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Remdesivir - Gilead Sciences

Drug Profile

Remdesivir - Gilead Sciences

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

Latest Information Update: 03 Jun 2020

At a glance

  • Originator Gilead Sciences
  • Developer China-Japan Friendship Hospital; Gilead Sciences; INSERM; National Institute of Allergy and Infectious Diseases
  • 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

  • Registered COVID 2019 infections
  • Phase II Ebola virus infections

Most Recent Events

  • 28 May 2020 Phase-III clinical trials in COVID-2019 infections (Combination therapy) in Europe, Canada (IV)
  • 28 May 2020 Roche initiates enrolment in the phase III REMDACTA trial for COVID-2019 infections (Combination therapy) in USA (IV)
  • 22 May 2020 Gilead Sciences plans clinical trials for remdesivir (Combination therapy) in COVID-2019 infections

Development Overview

Introduction

Remdesivir (GS 5734) is a small molecule monophosphoramidate prodrug of adenosine triphosphate analogue, that is being developed by Gilead Sciences for the treatment of viral infections including Ebola virus infections and COVID-2019 infections. Upon administration, remdesivir is metabolised into its active form GS 441524. GS 441524 is an ATP analogue that competes with ATP for incorporation into RNA and inhibits the action of viral RNA-dependent RNA polymerase (also known as RNA-replicase). This results in the termination of RNA transcription and decreases viral RNA production. Remdesivir is under regulatory review in the EU for the treatment of COVID-2019 infections. Remdesivir is approved in Japan for the treatment of COVID-2019 infections. The product is available globally on a compassionate basis for the same indication. Clinical development of remdesivir is underway for the treatment of COVID-2019 infections in multiple countries. Clinical development of the candidate is underway for the treatment of Ebola virus infections in Congo, Liberia and the US.

Company Agreements

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. [1]

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. In addition, remdesivir will be manufactured in India in the formulation facility which has been approved by regulatory authorities such as USFDA and EU.
[2]

In May 2020, Gilead Sciences entered into a worldwide collaboration agreement with Mylan to expand access to the investigational antiviral remdesivir for the treatment of COVID-2019 infections. Under the terms of agreement, Mylan has licensed the non-exclusive rights to manufacture and distribute remdesivir in 127 low- and middle-income countries, including India. [3]

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. [4]

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. [4]

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. Both the companies had entered into the agreement in December 2015, for the supply of Captisol® for use in a Captisol®-enabled programme 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. [5]

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).

Key Development Milestones

COVID-2019 infections

In May 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) recommended expanding the compassionate use 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). Earlier in the same month, the CHMP started a rolling review of data on the use of remdesivir for the treatment of coronavirus infections-2019 (COVID-2019 infections). The CHMP’s decision to start the rolling review of remdesivir was 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. However, EMA has not yet evaluated the full study and it is too early to draw any conclusions regarding the benefit-risk balance of the medicine [6] [7] .

In May 2020, Gilead Sciences announced that Japanese Ministry of Health (MHLW) has granted regulatory approval of Venklury® (remdesivir) as a treatment for COVID-2019 infections under an exceptional approval pathway. The approval was granted on the basis of clinical data obtained from the phase III SIMPLE trial (see below) and from Gilead's compassionate use program, that included patients from Japan [8] .

In May 2020, the US Food and Drug Administration (FDA) granted an emergency use authorization to remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 infections in adults and children [9] .

In May 2020, Roche in collaboration with Gilead Sciences initiated the phase III REMDACTA trial to evaluate the safety and efficacy of Actemra/RoActemra plus remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia. The randomised, double-blind trial intends to enroll approximately 450 patients in the US, Canada and Europe [10] .

