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Drug

Remdesivir

Approved · FDA / EMA
ClassRNA-directed RNA polymerase L inhibitorEmerging researchLate-stage development

Also known as INV-REMDESIVIR, Veklury, Remdésivir, Remdesivirum.

RxNorm2284718ChEMBLCHEMBL4065616ATCJ05AB16UNII3QKI37EEHE
2
Research papers
10
Active clinical trials
2
Protein targets
25
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: REMDESIVIR (NDA214787)

Regulatory2026-07-29FDA

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

Clinical trial2026-07-09Results expected Q3 2027 · ClinicalTrials.gov

OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial: the OPTICOV Study

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

An Open-Label Study to Assess the Safety and Efficacy of Remdesivir for Treatment of Symptomatic Laboratory-Confirmed Respiratory Syncytial Virus Infection of the Upper Respiratory Tract in Patients Receiving Cellular or Bispecific Antibody Therapies

Clinical trial2026-06-03Results expected Q4 2027 · ClinicalTrials.gov

A Phase II Study to Evaluate the Safety, Pharmacokinetics, Antiviral Activity and Acceptability of Remdesivir (VEKLURY®) in Hospitalized Children Aged 0 to Less Than 2 Years With Respiratory Syncytial Virus (RSV)-Associated Lower Respiratory Tract Infection.

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Adaptive Dengue Antiviral Platform Trial (ADAPT): a Phase 2 Randomized, Adaptive, Open Label Trial for Antiviral Screening in Patients With Early Symptomatic Dengue

Clinical trial2026-04-30Results expected Q4 2029 · ClinicalTrials.gov

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

Clinical trial2026-03-16Results expected Q3 2028 · ClinicalTrials.gov

Label change: REMDESIVIR (NDA214787)

Regulatory2025-10-07FDA

Label change: REMDESIVIR (NDA214787)

Regulatory2025-08-22FDA

Label change: REMDESIVIR (NDA214787)

Regulatory2025-01-10FDA

Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial.

Research2020-09-01JAMA

The antiviral compound remdesivir potently inhibits RNA-dependent RNA polymerase from Middle East respiratory syndrome coronavirus.

Research2020-02-24The Journal of biological chemistry

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Remdesivir
Aliases & brands
INV-REMDESIVIRVekluryRemdésivirRemdesivirum
RxNorm CUI
2284718
ChEMBL ID
CHEMBL4065616
ATC codes
J05AB16
UNII
3QKI37EEHE
Primary mechanism
RNA-directed RNA polymerase L inhibitor
Regulatory jurisdictions
emafda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

RNA-directed RNA polymerase L
L · Q05318
INHIBITORRNA-directed RNA polymerase L inhibitor
Replicase polyprotein 1ab
rep · P0DTD1
INHIBITORReplicase polyprotein 1ab inhibitor

Regulatory timeline

25 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2020-07-03 → 2022-04-25)
Earliest approval
2020-07-03
Latest approval
2024-02-28
Authorities
FDA · EMA
Total events
25
fdaU.S. Food and Drug Administration· 24 events
2026-07-29Label change
Label change: REMDESIVIR (NDA214787)
Evidence ↗
2025-10-07Label change
Label change: REMDESIVIR (NDA214787)
Evidence ↗
2025-08-22Label change
Label change: REMDESIVIR (NDA214787)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2020-07-03ApprovalMulti-authority
Approval: Veklury (EMA)
Indication: Veklury is indicated for the treatment of coronavirus disease 2019 (COVID 19) in adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg): … Show full indication

Veklury is indicated for the treatment of coronavirus disease 2019 (COVID 19) in adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg):  with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 (see section 5.1)

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

71 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
71
registered trials across all phases
LATEST COMPLETION 2025
10
Active studies
9
Recruiting
51
Late-stage (III+)
38
Completed
23
Discontinued
PHASE DISTRIBUTIONn = 71
Early Phase 11Phase 12Phase 1 / 21Phase 216Phase 2 / 37Phase 334Phase 46Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

RecruitingPH IVMount Sinai Hospital, Canadan=1182027

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

CompletedPH IVUniversity of Derbyn=732025

Long-term Follow-up of a Randomized Multicenter Trial on Impact of Long-COVID in Hospitalized COVID-19 Patients

Unknown statusPH IVClinical Urology and Epidemiology Working Groupn=2022023

Clinical Study to Evaluate the Possible Efficacy and Safety of Antibodies Combination (Casirivimab and Imdevimab) Versus Standard Antiviral Therapy (Remdesivir and Favipravir) as Antiviral Agent Against Corona Virus 2 Infection in Hospitalized COVID-19 Patients

CompletedPH IVMansoura University Hospitaln=2652022

Comparative Therapeutic Efficacy and Safety of Remdesivir Plus Lopinavir/ Ritonavir and Tocilizumab Versus Hydroxychloroquine Plus Ivermectin and Tocilizumab in COVID-19 Patients.

Unknown statusPH IVOctober 6 Universityn=1502021

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedPH IVUniversity of Derbyn=732025

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

CompletedPH IIIKey trialInstitut National de la Santé Et de la Recherche Médicale, Francen=1,5522023

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19

CompletedPH IIIKey trialNational Institute of Allergy and Infectious Diseases (NIAID)n=2,7532023

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H4: AZD7442)

CompletedPH IIIKey trialNational Institute of Allergy and Infectious Diseases (NIAID)n=1,4552023

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H5: MP0420)

CompletedPH IIINational Institute of Allergy and Infectious Diseases (NIAID)n=4852023

A Phase I, Randomized, Parallel-Controlled, Single and Multiple Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of CX2101A Enteric-Coated Tablets in Healthy Chinese Adult Subjects

CompletedPH IHeronova Pharmaceuticalsn=632023

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes1
Betacoronavirus1
Journals, researchers & institutions
Top journals
  • JAMA1
  • The Journal of biological chemistry1
Leading researchers
  • Ahn MY1
  • Arribas López JR1
  • Bernasconi E1
  • Bhagani S1
  • Blair C1
  • Brainard DM1
  • Cao H1
  • Castagna A1
Leading institutions
free-text, unnormalised
  • Baylor University Medical Center1
  • Brigham and Women's Hospital and Harvard Medical School1
  • Hospital Clinic of Barcelona1
  • Instituto de Investigación Hospital Universitario La Paz1
  • IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University1
  • King's College1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Alanine

Frequently co-studied with Remdesivir in the research literature.

1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.