trials in Atopic dermatitis in Czech Republic, France, Germany, India, Ireland, Mexico, Russia, Spain, Swaziland, Switzerland, Taiwan, Italy (PO) (NCT03334435) (EudraCT 2017-000873-35) Updated 23 Apr 2018
16 Mar 2018 Trial Update Eli lilly initiates enrolment in a phase III trial in Atopic dermatitis in Argentina, Australia, Austria, Hungary, Israel, Japan, Poland, South Korea (PO) (NCT03334435) (EudraCT2017-000873-35) Updated 23 Apr 2018
20 Feb 2018 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Treatment-experienced) in USA, Canada, Puerto Rico (PO) (NCT03435081) Updated 13 Mar 2018
15 Feb 2018 Trial Update Eli Lilly plans the BREEZE-AD5 phase III trial for Atopic Dermatitis in February 2018 , (NCT03435081) Updated 13 Mar 2018
09 Feb 2018 Trial Update Eli Lilly in collaboration with Incyte Corporation plans the BREEZE-AD4 phase III trial for Atopic Dermatitis (Combination therapy, Treatment-experienced) in May 2018 , (NCT03428100) Updated 06 Jun 2018
31 Jan 2018 Regulatory Status The US FDA accepts resubmission of baricitinib for Rheumatoid arthritis for review [21] Updated 19 Feb 2018
23 Jan 2018 Phase Change - Registered Registered for Rheumatoid arthritis (Treatment-experienced, Combination therapy) in Australia (PO) [18] Updated 01 Feb 2018
23 Jan 2018 Phase Change - Registered Registered for Rheumatoid arthritis (Treatment-experienced, Monotherapy) in Australia (PO) [18] Updated 01 Feb 2018
26 Nov 2017 Trial Update Eli Lilly initiates enrolment in a phase III trial in Atopic dermatitis in Spain and Switzerland (PO) (NCT03334422) Updated 01 Feb 2019
26 Nov 2017 Phase Change - III Phase-III clinical trials in Atopic dermatitis in South Korea, Poland, Japan, Israel, Hungary, Canada, Austria, Australia, Argentina (PO) (NCT03334422) Updated 19 Dec 2017
23 Nov 2017 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Treatment-experienced) in Denmark, France, India, Italy, Russia (PO) (NCT03334396) Updated 06 Feb 2019
23 Nov 2017 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Treatment-experienced) in Japan (PO) (NCT03334396) Updated 21 Dec 2017
23 Nov 2017 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Treatment-experienced) in Taiwan, Mexico (PO) (NCT03334396) Updated 21 Dec 2017
23 Nov 2017 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Treatment-experienced) in Czech Republic (PO) (NCT03334396) (EudraCT2017-000870-12) Updated 21 Dec 2017
23 Nov 2017 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Treatment-experienced) in Germany (PO) (NCT03334396) Updated 21 Dec 2017
07 Nov 2017 Trial Update Eli Lilly plans the phase III BREEZE-AD3 trial in Atopic dermatitis (PO) (NCT03334435) Updated 23 Apr 2018
07 Nov 2017 Trial Update Eli Lilly plans the phase III BREEZE-AD2 trial in Atopic dermatitis (NCT03334422) Updated 19 Dec 2017
01 Nov 2017 Trial Update Eli Lilly completes a phase II trial in Systemic lupus erythematosus in USA, Argentina, Austria, France, Japan, South Korea, Mexico, Poland, Puerto Rico, Romania, Spain, Taiwan and Japan (NCT02708095) Updated 19 Dec 2017
01 Nov 2017 Trial Update Eli Lilly and Company completes a phase I bioequivalence trial in Healthy volunteers in Singapore (NCT03212638) Updated 13 Dec 2017
31 Oct 2017 Trial Update Eli Lilly plans to initiate the phase III programme for Psoriatic arthritis in 2018 [175] Updated 18 Sep 2020
14 Sep 2017 Scientific Update Adverse events and efficacy data from a phase II trial in atopic dermatitis released by Eli Lilly [91] (NCT02576938) Updated 18 Sep 2017
01 Sep 2017 Phase Change - Marketed Launched for Rheumatoid arthritis (Treatment-experienced) in Japan (PO) [10] Updated 14 Sep 2017
30 Aug 2017 Regulatory Status Incyte Corporation and Eli Lilly announces intention to resubmit NDA to US FDA for Rheumatoid arthritis before the end of January 2018 [22] Updated 04 May 2018
01 Aug 2017 Trial Update Eli Lilly is still planning a phase III trial for Psoriatic arthritis in USA, Spain and Germany [173] Updated 09 Aug 2017
25 Jul 2017 Regulatory Status Eli Lilly and Company announces delay in resubmission of NDA to the US FDA for Rheumatoid arthritis beyond 2017 [23] Updated 28 Jul 2017
03 Jul 2017 Phase Change - Registered Registered for Rheumatoid arthritis (Treatment-experienced) in Japan (PO) [11] Updated 04 Jul 2017
27 Jun 2017 Trial Update Eli Lilly and Company initiates enrolment in a phase I bioequivalence trial in Healthy volunteers in Singapore (NCT03212638) Updated 18 Jul 2017
14 Jun 2017 Scientific Update Updated efficacy data from a phase III long-term extension trial in Rheumatoid arthritis presented at the 18th Annual Congress of the European League Against Rheumatism (EULAR-2017) Updated 23 Jul 2017
14 Jun 2017 Scientific Update Updated efficacy data from a phase III long-term extension trial in Rheumatoid arthritis presented at the 18th Annual Congress of the European League Against Rheumatism (EULAR-2017) [176] Updated 22 Jul 2017
01 Jun 2017 Phase Change - Registered Registered for Rheumatoid arthritis (Treatment-experienced) in Switzerland (PO) [11] Updated 04 Jul 2017
01 Jun 2017 Phase Change - Registered Registered for Rheumatoid arthritis in Kuwait (PO) [11] Updated 04 Jul 2017
01 May 2017 Trial Update Eli Lilly completes a phase III trial in Rheumatoid arthritis (Adjunctive treatment) in China (PO), Brazil (PO), Argentina (PO) (NCT02265705) Updated 21 Dec 2017