In April 2020, Gilead Sciences and University of Helsinki initiated the phase III SOLIDARITY Finland trial to assess the efficacy and safety of remdesivir and hydroxychloroquine compoared with standard of care in patients with COVID-2019 infections (EudraCT2020-001784-88; WHO-FIN-COVID-19). The main objective of the trial is to investigate effect on allcause in-hospital mortality compared to standard of care. The randomised trial intends to enrol approximately 664 patients in Finalnd [11] .

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 [12] [13] [14] .

In March 2020, Institut National de la Santé Et de la Recherche Médicale (INSERM) and Gilead Sciences initiated the phase III DisCoVeRy trial to assess safety and efficacy of remdesivir and other therapeutics including hydroxychloroquine, lopinavir/ritonavir compared with standard of care (NCT04315948; C20-15; EudraCT2020-000936-23). The primary endpoint of study is to determine the percentage of patients reporting each severity rating on a 7-point ordinal scale in 15 days. The randomised, adaptive trial intends to enrol approximately 3300 patients in France and will expands to other parts of Europe [15] [16] .

In March 2020, Gilead initiated an expanded access treatment protocol for remdesivir for the treatment of COVID-19 infections in the US, UK, Belgium, Canada, France, Germany, Italy, Israel, Netherlands, Romania, Spain, Switzerland (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 [17] [18] [19] .

In March 2020, the China-Japan Friendship Hospital, the Feinstein Institutes for Medical Research and Gilead Sciences initiated two phase III SIMPLE trials to evaluate the safety and efficacy of remdesivir for the treatment of COVID-2019 infections in China, as well as other Asian countries and other countries globally. The first trial of the programme will evaluate 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 will recruit approximately 400 patients globally including Germany, Spain, Italy, the Netherlands, the UK, Sweden, the US, Hong Kong, South Korea, Singapore, China, Taiwan, France, Japan and Switzerland [20] . The patients will be randomized in a 1:1 ratio to receive remdesivir 200mg on day one, followed by remdesivir 100mg each day until day 5 or 10, in addition to standard of care. The primary objective of this study is to evaluate the effect of remdesivir, as measured by the normalization of fever and oxygen saturation [T < 36.6 C armpit, < 37.2 C oral, < 37.8 C rectal; and Sp02 > 94%, sustained for at least 24 hours through Day 14]. In April 2020, the company reported that the study was stopped in patients with severe symptoms due to delayed enrollment [15] . In April 2020, efficacy and safety data from the trial was released by Gilead Sciences [21] . 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 [22] .

The second SIMPLE trial met its primary endpoint in April 2020 which is designed to evaluate 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 will recruit approximately 600 patients in Germany, Spain, Italy, the Netherlands, the UK, Sweden, the US, Hong Kong, Korea, Singapore, China and Taiwan [23] . The patients will be randomised in a 1:1:1 ratio to receive remdesivir 200mg on day one, followed by remdesivir 100mg in addition to standard of care each day until day 5 or 10, compared with standard of care alone. The primary objective of this study is to evaluate the effect of remdesivir, as measured by the proportion of participants in each group discharged by day 14. Gilead Sciences has donated remdesivir and provided scientific input for these studies [24] [25] .

In February 2020, National Institute of Allergy and Infectious Diseases initiated the phase II ACTT trial (Adaptive COVID-19 Treatment Trial) to evaluate the safety and efficacy of remdesivir for the treatment of COVID-2019 infections in patients (20-0006; U1111-1249-9599; EudraCT2020-001052-18; NCT04280705). The randomised, double-blind, placebo-controlled trial intends to enrol approximately 394 hospitalised patients in the US [26] . Moreover, 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 [27] . In April 2020, EvergreenHealth announced that it is preparing for the second arm of the trial, which will eliminate the placebo group and provide the study drug to all the patients to evaluate its effectiveness against the virus. Moreover, EvergreenHealth reported initial preliminary reports from the trial [28] . 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 [22] .

