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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 Oct 2021

At a glance

  • Originator Gilead Sciences
  • Developer Capital Medical University; China-Japan Friendship Hospital; Chinese Academy of Medical Sciences; Dr Reddys Laboratories; Gilead Sciences; INSERM; National Institute of Allergy and Infectious Diseases; NeuroActiva; 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 COVID-19 pneumonia
  • Phase II Ebola virus infections
  • Phase I Neurological disorders

Most Recent Events

  • 22 Sep 2021 Adverse events and efficacy data from a phase III trial in COVID-2019 infections released by Gilead Sciences
  • 26 Jul 2021 Phase-I clinical trials in COVID-2019 infections in Australia (IV) (ACTRN12620001048976)
  • 26 Jul 2021 Phase-I clinical trials in COVID-2019 infections in New Zealand (IV) (ACTRN12620001048976)

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, COVID-19 pneumonia, SARS-COV-2 acute respiratory disease, 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 a nucleoside monophosphate intermediate, which is subsequently phosphorylated by cellular kinases to form the pharmacologically active nucleoside triphosphate metabolite (GS 443902). GS 441524 is the predominant circulating metabolite of remdesivir. Remdesivir triphosphate (RDV-TP) acts as an analogue of adenosine triphosphate (ATP) and 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 the US and Egypt for the treatment of COVID-2019 infections. Remdesivir is approved in Japan, United Arab Emirates, US 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. In India, remdesivir is approved for emergency restricted use. 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 and COVID-19 pneumonia in multiple countries. 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 DCGI granted regulatory approval to Mylan (now Viatris), 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 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 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] .

In November 2020, Upjohn was merged with Mylan to form Viatris [5] .

In May 2021, NeuroRx was merged with Big Rock Partners to form NRx Pharmaceuticals [6] .

Company Agreements

In May 2020, Gilead Sciences entered into a worldwide collaboration agreement with Mylan (now Viatris) 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. [7] [5]

In October 2020, Gilead reported that it will be responsible for distributing remdesivir (Veklury®) in the United States, since 1st October 2020. Remdesivir distribution has transitioned from the US Government to Gilead. AmerisourceBergen will continue to serve as the sole US distributor of Veklury through the end of 2020 and will sell the product directly to hospitals. [8]

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 [9]

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] [10]

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 [11]

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. [12]

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. [13]

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. [14]

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. [15]

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. [15]

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). [16]

Key Development Milestones

COVID-2019 infections and COVID-19 pneumonia

In October 2020, US FDA approved remdesivir (Veklury®) for the treatment of COVID-2019 infection in patients (12 years of age and older and weighing at least 40 kilograms) requiring hospitalization, and subsequently launched the product in the US. The FDA granted this application Fast Track and Priority Review designations. The Agency also granted this application a Material Threat Medical Countermeasure Priority Review Voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats [17] [18] [19] . 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 [20] .

In October 2020, the US FDA revised the Emergency Use Authorization (EUA) for remdesivir to remove the uses that are approved under Gilead’s New Drug Application (NDA). Thus, the EUA for Veklury continues to authorize Veklury for emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. In August 2020, the 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, regardless of the need for supplemental oxygen. Earlier, in May 2020, the US Food and Drug Administration (FDA) granted an emergency use authoristion 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 [21] [22] [8] [23] [24] .

In September 2020, Dr Reddy's Laboratories announced the launch of remdesivir for restricted emergency use, under a brand name Redyx® in India for the treatment of COVID-2019 infections. The Drug Controller General of India (DCGI) granted regulatory approval for restricted emergency use to remdesivir, for the treatment of suspected or laboratory confirmed COVID-2019 infections in adults and children hospitalised with severe disease in June 2020 [25] [26] [27] .

In May 2021, the CHMP recommended the renewal of the conditional marketing authorisation for remdesivir (Veklury®), which was granted in July 2020 by the European Commission for the treatment of COVID-2019 infections in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen [28] . 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. However, in October 2020, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) initiated the review of a safety signal to assess the reports of acute kidney injury in few patients who were administered remdesivir for the treatment of COVID-2019 infections. The outcome of the PRAC’s review will be communicated after reviewing any new information that is available through monthly summary safety reports, periodic safety update reports, and signal detection [29] . Previously in June 2020, the EMA had received an application for CMA of remdesivir and had 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) 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 [30] [31] [32] [33] .

As of July 2020, the United Arab Emirates’ Ministry of Health and Prevention approved remdesivir for the treatment of patients with COVID-2019 infections [30] .

In June 2020, the US FDA reported that it 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 [34] .

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 [35] .

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 [36] .

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 exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization of remdesivir in the US. 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 [37] .

As of February 2021, remdesivir is available in Egypt (NCT04738045)

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 [38] [39] [40] .

In April 2021, NeuroRx in collaboration with National Institute of Allergy and Infectious Diseases (NIAID), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury (PETAL), Cardiothoracic Surgical Trials Network (CTSN), and Gilead Sciences initiated the phase III TESICO trial to assess the safety and effectiveness of aviptadil [see ADIS Insight drug profile800002016] and remdesivir in treating hospitalized COVID-19 patients, and patients with acute respiratory failure (ACTIV-3b; NCT04843761). The multicenter, adaptive, randomized, blinded control trial intends to enroll approximately 640 patients in the US and is expected to expand to the EU, the UK, and additional countries around the world. The first patient was dosed in the same month [41] [42] . Previously, in April 2021, NeuroRx had reported that aviptadil has been identified by the National Institutes of Health (NIH) as one of two drugs selected for inclusion in a planned phase III TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), multicenter clinical trial that will include the US and multiple foreign countries. The trial is funded by the US Government COVID-19 Therapeutics Response and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). NeuroRx reported that TESICO protocol has been reviewed and approved as a phase III trial by the US FDA [43] . In April 2021, NeuroRx was actively collaborating with NIH to provide remediated formulation and stability data to European and South American Regulatory Authorities so that NIH can extend TESICO trial to Europe [44] .

In March 2021, Gilead Sciences initiated a phase III trial to evaluate the efficacy and safety of remdesivir in patients with severely reduced kidney function who are hospitalized for coronavirus 2019 (COVID-2019) infections (GS-US-540-5912; EudraCT2020-005416-22; NCT04745351). This randomised, double-blind, placebo-controlled, parallel-group study is enrolling approximately 1 116 patients in the US, Portugal, and may expand to Spain and the UK [45] .

In February 2021, Daewoong Pharmaceutical initiated a phase III trial to evaluate the efficacy and safety of oral Camostat mesylate (DWJ1248) [see Adis Insight Drug profile [46] ] treatment along with remdesivir (IV) in severe COVID-19 patients (NCT04713176; DW_DWJ1248302). The double-blind, randomised, placebo-controlled, multi-center trial intends to enroll approximately 1022 participants in South Korea [47] .

In October 2020, the University of Minnesota, the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institutes of Health (NIH), initiated a phase III ITAC trial to evaluate the safety, tolerability and efficacy of anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG) versus placebo, along with remdesivir as standard of care, in adult patients hospitalised for COVID-19 and have had symptoms for 12 days or fewer without life-threatening organ dysfunction or end-organ failure (INSIGHT013; EudraCT2020-002542-16; INSIGHT 013; NCT04546581). The Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) trial is a double-blind, placebo-controlled, randomised, adaptive and enrolling approximately 500 patients in the US, Mexico and 16 other countries in Africa, Asia, Europe, North America and South America. The primary outcome of the trial is to compare the health status of participants in each group on day seven, based on an ordinal outcome with seven mutually exclusive categories ranging from no limiting symptoms due to COVID-19, to death [48] . Emergent BioSolutions [see adis profile 800057829] , Grifols [see adis profile 800057941] and, CSL Behring with Takeda [see adis profile 800057734] will provide anti-coronavirus hIVIG for the trial. In October 2020, NIAID announced that primary analysis was planned after all participants finish 28 days of follow-up. An independent data and safety monitoring board (DSMB) will review interim safety and efficacy data to ensure patient well-being and safety as well as study integrity [49] . In April 2021, Takeda announced that, top-line data from this trial demonstrated that the trial did not met its endpoint. However, no safety signals were observed [50] .

In April 2021, Gilead Sciences announced the termination of the phase III trial designed to evaluate the efficacy of remdesivir (RDV) in reducing the rate of hospitalisation or death in non-hospitalised participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting (NCT04501952; EudraCT-2020-003510-12; GS-US-540-9012). The trial was terminated due to study enrollment feasibility and changing needs of non-hospitalised patients. The decision to terminate the trial was not due to efficacy or safety concerns. Patients already enrolled in the study will continue to be followed and the study will remain blinded [51] . The randomised trial was initiated in September 2020 and intended to enroll 562 patients in the US, UK, Portugal, Denmark and Spain. In September 2021, Gilead Sciences released efficacy and safety data from a phase III trial [52] [53] .

In August 2020, National Institute of Allergy and Infectious Diseases (NIAID) 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, Japan, South Korea, Mexico and Singapore [54] . In September 2020, National Institute of Allergy and Infectious Diseases announced that the trial will no longer recruit severely ill COVID-19 patients after an interim review of 266 patients safety data by Data and Safety Monitoring Board (DSMB), however the study will continue to enrol hospitalised patients on low-flow oxygen and those not requiring supplemental oxygen. In October 2020, NIAID disclosed that in hospitalised patients with COVID-19 and lower respiratory tract involvement who received remdesivir had a statistically significant shorter time to recovery compared to patients who received placebo [55] [49] .

In March 2021, Genentech announced that the phase III REMDACTA trial did not meet its primary endpoint, measured by improved time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia receiving standard of care. REMDACTA did not meet key secondary endpoints, which included likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status. No new safety signals were identified for tocilizumab in the REMDACTA trial [56] . 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 (WA42511; EudraCT2020-002275-34; NCT04409262). The randomised, double-blind trial intends to enroll approximately 450 patients in the US, Canada, Spain, Russia and Brazil [57] [58] .

As of September 2021, Institut National de la Santé Et de la Recherche Médicale (INSERM) discontinued treatment with remdesivir in the phase III DisCoVeRy trial designed to assess safety and efficacy of remdesivir and other therapeutics including hydroxychloroquine, lopinavir/ritonavir compared with standard of care, based on analyses review by both independent data and safety monitoring board (DSMC/DSMB), the Solidarity Executive Group and the DisCoVeRy steering committee (NCT04315948; C20-15; EudraCT2020-000936-23). Institut National de la Santé Et de la Recherche Médicale (INSERM) and Gilead Sciences initiated the trial in March 2020. The primary endpoint of study was to determine the percentage of patients reporting each severity rating on a 7-point ordinal scale in 15 days. The randomised, adaptive trial intended to enrol approximately 3300 patients in France, Luxembourg, Austria, Belgium, Norway and Portugal [59] [60] .

In June 2020, Gilead Sciences 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. In October 2020, updated efficacy data from the trial were presented at the IDWeek 2020 (IDW-2020) [61] [62] [63] [64] [59] [65] [66] [67] .

In June 2020, Gilead Sciences 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 [64] [68] [69] [70] . In August 2020, updated results from the trial were released by the company [22] .

In October 2020, Gilead Sciences released final results and reported that the phase III ACTT-1 trial met its primary endpoint, demonstrating remdesivir plus standard of care was superior in shortening the time to recovery through Day 29 compared with placebo plus standard of care. The key secondary study endpoint of clinical status at Day 15 was also met [71] . In May 2020, National Institute of Allergy and Infectious Diseases completed 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 the UK. In April 2020, 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 [31] [72] [66] [73] . In August 2020, updated results from the trial were released by the company. As of October 2020, Gilead announced that remdesivir significantly improved time to recovery and also reduced the likelihood of disease progression [22] [8] .

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 [74] [75] [76] .

In April 2020, Capital Medical University, Chinese Academy of Medical Sciences, China-Japan Friendship Hospital and Gilead Sciences suspended the randomised, controlled, double blind phase III CAP-China remdesivir 1 trial, as the epidemic of COVID-2019 was well-controlled, and no eligible patients could be recruited further (NCT04252664; CAP-China remdesivir 1). The trial evaluated the efficacy and safety of remdesivir in patients hospitalised with mild or moderate COVID-2019 infections. Patients were randomised 1:1:1 to receive up to 5 days or 10 days of remdesivir with standard of care or standard of care alone. The trial was initiated in February 2020 and enrolled 584 patients in China [77] . In October 2020, Gilead Sciences presented the results of this trial at the IDWeek 2020 (IDW-2020) [78] [79] . In March 2021, Gilead Sciences presented results at the 28th Conference on Retroviruses and Opportunistic Infections (CROI-2021) demonstrating effect of remdesivir on renal function in hospitalized patients with moderate COVID-19 infections [80] .

In July 2020, Gilead Sciences initiated a phase II/III CARAVAN trial to evaluate the safety, tolerability, and pharmacokinetics of remdesivir in patients with COVID-19 infections (P201-2020; GS-US540-5823; EudraCT2020-001803-17; NCT04431453). The open-label trial intends to enrol approximately 52 patients, aged 0 to 18 years, in the US, the UK, Italy and Spain [81] . In March 2021, efficacy and adverse events data from a trial was presented at the 28th Conference on Retroviruses and Opportunistic Infections (CROI-2021) [82] .