14 Apr 2017 Regulatory Status Elli Lilly and Incyte receive complete response letter from the FDA for baricitinib in Rheumatoid arthritis [24] Updated 17 Apr 2017
09 Mar 2017 Phase Change - II Phase-II clinical trials in Giant cell arteritis (Adjunctive treatment) in USA (PO) (NCT03026504) Updated 26 Apr 2017
01 Mar 2017 Trial Update Eli Lilly completes a phase II trial in Atopic dermatitis in USA and Japan (PO) (NCT02576938) Updated 21 Mar 2017
15 Feb 2017 Scientific Update Updated efficacy and adverse events data from the phase III RA-BEAM trial released by Eli Lilly and Incyte Corporation [37] Updated 21 Feb 2017
13 Feb 2017 Phase Change - Registered Registered for Rheumatoid arthritis (Treatment-naive, Treatment-experienced) in European Union, Norway, Iceland and Liechtenstein (PO) - First global approval [15] Updated 14 Feb 2017
11 Feb 2017 Regulatory Status Baricitinib - Eli Lilly and Company/Incyte Corporation receives Orphan Drug status for Systemic lupus erythematosus (In children) in USA [134] Updated 03 Feb 2020
19 Jan 2017 Trial Update Mayo Clinic and Eli Lilly plan a phase II trial for Giant cell arteritis (Adjunctive treatment) in USA (PO, Tablet) (NCT03026504) Updated 31 Jan 2017
17 Jan 2017 Phase Change Investigation in Giant cell arteritis in USA (PO) before January 2017 Updated 01 Feb 2017
13 Jan 2017 Phase Change Investigation in Psoriatic arthritis in USA (PO) [25] Updated 20 Jan 2017
13 Jan 2017 Regulatory Status PDUFA action date extended by US FDA for NDA for Rheumatoid arthritis (Treatment-experienced, Treatment-naive) by three months [25] Updated 17 Jan 2017
13 Jan 2017 Trial Update Eli Lilly and Incyte plan a phase III trial for Psoriatic arthritis [25] Updated 17 Jan 2017
22 Dec 2016 Phase Change - Discontinued(II) Discontinued - Phase-II for Diabetic nephropathies in USA, Japan, Mexico, Puerto Rico (PO) Updated 22 Dec 2016
22 Dec 2016 Phase Change - Discontinued(II) Discontinued - Phase-II for Psoriasis in Puerto Rico, Canada, Japan, USA (PO) Updated 22 Dec 2016
21 Dec 2016 Phase Change - Discontinued(I) Discontinued - Phase-I for Rheumatoid arthritis (In volunteers) in Singapore (PO, Tablet; PO, Capsule) Updated 22 Dec 2016
16 Dec 2016 Regulatory Status The Committee for Medicinal Products for Human Use recommends approval of baricitinib for Rheumatoid Arthritis (Treatment-experienced, Treatment-naive) in European Union [12] Updated 19 Dec 2016
14 Nov 2016 Scientific Update Pooled results from the RA-BUILD and RA-BEAM trials presented at the 80th American College of Rheumatology and the 51st Annual Meeting of the Association of Rheumatology and Health Professionals (ACR/ARHP-2016) [177] Updated 03 Jan 2017
14 Nov 2016 Scientific Update Updated efficacy and adverse events data from the phase III RA-BEAM trial in Rheumatoid arthritis released by Eli Lilly and Incyte [38] Updated 06 Dec 2016
11 Nov 2016 Scientific Update Pooled analyses of pharmacodynamics data from phase II and III studies in Rheumatoid arthritis presented at the 80th American College of Rheumatology and the 51st Annual Meeting of the Association of Rheumatology and Health Professionals (ACR/ARHP-2016) [30] Updated 22 Feb 2017
02 Nov 2016 Scientific Update Updated efficacy and adverse events data from the phase III RA-BEACON trial in Rheumatoid arthritis released by Eli Lilly [178] Updated 15 Nov 2016
12 Oct 2016 Trial Update Eli Lilly completes enrolment in a phase II trial in Atopic dermatitis in USA and Japan (PO) (NCT02576938) Updated 21 Dec 2016
01 Jul 2016 Trial Update Eli Lilly completes a phase I trial in Healthy volunteers in China (PO) (NCT02758613) Updated 12 Sep 2016
09 Jun 2016 Scientific Update Efficacy and adverse events data from the RA-BEYOND phase III trial in Rheumatoid arthritis presented at the 17th Annual Congress of the European League Against Rheumatism (EULAR-2016) [34] Updated 15 Jun 2016
09 Jun 2016 Scientific Update Final efficacy and safety data from the phase III trials, RA-BEAM and RA-BEGIN in Rheumatoid arthritis were presented at the 17th Annual Congress of the European League Against Rheumatism (EULAR - 2016) [36] Updated 14 Jun 2016
01 May 2016 Trial Update Eli Lilly initiates a phase I trial in Healthy volunteers in China (PO) (NCT02758613) Updated 09 May 2016
31 Mar 2016 Phase Change - Preregistration Preregistration for Rheumatoid arthritis (Treatment-experienced, Treatment-naive) in Japan (PO) before March 2016 [12] Updated 20 Dec 2016
31 Mar 2016 Scientific Update Final efficacy and adverse events data from the phase-III RA-BEACON trial in Rheumatoid arthritis released by Eli Lilly [179] Updated 15 Apr 2016
10 Mar 2016 Trial Update Eli Lilly plans a phase II trial for Systemic lupus erythematosus in Argentina, Austria, France, Japan, South Korea, Mexico, Poland, Romania, Spain, Taiwan and USA (PO) (NCT02708095) Updated 17 Mar 2016
01 Mar 2016 Phase Change - II Phase-II clinical trials in Systemic lupus erythematosus in Japan, Taiwan (PO) (NCT02708095) Updated 12 Sep 2016
01 Mar 2016 Phase Change - II Phase-II clinical trials in Systemic lupus erythematosus in Argentina, Austria, France, Mexico, Poland, Puerto Rico, Romania, South Korea, Spain and USA (PO) (NCT02708095) Updated 23 May 2016
11 Feb 2016 Phase Change - Preregistration Preregistration for Rheumatoid arthritis (Treatment-experienced, Treatment-naive) in European Union (PO) [17] Updated 24 Feb 2016
11 Feb 2016 Regulatory Status Eli Lilly expects to launch Baricitinib for Rheumatoid arthritis in the US and Europe in early 2017 [17] Updated 24 Feb 2016