In May 2020, NIAID initiated the randomised, double-blind, controlled clinical trial to evaluate the safety and efficacy of remdesivir in combination with oral baricitinib, for the treatment of COVID-19 infections. Enrolment of hospitalised patients diagnosed with COVID-2019 infections has been initiated in this ACTT2 trial in the US and the trial may expand to Europe and Asia [29] .

In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19 [21] .

Compassionate use

In April 2020, the USFDA granted emergency use authorisation (EUA) for remdesivir for the treatment of hospitalized patients with COVID-19 infections. The EUA allowed both 5-day and 10-day treatment durations based on the severity of disease [30] .

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 [31] .

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 (NCT04302766) [32] .

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 [33] .

Gilead Sciences is also providing remdesivir for compassionate use to patients with COVID-2019 infections for emergency treatment outside of ongoing clinical studies [25] .

In April 2020, Gilead Sciences released efficacy and safety data of remdesivir from compassionate use programme for COVID-2019 infections [34] [35] . Gilead Sciences in April 2020, reported that intravenous infusion of remdesivir demonstrated clinical improvement in first 53 patients who received treatment in compassionate programme [15] .

Ebola virus infections

In August 2019, based on independent Data and Safety Monitoring Board’s (DSMB) recommendation, Ridgeback Biotherapeutics prematurely terminated the phase II/III PALM trial designed to assess the safety and effectiveness of mAb 114; REGN 3470/3471/3479 , porgaviximab and remdesivir separately in patients with Ebola virus infections (19-I-0003; NCT03719586). The open-label, randomised, controlled study initiated by Gilead Sciences and National Institute of Allergy and Infectious Diseases in October 2018 enrolled approximately 681 patients toward an enrollment goal of 725 in the US and Congo [36] [37] .

In June 2016, National Institute of Allergy and Infectious Diseases initiated 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 will enrol approximately 120 patients in the US and Liberia. Longer-term clearance of Ebola virus will be assessed during the 5-month follow-up phase [38] .

Gilead initiated a phase I trial in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of remdesivir [39] .

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 [40] .

Remdesivir has a broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple viral pathogens, including Ebola, Marburg, MERS and SARS [21] .

Drug Properties & Chemical Synopsis

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

    J05A-X (Other antivirals)

  • EPhMRA code

    J5B9 (Antivirals, others)

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

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections Adjunctive to standard-of-care Adjunctive treatment Registered Japan IV / Infusion Gilead Sciences 07 May 2020
COVID 2019 infections - - Preregistration European Union IV / Infusion Gilead Sciences 04 May 2020
COVID 2019 infections Adjunctive to standard-of-care Adjunctive treatment Phase III France, Germany, Hong Kong, Italy, Netherlands, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, USA, United Kingdom IV / Infusion Gilead Sciences 29 Apr 2020
COVID 2019 infections in combination with hydroxychloroqunie Combination therapy Phase III Canada, Europe, Finland IV / Infusion Gilead Sciences 28 May 2020
COVID 2019 infections Adjunctive to standard-of-care Adjunctive treatment Phase III Luxembourg IV / Infusion Gilead Sciences, INSERM 22 Mar 2020
COVID 2019 infections Adjunctive to standard-of-care Adjunctive treatment Phase III China IV / Infusion China-Japan Friendship Hospital, Gilead Sciences 01 Mar 2020
COVID 2019 infections - - Phase III Japan, Mexico, Singapore, South Korea, USA IV / Infusion Gilead Sciences, National Institute of Allergy and Infectious Diseases 21 Feb 2020
COVID 2019 infections In combination with baricitinib Combination therapy Clinical Phase Unknown USA IV / Infusion National Institute of Allergy and Infectious Diseases 05 May 2020
Ebola virus infections - - Phase II Congo, Liberia, USA IV / Injection Gilead Sciences, National Institute of Allergy and Infectious Diseases 25 Oct 2018

Commercial Information

Involved Organisations

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

Brand Names

Brand Name Organisations Indications Countries
GS-5734 - Unspecified USA
Veklury Gilead Sciences COVID 2019 infections Japan

Scientific Summary

Adverse Events

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

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 [40] . 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 [41] .