In June 2020, Gilead Sciences in collaboration with World Health Organisation, initiated a phase II/III WHO-SOLIDARITY-GERMANY trial to evaluate the clinical efficacy and safety of investigational therapeutics relative to the control arm among hospitalised adult patients who have COVID-19 (EudraCT2020-001549-38; NCT04575064). The open, parallel, prospective, randomised trial intends to enrol 400 participants in Germany [83] .

In March 2020, Gilead Sciences in collaboration with World Health Organisation, initiated a phase II//III NOR-SOLIDARITY trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalised adult patients diagnosed with COVID-19. This trial will follow the core WHO protocol but has additional efficacy, safety and explorative endpoints (N-ReCOVID 19; S-ReCOVID 19; 118684; EudraCT2020-000982-18; NCT04321616; WHO-NOR-COVID19). The multicentre, open, parallel, prospective, randomised trial intends to enrol 1218 participants in Norway [84] .

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 [85] .

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 [86] . Company announced the enrollment of the first patient in the trial [87] .

In October 2020, BioSig Technologies and ViralClear Pharmaceuticals announced that it has stopped enrollments and halted the phase II trial that designed 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, randomised, placebo-controlled trial was initiated in June 2020 in USA. The recent results showed the trial would not meet its primary safety endpoints [88] . In September 2020, ViralClear Pharmaceuticals expanded the size of the trial from 40 to 80 hospitalised COVID-19 patients, and that limited enrollment to seriously ill patients, (NIAID Grade 3, who required high flow, high concentration oxygen to maintain adequate oxygenation). At the time review of the data by the SMC, 44 patients had been enrolled in the trial of whom 42 had received study drug (either merimepodib solution or matching placebo). The most recent review of the data documented all 22 Grade 4 patients were discharged from the hospital and did not relapse during the 37 day follow-up period. However, patients who were NIAID Grade 3 patients (n = 20) at the time of enrollment had markedly different outcomes. Specifically, the unblinded SMC detected an imbalance in survival rates in these NIAID Grade 3 patients between the placebo and merimepodib making it unlikely that the trial would meet its primary safety endpoints. The company has therefore elected to stop enrollment into the clinical trial. Patients will be followed as per the protocol for safety monitoring; however, no further study drug treatments will be administered. The first patient was dosed in June 2020 [89] [90] .

In March 2021, Gilead Sciences completed a phase I/II trial that evaluated the safety, efficacy, and pharmacokinetics of remdesivir administered by inhalation for early stage COVID-2019 infections (NCT04539262; GS-US-553-9020). The randomised study was initiated in September 2020, and enrolled 156 patients in the US [91] .

In March 2020, Gilead Sciences 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 [92] [93] [94] .

In November 2020, the US FDA announced that the SOLIDARITY trial did not find a statistically significant difference in mortality between the remdesivir arm and the standard-of-care arm [95] .

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 [96]

In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19 [65] .

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 [97] .

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) [98] .

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 [99] .

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) [100] .

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 [101] .

Gilead Sciences is also providing remdesivir for compassionate use to patients with COVID-2019 infections for emergency treatment outside of ongoing clinical studies [69] .

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 [63] . In April 2020, Gilead Sciences released efficacy and safety data of remdesivir from compassionate use programme for COVID-2019 infections [102] [103] . Gilead Sciences in April 2020, reported that intravenous infusion of remdesivir demonstrated clinical improvement in first 53 patients who received treatment in compassionate programme [59] .

Ebola virus infections

In August 2019, based on independent Data and Safety Monitoring Board’s (DSMB) recommendation, Gilead Sciences, Ridgeback Biotherapeutics and National Institute of Allergy and Infectious Diseases prematurely 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 was initiated in October 2018, and enrolled 1 044 patients in the US and Congo [104] [105] .

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 [106] .

In July 2021, Gilead sciences initiated a phase I trial to evaluate the pharmacokinetics of remdesivir and metabolites in participants with normal renal function and renal impairment (ACTRN12620001048976; 380566). The open label trial intends to enroll 80 participants in Germany, New Zealand, Puerto Rico and the US [107] .

Gilead initiated a phase I trial in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of remdesivir [108] .

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 [109] .

Remdesivir has a broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple viral pathogens, including Ebola, Marburg, MERS, SARS and SARS-CoV-2 [65] [8] .

Supply arrangement

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 [110] .

In October 2020, Gilead Sciences signed a joint procurement agreement (JPA) that will enable rapid and equitable access to remdesivir (Veklury®) for the treatment of COVID-19 in the European Union (EU). The JPA enables participating countries in the EU and the European Economic Area (EEA) and the United Kingdom to purchase remdesivir for both real-time demand and stockpiling needs, coordinated by the European Commission. The agreement covers purchases of remdesivir over the next six months and has the option to be extended [111] .

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 [112] .

Financial information

In July 2020, The emergency authorization of remdesivir received $US6.5 billion in NIH funding for the treatment of COVID-19 infection [113] .

Patent Information

As at December 2020, Gilead Sciences was issued patent protection for remdesivir in the US and in the European Union valid through 2035 [114]

Drug Properties & Chemical Synopsis

  • Route of administration Inhalation, IV
  • Formulation Infusion, Injection, 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-B16 (Remdesivir)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

  • 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
  • SMILES C(C(NP(=O)(OC1C=CC=CC=1)OCC1OC(C(C1O)O)(C#N)C1=CC=C2C(=CC=NN21)N)C)(=O)OCC(CC)CC
  • Chemical Structure
  • CAS Registry Number 1809249-37-3

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

adult respiratory distress syndrome

Arm Group Description

Monocyte differentiation antigen CD14

histamine receptor H2

1

1

adult respiratory distress syndrome

Outcome Measure

Lactate dehydrogenase (LDH)

Fibrinogen

Ferritin

D-dimer

C-reactive protein (CRP)

1

1

1

1

1

cOVID 2019 infections

Arm Group Description

Monocyte differentiation antigen CD14

histamine receptor H2

1

1

cOVID 2019 infections

Eligibility Criteria

T-cell surface antigen CD4

protein tyrosine phosphatase, receptor type F

L-Aspartic acid

ALT

1

1

1

1

cOVID 2019 infections

Outcome Measure

Tumor necrosis factor alpha (TNF-alpha)

Lactate dehydrogenase (LDH)

KLHL2

Interleukin-6 (IL-6)

Fibrinogen

Ferritin

D-dimer

C-reactive protein (CRP)