01 Feb 2016 Phase Change - II Phase-II clinical trials in Atopic dermatitis in Japan (PO) (NCT02576938) Updated 22 Dec 2016
01 Feb 2016 Phase Change - II Phase-II clinical trials in Atopic dermatitis in USA (PO) (NCT02576938) Updated 18 Feb 2016
19 Jan 2016 Phase Change - Preregistration Preregistration for Rheumatoid arthritis (Treatment-experienced, Treatment-naive) in USA (PO) [26] Updated 21 Jan 2016
11 Jan 2016 Regulatory Status Eli Lilly intends to submit MAA to EMA [27] Updated 15 Jan 2016
11 Jan 2016 Regulatory Status Eli Lilly intends to submit NDA to the US FDA [27] Updated 15 Jan 2016
01 Dec 2015 Phase Change - No development reported(II) No development reported - Phase-II for Rheumatoid arthritis (Treatment-experienced) in Japan (PO) Updated 15 Feb 2017
07 Nov 2015 Scientific Update Efficacy and adverse events data from the phase III RA-BEAM trial in Rheumatoid arthritis presented at the 79th American College of Rheumatology and the 50th Annual Meeting of the Association of Rheumatology and Health Professionals (ACR/ARHP-2015) [39] Updated 02 Dec 2015
07 Nov 2015 Scientific Update Adverse events data from a phase III trial in Rheumatoid arthritis released by Eli Lilly [46] Updated 13 Nov 2015
23 Oct 2015 Trial Update Eli Lilly plans a phase II trial for Atopic dermatitis in USA and Japan (PO) (NCT02576938) Updated 23 Oct 2015
14 Oct 2015 Scientific Update Efficacy and adverse events data from a phase III RA-BEAM trial in Rheumatoid arthritis released by Eli Lilly and Incyte Corporation [40] Updated 21 Oct 2015
09 Oct 2015 Phase Change - No development reported(II) No recent reports on development identified - Phase-II for Rheumatoid arthritis in Ukraine (PO) Updated 09 Oct 2015
29 Sep 2015 Trial Update Eli Lilly completes the phase III RA-BEAM trial in Rheumatoid arthritis in USA, Canada, Puerto Rico, Argentina, Mexico, South Africa, the UK, Belgium, Netherlands, Croatia, Czech Republic, France, Germany, Greece, Hungary, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Switzerland, Russia, China, Japan, South Korea and Taiwan (NCT01710358) Updated 10 Nov 2015
29 Sep 2015 Scientific Update Interim adverse events data from the phase III RA-BEGIN trial in Rheumatoid arthritis released by Eli Lilly [47] Updated 22 Oct 2015
13 Aug 2015 Active Status Review Phase-II development is ongoing in Diabetic nephropathies Updated 13 Aug 2015
13 Aug 2015 Active Status Review Phase-II development is ongoing in Psoriasis Updated 13 Aug 2015
01 Aug 2015 Trial Update Eli Lilly completes a phase III RA-BEGIN trial in Rheumatoid arthritis in World (NCT01711359) Updated 03 Nov 2015
08 May 2015 Trial Update Eli Lilly completes enrolment in the phase III RA-BEAM trial for Rheumatoid arthritis in USA, Canada, Puerto Rico, Argentina, Mexico, South Africa, European Union, Switzerland, Russia, China, Japan, South Korea and Taiwan (NCT01710358) Updated 13 Aug 2015
08 May 2015 Trial Update Eli Lilly completes enrolment in the phase III RA-BEGIN trial for Rheumatoid arthritis (Treatment-naive) in USA, Canada, Mexico, Argentina, Brazil, Puerto Rico, European Union, South Africa, Japan, South Korea, Russia and India (NCT01711359) Updated 13 Aug 2015
23 Feb 2015 Scientific Update Efficacy and adverse events data from the RA-BUILD phase III trial in Rheumatoid arthritis released by Eli Lilly and Company [54] Updated 27 Feb 2015
17 Feb 2015 Patent Information Incyte has patent protection for baricitinib in USA, European Union and Japan (Incyte 10-K, February 2015) Updated 07 Dec 2015
17 Feb 2015 Patent Information Incyte has patents pending for baricitinib in USA, European Union and Japan (Incyte 10-K, February 2015) Updated 07 Dec 2015
01 Feb 2015 Trial Update Eli Lilly completes a phase I trial in Healthy volunteers in United Kingdom (NCT02340104) Updated 05 Mar 2015
01 Jan 2015 Trial Update Eli Lilly initiates enrolment in a phase I relative bioavailability trial in volunteers in United Kingdom (NCT02340104) Updated 03 Feb 2015
31 Dec 2014 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-naive) in Argentina, Austria, Belgium, Canada, Germany, Greece, India, Italy, Japan, South Korea, South Africa, Mexico, Portugal, Puerto Rico and Russia (PO) Updated 13 Aug 2015
13 Dec 2014 Trial Update Eli Lilly plans a phase I relative bioavailability trial in volunteers in United Kingdom (NCT02340104) Updated 20 Jan 2015
09 Dec 2014 Scientific Update Top-line efficacy and adverse events data from the phase III RA-BEACON trial in Rheumatoid arthritis released by Eli Lilly and Incyte Corporation [56] Updated 11 Dec 2014
01 Dec 2014 Trial Update Eli Lilly completes a phase I trial in Healthy volunteers in Japan (NCT02263911) Updated 31 May 2016
01 Dec 2014 Trial Update Eli Lilly completes the phase III RA-BUILD trial in Rheumatoid arthritis in the US, the UK, Argentina, Australia, Belgium, Canada, Croatia, Czech Republic, Germany, Hungary, Italy, India, Japan, Mexico, Puerto Rico, Portugal, Poland, Romania, Russia, Slovakia, Spain, South Korea and Taiwan (NCT01721057) Updated 09 Jan 2015
01 Nov 2014 Trial Update Eli Lilly and Incyte Corporation completes a phase II trial in Diabetic nephropathies in USA, Mexico, Puerto Rico and Japan (NCT01683409) Updated 31 Dec 2014
01 Nov 2014 Trial Update Eli Lilly initiates enrolment in a phase I trial for Healthy volunteers in Japan (NCT02263911) Updated 31 Dec 2014
08 Oct 2014 Trial Update Eli Lilly plans a phase I bioavailability trial for Healthy volunteers in Japan (NCT02263911) Updated 11 Nov 2014
01 Oct 2014 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Adjunctive treatment) in China (PO), Brazil (PO), Argentina (PO) (NCT02265705) Updated 21 Dec 2017
01 Oct 2014 Trial Update Eli Lilly initiates enrolment in a phase III trial for Rheumatoid arthritis in Argentina (NCT02265705) Updated 13 Nov 2014
01 Sep 2014 Trial Update Eli Lilly completes the phase III RA-BEACON trial in Rheumatoid arthritis (Treatment-experienced) in USA, Canada, Argentina, Mexico, Puerto Rico, Australia, Japan, South Korea, United Kingdom, Austria, Belgium, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, South Africa, Spain, Switzerland, Turkey, Israel and India (NCT01721044) Updated 07 Oct 2014
01 Aug 2014 Trial Update Eli Lilly completes a phase II trial in Psoriasis in USA, Canada, Japan and Puerto Rico (NCT01490632) Updated 06 Nov 2014
07 Apr 2014 Trial Update Eli Lilly & Incyte Corporation complete enrolment in a phase II trial for Diabetic nephropathies in USA, Mexico, Puerto Rico & Japan(NCT01683409) Updated 02 May 2014
31 Dec 2013 Trial Update Eli Lilly completes phase I pharmacokinetic trials in healthy volunteers in United Kingdom (NCT01960140, NCT01968057) Updated 03 Feb 2014
01 Dec 2013 Trial Update Eli Lilly completes a phase II trial in Rheumatoid arthritis in Japan (NCT01469013) Updated 09 May 2014
01 Nov 2013 Trial Update Eli Lilly completes phase I drug interaction trials in healthy volunteers in the United Kingdom (NCT01924299, NCT01925144) Updated 02 Dec 2013
31 Oct 2013 Trial Update Eli Lilly initiates a phase I drug-interaction trial in healthy volunteers in United Kingdom (NCT01968057) Updated 01 Nov 2013
18 Oct 2013 Trial Update Eli Lilly completes a phase I drug interaction trial in Healthy volunteers in United Kingdom (NCT01896726) Updated 12 Nov 2013
01 Oct 2013 Phase Change - No development reported(I) No development reported - Phase-I for Rheumatoid arthritis (In volunteers) in Singapore (PO, Tablet; PO, Capsule) Updated 22 Dec 2016
01 Oct 2013 Trial Update Eli Lilly initiates enrolment in a phase I pharmacokinetics trial in healthy volunteers in the United Kingdom(NCT01960140) Updated 29 Nov 2013
01 Oct 2013 Trial Update Eli Lilly completes a phase I drug interaction trial in Healthy volunteers in United Kingdom (NCT01910311) Updated 15 Nov 2013
13 Sep 2013 Trial Update Eli Lilly initiates a phase I drug-interaction trial in healthy volunteers in United Kingdom (NCT01937026) Updated 23 Sep 2013
01 Sep 2013 Trial Update Eli Lilly completes a phase I drug-interaction trial in healthy volunteers in United Kingdom (NCT01937026) Updated 09 Dec 2013
31 Aug 2013 Trial Update Eli Lilly completes a phase I drug-interaction trial in healthy volunteers in United Kingdom (NCT01859078) Updated 04 Sep 2013
14 Aug 2013 Trial Update Eli Lilly plans a phase I drug interaction trial in Healthy volunteers in United Kingdom (NCT01924299) Updated 20 Aug 2013
07 Aug 2013 Trial Update Eli Lilly initiates a phase I drug interaction trial in Healthy volunteers in United Kingdom (NCT01910311) Updated 21 Aug 2013
31 Jul 2013 Trial Update Eli Lilly initiates a phase I drug interaction trial in Healthy volunteers in United Kingdom (NCT01896726) Updated 21 Aug 2013
01 Jul 2013 Phase Change - Discontinued(II) Discontinued - Phase-II for Rheumatoid arthritis (Treatment-experienced) in Czech Republic (PO) Updated 15 Feb 2017
01 Jul 2013 Phase Change - Discontinued(II) Discontinued - Phase-II for Rheumatoid arthritis (Treatment-experienced) in USA (PO) Updated 15 Feb 2017
01 Jul 2013 Trial Update Eli Lilly completes a phase I pharmacokinetics trial in healthy volunteers in USA (NCT01870388) Updated 16 Sep 2013
30 Jun 2013 Trial Update Eli Lilly initiates enrolment in the phase III RA-BEYOND extension trial for Rheumatoid arthritis in USA (NCT01885078) Updated 15 Jul 2013
27 Jun 2013 Trial Update Eli Lilly and Company initiates phase III clinical trials in Rheumatoid arthritis in Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, the United Kingdom (PO, Tablet) after June 2013 (NCT01885078) Updated 18 Nov 2020
25 Jun 2013 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-naive) in United Kingdom, Germany, Portugal, Sweden, Russia and Japan (PO) (RA-BEGIN; NCT01711359) Updated 25 Jun 2013
14 Jun 2013 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in United Kingdom and Slovenia (PO) Updated 13 Aug 2015
14 Jun 2013 Phase Change - III Phase-III clinical trials (RA-BEACON) in Rheumatoid arthritis (Treatment-experienced) in Switzerland, Denmark and Turkey (PO) Updated 15 Jul 2013
14 Jun 2013 Phase Change - III Phase-III clinical trials (RA-BEAM) in Rheumatoid arthritis (Treatment-experienced) in Romania, Croatia & Lithuania (PO) Updated 15 Jul 2013
14 Jun 2013 Phase Change - III Phase-III clinical trials (RA-BUILD) in Rheumatoid arthritis (Treatment-experienced) in Russia (PO) Updated 15 Jul 2013
13 Jun 2013 Scientific Update 52-week efficacy and adverse events data from a phase IIb trial in Rheumatoid arthritis presented at the 14th Annual Congress of the European League Against Rheumatism (EULAR-2013) [60] Updated 25 Jun 2013
01 May 2013 Trial Update Eli Lilly and InCyte Corporation complete a phase I trial in Healthy volunteers in USA (NCT01536951) Updated 17 Jun 2013
