Data updated: May 26, 2026
VEKLURY (remdesivir)
Trial Activity: Declining 9 active trials
First-in-Class Priority Review Fast Track
Infectious Disease
Approved 2020-10-22
Development Insights
National Institute of Allergy and Infectious Diseases (NIAID) conducting 18 trials (35%)
27 indications explored (Broad Platform)
→ covid-19 (29 trials)
→ covid19 (7 trials)
→ sars-cov-2 (3 trials)
5
Indications
--
Phase 3 Trials
5
Priority Reviews
5
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2020-10-22
- Patent Cliff
- 2041
- Revenue
- $200M (Q4-2025)
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION, POWDER
VEKLURY Approval History
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
46 FDA actions from 2020 to 2025 · 4 indication expansions
What VEKLURY Treats
5 FDA approvalsOriginally approved for its first indication in 2020 . Covers 5 distinct patient populations.
- Other (5)
📋
Clinical Trial Registry
51 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07013474 | C5091018 2024-517671-21-00 | Ph 3 | recruiting | A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised |
| NCT04488081 I-SPY_COVID | I-SPY-COVID | Ph 2 | active not recruiting | I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients |
| NCT06817889 | RG1125015 NCI-2025-00572, 20650 | Ph 2 | recruiting | Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals |
| NCT05587894 OPTICOV | ANRS 0176s OPTICOV CT-2022-501408-81-01 | Ph 2 | recruiting | OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial |
| NCT05911906 ERASE-LC | UoD/ERASE-LC/23 | Ph 4 | completed | An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID. |
| NCT05041907 PLATCOV | VIR21001 | Ph 2 | recruiting | Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) |
| NCT04843761 TESICO results posted | 015 / ACTIV-3b | Ph 3 | completed | ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 |
| NCT06729593 results posted | 015/ACTIV-3b/H2 | Ph 3 | completed | Remdesivir for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial) |
| NCT06873633 THAI-CARES RSV | THAI-CARES RSV CO-US-540-7443 | Ph 2 | recruiting | Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV |
| NCT06860282 | SHRC-CX2101-01 | Ph 1 | completed | A Study of CX2101A Enteric-Coated Tablets in Healthy Chinese Adult Subjects |
| NCT04784559 Neptuno results posted | APL-D-003-20 2020-005951-19 | Ph 3 | terminated | Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection |
| NCT05780437 results posted | 014/ACTIV-3/H4 | Ph 3 | completed | AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) |
| NCT06792214 DEFEND | UTN: U1111-1311-3673 202309PPE, 185352 | Ph 4 | recruiting | 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 |
| NCT04575064 | WHO-SOLIDARITY-GERMANY 2020-001549-38 | Ph 2, Ph 3 | withdrawn | 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 |
| NCT04315948 DisCoVeRy | C20-15 101015736, 2020-000936-23 | Ph 3 | completed | Trial of Treatments for COVID-19 in Hospitalized Adults |
| NCT02735707 REMAP-CAP | U1111-1189-1653 2015-002340-14, 602525 | Ph 3 | recruiting | Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia |
| NCT04483960 ASCOT | X20-0159 | Ph 3 | active not recruiting | Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial |
| NCT04970719 | BADAS-ERC/EC/21/00311 | Ph 3 | withdrawn | Baricitinib in Hospitalized Covid-19 Patients With Diabetes Mellitus |
| NCT05780541 results posted | 014/ACTIV-3/H6 | Ph 3 | terminated | PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) |
| NCT04431453 CARAVAN results posted | GS-US-540-5823 2020-001803-17 | Ph 2, Ph 3 | completed | Study of Remdesivir in Participants Below 18 Years Old With COVID-19 |
| NCT05780463 results posted | 014/ACTIV-3/H5 | Ph 3 | completed | MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) |
| NCT05780424 results posted | 014/ACTIV-3/H3 | Ph 3 | completed | BRII-196/BRII-198 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) |
| NCT05780268 results posted | 014/ACTIV-3/H1 | Ph 3 | completed | LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) |
| NCT05780281 results posted | 014/ACTIV-3/H2 | Ph 3 | completed | VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) |
| NCT04593940 ACTIV-1 IM results posted | Pro00106301 | Ph 3 | completed | Immune Modulators for Treating COVID-19 |
| NCT04501978 TICO | 014 / ACTIV-3 | Ph 3 | completed | ACTIV-3: Therapeutics for Inpatients With COVID-19 |
| NCT05502081 results posted | MS.21.11.1737 35039/11/21 | Ph 4 | completed | Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients |
| NCT04391309 CaTT results posted | DAIT COVID-19-003 NIAID CRMS ID#: 38756, UM1AI109565 | Ph 2 | terminated | COVID-19 and Anti-CD14 Treatment Trial |
| NCT04988035 results posted | 20-0013C | Ph 2 | completed | ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19 |