1

1

1

1

1

1

2

3

COVID-19 pneumonia

Outcome Measure

L-Aspartic acid

ATP-binding cassette, sub-family B (MDR/TAP), member 7

Alkaline phosphatase (ALPL)

1

1

1

COVID-19 respiratory infection

Arm Group Description

Monocyte differentiation antigen CD14

histamine receptor H2

1

1

COVID-19 respiratory infection

Arm Group Label

interferon, beta 1, fibroblast

1

COVID-19 respiratory infection

Brief Title

interferon, beta 1, fibroblast

1

COVID-19 respiratory infection

Outcome Measure

Fibrinogen

Ferritin

D-dimer

C-reactive protein (CRP)

1

1

1

1

respiratory insufficiency

Outcome Measure

Lactate dehydrogenase (LDH)

Fibrinogen

Ferritin

D-dimer

C-reactive protein (CRP)

1

1

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

SARS-CoV-2 acute respiratory disease

Eligibility Criteria

protein tyrosine phosphatase, receptor type F

L-Aspartic acid

ALT

1

1

1

SARS-CoV-2 acute respiratory disease

Outcome Measure

D-dimer

C-reactive protein (CRP)

1

1

Biomarker

Drug Name Biomarker Name Biomarker Function
Remdesivir - Gilead Sciences 1-Methylnicotinamide Outcome Measure
ACE2 Outcome Measure
Aldosterone Outcome Measure
Alkaline phosphatase (ALPL) Outcome Measure
ALT Eligibility Criteria
Angiotensin II Outcome Measure
ATP-binding cassette, sub-family B (MDR/TAP), member 7 Outcome Measure
Bilirubin Detailed Description, Outcome Measure
BNP Detailed Description, Outcome Measure
C-reactive protein (CRP) Detailed Description, Eligibility Criteria, Outcome Measure
Canrenone Arm Group Description, Brief Title, Official Title
Cardiac Troponin I Detailed Description, Eligibility Criteria, Outcome Measure
Cardiac Troponin T Outcome Measure
Creatine Eligibility Criteria, Outcome Measure
Creatinine Detailed Description, Outcome Measure
Cystatin C Outcome Measure
D-dimer Detailed Description, Eligibility Criteria, Outcome Measure
dermo-distortive urticaria Eligibility Criteria
Escitalopram Arm Group Label
Factor V Eligibility Criteria
Ferritin Detailed Description, Eligibility Criteria, Outcome Measure
Fibrinogen Detailed Description, Eligibility Criteria, Outcome Measure
gamma-glutamyltransferase 2 Outcome Measure
gamma-glutamyltransferase light chain 3 Outcome Measure
GGT Outcome Measure
GGTLC4P Outcome Measure
GGTLC5P Outcome Measure
Granulocyte-macrophage colony-stimulating factor (GM-CSF) Outcome Measure
histamine receptor H2 Arm Group Description
IFN-alpha 2 Arm Group Description
interferon, beta 1, fibroblast Arm Group Label, Brief Title
Interleukin 1 alpha (IL-1α) Outcome Measure
Interleukin 1 Beta (IL-1β) Outcome Measure
interleukin 6 receptor Brief Summary, Official Title, Outcome Measure
Interleukin-10 (IL-10) Outcome Measure
Interleukin-6 (IL-6) Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title, Outcome Measure
Interleukin-8 (IL-8) Outcome Measure
KIM-1 Outcome Measure
KLHL2 Outcome Measure
L-Aspartic acid Eligibility Criteria, Outcome Measure
L-FABP Outcome Measure
Lactate dehydrogenase (LDH) Outcome Measure
Monocyte differentiation antigen CD14 Arm Group Description, Arm Group Label, Brief Title, Official Title
NGAL Outcome Measure
Nicotinic acid adenine dinucleotide Outcome Measure
NLR family, pyrin domain containing 3 Arm Group Description
Oxytocin Arm Group Label, Brief Title, Official Title
PAI-1 Outcome Measure
PDZ and LIM domain 7 Eligibility Criteria
phosphatidylinositol-4-phosphate 3-kinase catalytic subunit type 2 alpha Outcome Measure
protein tyrosine phosphatase, receptor type F Eligibility Criteria
Prothrombin (PT) Eligibility Criteria, Outcome Measure
Renin Arm Group Description, Brief Summary, Outcome Measure
seryl-tRNA synthetase Arm Group Description, Arm Group Label
SH3 and cysteine rich domain 3 Outcome Measure
T-Cell differentiation antigen CD8 Eligibility Criteria, Outcome Measure
T-cell surface antigen CD4 Eligibility Criteria, Outcome Measure
Thyroid stimulating hormone beta (TSH) Outcome Measure
Triiodothyronine Outcome Measure
Tubulin beta class IVb Outcome Measure
Tumor necrosis factor alpha (TNF-alpha) 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
COVID 2019 infections in patients aged 12 years and older In adolescents, In adults Marketed USA IV / Infusion Gilead Sciences 23 Oct 2020
COVID 2019 infections - Adjuvant therapy, Monotherapy Marketed Egypt IV / Infusion Gilead Sciences 04 Feb 2021
COVID 2019 infections in combination with lopinavir/ritonavir Adjuvant therapy, Combination therapy Marketed Egypt IV / Infusion Gilead Sciences 04 Feb 2021
COVID 2019 infections Adjunctive to standard-of-care; with conditional approval Adjunctive to standard-of-care 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 restricted emergency use In adolescents, In adults, In children Registered India IV / Infusion Dr Reddys Laboratories, Gilead Sciences 01 Jun 2020
COVID 2019 infections emergency use authorisation in patients aged less than 12 years In children Registered USA IV / Infusion Gilead Sciences 23 Oct 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 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 Adjunctive to standard-of-care Adjunctive to SOC Adjunctive treatment Phase III Austria, Belgium, Hungary, Ireland, Luxembourg, Norway, Portugal 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 - Early-stage disease, In adolescents, In adults, In children, In the elderly Phase III Denmark, Portugal, Spain, USA, United Kingdom IV / Infusion Gilead Sciences 22 Sep 2020
COVID 2019 infections - In adolescents, In adults, In the elderly Phase III Portugal, USA IV / Infusion Gilead Sciences 09 Mar 2021
COVID 2019 infections - - Phase III China IV / Injection Capital Medical University, Gilead Sciences, Chinese Academy of Medical Sciences, China-Japan Friendship Hospital 12 Feb 2020
COVID 2019 infections in combination with baricitinb In combination with baricitinib Combination therapy Phase III Japan, Mexico, Singapore, South Korea, USA IV / Infusion National Institute of Allergy and Infectious Diseases 08 May 2020
COVID 2019 infections - - Phase III 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 Italy, Spain, 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 - Early-stage disease Phase I/II USA Inhalation / unspecified Gilead Sciences 14 Sep 2020
COVID 2019 infections - - Phase I Australia, New Zealand, Puerto Rico IV / Infusion Gilead Sciences 26 Jul 2021
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 Israel IV / Infusion Gilead Sciences 27 Mar 2020
COVID-19 pneumonia in combination with tocilizumab associated with COVID-2019 infections Combination therapy Phase III Brazil, Canada, Russia, Spain, USA IV / Infusion Gilead Sciences, Roche 16 Jun 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

Commercial Information

Involved Organisations

Organisation Involvement Countries
Gilead Sciences Originator USA
Gilead Sciences Owner USA
Viatris Inc 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
Cardiothoracic Surgical Trials Network Collaborator USA
National Heart, Lung and Blood Institute Collaborator USA
Medical College of Wisconsin Collaborator USA
Capital Medical University Collaborator China
Roche Collaborator Switzerland
INSERM Collaborator France
Center for Disease Control Collaborator
Daewoong Pharmaceutical Collaborator South-Korea
NeuroActiva Collaborator USA
National Institute of Allergy and Infectious Diseases Collaborator USA
United States Army Medical Research Institute of Infectious Diseases Collaborator USA
University of Copenhagen Collaborator Denmark
NRx Pharmaceuticals Collaborator USA
Chinese Academy of Medical Sciences Collaborator China
Kirby Institute for infection and immunity in society Collaborator Australia
China-Japan Friendship Hospital Collaborator China
Medical Research Council Collaborator England

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, USA

Credit Suisse Market Status

Indication Region Company Phase Expected Launch Year Probability of Success% Patent Expiry Year Expected Generic Entry Last Update
severe COVID-19 ex US Gilead Sciences Marketed 2020 100 - - 01 Feb 2021
severe COVID-19 US Gilead Sciences Marketed 2020 100 - - 01 Feb 2021

Credit Suisse Financial Forecast

Indication Region 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 Last Update
severe COVID-19 ex US 0 0 0 0 726 386 212 114 88 75 01 Feb 2021
severe COVID-19 US 0 0 0 0 968 1928 1058 570 442 374 01 Feb 2021
Total 0 0 0 0 1694 2314 1270 684 530 449

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 [103] [63]

Treatment with remdesivir in a phase III SIMPLE-severe 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% in 10 days group and 2% in 5 days group, with 3% of patients discontinuing remdesivir treatment due to elevated liver tests. Also, AST increase in 5 days vs 10 days group was 3% vs 6% respectively. 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 [19] [65] [67] .

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%) [64] [70] .

In the phase III ACTT-1 trial, treatment with remdesivir was found to be generally safe and well tolerated. Overall, the incidence of adverse events associated with remdesivir was similar to placebo, with no new safety signals identified. Rates of serious adverse events (SAEs) were numerically higher in the placebo group compared with the remdesivir group (PBO + SOC: 32%; Veklury + SOC: 25%). Treatment discontinuation, all cause grade 3 and 4 adverse events and laboratory abnormalities were similar across groups [71] [73] .

Results from the phase III CAP-China remdesivir 1 trial demonstrated that remdesivir was well tolerated with grade 3 and grade 4 adverse events compared to fewer serious adverse events in 5 day and 10 day arm. Most common adverse events include nausea, headache and hypokalemia. Incidence of adverse events leading to discontinuation and death were low and no clinically relevant changes in laboratory parameters were observed. No statistically significant change was observed in renal and liver function tests between the remdesivir 5 day and 10 day groups compared to the standard of care only group at day 14 [79] . The further analysis of remdesivir effect on renal function in patients with COVID-19 infections demonstrated that patients treated with remdesivir (n=822) reported less frequent acute kidney injury events, compared with the patients receiving standard of care treatment (n=183) (7% vs 10%, p=0.03). After adjustment for age, remdesivir was not significantly associated with the risk of acute kidney injury compared to standard of care (RR=0.66; 95% CI 0.40, 1.09). Patients with baseline estimated glomerular filtration rate (eGFR) >90 ml/min reported more acute kidney injury events, with few events occurring in patients with a baseline eGFR 50-59 ml/min. At day 14, in patients with stage 3 acute kidney injury, creatinine values returned to baseline after treatment with remdesivir (n=2, 0.2%), while it remained elevated in patients receiving standard of care treatment (n=4, 2%). No difference in acute kidney injury was observed between treatment arms in patients with a history of chronic kidney disease (remdesivir: n=6 [12%] vs standard of care: n=2 [40%]; p=0.14). The open-label trial evaluated 1005 patients with similar creatinine and eGFR values in both the treatment arms, collected through day 14 [80] [77]

Results from phase II/III CARAVAN trial of remdesivir (RDV) in hospitalized pediatric patients with PCR-confirmed COVID-19 showed that, most RDV discontinuations were due to clinical improvement. Most (78%) had =1 AE, including 17% with study drug-related AEs; 7% discontinued study drug due to an AE. Serious AEs were reported for 33% of patients; no SAEs were study drug related. Two patients died within 30 days of completing treatment. Grade 3 or 4 lab abnormalities were reported in 52%; those reported in =1 patient were decreased hemoglobin (n=5), and hypoglycemia, glycosuria, and increased PTT (n=2 each). No safety trends related to RDV were apparent [81] [82] .

Adverse events data obtained from phase III data indicated similarity in safety profile of the treatment and placebo groups. the most common treatment emergent adverse event was reported to be nausea and headache in the treatment group (=5%). No new safety signals were identified. One death was reported at day 59 in the placebo group [52] [116] .

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 [109] . 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 [115] .

Therapeutic Trials

Efficacy data obtained from a phase III trial indicated 87% of significant reduction compared to placebo (5.3% [15/283]) p=0.008, in risk for the composite primary endpoint of COVID-19 related hospitalisation or all cause death by day 28 (0.7% [2/279]). By Day 28, 81% reduction was reported in all-cause death or risk for the composite secondary endpoint of medical visits in participants treated with Veklury (1.6% [4/246]) compared with placebo (8.3% [21/252]) p=0.002. In either of the arms, no deaths were observed by day 28 [52] [116] .

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 [102] [103] [63]

Updated results from the phase III SIMPLE-severe trial for COVID-19 infections showed that clinical outcomes varied by geography. Increased mortality and lower rate of clinical improvement, were observed in patients from Italy compared with other regions. At day 14, the overall mortality rate was 7% and 18% for all other countries and Italy, respectively. Clinical improvement at day 14, measured as ≥2-point increase in the ordinal scale, was lower in Italian patients (39%) versus all other countries combined (64%). The overall results showed that 5day remdesivir treatment was as effective as 10days. In a multivariable model, 5/10d remdesivir was significantly positively associated with clinical improvement (adjusted odds ratio [OR] 1.69, 95% CI: 1.08, 2.65; p = 0.0226). Age < 65y (p < 0.0001) and region of treatment (Europe and NA vs Asia, p< 0.0001 each were the significant covariables positively associated with clinical improvement. Other factors that were not significantly associated with clinical improvement, included gender, race, ethnicity, baseline oxygen support, duration of symptoms and hospitalization, obesity, and baseline transaminase levels. Earlier data 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). 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. Five and 10 day treatment course showed similar outcomes (odds ratio 0.75; 95% CI, 0.51 to 1.12) [19] . 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 [61] [62] [63] [65] [67] .

Final results from the phase III ACTT-1 trial showed that the primary endpoint was met with remdesivir plus standard of care demonstrating superiority in shortening the time to recovery through Day 29 compared with placebo plus standard of care. In the final Day 29 results, patients receiving remdesivir (n = 541) achieved clinical recovery five days faster than those receiving placebo, with a median time to recovery of 10 days with remdesivir and 15 days with placebo and an increased recovery rate by 29% compared with placebo (rate ratio for recovery, 1.29; 95% confidence interval [CI], 1.12 to 1.49; p<0.001). In patients who required oxygen support at baseline (n = 957)patients receiving remdesivir achieved clinical recovery seven days faster than those receiving placebo, with a median time to recovery of 11 days with remdesivir and 18 days with placebo (rate ratio for recovery, 1.31; 95% CI, 1.12 to 1.52). Patients receiving remdesivir demonstrated a 50% more likelihood to have improved by Day 15 compared with those receiving placebo (OR, 1.5; 95% CI, 1.2 to 1.9), and the effect was maintained through Day 29. Also, reduction in disease progression was observed in patients with oxygen requirement. This resulted in low incidence of new mechanical ventilation or ECMO (13% vs. 23%; 95% CI, -15 to -4). The benefit of remdesivir was found to be greater when given within 10 days of symptom onset. In the overall study population, a trend towards reduced mortality at Day 15 (6.7% vs. 11.9%; HR, 0.55; 95% CI, 0.36 to 0.83) and Day 29 (11.4% vs. 15.2%, HR 0.73; 95% CI, 0.52 to 1.03) was observed in remdesivir -treated patients compared with placebo [19] [71] . Earlier reported results from the 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 [22] . 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 [31] [72] [73] .

Updated results from phase III SIMPLE-moderate 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 [22] . 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) [64] [70] .

Interim results of the randomised, controlled, double blind phase III CAP-China remdesivir 1 trial demonstrated that remdesivir for up to 5 days was superior to standard of care (SoC) in improving the clinical status by day 11 in patients (n = 584) with mild or moderate COVID-2019 infections. By day 11, two-point improvement on the ordinal scale occurred in 70% of patients in the 5 day remdesivir arm, 65% in the 10 day remdesivir arm, and 61% in the SoC arm. Patients in the 5 day remdesivir arm were significantly more likely to have an improvement in clinical status than those receiving SoC (odds ratio [OR], 1.65; 95% confidence interval [CI]: 1.09-2.48; p = 0.017). The OR of improvement for the 10 day remdesivir arm compared to SoC was 1.31 (95% CI: 0.88-1.95]; p = 0.183). This improvement in the 5 day remdesivir arm over the SOC arm was noted from day 6 through day 11. A peak of discharge corresponding with the assigned treatment duration of remdesivir was observed, with increased discharges at day 6 in the 5 day remdesivir arm and at day 11 in the 10 day remdesivir arm. A worsening of clinical status of ≥ 1 point in the ordinal scale was observed more commonly in the SoC am (n = 19, 10%) versus the 5 day remdesivir (n = 7, 4%) and 10 day remdesivir (n = 9, 5%) arms [78] [77] .

Results from phase II/III CARAVAN trial of remdesivir (RDV) in hospitalized pediatric patients with PCR-confirmed COVID-19 showed that among pediatric patients aged 2m to 17y, 70% had clinical improvement. Median number of RDV doses was 5. At baseline, 67% required supplemental oxygen, including 22% on invasive ventilation; at Day 10, the values were 26% and 15%, respectively. In total, 70% showed clinical improvement on the 7-point ordinal scale at Day 10 [81] [82] .