31 Jan 2013 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Japan (PO)(NCT01721044) Updated 25 Jun 2018
14 Jan 2013 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Spain (PO) Updated 13 Feb 2013
10 Jan 2013 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Slovakia (PO) Updated 13 Feb 2013
10 Jan 2013 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Poland (PO) Updated 13 Feb 2013
01 Jan 2013 Trial Update Eli Lilly initiates enrolment in the global RA-BEACON trial for Rheumatoid arthritis (Treatment-experienced) in USA, Canada, Argentina, Mexico, Puerto Rico, Australia, Japan, South Korea, United Kingdom, Austria, Belgium, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, South Africa, Spain, Switzerland, Turkey, Israel and India (NCT01721044) Updated 13 Feb 2013
24 Dec 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Brazil (PO) Updated 13 Feb 2013
21 Dec 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Netherlands (PO) Updated 13 Feb 2013
21 Dec 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Argentina (PO) Updated 13 Feb 2013
21 Dec 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Australia (PO) Updated 13 Feb 2013
21 Dec 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Austria (PO) Updated 13 Feb 2013
21 Dec 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Canada (PO) Updated 13 Feb 2013
21 Dec 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in India (PO) Updated 13 Feb 2013
21 Dec 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Israel (PO) Updated 13 Feb 2013
21 Dec 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Italy (PO) Updated 13 Feb 2013
21 Dec 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Mexico (PO) Updated 13 Feb 2013
01 Dec 2012 Trial Update Eli Lilly initiates enrolment the global phase III RA-BUILD trial for Rheumatoid arthritis (NCT01721057) Updated 13 Feb 2013
15 Nov 2012 Trial Update Eli Lilly and Incyte Corporation plan a global phase III extension trial for Rheumatoid arthritis [28] Updated 21 Nov 2012
14 Nov 2012 Scientific Update Efficacy and adverse events data from a phase IIb trial in Rheumatoid arthritis presented at the 76th American College of Rheumatology and the 47th Annual Meeting of the Association of Rheumatology and Health Professionals (ACR/ARHP-2012) [180] Updated 28 Nov 2012
12 Nov 2012 Trial Update Eli Lilly and Company initiates enrolment in a compassionate use trial in Chronic atypical neutrophilic dermatosis with lipodystrophy, Juvenile dermatomyositis, Stimulator of interferon genes associated vasculopathy with onset during infancy and Aicardi-Goutières Syndromein USA and UK (NCT01724580) Updated 07 Feb 2020
09 Nov 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Puerto Rico (PO) Updated 21 Nov 2012
09 Nov 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in South Africa (PO) Updated 21 Nov 2012
09 Nov 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Taiwan (PO) Updated 21 Nov 2012
09 Nov 2012 Trial Update Eli Lilly plans the global phase III RA-BUILD trial for Rheumatoid arthritis (NCT01721057) Updated 21 Nov 2012
09 Nov 2012 Trial Update Eli Lilly plans the global phase III RA-BEACON trial for Rheumatoid arthritis (NCT01721044) Updated 21 Nov 2012
05 Nov 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Latvia, Greece, France, Belgium (PO) Updated 13 Feb 2013
05 Nov 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in USA (PO) Updated 21 Nov 2012
05 Nov 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in South Korea (PO) Updated 06 Nov 2012
05 Nov 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in USA (PO) Updated 06 Nov 2012
02 Nov 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Czech Republic (PO) Updated 13 Feb 2013
02 Nov 2012 Phase Change - III Phase-III clinical trials in Rheumatoid arthritis (Treatment-experienced) in Hungary (PO) Updated 13 Feb 2013
31 Aug 2012 Phase Change - II Phase-II clinical trials in Diabetic nephropathies in Mexico & Japan (PO) Updated 02 May 2014
31 Aug 2012 Phase Change - II Phase-II clinical trials in Diabetic nephropathies in Puerto Rico (PO) Updated 01 Oct 2012
31 Aug 2012 Phase Change - II Phase-II clinical trials in Diabetic nephropathies in USA (PO) Updated 01 Oct 2012
02 Aug 2012 Trial Update Incyte Corporation plans phase III development for Rheumatoid arthritis [42] Updated 01 Oct 2012
01 Jul 2012 Phase Change - No development reported(II) No development reported - Phase-II for Rheumatoid arthritis (Treatment-experienced) in Czech Republic (PO) Updated 15 Feb 2017
01 Jul 2012 Phase Change - No development reported(II) No development reported - Phase-II for Rheumatoid arthritis (Treatment-experienced) in USA (PO) Updated 15 Feb 2017
08 Jun 2012 Scientific Update Safety and efficacy data from a phase IIb JADA trial in Rheumatoid arthritis presented at the 13th Annual Congress of the European League Against Rheumatism (EULAR-2012) [59] Updated 12 Jun 2012
26 Apr 2012 Trial Update Eli Lilly completes a phase IIb trial in Rheumatiod arthritis in USA, Europe, South America and India Updated 02 May 2012
16 Apr 2012 Phase Change - II Phase-II clinical trials in Psoriasis in Canada (PO) Updated 02 May 2012
16 Apr 2012 Phase Change - II Phase-II clinical trials in Psoriasis in Japan (PO)(NCT01721044) Updated 02 May 2012
16 Apr 2012 Phase Change - II Phase-II clinical trials in Psoriasis in Puerto Rico (PO) Updated 02 May 2012