| NCT04583969 results posted | 20-0013B | Ph 2 | completed | ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19 |
| NCT04583956 results posted | 20-0013A | Ph 2 | completed | ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19 |
| NCT04745351 REDPINE results posted | GS-US-540-5912 2020-005416-22, DOH-27-012022-4779 | Ph 3 | terminated | 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) |
| NCT04640168 results posted | 20-0006 ACTT-4 | Ph 3 | completed | Adaptive COVID-19 Treatment Trial 4 (ACTT-4) |
| NCT04546581 results posted | INSIGHT 013 | Ph 3 | completed | Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC) |
| NCT04401579 results posted | 20-0006 ACTT-2 | Ph 3 | completed | Adaptive COVID-19 Treatment Trial 2 (ACTT-2) |
| NCT04492475 results posted | 20-0006 ACTT-3 | Ph 3 | completed | Adaptive COVID-19 Treatment Trial 3 (ACTT-3) |
| NCT04280705 results posted | 20-0006 | Ph 3 | completed | Adaptive COVID-19 Treatment Trial (ACTT) |
| NCT04409262 REMDACTA results posted | WA42511 2020-002275-34 | Ph 3 | completed | 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 |
| NCT05185284 | FAV-052021 | Ph 3 | completed | Randomized Multicenter Study on the Efficacy and Safety of Favipiravir for Parenteral Administration Compared to Standard of Care in Hospitalized Patients With COVID-19 |
| NCT03719586 results posted | 190003 19-I-0003 | Ph 2, Ph 3 | completed | Investigational Therapeutics for the Treatment of People With Ebola Virus Disease |
| NCT04385719 RemTLAR | PK-24 | Ph 2 | completed | Drug-drug Interactions Between Remdesivir and Commonly Used Antiretroviral Therapy |
| NCT04596839 | BEX-06001 | Ph 2 | completed | Antiviral Activity and Safety of Remdesivir in Bangladeshi Patients With Severe Coronavirus Disease (COVID-19) |
| NCT04345419 | COVID 19 treatment | Ph 2, Ph 3 | completed | Remdesivir Efficacy in Coronavirus Disease |
| NCT04853901 | FMASU P56a/ 2020 | Ph 3 | completed | Remdesivir Efficacy In Management Of COVID-19 Patients |
| NCT04678739 | M.A.R.M.C.D./2020/1985 | Ph 3 | completed | Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial |
| NCT04292730 results posted | GS-US-540-5774 2020-000842-32, ISRCTN85762140 | Ph 3 | completed | 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 |
| NCT04292899 results posted | GS-US-540-5773 2020-000841-15, ISRCTN15874265 | Ph 3 | completed | Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19) |
| NCT04410354 | VC-02-01 | Ph 2 | terminated | Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19 |
| NCT04349410 FMTVDM | FMTVDM2020 | Ph 2, Ph 3 | completed | The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol |
| NCT04257656 | CAP-China remdesivir 2 | Ph 3 | terminated | A Trial of Remdesivir in Adults With Severe COVID-19 |
Showing 50 of 51 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VEKLURY FDA Label Details
View full patent landscape →
32 OB patents · 6 families ·
470 international docs across 51 countries
VEKLURY Patents & Exclusivity
Latest Patent: Nov 2041
Exclusivity: Jan 2027
Patents (32 active)
US11491169*PED
Expires Nov 28, 2041
US11903953*PED
Expires Nov 28, 2041
US11975012*PED
Expires Nov 28, 2041
US11975012
Expires May 28, 2041
US11903953
Expires May 28, 2041
US11491169
Expires May 28, 2041
US10675296*PED
Expires Jan 10, 2039
US11266681*PED
Expires Jan 10, 2039
US11975017*PED
Expires Jan 10, 2039
US11266681
Expires Jul 10, 2038
US11975017
Expires Jul 10, 2038
US10675296
Expires Jul 10, 2038
US11007208*PED
Expires Mar 16, 2037
US11382926*PED
Expires Mar 16, 2037
US10695361*PED
Expires Mar 16, 2037
US11007208
Expires Sep 16, 2036
US11382926
Expires Sep 16, 2036
US10695361
Expires Sep 16, 2036
US9949994*PED
Expires Apr 29, 2036
US9724360*PED
Expires Apr 29, 2036
US9949994
Expires Oct 29, 2035
US9724360
Expires Oct 29, 2035
US11492353*PED
Expires Jun 8, 2032
US10065958*PED
Expires Mar 16, 2032
US11492353
Expires Dec 8, 2031
US10065958
Expires Sep 16, 2031
US8008264*PED
Expires Mar 6, 2030
US8318682*PED
Expires Oct 22, 2029
USRE46762*PED
Expires Oct 22, 2029
US8008264
Expires Sep 6, 2029
US8318682
Expires Apr 22, 2029
USRE46762
Expires Apr 22, 2029
Exclusivity
M-301
Until Jul 2026
NCE
Until Oct 2025
M-301
Until Jul 2026
NCE
Until Oct 2025
PED
Until Apr 2026
PED
Until Apr 2026
PED
Until Jan 2027
PED
Until Jan 2027
M-301
Until Jul 2026
NCE
Until Oct 2025
M-301
Until Jul 2026
NCE
Until Oct 2025
PED
Until Apr 2026
PED
Until Apr 2026
PED
Until Jan 2027
PED
Until Jan 2027
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for VEKLURY
Revenue Insights
- • Q4-2025: $200M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 142 active patents
Trial Analysis
- • 51 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment