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Remdesivir - Gilead Sciences

Drug Profile

Remdesivir - Gilead Sciences

Alternative Names: Captisol-enabled remdesivir; Captisol®-enabled GS 5734; GS-5734; Redyx; Veklury

Latest Information Update: 21 Sep 2020

At a glance

  • Originator Gilead Sciences
  • Developer China-Japan Friendship Hospital; Dr Reddys Laboratories; Gilead Sciences; INSERM; National Institute of Allergy and Infectious Diseases; NeuroActiva; Quantum Leap Healthcare Collaborative; Roche
  • Class Adenine nucleotides; Amines; Antivirals; Esters; Furans; Nitriles; Phosphorus compounds; Pyridazines; Pyrroles; Small molecules; Triazines
  • Mechanism of Action RNA replicase inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed COVID 2019 infections
  • Phase III Pneumonia
  • Phase II Adult respiratory distress syndrome; Ebola virus infections
  • Phase I Neurological disorders

Most Recent Events

  • 09 Sep 2020 Launched for COVID-2019 infections in India (for restricted emergency use) (IV)
  • 04 Sep 2020 Gilead Sciences plans a phase I/II trial for COVID-2019 infections (Early-stage disease) in September 2020 (Inhalation,Aerosol) (NCT04539262)
  • 30 Aug 2020 US FDA expanded emergency use authorization of remdesivir in COVID-19 infections

Development Overview

Introduction

Remdesivir (GS 5734) is a small molecule monophosphoramidate prodrug of adenosine triphosphate analogue being developed by Gilead Sciences for the treatment of viral infections including COVID-2019 infections and Ebola virus infections. An inhaled nanopartical formulation of the drug is being developed for the treatment of neurological disorders and COVID-2019 infections. Upon administration, remdesivir is metabolised into its active form GS 441524. GS 441524 is an ATP analogue that competes with ATP for incorporation into RNA and inhibits the action of viral RNA-dependent RNA polymerase (also known as RNA-replicase). This results in the termination of RNA transcription and decreases viral RNA production. Remdesivir is launched in India for the treatment of COVID-2019 infections for restricted emergency use . Remdesivir is approved in Japan, United Arab Emirates and conditionally approved in Taiwan and Singapore for the treatment of COVID-2019 infections. The drug is also approved on conditional basis in the EU, Iceland, Norway and Liechtenstein for the treatment of COVID-2019 infections. The product is pending regulatory review in the US for COVID-2019 infections. The product is available globally on a compassionate basis for the same indication. Clinical development of remdesivir is underway for the treatment of COVID-2019 infections in multiple countries. Clinical development for adult respiratory distress syndrome associated with COVID-2019 is underway in the US. Clinical development of the intravenous formulation is underway for the treatment of Ebola virus infections in Congo, Guinea, Liberia and the US. Clinical development of the inhaled nanopartical formulation is ongoing in the US.

The Drug Controller General of India (DCGI) granted regulatory approval to Jubilant Life Sciences, for restricted emergency use of generic version of remdesivir, called JUBI-R, for the treatment of COVID-2019 infections, in July 2020. The drug will be available by the first week of August 2020 [1] .

The Drug Controller General of India (DCGI) granted regulatory approval to Mylan, for restricted emergency use of generic version of remdesivir lyophilised powder for injection called DESREM™ for the treatment of COVID-2019 infections, in July 2020 [2] .

The Drug Controller General of India (DCGI) granted regulatory approval to Hetero, for use of generic version of remdesivir, called COVIFOR (injectable vial) in India., for the treatment of COVID-2019 infections, in June 2020. The product is launched under a licensing agreement with Gilead Sciences [3] .

The Drug Controller General of India (DCGI) granted regulatory approval to Cipla, for restricted emergency use of generic version of remdesivir called CIPREMI for the treatment of COVID-2019 infections, in June 2020 [4] .

Company Agreements

In August 2020, Pfizer entered into an agreement with Gilead Sciences to manufacture and supply Gilead’s investigational antiviral remdesivir, as one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19. Under the terms of the agreement, Pfizer will provide contract manufacturing services at Pfizer’s McPherson, Kansas facility to manufacture and supply remdesivir for Gilead [5]

In May 2020, Gilead Sciences entered into a non-exclusive licensing agreement with Jubilant Life Sciences, for the approval, manufacture and distribution of remdesivir, for the treatment of COVID-19 infections. Under the terms of this agreement, Jubilant will manufacture the API and Finished product at a commercial scale and market it in 127 countries, including India. In addition, Jubilant has the right to receive the technology transfer of the Gilead manufacturing process, so as to scale up production. [1] [6]

In June 2020, Gilead Sciences entered into a non-excusive licensing agreement with Dr. Reddy's Laboratories for manufacturing and marketing of remdesivir. Under the terms of the agreement, Dr. Reddy's will register, manufacture and sell remdesivir, in 127 countries including India. Dr Reddy’s will receive technology transfer from Gilead for manufacturing of this drug [7]

In June 2020, Zydus Cadila, entered into a non-exclusive licensing agreement with Gilead Sciences for the manufacturing and distribution of remdesivir for the treatment of COVID-2019 infections. Under the terms of the agreement, Zydus will receive the manufacturing know-how from Gilead Sciences to manufacture the API for remdesivir and finished product and market it in 127 countries including India. The license is royalty free until another pharmaceutical product or vaccine is approved for the treatment or prevention of COVID 2019 by the US FDA or EMA or the WHO announcing the end of the public health emergency. Zydus will leverage its ability to scale up production to reach patients across India and across the 127 countries in Gilead’s Global Patient Solution region. [8]

In May 2020, Gilead Sciences entered into a non-exclusive licensing agreement with Cipla for the manufacturing and distribution of remdesivir for the treatment of COVID-19 infections. Under the terms of this agreement, Cipla will manufacture the API and Finished product at a commercial scale and market it in 127 countries including India and South Africa under Cipla's own brand name. In addition, Cipla will receive the manufacturing know-how from Gilead Sciences. [9]

In May 2020, Hetero and Gilead Sciences entered into a licensing agreement for the manufacturing and distribution of remdesivir for the treatment of COVID-19 infections. Under the terms of the agreement, Hetero can supply remdesivir in 127 countries including India, subjective to regulatory approvals in respective countries. [10]

In May 2020, Gilead Sciences entered into a worldwide collaboration agreement with Mylan to expand access to the investigational antiviral remdesivir for the treatment of COVID-2019 infections. Under the terms of agreement, Mylan has licensed the non-exclusive rights to manufacture and distribute remdesivir in 127 low- and middle-income countries, including India. [11]

In February 2020, Ligand Pharmaceuticals entered into a supply agreement of Captisol with Double-Crane Pharmaceuticals. As per the terms , Ligand Pharmaceuticals will supply Captisol to Double Crane for use in preclinical and clinical studies of remdesivir to treat COVID-19 infections. Ligand Pharmaceuticals will receive revenues based on the amount of Captisol ordered by Double Crane. [12]

Ligand Pharmaceuticals in May 2020, entered into a supply agreement of Captisol with OnKure Therapeutics​ for use in clinical studies of remdesivir to treat COVID-19 infections. [12]

As at April 2020, Ligand under a supply agreement is supplying Captisol to Gilead Sciences to evaluate remdesivir in clinical trials for the treatment for COVID-2019 infections. Earlier, in December 2015, Gilead Sciences entered into a supply agreement with Ligand Pharmaceuticals for the supply of Captisol® to Gilead for use in a Captisol®-enabled program directed against Ebola virus disease including remdesivir, and in such other programs, if the companies intend to expand the agreement. Under the terms of the agreement, Ligand will receive an upfront Drug Master File reference fee, and it is also eligible to receive commercial revenue from the shipment of Captisol to Gilead (Ligand Pharmaceuticals, Form 10-K, December 2015). [13]

Key Development Milestones

Inhalation (nanopartical formulation)

In July 2020, NeuroActiva initiated the phase I NEUROSIVIR trial to evaluate the safety, tolerability and pharmacokinetics of inhaled nanoparticle formulation of remdesivir alone and in combination with traneurocin [see Adis Insight Drug Profile 800051889] in healthy adults (NCT04480333). The randomised, placebo controlled trial intends to enrol approximately 48 volunteers in the US [14] .