29 Feb 2012 Trial Update Eli Lilly and InCyte Corporation initiates enrolment in a phase I trial in Healthy volunteers in USA (NCT01536951) Updated 08 Mar 2012
30 Nov 2011 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis in Japan (PO) Updated 20 Jan 2012
01 Nov 2011 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis (Treatment-experienced) in Japan (PO) (NCT01469013) Updated 15 Feb 2017
11 Oct 2011 Trial Update Eli Lilly and Incyte Corporation complete enrolment in their phase II trial for Rheumatoid arthritis in Croatia, Czech Republic, Hungary, India, Mexico, Poland, Romania, Ukraine and USA (NCT01185353) Updated 02 Nov 2011
12 Sep 2011 Trial Update Eli Lilly completes a phase I trial in Rheumatoid arthtitis (in healthy volunteers) in Singapore (NCT01398475) Updated 26 Sep 2011
01 Jul 2011 Phase Change - I Phase-I clinical trials in Rheumatoid arthritis in Singapore (PO) Updated 01 Aug 2011
01 Jul 2011 Trial Update Eli Lilly initiates enrolment in a phase I trial for Rheumatoid arthritis in Singapore (NCT01398475) Updated 01 Aug 2011
16 Jun 2011 Phase Change - II Phase-II clinical trials in Psoriasis in USA (PO) Updated 06 Jul 2011
16 May 2011 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis in Ukraine (PO) Updated 26 May 2011
12 May 2011 Trial Update Eli Lilly completes a phase I trial in Healthy volunteers in USA (NCT01247350) Updated 26 May 2011
19 Apr 2011 Trial Update Eli Lilly completes enrolment in its phase I trial in Healthy volunteers in USA (NCT01247350) Updated 05 May 2011
10 Apr 2011 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis in Argentina (PO) Updated 05 May 2011
10 Apr 2011 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis in India (PO) Updated 05 May 2011
10 Apr 2011 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis in Mexico (PO) Updated 05 May 2011
31 Mar 2011 Trial Update Eli Lilly completes a phase I trial in Healthy volunteers in USA (NCT01299285) Updated 08 Apr 2011
16 Feb 2011 Trial Update Eli Lilly initiates enrolment in a phase I trial in Healthy volunteers in USA (NCT01299285) Updated 07 Mar 2011
17 Nov 2010 Trial Update Eli Lilly initiates enrolment in a phase I trial in Healthy volunteers in USA [NCT01247350] Updated 15 Dec 2010
11 Nov 2010 Scientific Update Final efficacy and adverse events data from a phase II trial in Rheumatoid arthritis presented at the 74th Annual Scientific Meeting of the American College of Rheumatology and the 45th Annual Meeting of the Association of Rheumatology Health Professionals (ACR/ARHP-2010) [64] Updated 08 Dec 2010
10 Nov 2010 Licensing Status Incyte and Eli Lilly agree to co-develop LY 3009104 worldwide for Rheumatoid arthritis [8] Updated 11 Nov 2010
21 Oct 2010 Trial Update Eli Lilly initiates enrolment in a phase IIb trial in Rheumatoid arthritis in USA [NCT01185353] Updated 21 Oct 2010
31 Jul 2010 Trial Update Incyte completes a phase II trial in Rheumatoid arthritis in USA and Czech Republic [NCT00902486] Updated 13 Jan 2011
12 May 2010 Scientific Update Interim 12-week efficacy and adverse event data from a phase II trial in Rheumatoid arthritis released by Incyte Corporation [65] Updated 12 May 2010
25 Feb 2010 Trial Update Incyte completes enrolment in the phase II trial in Rheumatoid arthritis in the US Updated 25 Feb 2010
23 Dec 2009 Licensing Status INCB 28050 and follow-on JAK1/JAK2 inhibitors licensed exclusively to Eli Lilly worldwide, for inflammatory and autoimmune diseases [7] Updated 23 Dec 2009
31 May 2009 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis in Croatia (PO) Updated 02 May 2012
31 May 2009 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis in Czech Republic (PO) Updated 02 May 2012
31 May 2009 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis in Hungary (PO) Updated 02 May 2012
31 May 2009 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis in Poland (PO) Updated 02 May 2012
31 May 2009 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis in Czech Republic (PO) Updated 11 Nov 2010
31 May 2009 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis in USA (PO) Updated 17 Aug 2009
01 May 2009 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis (Treatment-experienced) in Czech Republic (PO) (NCT00902486) Updated 15 Feb 2017
01 May 2009 Phase Change - II Phase-II clinical trials in Rheumatoid arthritis (Treatment-experienced) in USA (PO) (NCT00902486) Updated 15 Feb 2017
29 Oct 2008 Scientific Update Pharmacodynamics and pharmacokinetics data from a Preclinical trial in Rheumatoid arthritis presented at the 72nd Annual Scientific Meeting of the American College of Rheumatology and the 43rd Annual Meeting of the Association of Rheumatology Health Professionals (ACR/ARHP-2008) [181] Updated 11 Nov 2008
30 Jul 2008 Trial Update Incyte Corporation completes a phase I trial for Rheumatoid arthritis in USA Updated 12 Aug 2008
30 Jun 2008 Phase Change - I Phase-I clinical trials in Rheumatoid arthritis in USA (PO) Updated 12 Aug 2008
15 Feb 2008 Active Status Review This programme is still in active development Updated 26 Feb 2008
10 May 2006 Active Status Review This programme is still in active development Updated 10 May 2006
30 Apr 2003 Company Involvement Incyte Genomics is now called Incyte Corporation Updated 10 Jul 2003
03 Mar 2003 Company Involvement Maxia Pharmaceuticals has been acquired by Incyte Genomics Updated 03 Mar 2003
25 Nov 2002 Phase Change - Preclinical Preclinical trials in Inflammation in USA (PO) Updated 25 Nov 2002

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  70. Incyte Reports 2020 Fourth Quarter and Year-End Financial Results, Provides 2021 Financial Guidance and Updates on Key Clinical Programs.

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  71. Lilly Reports Third-Quarter Financial Results, Updates Guidance.

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  72. CHMP Recommends Approval of Lilly's Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis.

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  73. Lilly and Incyte Announce Top-Line Results from Phase 3 Study (BREEZE-AD4) of Oral Selective JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids in Patients with Moderate to Severe Atopic Dermatitis Not Controlled with Cyclosporine.

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  74. Lilly and Incyte provide update on supplemental New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis.

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  75. Eli Lilly and Company Sec filing, Form 10 K, 2021. Internet-Doc 2021;.

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  77. Wollenberg A, Boguniewicz M, vers JT, Thyssen J, Goldblum O, Ball S, et al. Efficacy of Baricitinib in Patients with Atopic Dermatitis and Atopic Comorbidities: Results of Pooled Data from 2 Phase 3 Monotherapy Randomized, Double-Blind, Placebo-Controlled 16-week Trials (BREEZE-AD1 and BREEZE-AD2). AAAAI-2020 2020; abstr. 610.

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  79. Lilly and Incyte Announce Positive Top-Line Results from the North American (BREEZE-AD5) Phase 3 Study of Oral Selective JAK Inhibitor Baricitinib in Patients with Moderate to Severe Atopic Dermatitis.

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  80. A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis

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  81. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate to Severe Atopic Dermatitis BREEZE-AD7

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  82. Lilly Announces Top-Line Phase 3 Results for Oral JAK Inhibitor Baricitinib, in Combination with Topical Corticosteroids in Adult Patients with Moderate to Severe Atopic Dermatitis.

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  83. A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine

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  84. EADV 2020: Lilly and Incyte Showcase New Data for Baricitinib for the Treatment of Moderate to Severe Atopic Dermatitis.

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  85. Protocol I4V-MC-JAHN: A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients with Atopic Dermatitis

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  86. A Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

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  87. Lilly Announces Top-Line Phase 3 Results for Baricitinib in Patients with Moderate to Severe Atopic Dermatitis.

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  90. Baricitinib Meets Primary Endpoint in Phase 2 Study of Patients with Moderate-to-Severe Atopic Dermatitis.

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  91. A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Baricitinib in Patients With Moderate-to-Severe Atopic Dermatitis

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  92. FDA broadens existing emergency use of Lilly and Incyte's baricitinib in patients hospitalized with COVID-19 requiring oxygen.

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  93. Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19.

    Media Release
  94. FDA grants Emergency Use Authorisation for baricitinib in hospitalised COVID-19 patients nine months after initial hypothesis was published by BenevolentAI.

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  95. Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial.

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  96. Approved Medical Products for COVID-19 -Japan, PMDA. Internet-Doc 2021;.

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  97. Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries.

    Media Release
  98. NATCO receives Emergency Use approval for Baricitinib tablets for Covid-19 treatment.

    Media Release
  99. Lilly accelerating baricitinib's availability in India following receipt of permission for restricted emergency use as a COVID-19 therapy via donations and licensing agreements.

    Media Release
  100. EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen.

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  101. A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-4)

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  102. Lilly and Incyte's baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation.

    Media Release
  103. Lilly and Incyte announce results from the Phase 3 COV-BARRIER study of baricitinib in hospitalized COVID-19 patients.

    Media Release
  104. Lilly Begins a Phase 3 Clinical Trial with Baricitinib for Hospitalized COVID-19 Patients.

    Media Release
  105. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients With COVID-19 Infection

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  106. Clinical Data Validates BenevolentAI's AI Predicted Hypothesis For Baricitinib As A Potential Treatment For COVID-19.

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  107. Incyte Reports 2020 Second Quarter Financial Results and Provides Updates on Key Clinical Programs.

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  108. A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-2)

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  109. NIH Clinical Trial Testing Antiviral Remdesivir Plus Anti-Inflammatory Drug Baricitinib for COVID-19 Begins. Internet-Doc 2020;.

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  110. BenevolentAI's platform-derived hypothesis for COVID-19 treatment validated in US NIAID randomised control trial.

    Media Release
  111. Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19.

    Media Release
  112. Baricitinib has Significant Effect on Recovery Time, Most Impactful in COVID-19 Patients Requiring Oxygen.

    Media Release
  113. Data from ACTT-2 Trial of Baricitinib in Hospitalized COVID-19 Patients Supportive of the EUA Published in New England Journal of Medicine.

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  114. Baricitinib Plus Remdesivir Shows Promise for Treating COVID-19. Internet-Doc 2020;.

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  116. CHMP draft agenda for the meeting 11-14 October 2021. Internet-Doc 2021;.

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  118. Lilly Receives FDA Breakthrough Therapy Designation for Baricitinib for the Treatment of Alopecia Areata.

    Media Release
  119. Lilly and Incyte's Baricitinib Improved Hair Regrowth for Alopecia Areata Patients in Second Phase 3 Study.

    Media Release
  120. OLUMIANT(R)Significantly Improved Hair Regrowth to At Least 80% Scalp Coverage as Early as 24 Weeks Across First Completed Phase 3 Studies for Alopecia Areata .

    Media Release
  121. Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial.

    Media Release
  122. A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata

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  123. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata

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  124. Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata.

    Media Release
  125. A Randomised, Phase IIa Treatment Delayed-start Trial of the Oral JAK 1/2 Inhibitor, Baricitinib, in the Treatment of Adult Idiopathic Inflammatory Myopathy

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  126. Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis

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  127. A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)

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  128. A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)

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  129. BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)

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  130. A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Primary Biliary Cholangitis Who Have an Inadequate Response or Are Intolerant to UDCA

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  131. Lupus Research Alliance Applauds FDA's Fast Track Designation to Develop Baricitinib for Lupus.

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  132. FDA Grants Fast Track Designation to the Baricitinib Development Program for the Treatment of Systemic Lupus Erythematosus (SLE).

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  134. A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

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  135. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus

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  136. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus

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  137. Incyte Reports 2016 First-Quarter Financial Results and Updates Shareholders on Key Clinical Programs.

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  138. A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

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  139. Wallace DJ, Furie RA, Tanaka Y, Kalunian KC, Mosca M, Petri MA, et al. Baricitinib in Systemic Lupus Erythematosus (Sle): Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study. EULAR-2018 2018; abstr. OP0019.