Therapeutic Trials

In a compassionate use programme treatment with remdesivir 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 [34] [35] .

Treatment with remdesivir in a phase III SIMPLE trial for COVID-2019 infections showed that the time to clinical improvement for 50% patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. Greater than 2-point improvement in ordinal scale was seen in 65% and 54% patients for 5 and 10 day treatment respectively. More than half of patients in both treatment groups were discharged from the hospital by day 14 (5-day: 60.0%, n=120/200 vs.10-day: 52.3% n=103/197; p=0.14). At day 14, 64.5% patients in the 5-day treatment group and 53.8% of patients in the 10-day treatment group achieved clinical recovery. Clinical outcomes varied by geography. Outside of Italy, the overall mortality rate at day 14 was 7% across both treatment groups, with 64% of patients experiencing clinical improvement at day 14 and 61 percent (n=196/320) of patients discharged from the hospital. In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms. Pooling data across treatment arms, by day 14, 62% patients treated early were able to be discharged from the hospital, compared with 49% patients who were treated late [21] [20] .

Initial preliminary results from the phase III ACTT trial, treatment with remdesivir showed 31% of recovery from a 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 [28] [26] .

Future Events

Expected Date Event Type Description Updated
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
28 May 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Combination therapy) in Europe, Canada (IV) [10] Updated 03 Jun 2020
28 May 2020 Trial Update Roche initiates enrolment in the phase III REMDACTA trial for COVID-2019 infections (Combination therapy) in USA (IV) [10] Updated 03 Jun 2020
22 May 2020 Trial Update Gilead Sciences plans clinical trials for remdesivir (Combination therapy) in COVID-2019 infections [22] Updated 01 Jun 2020
13 May 2020 Licensing Status Gilead sciences and Hetero enters into licensing agreement to manufacture and distribute remdesivir for COVID-19 infections [2] 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 [1] 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 [3] 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 [6] Updated 15 May 2020
07 May 2020 Phase Change - Registered Registered for COVID-2019 infections (Adjunctive treatment) in Japan (IV) [8] Updated 18 May 2020
06 May 2020 Regulatory Status Gilead Sciences receives emergency use authorization from the US FDA for remdesivir in COVID-19 infections [9] Updated 11 May 2020
05 May 2020 Phase Change - Clinical Clinical trials in COVID-2019 infections (Combination therapy) in USA (IV) Updated 11 May 2020
04 May 2020 Phase Change - Preregistration Preregistration for COVID-2019 infections in European Union (IV) - rolling review by Committee for Medicinal Products for Human Use (CHMP) [7] Updated 05 May 2020
04 May 2020 Regulatory Status Gilead Sciences receives emergency use authorization from the FDA for remdesivir in COVID-19 infections [30] 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 Updated 06 May 2020
30 Apr 2020 Trial Update Gilead initiated an expanded access programme for COVID-2019 infections in Belgium, Canada, Germany, Israel, Netherlands, Romania, 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 [24] 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 [21] Updated 04 May 2020
29 Apr 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Combination therapy) in Finland (IV) (EudraCT2020-001784-88) Updated 12 May 2020
29 Apr 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Adjunctive treatment) in Japan, Switzerland (IV) before April 2020 (NCT04292899) Updated 04 May 2020
12 Apr 2020 Scientific Update Efficacy data from a compassionate use programme in COVID-2019 infections released by Gilead Sciences [34] Updated 17 Apr 2020
03 Apr 2020 Regulatory Status EMA provides recommendations for compassionate use of remdesivir for COVID-2019 infections in European Union [31] Updated 29 Apr 2020
03 Apr 2020 Active Status Review 9289127 - No updates Updated 03 Apr 2020
30 Mar 2020 Trial Update Oslo University Hospital plans a phase II/III trial for COVID-2019 infections in Norway (IV) (NCT04321616) Updated 30 Mar 2020
27 Mar 2020 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 [13] 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 [13] [14] 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 Luxembourg (IV, Infusion) (NCT04315948) (EudraCT2020-000936-23) [15] 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
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 [34] Updated 20 Apr 2020
01 Mar 2020 Phase Change - III Phase-III clinical trials in COVID-2019-infections (Adjunctive treatment) in China (IV) [25] (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) [25] Updated 02 Mar 2020
21 Feb 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections in Denmark, Germany, Greece, Japan, Mexico, United Kingdom (IV) (NCT04280705) Updated 05 May 2020
21 Feb 2020 Phase Change - III Phase-III clinical trials in COVID-2019-infections in USA, Singapore, South Korea and Spain (IV) (NCT04280705) Updated 27 Feb 2020
05 Feb 2020 Trial Update Capital Medical University plans a phase III trial for COVID-2019-infections (NCT04252664) Updated 13 Feb 2020
12 Aug 2019 Trial Update Ridgeback Biotherapeutics terminates the phase I/II PALM trial for Ebola virus infections in Congo and USA (IV) (NCT03719586) [36] 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 USA and Liberia (IV) (NCT02818582) Updated 04 Jul 2016
01 Jun 2016 Phase Change - II Phase-II clinical trials in Ebola virus infections in USA 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 [39] 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 [40] Updated 05 Oct 2015

