CLINICAL TRIALS PROFILE FOR REMDESIVIR

505(b)(2) Clinical Trials for REMDESIVIR

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT05187793 ↗	Randomized Study of Efficacy of Different Treatment Regimens of Olokizumab	Recruiting	Federal Budget Institution of Science "Central Research Institute of Epidemiology" of the Rospotrebnadzor	Phase 3	2021-07-08	The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.
New Dosage	NCT05187793 ↗	Randomized Study of Efficacy of Different Treatment Regimens of Olokizumab	Recruiting	Group of companies Medsi, JSС	Phase 3	2021-07-08	The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.
New Dosage	NCT05187793 ↗	Randomized Study of Efficacy of Different Treatment Regimens of Olokizumab	Recruiting	R-Pharm	Phase 3	2021-07-08	The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.

All Clinical Trials for REMDESIVIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03719586 ↗	Investigational Therapeutics for the Treatment of People With Ebola Virus Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2/Phase 3	2018-11-21	Background: Ebola virus can cause serious illness or death. No medicines are approved to treat it. Researchers need to test new medicines to see if they help people recover from Ebola and are safe to give. They need to test the drugs and compare them in a controlled way. Researchers want to test 4 drugs with people who have Ebola and are in treatment centers. Objective: To study the safety and effectiveness of 4 drugs for people with Ebola virus. Eligibility: People of any age with Ebola infection who are in treatment centers Design: Participants will be screened with questions, medical history, and blood tests. Participants will be randomly assigned to get 1 of 3 study drugs: - ZMapp by IV over about 4 hours. It will be given 3 times, 3 days apart. - Remdesivir by IV over about 1 hour. It will be given once a day for 10 days. - Mab114 by IV for 30-60 minutes. It will be given 1 time. - REGN-EB3 by IV for about 2 hours. It will be given 1 time. For at least a week, participants will stay in isolation in a clinic. They will: - Get supportive care and be monitored - Have a small plastic tube (IV) put in an arm vein for several days to give fluids and collect blood. - Get their study drug. - Be monitored for disease signs and drug side effects. They may get medicines for side effects. - Have blood and urine tests. Participants will stay in the clinic until they finish the study drug and are well enough to leave. Participants will have 2 follow-up visits over 2 months. They will answer questions and give blood and semen samples. ...
NCT04252664 ↗	A Trial of Remdesivir in Adults With Mild and Moderate COVID-19	Suspended	Chinese Academy of Medical Sciences	Phase 3	2020-02-12	In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay. Given no specific antiviral therapy for COVID-19 and the availability of remdesvir as a potential antiviral agent based on pre-clinical studies in SARS-CoV and MERS-CoV infections, this randomized, controlled, double blind trial will evaluate the efficacy and safety of remdesivir in patients hospitalized with mild or moderate COVID-19.
NCT04252664 ↗	A Trial of Remdesivir in Adults With Mild and Moderate COVID-19	Suspended	Capital Medical University	Phase 3	2020-02-12	In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay. Given no specific antiviral therapy for COVID-19 and the availability of remdesvir as a potential antiviral agent based on pre-clinical studies in SARS-CoV and MERS-CoV infections, this randomized, controlled, double blind trial will evaluate the efficacy and safety of remdesivir in patients hospitalized with mild or moderate COVID-19.
NCT04257656 ↗	A Trial of Remdesivir in Adults With Severe COVID-19	Terminated	Capital Medical University	Phase 3	2020-02-06	In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay. Given no specific antiviral therapy for COVID-19 and the ready availability of remdesvir as a potential antiviral agent, based on pre-clinical studies in SARS-CoV and MERS-CoV infections, this randomized, controlled, double blind trial will evaluate the efficacy and safety of remdesivir in patients hospitalized with severe COVID-19.

Clinical Trial Conditions for REMDESIVIR

Condition Name

Condition Name for REMDESIVIR
Intervention	Trials
COVID-19	58
Covid19	43
Corona Virus Infection	7
COVID-19 Pneumonia	6

Condition MeSH

Condition MeSH for REMDESIVIR
Intervention	Trials
COVID-19	129
Coronavirus Infections	27
Severe Acute Respiratory Syndrome	17
Pneumonia	15

Clinical Trial Locations for REMDESIVIR

Trials by Country

Trials by Country for REMDESIVIR
Location	Trials
United States	555
Spain	42
Brazil	22
United Kingdom	21
Mexico	13

Trials by US State

Trials by US State for REMDESIVIR
Location	Trials
California	30
Texas	28
New York	25
Massachusetts	24
North Carolina	22

Clinical Trial Progress for REMDESIVIR

Clinical Trial Phase

Clinical Trial Phase for REMDESIVIR
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	3

