Product Description
Remdesivir is a nucleotide prodrug of an adenosine analog. It binds to the viral RNA-dependent RNA polymerase and inhibits viral replication by terminating RNA transcription prematurely.
Mechanisms of Action: RdRp Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: Breakthrough Therapy - COVID-19Breakthrough Therapy - Respiratory Insufficiency|COVID-19 *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Canada | Croatia | Czech | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Malaysia | Netherlands | Norway | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Ukraine | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Gilead Sciences
Company Location: Western America
Company CEO: Daniel P. O’Day
Additional Commercial Interests: Dr. Reddy's Laboratories
Clinical Description
Countries in Clinic: Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Nepal, Netherlands, New Zealand, Pakistan, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 8
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Gilead Sciences presented P3 COVID-19 results on 2024-03-03 for Remdesivir
Highest Development Phases
Phase 3: COVID-19|Influenza, Human|Kidney Diseases|Pneumonia
Phase 2: Renal Transplant|Respiratory Syncytial Virus Infections
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT02735707 |
REMAP-CAP | P3 |
Recruiting |
Pneumonia|Influenza, Human|COVID-19 |
2026-02-01 |
2024-11-27 |
||
2020-005416-22 |
2020-005416-22 | P3 |
Active, not recruiting |
Kidney Diseases|COVID-19 |
2022-07-24 |
60% |
2022-03-13 |
Treatments |
NCT07197164 |
COVIDKIDNEY | P2 |
Recruiting |
COVID-19|Renal Transplant |
2026-12-30 |
2% |
2025-09-30 |
Primary Endpoints |
NCT06817889 |
RG1125015 | P2 |
Recruiting |
Respiratory Syncytial Virus Infections |
2027-11-30 |
12% |
2025-12-27 |
Primary Endpoints|Start Date|Treatments |
NCT04431453 |
CARAVAN | P3 |
Completed |
COVID-19 |
2023-02-10 |
58% |
2023-12-23 |
|
2022-501408-81-01 |
ANRS0176s OPTICOV | P2 |
Recruiting |
COVID-19 |
2024-06-29 |
2025-05-02 |
Treatments |
|
2020-000936-23 |
DisCoVeRy | P3 |
Completed |
COVID-19 |
2023-09-25 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
ACTRN12620001048976 |
ACTRN12620001048976 | P1 |
Recruiting |
COVID-19 |
2022-02-25 |
2024-08-29 |
Treatments |
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