References

  1. Cipla Enters Into a Licensing Agreement With Gilead to Expand Access to COVID-19 Treatment.

    Media Release
  2. Hetero Enters Into a Licensing Agreement With Gilead Sciences, Inc. for the Manufacturing and Distribution of Remdesivir in 127 Countries, Including India, for COVID-19.

    Media Release
  3. Mylan to Supply Investigational Antiviral Remdesivir for the Potential Treatment of COVID-19.

    Media Release
  4. Ligand Reports First Quarter 2020 Financial Results.

    Media Release
  5. Ligand Provides a Corporate Update and Announces May 6th as the Date for First Quarter Earnings Call.

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

    Media Release
  7. EMA starts rolling review of remdesivir for COVID-19.

    Media Release
  8. Gilead Announces Approval of Veklury(Rm) (remdesivir) in Japan for Patients With Severe COVID-19.

    Media Release
  9. Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment.

    Media Release
  10. Roche initiates phase III clinical trial of Actemra/RoActemra plus remdesivir in hospitalised patients with severe COVID-19 pneumonia.

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

    ctiprofile
  12. Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation. Internet-Doc 2020;.

    Available from: URL: https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-request-to-rescind-remdesivir-orphan-drug-designation
  13. US Food & Drug Administration. Internet-Doc 2020;.

    Available from: URL: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=739020
  14. AHF Demands Gilead Drop Exclusive Orphan Drug Claim on COVID-19 Treatment.

    Media Release
  15. An Open Letter from our Chairman & CEO.

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

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

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

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

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

    ctiprofile
  21. Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19.

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

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

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

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

    Media Release
  26. A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

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

    Media Release
  28. Seattle Cancer Care Alliance Selected as Authorized Treatment Center for Yescarta(TM) - A Novel, New Immunotherapy Treatment.

    Media Release
  29. Incyte Reports 2020 First Quarter Financial Results and Provides Updates on Key Clinical Programs.

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

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

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

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

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

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

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

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

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

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

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

    Available from: URL: https://idsa.confex.com/idsa/2015/webprogram/Paper54208.html
  41. Jordan R, Hogg A, Warren T, De Wit E, Sheahan T, Lo M, et al. Broad Spectrum Investigational Agent GS-5734 for the Treatment of Ebola, MERS Coronavirus and Other Pathogenic Viral Infections with High Outbreak Potential. IDW-2017 2017; abstr. LB-9.

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