Future Events

Expected Date Event Type Description Updated
28 Feb 2021 Trial Update Gilead Sciences plans a phase III trial for COVID-2019 infections (In children, In adolescents, In adults, In the elderly, Combination therapy) in February 2021 (NCT04745351) (EudraCT2020-005416-22) 23 Mar 2021
02 Nov 2020 Trial Update Gilead Sciences plans a phase I pharmacokinetic trial in New Zealand, Germany, USA and Puerto Rico (IV, infusion) in November 2020 (ACTRN12620001048976p) (700328720) 01 Nov 2021
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) 29 Sep 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) 29 Sep 2020
31 Aug 2020 Regulatory Status Gilead Sciences plans to launch remdesivir in the EU on emergency use basis in August 2020 [112] 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
19 Oct 2021 Biomarker Update Biomarkers information updated Updated 21 Oct 2021
22 Sep 2021 Scientific Update Adverse events and efficacy data from a phase III trial in COVID-2019 infections released by Gilead Sciences [52] Updated 28 Sep 2021
01 Sep 2021 Trial Update Institut National de la Santé Et de la Recherche Médicale (INSERM) discontinues treatment with remdesivir in the phase III DisCoVeRy trial for COVID-2019 infections (Adjunctive treatment) France, Luxembourg, Austria, Belgium, Norway, Ireland, Hungary and Portugal, based on analyses review by both DSMC/DSMB, the Solidarity Executive Group and the DisCoVeRy steering committee, before September 2021 (NCT04315948) Updated 06 Sep 2021
26 Jul 2021 Phase Change - I Phase-I clinical trials in COVID-2019 infections in Australia (IV) (ACTRN12620001048976) Updated 01 Nov 2021
26 Jul 2021 Phase Change - I Phase-I clinical trials in COVID-2019 infections in New Zealand (IV) (ACTRN12620001048976) Updated 01 Nov 2021
26 Jul 2021 Phase Change - I Phase-I clinical trials in COVID-2019 infections in Puerto Rico (IV) (ACTRN12620001048976) Updated 01 Nov 2021
26 Jul 2021 Trial Update Gilead Sciences initiates phase I trial pharmacokinetic trial for COVID-2019 infections in USA (ACTRN12620001048976) Updated 01 Nov 2021
25 May 2021 Company Involvement NeuroRx has merged with Big Rock Partners to form NRx Pharmaceuticals Updated 31 May 2021
24 May 2021 Regulatory Status The Committee for Medicinal Products for Human Use (CHMP) recommends renewal of conditional marketing authorisation of remdesivir for COVID-2019 infections in European Union [28] Updated 28 May 2021
20 Apr 2021 Trial Update NeuroRx in collaboration with National Institute of Allergy and Infectious Diseases, University of Copenhagen, Medical Research Council, Kirby Institute, National Heart, Lung, and Blood Institute, Cardiothoracic Surgical Trials Network, and Gilead Sciences initiates enrolment in the phase III TESICO trial for COVID-19 respiratory infection and SARS-COV-2 acute respiratory disease (Monotherapy, Combination therapy) in USA (NCT04843761) Updated 28 Apr 2021
12 Apr 2021 Trial Update Gilead Sciences terminates a phase III trial in COVID-2019 infections (In adults, In adolescents, In children, In the elderly, Early-stage disease) in the USA, United Kingdom, Spain, Denmark and Portugal (IV) [51] (NCT04501952) Updated 21 Apr 2021
06 Apr 2021 Regulatory Status The US FDA approves phase III TESICO trial protocol in COVID-2019 infections (Monotherapy, Combination therapy), in the US [43] Updated 09 Apr 2021
06 Apr 2021 Trial Update National Institutes of Health and National Institute of Allergy and Infectious Diseases plans a phase III TESICO trial in COVID-2019 infections (Monotherapy, Combination therapy), in the US and Other countries [43] Updated 09 Apr 2021
22 Mar 2021 Trial Update Gilead Sciences completes a phase I/II trial in COVID-2019 infections (Early-stage disease) in USA (Inhalation) (NCT04539262) Updated 20 Apr 2021
11 Mar 2021 Regulatory Status Roche plans to share REMDACTA trial data with regulatory authorities Updated 12 Mar 2021
09 Mar 2021 Phase Change - III Phase-III clinical trials in COVID-2019 infections (In adolescents, In adults, In the elderly) in USA and Portugal (IV) (NCT04745351) (EudraCT2020-005416-22) Updated 23 Mar 2021
08 Mar 2021 Active Status Review CTP push 326271: initiation for NIO-sponsored trial post authorisation of Remdesivir, thus trial (NCT04583969) not added to profile Updated 10 Mar 2021
06 Mar 2021 Scientific Update Efficacy and adverse events data from a phase II/III CARAVAN trial in COVID-2019 infections presented at the 28th Conference on Retroviruses and Opportunistic Infections (CROI-2021) [82] Updated 22 Apr 2021
06 Mar 2021 Scientific Update Adverse events data from a phase III trial in COVID-2019 infections presented at the 28th Conference on Retroviruses and Opportunistic Infections (CROI-2021) [80] Updated 20 Apr 2021
09 Feb 2021 Trial Update Gilead Sciences plans a phase III trial for COVID-2019 infections (In children, In adolescents, In adults, In the elderly, Combination therapy) in February 2021 (NCT04745351) (EudraCT2020-005416-22) Updated 23 Mar 2021
04 Feb 2021 Phase Change - Marketed Launched for COVID-2019 infections (Adjuvant therapy, Combination therapy) in Egypt (IV) prior to February 2021 (NCT04738045) Updated 04 Mar 2021
04 Feb 2021 Phase Change - Marketed Launched for COVID-2019 infections (Monotherapy, Adjuvant therapy) in Egypt (IV) prior to February 2021(NCT04738045) Updated 04 Mar 2021
02 Feb 2021 Trial Update Daewoong Pharmaceutical initiates enrolment in a phase III trial for COVID-2019 infections (Combination therapy, In adults, In the elderly) in South Korea (IV) (NCT04713176) Updated 11 Mar 2021
01 Feb 2021 Financial Update Credit Suisse financial data update Updated 14 Mar 2021
31 Dec 2020 Patent Information Gilead Sciences has patent protection for remdesivir in USA and European Union [114] Updated 28 Apr 2021
16 Nov 2020 Company Involvement Upjohn has merged with Mylan to form Viatris Updated 17 Dec 2020
27 Oct 2020 Trial Update BioSig Technologies paused enrollments and halted a phase-II clinical trial in COVID-2019 infections (Combination therapy) in USA (PO) (NCT04410354) [88] Updated 29 Oct 2020
23 Oct 2020 Phase Change - Registered Registered (emergency use authorisation) for COVID-2019 infections (In children) in USA (IV) [17] [21] Updated 17 Dec 2020
23 Oct 2020 Phase Change - Marketed Launched for COVID-2019 infections (In adolescents, In adults) in USA (IV) [17] Updated 27 Oct 2020
23 Oct 2020 Regulatory Status The US FDA revises emergency use authorisation of remdesivir in COVID-19 infections in pediatric patients less than 12 years [21] Updated 27 Oct 2020
22 Oct 2020 Phase Change - Registered Registered for COVID-2019 infections (In adults, In adolescents) in USA (IV) [19] Updated 26 Oct 2020
22 Oct 2020 Regulatory Status The US FDA granted Fast track and priority Review designation to the NDA submitted for remdesivir for COVID-2019 infections requiring hospitalization (In adolescent, In adults) [18] Updated 26 Oct 2020
21 Oct 2020 Scientific Update Adverse event data from a phase III CAP-China remdesivir 1 trial in COVID-2019 infections presented at the IDWeek 2020 (IDW-2020) [79] Updated 10 Dec 2020
21 Oct 2020 Scientific Update Interim efficacy data from a phase III CAP-China remdesivir 1 trial in COVID-2019 infections presented at the IDWeek 2020 (IDW-2020) [78] Updated 10 Dec 2020
21 Oct 2020 Scientific Update Updated efficacy data from the phase III SIMPLE SEVERE clinical trial in COVID-2019 infections presented at the IDWeek 2020 [61] Updated 10 Dec 2020
21 Oct 2020 Scientific Update Updated efficacy data from the phase III SIMPLE SEVERE clinical trial in COVID-2019 infections presented at the IDWeek 2020 [62] Updated 09 Dec 2020
15 Oct 2020 Trial Update Gilead Sciences plans a phase I pharmacokinetic trial in New Zealand, Germany, USA and Puerto Rico (IV, infusion) in November 2020 (ACTRN12620001048976p) Updated 01 Nov 2021
08 Oct 2020 Trial Update University of Minnesota and National Institute of Allergy and Infectious Diseases initiate phase III ITAC trial in COVID-2019 infections in Mexico and USA (IV) [49] (NCT04546581) Updated 26 Oct 2020