COVID-2019 infections

In September 2020, Dr Reddys Laboratories announced the launch of remdesivir for restricted emergency use, under a brand name Redyx® in India for the treatment of COVID-2019 infections [15] .

In August 2020, Gilead completed the submission of a rolling NDA to the US FDA, seeking approval for usage of remdesivir (Veklury®), for the treatment of patients with COVID-2019 infections. The completion of this filing constituted the final tier of the submission, that was initiated in April 2020. The filing was supported by data from two phase III company-conducted drug trials, along with a phase III study conducted by National Institute of Allergy and Infectious Diseases (NIAID) [see below]. Drug treatment in these studies manifested faster recovery times relative to placebo, with comparable clinical improvements witnessed with both 5-day or 10-day treatment duration. Both treatment groups were reflective of a well-tolerated safety profile for the drug, bereft of new safety signals [16] .

In July 2020, Gilead Sciences entered into an agreement with U.S. Department of Health and Human Services (HHS) to manage the allocation of remdesivir to hospitals until the end of September [17] .

In July 2020, Gilead entered into an agreement with the European Commission to enable the European Commission to secure treatment doses of remdesivir (Veklury) in order to meet immediate needs. The drug will be made available in the member states and the UK from early August [18] .

In July 2020, the European Commission granted conditional marketing authorization for remdesivir for the treatment of COVID-2019 infections in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. The expansion of the scope was based on results from ACTT-1 [see below] and SIMPLE trial [see below] [19] . Earlier in June 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) adopted a positive opinion recommending the granting a conditional marketing authorisation (CMA) to remdesivir. The company will have to submit the final reports of the remdesivir studies to the Agency by December 2020, and further data on the quality of the medicine, as well as the final data on mortality, by August 2020. The EMA received an application for CMA of remdesivir in June 2020 and formally started its evaluation. At the conclusion of the first cycle of the rolling review in May 2020, the CHMP invited the company to submit further data together with an application for a conditional marketing authorisation. Also, EMA’s committee for medicines for children (PDCO) has rapidly issued its opinion on the company’s paediatric investigation plan (PIP). Earlier, the CHMP started a rolling review of data on the use of remdesivir based on preliminary results from the NIAID- ACTT study [see below], which suggested a beneficial effect of remdesivir in the treatment of hospitalised patients with mild-to-moderate or severe COVID-2019 infections [20] [21] [22] [23] .

In May 2020, Gilead Sciences announced that Japanese Ministry of Health (MHLW) has granted regulatory approval of Venklury® (remdesivir) as a treatment for COVID-2019 infections under an exceptional approval pathway. The approval was granted on the basis of clinical data obtained from the phase III SIMPLE trial (see below) and from Gilead's compassionate use program, that included patients from Japan [24] .

In June 2020, The Health Sciences Authority (HSA), in consultation with its Medicines Advisory Committee, granted conditional approval for remdesivir. As part of the conditional approval, Gilead is required to collect the relevant safety data and to monitor the use of remdesivir. HSA will also require data from ongoing clinical studies to be submitted post-approval to ensure the continued safety and efficacy of the product. Earlier in March 2020, HSA initiated an early access of remdesivir to COVID-19 patients in Singapore through the expeditious evaluation and approval of its use in clinical trials. Gilead filed for registration of remdesivir in Singapore in May 2020 [25] .

In June 2020, the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare (MOHW) conditionally approved remdesivir for patients with severe SARS-CoV-2 infection, according to the Article 48-2 of Pharmaceutical Affairs Act, provided that the pharmaceutical company would implement a risk management plan (RMP) to ensure the safety after the importation. Earlier in May 2020, TFDA hold a meeting and invited pharmaceutical and clinical experts to discuss the application and approval requirements of remdesivir [26] .

As of July 2020, the United Arab Emirates’ Ministry of Health and Prevention approved remdesivir for the treatment of patients with COVID-2019 infections [20] .

In August 2020, US FDA expanded the scope of the emergency use authorization for remdesivir to include treatment of hospitalised adult and paediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease [19] . In May 2020, the US Food and Drug Administration (FDA) granted an emergency use authorization to remdesivir for the treatment of suspected or laboratory-confirmed severe COVID-19 infections in adults and children with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. The drug is administered via intravenous infusion and is supplied either as an injection, 100mg, lyophilised powder, or as an injection, 100mg/20 mL (5mg/mL), concentrated solution [27] . In June 2020, US FDA is revising fact sheet for health care providers to state that administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. However, US FDA is not aware of any instances of reduced activity occurring in clinical setting and it will continue to evaluate all the data related to remdesivir. The FDA has also revised the fact sheet for health care providers to clarify dosing and administration recommendations and to provide additional safety data and supporting data from clinical trials [28] .

In March 2020, the US FDA granted orphan drug designation to remdesivir for the treatment of of COVID-2019 infections. However the status was withdrawn by the US FDA in the same month following submission of a request by Gilead to the US FDA to rescind the orphan drug designation [29] [30] [31] .

In August 2020, National Institute of Allergy and Infectious Diseases initiated the phase III ACTT-3 trial to evaluate safety and efficacy of remdesivir with interferon beta-1a [see Adis Insight drug profile 800007022] in patients with COVID-2019 infection (NCT04492475; 20-0006 ACTT-3). The randomised, double-blind trial intends to enrol approximately 1 038 adults and the elderly patients in the US [32] .

In May 2020, Roche in collaboration with Gilead Sciences initiated the phase III REMDACTA trial to evaluate the safety and efficacy of tocilizumab [see Adis Insight drug profile 800010359] plus remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia. The randomised, double-blind trial intends to enroll approximately 450 patients in the US, Canada, Europe and might expand to Brazil [33] [34] .

In April 2020, Gilead Sciences and University of Helsinki initiated the phase III SOLIDARITY Finland trial to assess the efficacy and safety of remdesivir and hydroxychloroquine compoared with standard of care in patients with COVID-2019 infections (EudraCT2020-001784-88; WHO-FIN-COVID-19). The main objective of the trial is to investigate effect on allcause in-hospital mortality compared to standard of care. The randomised trial intends to enrol approximately 664 patients in Finalnd [35] .

In March 2020, Sunnybrook Health Sciences Centre initiated the phase II Canadian Arm of the SOLIDARITY Trial (CATCO) trial to evaluate the safety and efficacy of standard-of-care products plus remdesivir or hydroxycholoroquine or lopinavir/ritonavir (2114; NCT04330690). The adaptive, randomised, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization intends to enrol approximately 2900 patients in Canada [36] .

In March 2020, Institut National de la Santé Et de la Recherche Médicale (INSERM) and Gilead Sciences initiated the phase III DisCoVeRy trial to assess safety and efficacy of remdesivir and other therapeutics including hydroxychloroquine, lopinavir/ritonavir compared with standard of care (NCT04315948; C20-15; EudraCT2020-000936-23). The primary endpoint of study is to determine the percentage of patients reporting each severity rating on a 7-point ordinal scale in 15 days. The randomised, adaptive trial intends to enrol approximately 3300 patients in France, Luxembourg, Austria and will expand to other parts of Europe [37] [38] .

In March 2020, Gilead initiated an expanded access treatment protocol for remdesivir for the treatment of COVID-19 infections in the US, the UK, Belgium, Canada, France, Germany, Italy, Israel, Netherlands, Romania, Spain, Switzerland, Australia, Austria, Cyprus, Croatia, Denmark, Estonia, Greece, Hungary, Ireland, Iceland, Czech Republic, Poland, Portugal, Slovakia and Slovenia (GS-US540-5821; EudraCT2020-001453-49; NCT04323761). In April 2020, Froedtert & the Medical College of Wisconsin granted an approval for the enrollment in the expanded access programme [39] [40] [41] .