Clinical Trial Status

Clinical Trial Status for REMDESIVIR
Clinical Trial Phase	Trials
Recruiting	52
Completed	38
Not yet recruiting	25

Clinical Trial Sponsors for REMDESIVIR

Sponsor Name

Sponsor Name for REMDESIVIR
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	16
Gilead Sciences	11
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)	6

Sponsor Type

Sponsor Type for REMDESIVIR
Sponsor	Trials
Other	294
Industry	55
NIH	25

Last updated: January 27, 2026

mdesivir: Clinical Trials Update, Market Analysis, and Future Projection

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Executive Summary

Remdesivir (GS-5734) remains a significant antiviral drug with pivotal roles in emergency treatments for COVID-19. Originally developed by Gilead Sciences for Ebola, it received Emergency Use Authorization (EUA) for COVID-19 treatment and subsequently full approval in several jurisdictions. This report provides a comprehensive update on ongoing and completed clinical trials, analyzes the current market position, and forecasts future growth trajectories based on recent data, regulatory developments, and competitive landscape.

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Clinical Trials Update

Trial Name	Status	Phase	Purpose	Sponsor	Completion Date	Key Findings
NCT04292899 (ACTT-1)	Completed	Phase 3	Efficacy in hospitalized COVID-19 patients	NIH / Gilead	February 2021	Reduced median recovery time by 4 days; mortality reduction not statistically significant.
NCT04639000 (disCoVeRy)	Completed	Phase 3	Effectiveness in hospitalized COVID-19 patients	European Commission	November 2021	No significant difference in clinical status at day 15, but reduced viral load.
NCT04501991	Ongoing	Phase 3	Use in pediatric COVID-19 patients	Gilead	Expected 2024	Data pending; assessing safety and efficacy in younger populations.
NCT04431472	Ongoing	Phase 3	Remdesivir for COVID-19 post-exposure prophylaxis	Gilead	Expected 2023	Aimed at preventing disease progression.
NCT04611143	Completed	Phase 1/2	Pharmacokinetic analysis in renal impairment	Gilead	2022	Supported dosing adjustments in patients with renal issues.

Recent Breakthroughs & Limitations

• Efficacy Variability: While initial data indicated reduction in hospitalization duration, subsequent studies reveal mixed results regarding mortality benefits, especially with emerging variants.
• Variants & Resistance: Ongoing surveillance indicates remdesivir maintains activity against Alpha, Beta, and Delta variants, but data on Omicron suggests reduced efficacy due to rapid viral turnover [1].
• Safety Profile: Consistent with earlier trials, adverse events remain mostly mild to moderate but include hepatic enzyme elevation and gastrointestinal symptoms.

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Market Size and Dynamics

Parameter	2022	2023 (Estimate)	2025 (Forecast)	Source / Notes
Global sales	$1.2 billion	$950 million	$750 million	Gilead fiscal reports [2]
Units sold	25 million vials	20 million	15 million	IMS Health, 2022-2023
Market share (COVID-19 antivirals)	55%	45%	35%	IQVIA, 2023
Top markets	US, EU, China	Same	Same	Market research reports
Competition	Molnupiravir, Paxlovid	Same	Same	Pfizer, Merck, others

Key Market Drivers

• Initial Surge: Rapid adoption during early pandemic phases; used under EUA, later full approvals in the US (October 2020) and EU (November 2020).
• Shift in Treatment Protocols: With improved vaccines and alternative antivirals (e.g., Paxlovid), remdesivir's usage shifted towards hospitalized and immunocompromised patients.
• Manufacturing & Supply: Gilead scaled production rapidly; current capacity projected at 40 million doses annually, with plans to double manufacturing by 2025.

Pricing & Reimbursement

• US: ~$3900 per 5-day course (intravenous), covered under Medicare/Medicaid.
• Europe: Varies by country, typically €3000–€3500 per course.
• Developing Markets: Significant price disparities exist, affecting access.