08 Oct 2020 Scientific Update Final efficacy data and safety data from the phase III ACTT-1 trial in COVID-19 infections released by Gilead [71] Updated 13 Oct 2020
08 Oct 2020 Licensing Status Gilead Sciences signs Joint Procurement Agreement with the European Commission for remdesivir (Veklury®) for COVID-2019 infections [111] Updated 12 Oct 2020
02 Oct 2020 Regulatory Status The Pharmacovigilance Risk Assessment Committee (PRAC) initiates review of a safety signal for remdesivir in COVID-19 infections [29] Updated 09 Oct 2020
22 Sep 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (In adults, In adolescents, In children, In the elderly, Early-stage disease) in USA, United Kingdom (IV) (NCT04501952) (EudraCT-2020-003510-12) Updated 29 Sep 2020
18 Sep 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (In children, In adolescents, In adults, In the elderly, Early-stage disease) in Denmark, Spain and Portugal (IV) (NCT04501952) (EudraCT-2020-003510-12) Updated 15 Jun 2021
14 Sep 2020 Phase Change - I/II Phase-I/II clinical trials in COVID-2019 infections (Early-stage disease) in USA (Inhalation) (NCT04539262) Updated 12 Oct 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 29 Sep 2020
30 Aug 2020 Regulatory Status The US FDA expands emergency use authorization of remdesivir in COVID-19 infections [22] 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 [22] Updated 02 Sep 2020
30 Aug 2020 Scientific Update Efficacy data from a phase III SIMPLE trial in COVID-19 infections released by Gilead [22] 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 29 Sep 2020
10 Aug 2020 Regulatory Status Gilead Sciences completes rolling NDA submission to the US FDA for COVID-2019 infections (In adults) (IV) [20] Updated 12 Aug 2020
04 Aug 2020 Trial Update National Institute of Allergy and Infectious Diseases initiates the phase III ACTT-3 trial for COVID-2019 infections (Combination therapy, In adults, In the elderly) in Japan, Mexico, South Korea and Singapore (NCT04492475) Updated 26 Oct 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 QuantumLeap Healthcare Collaborative initiates a phase II clinical trials in COVID-2019 infections (Combination therapy) in USA (IV) [87] (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 [112] 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) (NCT04431453) 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) (EudraCT2020-001803-17) Updated 29 Jul 2020
21 Jul 2020 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (In neonates, In infants, In children, In adolescents, In adults) in Spain, Italy (IV) after July 2020 (NCT04431453) (EudraCT2020-001803-17) Updated 10 Dec 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 [63] 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 [63] 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) - conditional marketing authorisation (rolling review) [30] Updated 07 Jul 2020
03 Jul 2020 Phase Change - Registered Registered for COVID-2019 infections in United Arab Emirates (IV) [30] 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 Gilead Sciences and WHO initiate phase II/III trial in COVID-2019 infections (Adjunctive treatment) in Germany (IV, Infusion) (NCT04575064) Updated 27 Jan 2021
29 Jun 2020 Trial Update INSERM initiates enrolment in the phase III Discovery trial for COVID-2019 infections in France , Portugal (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 [31] 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 [31] 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 - II Phase-II clinical trials in COVID-2019 infections (Combination therapy) in USA (IV) (NCT04410354) [89] 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 [12] 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 [11] 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 [35] Updated 16 Jun 2020
10 Jun 2020 Phase Change - Registered Registered for COVID-2019 infections (Adjunctive treatment) in Taiwan (IV) - conditional approval [36] Updated 16 Jun 2020
08 Jun 2020 Regulatory Status The EMA receives application for conditional marketing authorisation (CMA) of remdesivir for COVID-2019 infections [32] 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 [32] Updated 11 Jun 2020
01 Jun 2020 Phase Change - Registered Registered (Restricted emergency use) for COVID-2019 infections (In adults, In adolescents, In children) in India (IV) Updated 14 Oct 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 [64] 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 [36] Updated 16 Jun 2020
28 May 2020 Phase Change - III Phase-III clinical trials in COVID-19 pneumonia(Combination therapy) in Spain, Canada, Brazil, USA and Russia (IV) [57] (NCT04409262) Updated 03 Jun 2020
22 May 2020 Phase Change - Preregistration Preregistration for COVID-2019 infections (Adjunctive treatment) in Singapore (IV), before May 2020 [35] Updated 16 Jun 2020
22 May 2020 Trial Update Gilead Sciences plans clinical trials for remdesivir (Combination therapy) in COVID-2019 infections [66] 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 [32] 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 [14] 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 [13] 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 [7] 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 [98] Updated 15 May 2020
07 May 2020 Phase Change - Registered Registered for COVID-2019 infections (Adjunctive treatment) in Japan - First global approval (exceptional approval pathway) (IV) [37] Updated 18 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)) [75] (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) [33] Updated 05 May 2020
04 May 2020 Regulatory Status Gilead Sciences receives emergency use authorization from the FDA for remdesivir in COVID-19 infections [24] [23] 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 [72] 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 [68] 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 [65] Updated 04 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
15 Apr 2020 Trial Update Capital Medical University, Chinese Academy of Medical Sciences and China-Japan Friendship Hospital suspended the phase III trial for COVID-2019 infections in China (IV) (NCT04252664) Updated 10 Dec 2020
12 Apr 2020 Scientific Update Efficacy data from a compassionate use programme in COVID-2019 infections released by Gilead Sciences [102] Updated 17 Apr 2020
08 Apr 2020 Phase Change - Preregistration Preregistration for COVID-2019 infections (In adults) in USA (IV) [20] Updated 12 Aug 2020
03 Apr 2020 Regulatory Status EMA provides recommendations for compassionate use of remdesivir for COVID-2019 infections in European Union [99] 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 [35] 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
28 Mar 2020 Trial Update Gilead Sciences and WHO initiate phase II/III trial in COVID-2019 infections (Adjunctive treatment) in Norway(IV, Infusion) (NCT04321616) Updated 27 Jan 2021
27 Mar 2020 Phase Change - Clinical Clinical trials in COVID-2019 infections in Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, Greece, Greece, 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 [39] 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 [39] [40] 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 Belgium, Norway, Portugal, Ireland, Hungary (IV) (NCT04315948) (EudraCT2020-000936-23) Updated 06 Sep 2021
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) [59] 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 [102] Updated 20 Apr 2020
01 Mar 2020 Phase Change - III Phase-III clinical trials in COVID-2019-infections (Adjunctive treatment) in China (IV) [69] (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) [69] 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
12 Feb 2020 Phase Change - III Phase-III clinical trials in COVID-2019-infections in China (IV) (NCT04252664) Updated 10 Dec 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) [104] 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 [108] 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 [109] Updated 05 Oct 2015

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