In June 2020 completed the first phase III SIMPLE trials that evaluated the safety and efficacy of both a 5-day and a 10-day dosing regimen of remdesivir administered intravenously in patients with severe manifestations of COVID-19 (NCT04292899; GS-US-540-5773; EudraCT2020-000841-15; SIMPLE-severe). The trial was initiated in March 2020 and recruited 4891 patients globally including Germany, Spain, Italy, the Netherlands, the UK, Sweden, the US, Hong Kong, South Korea, Singapore, China, Taiwan, France, Japan and Switzerland. In April 2020, the company reported that the study was stopped in patients with severe symptoms due to delayed enrollment. However in June 2020, Gilead announce addition of expansion phase of the study was added to enroll up to 5 600 additional patients, including those on mechanical ventilation. In April 2020, efficacy and safety data from the trial was released by Gilead Sciences. In May 2020, Gilead announced that the data from the SIMPLE-Severe study support treatment of some patients for 5 days rather than 10 days, depending on clinical status. In July 2020, efficacy data from the trial were released by Gilead Sciences [42] [43] [37] [44] [45] [46] . In June 2020, Gilead completed the second SIMPLE trial that evaluated the safety and efficacy of a 5-day and a 10-day dosing regimen of remdesivir administered intravenously in patients with moderate manifestations of COVID-19, compared with standard of care (NCT04292730; GS-US-540-5774; EudraCT2020-000842-32; SIMPLE-moderate) . The trial enrolled 1113 patients . Previously in April 2020, Gilead sciencs announced that the trail met its primary endpoint in China, France, Germany, Hong Kong, Iran, Italy, Japan, Netherlands, Scotland, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, USA. Gilead Sciences has donated remdesivir and provided scientific input for these studies. In June 2020, Gilead Sciences release data from the trial [43] [47] [48] [49] . In August 2020, updated results from the trial were released by the company [19] .

In May 2020, National Institute of Allergy and Infectious Diseases completes the phase III ACTT-1 trial (Adaptive COVID-19 Treatment Trial) that evaluated the safety and efficacy of remdesivir for the treatment of COVID-2019 infections (ACTT; 20-0006; U1111-1249-9599; EudraCT2020-001052-18; NCT04280705). The randomised, double-blind, placebo-controlled trial was initiated in February 2020 and enrolled 1062 hospitalised patients in the US, Denmark, Germany, Greece, South Korea, Japan, Mexico, Singapore, Spain and United Kingdom. In April 2020, EvergreenHealth announced that it is preparing for the second arm of the trial, which will eliminate the placebo group and provide the study drug to all the patients to evaluate its effectiveness against the virus. Moreover, EvergreenHealth reported initial preliminary reports from the trial. In May 2020, Gilead announced that the trial findings support the use of remdesivir with the largest benefit observed among individuals who required oxygen supplementation but were not mechanically ventilated. In June 2020, the EMA released the efficacy data from the trial [21] [50] [45] [51] . In August 2020, updated results from the trial were released by the company [19] .

In May 2020, NIAID initiated the phase III trial to evaluate the safety and efficacy of remdesivir in combination with oral baricitinib, for the treatment of COVID-19 infections (20-0006 ACTT-II; NCT04401579). The randomised, blinded, controlled trial intends to enrol 1032 patients in the US, Japan, South Korea, Mexico and Singapore [52] [53] [54] .

In July 2020, Gilead Sciences initiated a phase II/III CARAVAN trial to evaluate the safety, tolerability, and pharmacokinetics (PK) of remdesivir in patients aged 0 to 18 years old with COVID-19 infections (EudraCT2020-001803-17; GS-US540-5823; NCT04431453; P201-2020). The open-label trial intends to enrol approximately 52 patients in the US and UK and expected to expand to Italy and Spain [55] .

In August 2020, QuantumLeap Healthcare Collaborative initiated phase II I-SPY-COVID trial to evaluate efficacy of remdesivir in combination with cenicriviroc [see Adis Insight Drug profile800043325], icatibant [see Adis Insight Drug profile800001708], razuprotafib [see Adis Insight Drug profile800035272] and apremilast [see Adis Insight Drug profile800019919] in patients with acute respiratory distress syndrome associated with COVID-19 infections (NCT04488081). An open label, randomised trial intends to enrol 1500 patients in the US [56] . Company announced the enrollment of the first patient in the trial [57] .

In June 2020, ViralClear Pharmaceuticals (BioSig's subsidiary) initiated a phase II trial to evaluate the efficacy and safety of merimepodib [see Adis Insight Drug profile 800008158] in combination with remdesivir in patients with COVID-19 infections (VC02-01; NCT04410354). The double blind, randomized trial initiated enrolment of 40 patients in USA. The first patient was dosed in June 2020 [58] [59] .

In February 2020, Gilead Sciences reported that remdesivir was purportedly used in treating the first case of 2019 novel coronavirus (2019-nCoV), in the US. There was no data for remdesivir displaying activity against 2019-nCoV, but data was available for other coronaviruses [60]

In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19 [44] .

Compassionate use

In May 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) recommended expanding the compassionate use of remdesivir for the treatment of patients with COVID-2019 infections. The compassionate use recommendations covered the treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation) [61] .

In April 2020, the USFDA granted emergency use authorisation (EUA) for remdesivir for the treatment of hospitalized patients with COVID-19 infections. The EUA allowed both 5-day and 10-day treatment durations based on the severity of disease [62] .

In April 2020, EMA’s human medicines committee (CHMP) gave recommendations for the compassionate use programmes of remdesivir for treatment of coronavirus infections (COVID-19) in the European Union. earlier, Estonia, Greece, the Netherlands and Romania requested an opinion from the CHMP on the conditions for early access to remdesivir through compassionate use could be given to patients with COVID‑19 [63] .

Remdesivir is available through an expanded access programme conducted by U.S. Army Medical Research and Development Command for the treatment of COVID-2019 infections in the US (S-20-01; NCT04302766) [64] .

Gilead Sciences provided remdesivir for compassionate use to 2 patients, one a female patient in the Royal Free Hospital in London in October and one in Guinea the following month [65] .

Gilead Sciences is also providing remdesivir for compassionate use to patients with COVID-2019 infections for emergency treatment outside of ongoing clinical studies [48] .

In July 2020, Gilead Sciences released efficacy and safety data of remdesivir from compassionate use programme for COVID-2019 infections in pediatric patients and in pregnant and postpartum women [42] . In April 2020, Gilead Sciences released efficacy and safety data of remdesivir from compassionate use programme for COVID-2019 infections [66] [67] . Gilead Sciences in April 2020, reported that intravenous infusion of remdesivir demonstrated clinical improvement in first 53 patients who received treatment in compassionate programme [37] .

Ebola virus infections

In August 2019, based on independent Data and Safety Monitoring Board’s (DSMB) recommendation, Ridgeback Biotherapeutics prematurely terminated the phase II/III PALM trial designed to assess the safety and effectiveness of mAb 114; REGN 3470/3471/3479 , porgaviximab and remdesivir separately in patients with Ebola virus infections (19-I-0003; NCT03719586). The open-label, randomised, controlled study initiated by Gilead Sciences and National Institute of Allergy and Infectious Diseases in October 2018 enrolled approximately 681 patients toward an enrollment goal of 725 in the US and Congo [68] [69] .

In October 2019, National Institute of Allergy and Infectious Diseases completed the phase II PREVAIL IV trial to assess the antiviral activity, safety and tolerability of remdesivir 100mg IV in male Ebola survivors with evidence of Ebola virus persistence (999916137; 16-I-N137; NCT02818582). The randomised 1:1, double-blind, parallel, placebo-controlled, two-phase (treatment and longer-term follow-up) trial was initiated in June 2016 and enrol approximately 30 patients in the Guinea and Liberia. Longer-term clearance of Ebola virus will be assessed during the 5-month follow-up phase [70] .

Gilead initiated a phase I trial in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of remdesivir [71] .

Preclinical studies

In a monkey model of Ebola virus infections, remdesivir displayed efficacy as well as potential for broad-spectrum anti-filovirus activity with 100% survival of monkeys [72] .

Remdesivir has a broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple viral pathogens, including Ebola, Marburg, MERS and SARS [44] .

Financial information

In July 2020, The emergency authorization of remdesivir received $US6.5 billion in NIH funding for the treatment of COVID-19 infection [73] .

Drug Properties & Chemical Synopsis

  • Route of administration Inhalation, IV
  • Formulation Infusion, unspecified
  • Class Adenine nucleotides, Amines, Antivirals, Esters, Furans, Nitriles, Phosphorus compounds, Pyridazines, Pyrroles, Small molecules, Triazines
  • Target RNA replicase
  • Mechanism of Action RNA replicase inhibitors
  • WHO ATC code

    J05A-X (Other antivirals)

    N07X (Other Nervous System Drugs)

    R07A-X (Other respiratory system products)

  • EPhMRA code

    J5B9 (Antivirals, others)

    N7X (All other CNS drugs)

    R7X (All Other Respiratory System Products)

  • Chemical name 2-ethylbutyl ((S)-(((2R,3S,4R,5R)-5-(4-aminopyrrolo[1,2-b]pyridazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)-L-alaninate
  • Molecular formula C28 H36 N5 O8 P
  • Chemical Structure
  • CAS Registry Number 1809249-37-3

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Adult respiratory distress syndrome associated with COVID-19 infections Combination therapy Phase II USA IV / unspecified Quantum Leap Healthcare Collaborative 04 Aug 2020
COVID 2019 infections for restricted emergency use - Marketed India IV / Infusion Dr Reddys Laboratories, Gilead Sciences 09 Sep 2020
COVID 2019 infections Adjunctive to standard-of-care Adjunctive to standard-of-care; with conditional approval Adjunctive treatment Registered Japan, Singapore, Taiwan IV / Infusion Gilead Sciences 10 Jun 2020
COVID 2019 infections - - Registered United Arab Emirates IV / Infusion Gilead Sciences 03 Jul 2020
COVID 2019 infections in patients from 12 years of age with pneumonia who require supplemental oxygen In adolescents, In adults, In children Registered European Union, Iceland, Liechtenstein, Norway IV / Infusion Gilead Sciences 06 Jul 2020
COVID 2019 infections - In adults Preregistration USA IV / Infusion Gilead Sciences 08 Apr 2020
COVID 2019 infections In combination with baricitinib Combination therapy, In adults, In the elderly Phase III USA IV / Infusion National Institute of Allergy and Infectious Diseases 08 May 2020
COVID 2019 infections Adjunctive to standard-of-care Adjunctive treatment Phase III France, Germany, Hong Kong, Italy, Netherlands, South Korea, Spain, Sweden, Switzerland, USA, United Kingdom IV / Infusion Gilead Sciences 29 Apr 2020
COVID 2019 infections in combination with hydroxychloroqunie in combination with tocilizumab Combination therapy Phase III Canada, Europe, Finland IV / Infusion Gilead Sciences 28 May 2020
COVID 2019 infections Adjunctive to standard-of-care Adjunctive treatment Phase III Austria, Luxembourg IV / Infusion Gilead Sciences, INSERM 22 Mar 2020
COVID 2019 infections Adjunctive to standard-of-care Adjunctive treatment Phase III China IV / Infusion China-Japan Friendship Hospital, Gilead Sciences 01 Mar 2020
COVID 2019 infections in combination with baricitinb Combination therapy Phase III Japan, Mexico, Singapore, South Korea IV / Infusion National Institute of Allergy and Infectious Diseases 08 May 2020
COVID 2019 infections - - Phase III Denmark, Greece, Japan, Mexico, Singapore, South Korea IV / Infusion Gilead Sciences, National Institute of Allergy and Infectious Diseases 21 Feb 2020
COVID 2019 infections - In adolescents, In children, In infants, In neonates Phase II/III USA IV / Infusion Gilead Sciences 23 Jul 2020
COVID 2019 infections - In adolescents, In adults, In children, In infants, In neonates Phase II/III United Kingdom IV / Infusion Gilead Sciences 23 Jul 2020
COVID 2019 infections in combination with optimised supportive care Adjunctive treatment Phase II Canada IV / Infusion Gilead Sciences 18 Mar 2020
COVID 2019 infections - In volunteers, Monotherapy Phase I USA Inhalation / unspecified NeuroActiva 21 Jul 2020
COVID 2019 infections in combination with traneurocin Combination therapy, In volunteers Phase I USA Inhalation / unspecified NeuroActiva 21 Jul 2020
COVID 2019 infections - - Clinical Phase Unknown Australia, Iceland, Israel IV / Infusion Gilead Sciences 27 Mar 2020
Ebola virus infections - - Phase II Congo, Guinea, Liberia, USA IV / Infusion Gilead Sciences, National Institute of Allergy and Infectious Diseases 25 Oct 2018
Neurological disorders in combination with traneurocin In volunteers, Monotherapy Phase I USA Inhalation / unspecified NeuroActiva 21 Jul 2020
Neurological disorders in combination with traneurocin Combination therapy, In volunteers Phase I USA Inhalation / unspecified NeuroActiva 21 Jul 2020
Pneumonia associated with COVID-2019 infections Combination therapy Phase III Canada, Europe, USA IV / Infusion Gilead Sciences, Roche 16 Jun 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Gilead Sciences Originator USA
Gilead Sciences Owner USA
Mylan Market Licensee World
Jubilant Life Sciences Market Licensee India
Zydus Cadila Market Licensee India
Cipla Market Licensee India, South Africa
Dr Reddys Laboratories Market Licensee India
Hetero Drugs Market Licensee India
Ligand Pharmaceuticals Technology Provider USA
Quantum Leap Healthcare Collaborative Collaborator USA
Medical College of Wisconsin Collaborator USA
Roche Collaborator Switzerland
INSERM Collaborator France
Center for Disease Control Collaborator
NeuroActiva Collaborator USA
National Institute of Allergy and Infectious Diseases Collaborator USA
United States Army Medical Research Institute of Infectious Diseases Collaborator USA
China-Japan Friendship Hospital Collaborator China

Brand Names

Brand Name Organisations Indications Countries
Redyx Dr Reddys Laboratories COVID 2019 infections India
Veklury Gilead Sciences COVID 2019 infections European Union, Japan, Singapore

Scientific Summary

Adverse Events

In a compassionate use programme in pediatric patients and in pregnant and postpartum women, treatment with remdesivir was well tolerated and no new safety signals were reported. The most common AEs were observed to be due to underlying disease and most laboratory abnormalities were reported to be grade 1–2 [67] [42]

Treatment with remdesivir in a phase III SIMPLE trial for COVID-2019 infections showed that the drug was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events (AE) occurring in more than 10% of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3% of patients, with 3% of patients discontinuing remdesivir treatment due to elevated liver tests. Study drug-related serious adverse event were observed in 2% patients in both groups. AE leading to discontinuation were observed in 5% and 10% patients in 5 day and 10 day groups respectively [44] [46] .

In the phase III SIMPLE trial (SIMPLE moderate), conducted in patients with moderate manifestations of COVID-19, remdesivir in combination with standard of care was generally well-tolerated in both the 5-day and 10-day treatment groups and did not showed any new safety signal. Adverse events were reported in 51% (97/191) patients in 5-day course, in 55% (106/193) patients in 10-day course and 45% (90/200) patients in standard-of-care group. Grade >3 AE were reported in 10% (20/191) patients in 5-day course, in 11% (21/193) patients in 10-day course and 12% (24/200) patients in standard-of-care group. Serious events were reported in 4% (8/191) patients in 5-day course, in 4% (7/193) patients in 10-day course and 9% (18/200) patients in standard-of-care group. The most common adverse events occurring in more than 5 percent of patients in both treatment groups were nausea (5-day: 10% / 10-day: 9% / SOC: 3%), diarrhoea (5-day: 5% / 10-day: 5% / SOC: 7%) and headache (5-day: 5% / 10-day: 5% / SOC: 3%) [43] [49] .

Pharmacodynamics

Summary

Remdesivir was shown in vitro to inhibit Ebola virus (Kikwit and Makona variants), Sudan and Marburg virus at EC50 = 0.01 to 0.20µM. In Ebola virus(EV)-infected rhesus monkeys, intramuscular injection of remdesivir led to 50% survival versus 0% survival in placebo-treated animals (p<0.003). Intravenous injection of remdesivir resulted in 100% survival in EV-infected animals, with a mean plasma viral RNA reduction of 5log10 copies/mL relative to placebo (p<0.001), as well as suppression of EV infection signs [72] . In rhesus monkey filovirus infection models, remdesivir significantly reduced systemic viraemia and ameliorated severe clinical disease signs and anatomic pathology. In mice infected with MERS-CoV, twice daily SC administration of remdesivir, at dose 25 mg/kg, significantly reduced lung viral load and improved respiratory function. In rhesus monkeys, once-daily IV administration of remdesivir, at dose 5 mg/kg, initiated one day prior to MERS-CoV infection reduced lung viral load, improved clinical disease signs, and ameliorated severe lung pathology [74] .

Therapeutic Trials

In a compassionate use programme treatment with remdesivir, 77 pediatric patients treated with remdesivir demonstrated significant improvement in clinical status by day 28, with 73 percent discharged from the hospital, 12 percent remained hospitalized but on ambient air and four percent had died. Of the 39 pediatric patients who required invasive mechanical ventilation at baseline, 80% patients of these critically ill patients were observed to recover whereas out of 38 patients not requiring invasive ventilation, 87% were observed to recover. Treatment of 86 pregnant and postpartum women with remdesivir showed that 96% of pregnant and 89% of postpartum women achieved improvement in oxygen support levels. Pregnant and postpartum women who had more severe illness at baseline were reported to achieve similar high rates of clinical recovery, at 93% and 89% respectively. Pregnant women not on invasive oxygen support at baseline were reported to have shortest median time to recovery (5 days), and both pregnant and postpartum women on invasive ventilation at baseline were reported to have similar median times to recovery (13 days). Earlier results from the compassionate use programme demonstrated improvement in oxygen support class in 68% of patients (n=36/53), with COVID-2019 infections over a median follow-up of 18 days from the first dose. More than half of patients on mechanical ventilation were extubated (57 percent, n=17/30) and nearly half of all patients (47 percent, n=25/53) were discharged from the hospital. After 28 days of follow-up, the cumulative incidence of clinical improvement, was reported to be 84% according to Kaplan-Meier analysis. Clinical improvement was reported to less frequent among patients on invasive ventilation versus noninvasive ventilation (HR: 0.33 [95% CI 0.16, 0.68]) and among patients at least 70 years of age (HR vs < 50 years: 0.29 [95% CI 0.11, 0.74]). The overall mortality rate was reported to be 13%. The mortality rate was higher in the subgroup of patients on invasive ventilation (18%), compared with patients on noninvasive oxygen support (5%). Mild to moderate liver enzyme elevations were reported in 23% of patients [66] [67] [42]

Treatment with remdesivir in a phase III SIMPLE trial for COVID-19 infections showed significant improvement in clinical recovery and a 62 percent reduction was observed in the risk of mortality in comparison to standard of care. Recovery was observed in 74.4% remdesivir treated patients on day 14 in comparison to 59% patients receiving standard of care. The mortality rate for patients treated with remdesivir in the analysis was observed to be 7.6% at day 14 in comparison to 12.5% patients not taking remdesivir (adjusted odds ratio 0.38, 95% confidence interval 0.22-0.68, p=0.001). Median follow-up of 14 days, the rates and likelihood of recovery were observed to be lower in patients who received concomitant hydroxychloroquine in comparison to patients treated with remdesivir who did not receive hydroxychloroquine (57 percent vs. 69 percent, covariate-adjusted HR [95% CI] 0.61 [0.45, 0.83], p=0.002). Earlier results showed that clinical outcomes varied by geography. Outside of Italy, the overall mortality rate at day 14 was 7% across both treatment groups, with 64% of patients experiencing clinical improvement at day 14 and 61 percent (n=196/320) of patients discharged from the hospital. In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms. Pooling data across treatment arms, by day 14, 62% patients treated early were able to be discharged from the hospital, compared with 49% patients who were treated late [42] [44] [46] .

Updated results from the phase III ACTT-1 trial demonstrated that administration of remdesivir statistically and significantly improved clinical odds at day 15 as compared to placebo group. The time for recovery as well as odds of improvement at day 15 were favourable for remdesivir group and consistent with overall study results [19] . Earlier results demonstrated that patients treated with remdesivir recovered after about 10 days, compared with 15 days for patients given placebo. In patients with mild to moderate disease this effect was not observed, where time to recovery was 5 days for both the remdesivir group and the placebo group. Approximately 90% of the study population constituted patients with severe disease, where in time to recovery was 12 days in the remdesivir group and 18 days in the placebo group. However, no difference was observed in time to recovery in patients who started remdesivir when they were already on mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Data on the proportion of patients who died up to 28 days after starting treatment are currently being collected for final analysis. Initial preliminary results from the trial showed that treatment with remdesivir exhibited 31% of recovery from hospitalised patients (n = 1063) than those who received the placebo and suggested a survival benefit with mortality rate of 8.0% for the remdesivir group versus 11.6% for the placebo group [21] [50] [51] .

Updated results from phase III SIMPLE trial demonstrated that treatment with remdesivir improved COVID-19 symptoms statistically and significantly at day 5 compared to day 11 as compared to standard of care. The odds of improvement with the day 10 treatment group when compared to those receiving only standard of care were numerically favourable, but not statistically significantly different. The mortality reported was less than or equal to 2 percent in all treatment groups [19] . Earlier data from the trial showed greater clinical benefit in higher number of patients than 10 days regimen. In the 5-day treatment group, 76% (146/191) of patients achieved clinical improvement at Day 11, showing statistical significance for a ≥ 1-point improvement in ordinal scale compared with 66% (132/200) of patients in the standard of care alone, (p = 0.026). In the 10-day treatment group, 70% (135/193) of patients achieved clinical improvement at Day 11. In the 5-day and 10 day treatment group, 70% (134/191) and 65% (26/193) of patients showed a ≥ 2-point improvement in ordinal scale at Day 11 compared with 61% (121/200) of patients in the standard of care alone. Number of patients who required oxygen support in 5-day, 10-day and SoC treatment group were 12, 13 and 22, respectively. No patient was died due to worsening disease in 5-day course treatment whereas 2 and 4 patients were died in 10-day and SoC treatment group. Patients with moderate disease who received the 5-day remdesivir plus standard-of-care treatment were 65% more likely to have clinical improvement at Day 11 compared with those in the standard of care group as assessed by a 7-point ordinal score (OR 1.65 [95% CI 1.09-2.48]; p=0.017). The odds of improvement in clinical condition with the 10-day treatment course of remdesivir versus standard of care also showed trend toward improvement but not reaching statistical significance (OR 1.31 [95% CI 0.88-1.95]; p=0.18) [43] [49] .