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  140. Study Published in The Lancet Shows Benefit of Baricitinib 4 mg for the Treatment of Systemic Lupus Erythematosus (SLE).

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  141. Dorner T, Tanaka Y, Petri MA, Smolen JS, Dow E, Higgs RE, et al. Baricitinib-Associated Changes in Global Gene Expression During a 24-Week Phase 2 Clinical Sle Trial Describe a Mechanism of Action Through Inhibition of Jak/Stat and Ifn Responsive Gene Expression. EULAR-2019 2019; abstr. THU0212.

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  144. An Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis

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  145. Baricitinib in Relapsing Giant Cell Arteritis (GCA): A Phase II, Single-institution, Open-label Pilot Study

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  146. A Phase 2/3, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Baricitinib in Adult and Pediatric Japanese Patients With NNS/CANDLE, SAVI, and AGS

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  147. Compassionate Use Treatment Protocol I4V-MC-JAGA: Treatment of Conditions Expected to Benefit From JAK 1/2 Inhibition: CANDLE, CANDLE-Related Conditions, and Severe Juvenile Dermatomyositis

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  148. A Bioequivalence and Food Effect Study in Healthy Subjects Comparing Baricitinib Suspension and Commercial Tablet Formulations

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  149. A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3009104 in Healthy Chinese Subjects

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  150. Zhao X, Payne C, Wang F, Cui Y. Pharmacokinetics, Safety and Tolerability of Single- and Multiple- Dose Once-Daily Baricitinib in Chinese Healthy Volunteers - a Randomized Placebo-Controlled Study. EULAR-2019 2019; abstr. THU0199.

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  151. The Effects of Multiple Doses of Baricitinib on the Pharmacokinetics of a Single Dose of an Oral Contraceptive in Healthy Female Subjects

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  152. The Effect of CYP3A Induction by Rifampicin on the Pharmacokinetics of Baricitinib in Healthy Subjects

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  153. A Study to Investigate the Potential Impact of Organic Anion Transporter 3 Inhibition by Probenecid on the Pharmacokinetics of Baricitinib (LY3009104) in Healthy Subjects

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  154. Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects

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  155. A Study to Investigate the Effect of Ciclosporin on the Pharmacokinetics of Baricitinib (LY3009104) in Healthy Subjects

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  156. Evaluation of the Impact of Increased Gastric pH Following Omeprazole Administration on the Absorption of Baricitinib in Healthy Subjects

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  157. The Effect of Ketoconazole or Fluconazole on the Pharmacokinetics of Baricitinib in Healthy Subjects

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  158. Effects of Multiple Baricitinib (LY3009104) Doses on the Pharmacokinetics of a Cytochrome P450 3A Substrate, Simvastatin, in Healthy Subjects

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  159. An Absolute Bioavailability Study of Baricitinib in Healthy Subjects Using the Intravenous Tracer Method

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  160. Relative Bioavailability of the Baricitinib (LY3009104) Commercial Tablet Compared to the Phase 2 Tablets and the Effect of Food on the Bioavailability of the Commercial Tablet in Healthy Japanese Subjects

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  161. A Pharmacokinetic Study of Baricitinib in Subjects With Hepatic Dysfunction

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  162. A Placebo-Controlled, Single Dose, Dose Escalation (Part A) and a Placebo- and Positive-Controlled Study of the Effect on the Electrocardiographic QT Interval of a Single Dose (Part B) of LY3009104 in Healthy Subjects.

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  163. Relative Bioavailability of the LY3009104 Free Base Test Formulation Compared to the Reference Phosphate Salt Formulation and the Effect of Food on the Bioavailability of the Test Formulation in Healthy Subjects.

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  164. Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Male Subjects.

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  165. A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3009104 in Japanese Healthy Subjects.

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  166. Incyte Reports Fourth Quarter and Year-End 2008 Financial Results; Announces 2009 Financial Guidance.

    Media Release
  167. Incyte Reports Progress in Multiple Clinical Programs; Announces Second Quarter Financial Results.

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  168. A Phase 2, Randomised, Placebo Controlled Study Investigating the Efficacy of Baricitinib in New Onset Type 1 Diabetes Mellitus

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  169. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2 Study to Evaluate the Safety and Renal Efficacy of Baricitinib in Patients With Diabetic Kidney Disease

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  170. A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2b Study of Baricitinib in Patients With Moderate-to-Severe Plaque Psoriasis

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  171. Incyte Reports 2019 First Quarter Financial Results and Provides Updates on Key Clinical Programs.

    Media Release
  172. Incyte Reports 2017 Second-Quarter Financial Results and Updates on Key Clinical Programs.

    Media Release
  173. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24 Week Study Followed by Long-Term Treatment for Evaluation of Efficacy and Safety of Baricitinib in Patients with Active Psoriatic Arthritis

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  174. Incyte Reports 2017 Third-Quarter Financial Results and Updates on Key Clinical Programs.

    Media Release
  175. van der Heijde D, Schiff M, Tanaka Y, Klar R, Xie L, Meszaros G, et al. Low Rates of Radiographic Progression of Structural Joint Damage over 2 Years of Baricitinib Treatment in Patients with Rheumatoid Arthritis. EULAR-2017 2017; abstr. FRI0087.

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  176. New Analyses of Phase 3 Trials Show Improvements in Rheumatoid Arthritis Symptoms Following Treatment with Baricitinib Across Diverse Population of Patients.

    Media Release
  177. New data from pivotal RA-BEACON study show significant improvement in patient-reported outcomes in rheumatoid arthritis patients treated with baricitinib compared to placebo.

    Media Release
  178. Phase 3 Study Findings Demonstrate Treatment with Baricitinib Results in Significant Improvements for Patients with Rheumatoid Arthritis Who Had Inadequate Response to Biologics.

    Media Release
  179. Lilly and Incyte Announce Additional Phase IIb Baricitinib Data, Including MRI Results, in Patients with Rheumatoid Arthritis.

    Media Release
  180. Fridman J, Scherle P, Collins R, Burn T, Li Y, Li J, et al. Preclinical characterization of INCB028050, JAK1/JAK2 selective clinical candidate. 72nd-ACR-43rd-ARHP-2008 2008; abstr. 352.

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