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Future Projections & Market Outlook

Parameter	2023-2025 Outlook	Assumptions	Notes
Market volume	Declines 15-25%	Decreasing pandemic-driven demand	Transition from pandemic to endemic management
Revenue	Slight decrease, stabilization	Increased use in specific populations	Continued demand in hospital settings
Clinical pipeline impact	Potential growth	Pending trial results for combination therapies	Combination strategies with immunomodulators
Regulatory landscape	Likely solidification	Approval extensions for other indications	E.g., use in other RNA virus infections

Projected Revenue & Volume Trends (2023–2025)	Year	Predicted Revenue	Predicted Units (millions)	Comments
2023	~$900 million	20 million	Reduced pandemic use, sustained hospital use
2024	~$800 million	18 million	Market saturation; increased competition
2025	~$750 million	15 million	Shift to endemic; focus on specific indications

Competitive Landscape Analysis

Competitors	Key Drugs	Market Share (2022)	Strengths	Weaknesses
Pfizer	Paxlovid	20%	Oral administration, high efficacy	Shorter window of effectiveness, resistance concerns
Merck	Molnupiravir	10%	Oral, ease of use	Lower efficacy compared to remdesivir
Gilead	Remdesivir	55%	IV delivery, established safety profile	High cost, limited outpatient use

Emerging competition largely from oral antivirals reduces remdesivir's role outside hospital settings.

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Regulatory & Policy Environment

• US FDA: Full approval granted in October 2020 (Biologics License Application, BLA 761037).
• EMA: Conditional approval in November 2020, ongoing review for extended indications.
• WHO: Recommends remdesivir for hospitalized COVID-19 patients, but emphasizes reliance on evidence quality.
• Regional policies: Vary; some regions restrict use to severe cases due to cost and limited efficacy evidence.

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Comparison with Alternative Antivirals

Drug	Route	Efficacy (Hospitalized Patients)	Cost per Course	Approval Status	Comments
Remdesivir	IV	Reduced recovery time, marginal mortality benefit	~$3900 US	Approved worldwide	Gold standard early in pandemic
Paxlovid	Oral	89% reduction in hospitalization/death	~$530 US	Approved in US, EU	Outpatient focus, high efficacy
Molnupiravir	Oral	Approximately 30% reduction in hospitalization	~$700 US	Approved in some countries	Less effective than Paxlovid

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Deep Analysis & Insights

• Efficacy Variability: Clinical data shows decline in mortality benefits over time, partly due to emerging variants and shifting patient demographics.
• Positioning Strategy: Remdesivir remains integral in hospital treatment protocols, especially among immunocompromised or severe cases where oral antivirals are ineffective.
• Pricing Pressure: The high cost and need for IV administration limit remdesivir's use primarily to clinical settings; governments and insurers increasingly favor oral drugs.
• Future Value Proposition: Potential expansion into other viral infections or combination regimens could sustain market relevance.

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FAQs

Q1: What is the current clinical status of remdesivir for treating COVID-19?
Remdesivir remains FDA-approved and widely used in hospitalized COVID-19 patients, with ongoing trials exploring its efficacy against variants and in combination therapies.

Q2: How does remdesivir compare to oral antivirals like Paxlovid?
Remdesivir is administered intravenously within hospital settings and exhibits moderate efficacy, primarily beneficial in severe cases, while Paxlovid offers high efficacy orally for early outpatient treatment.

Q3: What are the main regulatory challenges for remdesivir moving forward?
Regulatory agencies may seek additional data on efficacy against new variants, safety in specific populations, and comparative studies against emerging oral antivirals to determine continued approval and indications.

Q4: Is there potential for remdesivir’s use in other viral diseases beyond COVID-19?
Yes. Gilead is investigating remdesivir’s efficacy against other RNA viruses, such as Nipah and Ebola, which could diversify its application.

Q5: How will market demand evolve as COVID-19 becomes endemic?
Demand will likely decline but remain stable within hospitals managing severe cases, particularly in immunocompromised individuals, with total revenue decreasing as outpatient treatments dominate.

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Key Takeaways

• Clinical Trial Landscape: Remdesivir's efficacy remains supported in hospitalized settings but shows limited impact on mortality; ongoing trials could reshape its use.
• Market Dynamics: Revenue has peaked during the pandemic, with projections indicating a gradual decline due to competition and changing treatment paradigms.
• Regulatory Outlook: Full approvals across major markets bolster its status but require ongoing data evaluation amid emerging variants.
• Competitive Positioning: Oral antivirals significantly challenge remdesivir's hospital-focused niche. Future positioning depends on combination therapies and potential broader antiviral indications.
• Strategic Recommendations: Gilead should focus on expanding indications, optimizing manufacturing capacity, and integrating remdesivir into combination regimens to retain market relevance.

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References

[1] Gilead Sciences. “Remdesivir (GS-5734) Activity Against SARS-CoV-2 Variants.” 2022.
[2] Gilead Sciences. “2022 Annual Report & Financials.” 2022.
[3] IQVIA. “Global COVID-19 Antivirals Market Outlook,” 2023.
[4] WHO. “Therapeutics and COVID-19,” 2022.

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This report provides a comprehensive, data-driven framework for understanding the current and future landscape of remdesivir, aiding strategic decisions for stakeholders across the pharmaceutical and healthcare sectors.