Future Events

Expected Date Event Type Description Updated
30 Sep 2020 Trial Update Gilead Sciences plans a phase III trial for COVID-2019 infections (Early-stage disease) in September 2020 (NCT04501952) (EudraCT2020-003510-12) (700326333) 14 Aug 2020
30 Sep 2020 Trial Update Gilead Sciences plans a phase I/II trial for COVID-2019 infections (Early-stage disease) in September 2020 (Inhalation,Aerosol) (NCT04539262) (700327349) 10 Sep 2020
31 Aug 2020 Regulatory Status Gilead Sciences plans to launch remdesivir in the EU on emergency use basis in August 2020 [18] 04 Aug 2020
30 Jun 2020 Trial Update Gilead Sciences plans the phase II/III CARAVAN trial for COVID-2019 infections (In neonates, In infants, In children, In adolescents) (IV) in June 2020 (NCT04431453) (700323291) 29 Jul 2020
31 Mar 2020 Trial Update Institut National de la Santé et de la Recherche Médicale (INSERM) plans the phase III DisCoVeRy trial for COVID-2019 infections in France (IV, Infusion), in March 2020 (700320029), (NCT04315948) 15 Apr 2020

Development History

Event Date Update Type Comment
09 Sep 2020 Phase Change - Marketed Launched for COVID-2019 infections in India (for restricted emergency use) (IV) [15] Updated 21 Sep 2020
04 Sep 2020 Trial Update Gilead Sciences plans a phase I/II trial for COVID-2019 infections (Early-stage disease) in September 2020 (Inhalation,Aerosol) (NCT04539262) Updated 10 Sep 2020
30 Aug 2020 Regulatory Status US FDA expanded emergency use authorization of remdesivir in COVID-19 infections [19] Updated 02 Sep 2020
30 Aug 2020 Scientific Update Efficacy data from a phase III ACTT-1 trial in COVID-19 infections released by Gilead [19] Updated 02 Sep 2020
30 Aug 2020 Scientific Update Efficacy data from a phase III SIMPLE trial in COVID-19 infections released by Gilead [19] Updated 02 Sep 2020
10 Aug 2020 Trial Update Gilead Sciences plans a phase III trial for COVID-2019 infections (Early-stage disease) in September 2020 (NCT04501952) (EudraCT2020-003510-12) Updated 14 Aug 2020
10 Aug 2020 Regulatory Status Gilead Sciences completes rolling NDA submission to the US FDA for COVID-2019 infections (In adults) (IV) [16] Updated 12 Aug 2020
04 Aug 2020 Trial Update National Institute of Allergy and Infectious Diseases initiates enrolment in the phase III ACTT-3 trial for COVID-2019 infections (Combination therapy, In adults, In the elderly) in USA (NCT04492475) Updated 17 Aug 2020
04 Aug 2020 Phase Change - II Phase-II clinical trials in Adult respiratory distress syndrome (Combination therapy) associated with COVID-19 infections in USA (IV) [57] (NCT04488081) Updated 07 Aug 2020
29 Jul 2020 Regulatory Status Gilead Sciences plans to launch remdesivir in the EU on emergency use basis in August 2020 [18] Updated 04 Aug 2020
23 Jul 2020 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (In adolescents, In children, In infants, In neonates, In adults) in United Kingdom (IV) (EudraCT2020-001803-17) Updated 29 Jul 2020
23 Jul 2020 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (In adolescents, In children, In infants, In neonates, In adults) in USA (IV) (NCT04431453) Updated 29 Jul 2020
21 Jul 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (In volunteers, Combination therapy) in USA (Inhalation) (NCT04480333) Updated 24 Jul 2020
21 Jul 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (In volunteers, Monotherapy) in USA (Inhalation) (NCT04480333) Updated 24 Jul 2020
21 Jul 2020 Phase Change - I Phase-I clinical trials in Neurological disorders (In volunteers, Combination therapy) in USA (Inhalation) (NCT04480333) Updated 24 Jul 2020
21 Jul 2020 Phase Change - I Phase-I clinical trials in Neurological disorders (In volunteers, Monotherapy) in USA (Inhalation) (NCT04480333) Updated 24 Jul 2020
13 Jul 2020 Scientific Update Efficacy and adverse event data from a compassionate use programme in COVID-2019 infections released by Gilead Sciences [42] Updated 14 Jul 2020
13 Jul 2020 Scientific Update Efficacy data from the phase III SIMPLE-SEVERE trial in COVID-2019 infection released by Gilead Sciences [42] Updated 14 Jul 2020
06 Jul 2020 Phase Change - Registered Registered for COVID-2019 infections (In adolescents, In children, In adults) in European Union, Iceland, Norway, Liechtenstein (IV) [20] Updated 07 Jul 2020
03 Jul 2020 Phase Change - Registered Registered for COVID-2019 infections in United Arab Emirates (IV) [20] Updated 08 Jul 2020
30 Jun 2020 Trial Update Gilead Sciences completes the phase III SIMPLE MODERATE trial in COVID-2019 infections (Adjunctive treatment) in China, France, Germany, Hong Kong, Italy, Japan, Netherlands, Scotland, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, USA(NCT04292730) Updated 07 Aug 2020
30 Jun 2020 Trial Update Gilead Sciences completes a phase-III SIMPLE SEVERE clinical trial in COVID-2019 infections (Adjunctive treatment) in China, France, Germany, Hong Kong, Italy, Japan, Netherlands, Scotland, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, USA (IV) (NCT04292899) Updated 06 Aug 2020
29 Jun 2020 Trial Update INSERM initiates enrolment in the phase III Discovery trial for COVID-2019 infections in France (NCT04315948) Updated 29 Jun 2020
25 Jun 2020 Regulatory Status The Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion for conditional marketing authorisation (CMA) of remdesivir for the treatment of COVID-2019 infections [21] Updated 29 Jun 2020
25 Jun 2020 Scientific Update Efficacy data from the phase III trial in COVID-2019 infections released by European Medicines Agency [21] Updated 29 Jun 2020
16 Jun 2020 Trial Update Gilead Sciences plans the phase II/III CARAVAN trial for COVID-2019 infections (In neonates, In infants, In children, In adolescents) (IV) in June 2020 (NCT04431453) Updated 29 Jul 2020
16 Jun 2020 Phase Change - III Phase-III clinical trials in Pneumonia (associated with COVID-2019 infections; Combination therapy) in Europe, Canada, USA (IV) [33] (NCT04409262) Updated 03 Jul 2020
16 Jun 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (Combination therapy) in USA (IV) (NCT04410354) [58] Updated 24 Jun 2020
15 Jun 2020 Licensing Status Gilead Sciences and Zydus Cadila enter into a non-exclusive licensing agreement to manufacture and distribute remdesivir for COVID-2019 infections [8] Updated 22 Jun 2020
13 Jun 2020 Licensing Status Gilead Sciences enters into a licensing agreement with Dr Reddy’s Laboratories to market remdesivir for COVID-2019 infections [7] Updated 17 Jun 2020
10 Jun 2020 Phase Change - Preregistration Preregistration for COVID-2019 infections (Adjunctive treatment) in Taiwan (IV) before June 2020 Updated 16 Jun 2020
10 Jun 2020 Phase Change - Registered Registered for COVID-2019 infections (Adjunctive treatment) in Singapore (IV) - conditional approval [25] Updated 16 Jun 2020
10 Jun 2020 Phase Change - Registered Registered for COVID-2019 infections (Adjunctive treatment) in Taiwan (IV) - conditional approval [26] Updated 16 Jun 2020
08 Jun 2020 Regulatory Status The EMA receives application for conditional marketing authorisation (CMA) of remdesivir for COVID-2019 infections [22] Updated 29 Jun 2020
08 Jun 2020 Regulatory Status The Paediatric Committee (PDCO) of EMA issues opinion on the paediatric investigation plan (PIP) for remdesivir in COVID-2019 infections before June 2020 [22] Updated 11 Jun 2020
01 Jun 2020 Scientific Update Efficacy and adverse events data from the phase III SIMPLE-moderate trial in COVID-2019 infection released by Gilead Sciences [43] Updated 06 Jun 2020
29 May 2020 Regulatory Status Taiwan Food and Drug Administration holds a meeting with pharmaceutical and clinical experts to discuss the application and approval requirements of remdesivir for COVID-2019 infections [26] Updated 16 Jun 2020
28 May 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Combination therapy) in Europe, Canada (IV) [33] Updated 03 Jun 2020
28 May 2020 Trial Update Roche initiates enrolment in the phase III REMDACTA trial for COVID-2019 infections (Combination therapy) in USA [33] Updated 03 Jun 2020
22 May 2020 Phase Change - Preregistration Preregistration for COVID-2019 infections (Adjunctive treatment) in Singapore (IV), before May 2020 [25] Updated 16 Jun 2020
22 May 2020 Trial Update Gilead Sciences plans clinical trials for remdesivir (Combination therapy) in COVID-2019 infections [45] Updated 01 Jun 2020
21 May 2020 Trial Update National Institute of Allergy and Infectious Diseases completes the phase III (ACTT) trial in COVID-2019 infections in USA, Denmark, Germany, Greece, South Korea, Japan, Mexico, Singapore, Spain and United Kingdom (NCT04280705) Updated 16 Jul 2020
15 May 2020 Regulatory Status The Committee for Medicinal Products for Human Use (CHMP) invites Gilead Sciences to submit additional data and a conditional marketing authorisation application for remdesivir in COVID-2019 infections [22] Updated 11 Jun 2020
