Veklury

(Remdesivir)

ApprovedBiologic

Remdesivir is an antiviral medication used to treat COVID-19 infections, particularly in hospitalized patients. It works by interfering with the virus's ability to reproduce in the body.[2] Veklury is currently approved and in use across 11 indications[4].[1]

Veklury is one of 251 biologic programs targeting Respiratory tract infection. It is currently in Approved.

Indications

Total Trials

Active Trials

250

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Respiratory Tract InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

Ebola Hemorrhagic FeverApproved

Severe Acute Respiratory SyndromeApproved

Kidney TransplantActive, not recruiting

Viral PneumoniaActive, not recruiting

PneumoniaActive, not recruiting

Diabetes MellitusActive, not recruiting

COVID-19Active, not recruiting

Corona Virus InfectionCompleted

Respiratory Tract InfectionPhase 2

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

Ebola Hemorrhagic FeverApproved

Approved

Severe Acute Respiratory SyndromeApproved

Approved

Kidney TransplantPhase 2

Active, not recruiting

Viral PneumoniaPreclinical

Active, not recruiting

PneumoniaPhase 3

Active, not recruiting

Diabetes MellitusPhase 3

Active, not recruiting

COVID-19Approved

Active, not recruiting

Corona Virus InfectionPhase 3

Completed

Showing 10 of 11 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Veklury

Gilead

Approved

59 2

COVID-19 Vaccine

Moderna

Preclinical

27 3

Aldactone

Pfizer

Preclinical

1 4

Nexavar

Bayer

Preclinical

1 5

Activella

Eli Lilly

Preclinical

—6

Proventil

Mylan Pharmaceuticals Inc

Preclinical

1 7

Benadryl

PParkedale

Preclinical

1 8

Nadroparin

GSK

Preclinical

1 9

Achromycin V

WWyeth-Lederle Vaccines

Statin

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

COVID-19

NCT05041907

Post-ApprovalRecruiting

COVID-19

NCT06792214

Phase 2Recruiting

Children

NCT06873633

Phase 2Recruiting

Kidney Transplant

NCT07197164

Q3 2027

Recruiting

Infants

NCT03511118

Q4 2027

Phase 2Recruiting

Respiratory Tract Infection

NCT06817889

Clinical

Trials by Indication[1]

COVID-1959 trials

BRII-196/BRII-198 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT05780424·353 enrolled

REMdesivir-HU Clinical Study and Severe Covid-19 Patients

Unknown status·UUniversity of Pecs·Phase 3·NCT04610541·2,000 enrolled

Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19

Terminated·VViralClear Pharmaceuticals, Inc.·Phase 2·NCT04410354·44 enrolled

Show 56 more trials

Investigational Treatments for COVID-19 in Tertiary Care Hospital of Pakistan

Completed·UUNICEF·N/A·NCT04492501·600 enrolled

Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis

Completed·SSemmelweis University··NCT04854837·45 enrolled

A Trial of Remdesivir in Adults With Mild and Moderate COVID-19

Suspended·—·Phase 3·NCT04252664·308 enrolled

Multicenter, Retrospective Study of the Effects of Remdesivir in the Treatment of Severe Covid-19 Infections

Completed·AAssistance Publique - Hôpitaux de Paris··NCT04365725·84 enrolled

Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)

Completed·UUniversity of Minnesota·Phase 3·NCT04546581·593 enrolled

Remdesivir and Convalescent Plasma Therapy for Treatment of COVID-19 Infection in Nepal : A Registry Study

Unknown status·NNepal Health Research Council··NCT04669990·2,000 enrolled

Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection

Terminated·PPharmaMar·Phase 3·NCT04784559·205 enrolled

Remdesivir in COVID-19 Lahore General Hospital

Unknown status·LLahore General Hospital·Phase 1·NCT04560231·30 enrolled

Remdesivir in Adults With Covid-19: Mansoura University Hospital Experience

Unknown status·MMansoura University··NCT04728880·300 enrolled

Comparison of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients

Unknown status·AAhmed Essam·Phase 4·NCT04738045·90 enrolled

Factorial Randomized Trial of Rendesivir and Baricitinib Plus Dexamethasone for COVID-19 (the AMMURAVID Trial)

Unknown status·AASST Fatebenefratelli Sacco·Phase 3·NCT04832880·4,000 enrolled

Effectiveness of Remedesvir in COVID-19 Patients Presenting at Mayo Hospital Lahore

Completed·KKing Edward Medical University·N/A·NCT04871633·66 enrolled

Remdesivir Efficacy In Management Of COVID-19 Patients

Completed·—·Phase 3·NCT04853901·77 enrolled

A Trial of Remdesivir in Adults With Severe COVID-19

Terminated·—·Phase 3·NCT04257656·237 enrolled

Adaptive COVID-19 Treatment Trial (ACTT)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT04280705·1,062 enrolled

PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT04582266·54 enrolled

An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care - WHO-SOLIDARITY-GERMANY

Withdrawn·PProfessor Dr. Bernd Mühlbauer·Phase 2/3·NCT04575064

ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04988035·201 enrolled

Remdesivir for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT06729593·87 enrolled

Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation

Completed· Gilead logo

Gilead·Phase 1/2·NCT04539262·156 enrolled

LUSZ Treatment Efficacy in Hospitalized COVID-19 Patients

Unknown status·LLebanese University·Phase 1·NCT05925140·1,000 enrolled

Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

Unknown status·LLisa Barrett·Phase 2·NCT04321993·363 enrolled

Adaptive COVID-19 Treatment Trial 3 (ACTT-3)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT04492475·969 enrolled

ACTIV-3: Therapeutics for Inpatients With COVID-19

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT04501978·2,753 enrolled

Comparative Therapeutic Efficacy and Safety of Different Antiviral and Anti Inflammatory Drugs in COVID-19 Patients.

Unknown status·OOctober 6 University·Phase 4·NCT04779047·150 enrolled

I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients

Active, not recruiting·QQuantumLeap Healthcare Collaborative·Phase 2·NCT04488081·1,500 enrolled

MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT05780463·485 enrolled

Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial

Completed·—·Phase 3·NCT04678739·205 enrolled

Adaptive COVID-19 Treatment Trial 2 (ACTT-2)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT04401579·1,033 enrolled

Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients

Completed·MMansoura University Hospital·Phase 4·NCT05502081·265 enrolled

Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)

Recruiting·UUniversity of Oxford·Phase 2·NCT05041907·3,800 enrolled

Austrian CoronaVirus Adaptive Clinical Trial (COVID-19)

Unknown status·MMedical University of Vienna·Phase 2/3·NCT04351724·500 enrolled

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)

Approved for marketing· Gilead logo

Gilead··NCT04323761

AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT05780437·1,455 enrolled

Efficacy of Favipiravir in Treatment of Mild & Moderate COVID-19 Infection in Nepal

Unknown status·NNepal Health Research Council·Phase 3·NCT04694612·676 enrolled

The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol

Completed·TThe Camelot Foundation·Phase 2/3·NCT04349410·1,800 enrolled

Adaptive COVID-19 Treatment Trial 4 (ACTT-4)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT04640168·1,010 enrolled

Randomized Multicenter Study on the Efficacy and Safety of Favipiravir for Parenteral Administration Compared to Standard of Care in Hospitalized Patients With COVID-19

Completed·PPromomed, LLC·Phase 3·NCT05185284·217 enrolled

ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT04843761·473 enrolled

Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial

Active, not recruiting·UUniversity of Melbourne·Phase 3·NCT04483960·2,200 enrolled

ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04583969·527 enrolled

COVID-19 and Anti-CD14 Treatment Trial

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04391309·49 enrolled

Study of Remdesivir in Participants Below 18 Years Old With COVID-19

Completed· Gilead logo

Gilead·Phase 2/3·NCT04431453·59 enrolled

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment

Completed· Gilead logo

Gilead·Phase 3·NCT04292730·1,113 enrolled

Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.

Completed·NNEAT ID Foundation··NCT04847622·451 enrolled

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

Completed· Gilead logo

Gilead·Phase 3·NCT04292899·4,891 enrolled

LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT05780268·314 enrolled

Antiviral Strategies in the Prevention of Long-term Cardiovascular Outcomes Following COVID-19: The paxloviD/Remdesivir Effectiveness For the prEvention of loNg coviD Clinical Trial

Recruiting·MMount Sinai Hospital, Canada·Phase 4·NCT06792214·118 enrolled

Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)

Terminated· Gilead logo

Gilead·Phase 3·NCT04745351·249 enrolled

PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT05780541·58 enrolled

IFN-beta 1b and Remdesivir for COVID19

Unknown status·TThe University of Hong Kong·Phase 2·NCT04647695·100 enrolled

Antiviral Activity and Safety of Remdesivir in Bangladeshi Patients With Severe Coronavirus Disease (COVID-19)

Completed·—·Phase 2·NCT04596839·60 enrolled

VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT05780281·367 enrolled

World Health Organization (WHO) COVID-19 Solidarity Trial for COVID-19 Treatments

Unknown status·TThe University of The West Indies·Phase 3·NCT04647669·100 enrolled

ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04583956·214 enrolled

Immune Modulators for Treating COVID-19

Completed·DDaniel Benjamin·Phase 3·NCT04593940·1,971 enrolled

Pneumonia2 trials

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Recruiting·UUMC Utrecht·Phase 3·NCT02735707·20,000 enrolled

A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia

Completed· Roche logo

Roche·Phase 3·NCT04409262·649 enrolled

Baricitinib1 trial

Efficacy of Ramdicivir and Baricitinib for the Treatment of Severe COVID 19 Patients

Unknown status·—·Phase 3·NCT04693026·150 enrolled

Respiratory tract infection1 trial

Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals

Recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT06817889·60 enrolled

Antiviral Drug1 trial

Antiviral Drugs on the Treatment of SARS-CoV-2

Completed·—··NCT04727775·150 enrolled

17 more indications

Infants1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·—··NCT03511118·1,600 enrolled

Kidney Transplant1 trial

Safety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients

Recruiting·FFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia·Phase 2·NCT07197164·15 enrolled

Long COVID1 trial

An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.

Completed·—·Phase 4·NCT05911906·73 enrolled

Drug Interactions1 trial

Drug-drug Interactions Between Remdesivir and Commonly Used Antiretroviral Therapy

Completed·MMakerere University·Phase 2·NCT04385719·24 enrolled

Observational Study1 trial

OBSERVATIONAL STUDY OF COMPARISON EFFECTIVITY BETWEEN REMDESIVIR AND FAVIPIRAVIR IN SURABAYA, INDONESIA

Completed·—··NCT05222113·87 enrolled

Diabetes Mellitus1 trial

Baricitinib in Hospitalized Covid-19 Patients With Diabetes Mellitus

Withdrawn·—·Phase 3·NCT04970719

Coronavirus1 trial

Remdesivir Efficacy in Coronavirus Disease

Completed·TTanta University·Phase 2/3·NCT04345419·200 enrolled

Efficacy1 trial

The Efficacy of Different Anti-viral Drugs in COVID 19 Infected Patients

Unknown status·OOslo University Hospital·Phase 2/3·NCT04321616·700 enrolled

Trial1 trial

Public Health Emergency: SOLIDARITY TRIAL Philippines

Completed·UUniversity of the Philippines·N/A·NCT05024006·1,314 enrolled

Adult Subject1 trial

A Study of CX2101A Enteric-Coated Tablets in Healthy Chinese Adult Subjects

Completed·HHeronova Pharmaceuticals·Phase 1·NCT06860282·63 enrolled

Long-term Follow-up1 trial

SOLIDARITY Finland Long-COVID (Remdesivir Long-term Follow-up Study of COVID Patients)

Unknown status·CClinical Urology and Epidemiology Working Group·Phase 4·NCT04978259·202 enrolled

Children1 trial

Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV

Recruiting·PPENTA Foundation·Phase 2·NCT06873633·120 enrolled

Ebola Virus Disease1 trial

Investigational Therapeutics for the Treatment of People With Ebola Virus Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2/3·NCT03719586·681 enrolled

SARS-CoV-21 trial

SARS-CoV-2 Human Challenge Characterisation Study

Completed·IImperial College London·N/A·NCT04865237·36 enrolled

ESS1 trial

Expanded Access Remdesivir (RDV; GS-5734™)

No longer available·UU.S. Army Medical Research and Development Command··NCT04302766

COVID-19 Infection1 trial

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE IBUZATRELVIR IN ADULTS WITH SYMPTOMATIC COVID-19 WHO ARE SEVERELY IMMUNOCOMPROMISED

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT07013474·300 enrolled

Corona Virus Infection1 trial

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

Completed·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 3·NCT04315948·1,552 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 22, 2020

VEKLURY

NDA NDA214787

Sources

References

[1]
ClinicalTrials.gov — 81 trial records for Remdesivir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Veklury drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Remdesivir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Remdesivir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214787). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Veklury. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: RNA-Directed RNA Polymerase L Inhibitor; Replicase Polyprotein 1ab Inhibitor[3]
Modality: Biologic[3]
Highest Phase: Approved[1]
Company: Gilead