13 May 2020 Licensing Status Gilead sciences and Hetero enters into licensing agreement to manufacture and distribute remdesivir for COVID-19 infections [10] Updated 19 May 2020
12 May 2020 Licensing Status Gilead Sciences and Cipla enter into a non-exclusive licensing agreement to manufacture and distribute remdesivir for COVID-2019 infections [9] Updated 16 May 2020
12 May 2020 Licensing Status Gilead Sciences and Mylan enters into a non-exclusive licensing agreement to manufacture and distribute remdesivir worldwide for COVID-2019 infections [11] Updated 14 May 2020
11 May 2020 Regulatory Status The Committee for Medicinal Products for Human Use of EMA recommends expanding the compassionate use remdesivir for COVID-2019 infections [61] Updated 15 May 2020
07 May 2020 Phase Change - Registered Registered for COVID-2019 infections (Adjunctive treatment) in Japan - First global approval (IV) [24] Updated 18 May 2020
06 May 2020 Regulatory Status Gilead Sciences receives emergency use authorization from the US FDA for remdesivir in COVID-19 infections [27] Updated 06 May 2020
05 May 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Combination therapy) in USA, USA, Japan, South Korea, Mexico, Singapore (IV)) [53] (NCT04401579) Updated 11 May 2020
04 May 2020 Phase Change - Preregistration Preregistration for COVID-2019 infections (In children, In adults, In adolescents) in European Union (IV) - rolling review by Committee for Medicinal Products for Human Use (CHMP) [23] Updated 05 May 2020
04 May 2020 Regulatory Status Gilead Sciences receives emergency use authorization from the FDA for remdesivir in COVID-19 infections [62] Updated 05 May 2020
30 Apr 2020 Scientific Update Initial primary efficacy data from the phase II ACTT trial in COVID-2019 infections released by EvergreenHealth [50] Updated 06 May 2020
30 Apr 2020 Trial Update Gilead initiated an expanded access programme for COVID-2019 infections in Canada, Germany, Netherlands, Spain, Switzerland (EudraCT2020-001453-49) (NCT04323761) in April 2020 Updated 05 May 2020
30 Apr 2020 Regulatory Status Gilead Sciences discussing with regulatory authorities regarding data on remdesivir for the treatment of COVID-19 infections [47] Updated 04 May 2020
30 Apr 2020 Scientific Update Efficacy and safety data from a phase III SIMPLE trial in COVID-2019 infections released by Gilead Sciences [44] Updated 04 May 2020
29 Apr 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Combination therapy) in Finland (IV) (EudraCT2020-001784-88) Updated 12 May 2020
29 Apr 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Adjunctive treatment) in Japan, Switzerland (IV) before April 2020 (NCT04292899) Updated 04 May 2020
12 Apr 2020 Scientific Update Efficacy data from a compassionate use programme in COVID-2019 infections released by Gilead Sciences [66] Updated 17 Apr 2020
08 Apr 2020 Phase Change - Preregistration Preregistration for COVID-2019 infections (In adults) in USA (IV) [16] Updated 12 Aug 2020
03 Apr 2020 Regulatory Status EMA provides recommendations for compassionate use of remdesivir for COVID-2019 infections in European Union [63] Updated 29 Apr 2020
03 Apr 2020 Active Status Review 9289127 - No updates Updated 03 Apr 2020
31 Mar 2020 Trial Update The Health Sciences Authority initiated an early access programme in Singapore for treatment of COVID-2019 infections [25] Updated 16 Jun 2020
30 Mar 2020 Trial Update Oslo University Hospital plans a phase II/III trial for COVID-2019 infections in Norway (IV) (NCT04321616) Updated 30 Mar 2020
27 Mar 2020 Phase Change - Clinical Clinical trials in COVID-2019 infections in Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, Greece, Greece, Iceland, Israel; Hungary, Ireland, Poland, Portugal, Romania, Slovakia, Slovenia (IV) - expanded access (NCT04323761) Updated 29 Jun 2020
27 Mar 2020 Trial Update National institute of allergy and infectious diseases initiates a phase II trial for COVID-2019 infections in USA (IV) Updated 01 Apr 2020
27 Mar 2020 Trial Update Gilead initiated an expanded access programme for COVID-19 infections in USA, France, Italy and United Kingdom (NCT04323761) Updated 31 Mar 2020
25 Mar 2020 Regulatory Status The US FDA withdraws the Orphan Drug status of remdesivir for COVID-2019 infections [30] Updated 27 Mar 2020
23 Mar 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Adjunctive treatment) in France (IV) (NCT04292899) Updated 14 Apr 2020
23 Mar 2020 Regulatory Status The US FDA grants Orphan Drug status to remdesivir for COVID-2019 infections [30] [31] Updated 27 Mar 2020
23 Mar 2020 Trial Update Gilead Sciences initiates phase III clinical trials in COVID-2019 infections (Adjunctive treatment) in China, Taiwan, Singapore, South Korea, Hong Kong, USA, Sweden, United Kingdom, Netherlands, Italy, Spain, Germany (IV) before March 2020 (NCT04292730) Updated 24 Mar 2020
22 Mar 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Adjunctive treatment) in Austria (IV) (NCT04315948) Updated 29 Jun 2020
22 Mar 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Adjunctive treatment) in Luxembourg (IV, Infusion) (NCT04315948) (EudraCT2020-000936-23) [37] Updated 15 Apr 2020
20 Mar 2020 Trial Update Institut National de la Santé et de la Recherche Médicale (INSERM) plans the phase III DisCoVeRy trial for COVID-2019 infections in France (IV, Infusion), in March 2020 , (NCT04315948) Updated 15 Apr 2020
18 Mar 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (Adjunctive treatment) in Canada (IV) (NCT04330690) Updated 29 Jun 2020
10 Mar 2020 Trial Update U.S. Army Medical Research and Development Command initiates an Expanded access programme for COVID-19 infections in USA (NCT04302766) Updated 17 Mar 2020
06 Mar 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Adjunctive treatment) in Taiwan, Singapore, South Korea, Hong Kong, USA, Sweden, United Kingdom, Netherlands, Italy, Spain, and Germany (IV) (NCT04292899) Updated 24 Mar 2020
01 Mar 2020 Trial Update Gilead Sciences initiates a compassionate use programme for COVID-2019 infections in USA, Europe, Canada and Japan, before March 2020 [66] Updated 20 Apr 2020
01 Mar 2020 Phase Change - III Phase-III clinical trials in COVID-2019-infections (Adjunctive treatment) in China (IV) [48] (NCT04292899) Updated 01 Mar 2020
28 Feb 2020 Trial Update Remdesivir is available on a Compassionate basis for the treatment of COVID-2019-infections globally (IV) [48] Updated 02 Mar 2020
21 Feb 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections in Denmark (IV) (NCT04280705) Updated 26 Jul 2020
21 Feb 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections in Greece (IV) (NCT04280705) Updated 06 Jul 2020
21 Feb 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections in Denmark, Germany, Greece, Japan, Mexico, United Kingdom (IV) (NCT04280705) Updated 05 May 2020
21 Feb 2020 Phase Change - III Phase-III clinical trials in COVID-2019-infections in USA, Singapore, South Korea and Spain (IV) (NCT04280705) Updated 27 Feb 2020
05 Feb 2020 Trial Update Capital Medical University plans a phase III trial for COVID-2019-infections (NCT04252664) Updated 13 Feb 2020
07 Oct 2019 Trial Update National Institute of Allergy and Infectious Diseases completes the phase II PREVAIL IV trial for Ebola virus infections in Guinea and Liberia (NCT02818582) Updated 29 Jun 2020
12 Aug 2019 Trial Update Ridgeback Biotherapeutics terminates the phase I/II PALM trial for Ebola virus infections in Congo and USA (IV) (NCT03719586) [68] Updated 14 Aug 2019
25 Oct 2018 Phase Change - II Phase-II clinical trials in Ebola virus infections in Congo (IV) (NCT03719586) Updated 02 Nov 2018
25 Oct 2018 Trial Update Gilead Sciences and National institute of allergy and infectious diseases initiates a phase II trial for Ebola virus infections in USA (IV) (NCT03719586) Updated 02 Nov 2018
29 Jan 2018 Other Chemical structure information added Updated 29 Jan 2018
28 Jun 2016 Trial Update National Institute of Allergy and Infectious Diseases plans the phase II PREVAIL IV trial for Ebola virus infections in Guinea and Liberia (IV) (NCT02818582) Updated 04 Jul 2016
01 Jun 2016 Phase Change - II Phase-II clinical trials in Ebola virus infections in Guinea and Liberia (IV) (NCT02818582) Updated 09 Nov 2016
01 Dec 2015 Licensing Status Gilead Sciences and Ligand Pharmaceuticals enter into supply agreement for Captisol®-enabled remdesivir for Ebola virus infections (Ligand Pharmaceuticals, Form 10-K, December 2015) Updated 28 Feb 2018
21 Oct 2015 Regulatory Status GS 5734 is available on a Compassionate basis for the treatment of Ebola virus infections in United Kingdom [71] Updated 28 Oct 2015
05 Oct 2015 Phase Change - I Phase-I clinical trials in Ebola virus infections in USA (Parenteral) Updated 05 Oct 2015
05 Oct 2015 Scientific Update Preclinical pharmacodynamics data in Ebola virus infections released by Gilead Sciences [72] Updated 05 Oct 2015

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    Media Release
  34. A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia

    ctiprofile
  35. WHO SOLIDARITY Finland: The multicenter trial on the efficacy of different anti-viral drugs in SARS-CoV-2 infected patients (COVID-19)

    ctiprofile
  36. A Multi-centre, Adaptive, Randomized, Open-label, Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients (CATCO: Canadian Treatments for COVID-19), in Conjunction With the Public Health Emergency SOLIDARITY Trial (World Health Organization)

    ctiprofile
  37. An Open Letter from our Chairman & CEO.

    Media Release
  38. Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults

    ctiprofile
  39. Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection

    ctiprofile
  40. Prime Healthcare Participating in Program for Promising COVID-19 Treatment.

    Media Release
  41. Froedtert & the Medical College of Wisconsin Bolster Resources in Fight Against COVID-19 with Study of Remdesivir.

    Media Release
  42. Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19.

    Media Release
  43. Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19.

    Media Release
  44. Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19.

    Media Release
  45. Gilead Sciences Statement on NEJM Publication of Remdesivir Data From NIAID Study.

    Media Release
  46. A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe COVID-19

    ctiprofile
  47. Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases Study of Investigational Antiviral Remdesivir for COVID-19.

    Media Release
  48. Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19.

    Media Release
  49. A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-573) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment

    ctiprofile
  50. EvergreenHealth Prepares for Second Arm of Clinical Trial After Initial Findings Show Promising Results for Remdesivir as Potential Treatment for COVID-19.

    Media Release
  51. A multicentre, adaptive, randomized blinded controlled trial of the safety and efficacy of investigational therapeutics for the treatment of COVID-19 in hospitalized adults – version for European Union/United Kingdom sites

    ctiprofile
  52. Incyte Reports 2020 First Quarter Financial Results and Provides Updates on Key Clinical Programs.

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

    Available from: URL: https://www.niaid.nih.gov/news-events/nih-clinical-trial-testing-antiviral-remdesivir-plus-anti-inflammatory-drug-baricitinib
  54. 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)

    ctiprofile
  55. A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734) in Participants From Birth to < 18 Years of Age With COVID-19

    ctiprofile
  56. I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients

    ctiprofile
  57. Members Of The COVID R&D Alliance And Quantum Leap Healthcare Collaborative Enroll First Patients In I-SPY COVID Trial.

    Media Release
  58. ViralClear Opens Enrollment with First Patient Dosing in Phase II Human Trial of Anti-Viral MMPD Oral Solution for Treatment of COVID-19.

    Media Release
  59. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination With Intravenous Remdesivir in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)

    ctiprofile
  60. Ligand's Technologies Support and Enable Potential Coronavirus Treatments.

    Media Release
  61. EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation.

    Media Release
  62. Gileads Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19.

    Media Release
  63. EMA provides recommendations on compassionate use of remdesivir for COVID-19

    Media Release
  64. Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)

    ctiprofile
  65. Gilead Sciences Announces Fourth Quarter and Full Year 2015 Financial Results.

    Media Release
  66. Data on 53 Patients Treated With Investigational Antiviral Remdesivir Through the Compassionate Use Program Published in New England Journal of Medicine.

    Media Release
  67. Compassionate Use Program For the Treating Severely Ill Patients of COVID-19 With Remdesivir

    ctiprofile
  68. Ridgeback Biotherapeutics LP announces an update on mAb114, an experimental treatment for Ebola.

    Media Release
  69. A Multicenter, Multi-Outbreak, Randomized, Controlled Safety and Efficacy Study of Investigational Therapeutics for the Treatment of Patients With Ebola Virus Disease

    ctiprofile
  70. PREVAIL IV: Double-Blind, Randomized, Two-Phase, Placebo-Controlled, Phase II Trial of GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen

    ctiprofile
  71. Gilead Provides Update on Investigational Compound, GS-5734, for the Treatment of Ebola Virus Disease.

    Media Release
  72. Nucleotide prodrug GS-5734 is a broad-spectrum filovirus Inhibitor that provides complete therapeutic protection against the development of Ebola virus disease (EVD) in infected non-human primates. Internet-Doc 2015;.

    Available from: URL: https://idsa.confex.com/idsa/2015/webprogram/Paper54208.html
  73. $6.5 billion in NIH funding for foundational research enabled Emergency Use Authorization of remdesivir for treating COVID-19.

    Media Release
  74. Jordan R, Hogg A, Warren T, De Wit E, Sheahan T, Lo M, et al. Broad Spectrum Investigational Agent GS-5734 for the Treatment of Ebola, MERS Coronavirus and Other Pathogenic Viral Infections with High Outbreak Potential. IDW-2017 2017; abstr. LB-9.

    Available from: URL: https://idsa.confex.com/idsa/2017/webprogram/Paper67515.html
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