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.
NCT04280705 ↗	Adaptive COVID-19 Treatment Trial (ACTT)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2020-02-21	This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

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
University of Minnesota	6

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Remdesivir

Last updated: October 28, 2025

Introduction

Remdesivir (brand name Veklury) stands at the forefront of antiviral therapeutics, notably for treating COVID-19. Originally developed for Ebola virus disease, its repositioning has underscored its potential against acute viral infections. As of 2023, ongoing clinical evaluations, regulatory considerations, and evolving market dynamics shape Remdesivir’s trajectory. This report provides a comprehensive update on its clinical trial landscape, economic implications, and future market projections, aimed at guiding stakeholders across the pharmaceutical, healthcare, and investment sectors.

Clinical Trial Landscape

Overview of Current Clinical Trials

Remdesivir has been extensively studied since its emergency use authorization (EUA) in 2020 by the U.S. FDA. As of early 2023, over 100 clinical trials are registered globally, with the majority focusing on COVID-19 treatment outcomes. Notably:

• Phase III Trials: Multiple large-scale, randomized controlled trials (RCTs), such as ACTT-3 and SIMPLE-3, continue to evaluate efficacy and safety across diverse patient populations—ranging from hospitalized severe cases to outpatient settings. Preliminary results reaffirm its benefits in reducing hospitalization duration and mortality, especially when administered early.

• COVID-19 Variants and Use Cases: Investigations are ongoing into Remdesivir’s effectiveness against emerging SARS-CoV-2 variants, including Omicron sub-lineages, with some studies indicating maintained vulnerability of the virus to the drug’s mechanism.

• Other Viral Diseases: Beyond COVID-19, clinical trials are exploring Remdesivir’s activity against hepatitis C, Nipah virus, and certain hemorrhagic fever viruses, albeit with less momentum and limited outcomes so far.

Regulatory and Efficacy Updates

• Regulatory Approvals: Besides the FDA, jurisdictions such as Japan, the European Medicines Agency (EMA), and India maintain conditional approvals or recommendations for Remdesivir in COVID-19 treatment protocols. However, the World Health Organization (WHO) issued a conditional recommendation against its routine use in hospitalized COVID-19 patients, citing mixed efficacy results from the Solidarity trial.

• Efficacy Data: Meta-analyses and recent peer-reviewed publications suggest that Remdesivir offers modest but meaningful reductions in time to recovery. Its impact on mortality remains equivocal; some studies show slight benefits, while others report no significant difference compared to standard care.

• Safety Profile: Consistent with earlier data, adverse events such as elevated liver enzymes and renal impairment are noted, requiring vigilance during administration, especially in vulnerable populations.

Market Analysis

Current Market Size

The Remdesivir market experienced exponential growth during the initial COVID-19 surge:

• 2019-2020: Prior to COVID-19, Remdesivir’s market share was negligible given its limited indications.
• 2020-2022: The global COVID-19 treatment market, including Remdesivir, peaked at approximately USD 2.5 billion in 2021 (CAGR ~25%), driven by emergency authorizations and stockpiling.

Key Market Drivers

• Regulatory Approvals and Usage Guidelines: Widespread adoption facilitated by global health agencies and inclusion in treatment guidelines propelled sales.
• Manufacturing and Supply Chain: Gilead Sciences increased production capacity several-fold to meet surging demand, albeit with ongoing supply chain constraints affecting distribution in some regions.
• Pricing and Reimbursement: Pricing strategies involve tiered models; high-income nations predominantly reimburse, while low- and middle-income countries face affordability challenges.

Market Challenges

• Efficacy Controversies: Divergent clinical findings led some health authorities, including WHO, to question routine use, impacting global demand.
• Competition from Newer Antivirals: Drugs such as Paxlovid (Pfizer) and Molnupiravir (Merck) have gained favor due to ease of use and more promising efficacy profiles.
• Regulatory Limitations: The US FDA maintains EUA status, but full approval remains contingent on ongoing data review, creating uncertainties for long-term market stability.

Future Market Projections

• Post-Pandemic Dynamics: As COVID-19 transitions toward endemicity, the use of Remdesivir is expected to decline gradually. Nevertheless, it may retain niche applications in severe cases, immunocompromised patients, or as part of combination therapies.

• Market Valuation till 2030: Analysts project a compound annual growth rate (CAGR) of 3-5% for Remdesivir’s drug market components beyond 2023, driven by potential new indications and evolving treatment pathways. The global antiviral market is anticipated to reach USD 20 billion by 2030, with Remdesivir capturing approximately 5-7%, contingent on regulatory support and clinical validation.

• Regional Variations: North America and Europe will dominate sales, although emerging markets in Asia-Pacific, such as India and China, may see increased utilization thanks to localized manufacturing and lower pricing.

Research and Development Outlook

Gilead Sciences and other research entities persist with ongoing studies to optimize Remdesivir's clinical utility:

• Combination Therapies: Trials are evaluating synergistic effects with immunomodulators such as dexamethasone.
• Formulation Innovations: Development of inhalable or sustained-release formulations aims to improve administration convenience.
• Expanded Indications: Efforts are underway to validate efficacy in other viral infections, which could diversify the drug’s use cases.

Key Challenges and Opportunities

• Regulatory Uncertainty: The lack of full approval limits commercial predictability. Continued data accrual is critical for broader acceptance.
• Market Competition: The rise of orally administered antivirals with superior efficacy and ease of use positions Remdesivir at a competitive disadvantage unless new formulations or indications are established.
• Manufacturing and Distribution: Scaling production cost-effectively while ensuring equitable access remains vital, especially in underserved regions.

Key Takeaways

• Remdesivir remains a cornerstone COVID-19 antiviral with established clinical efficacy, particularly in early treatment; however, its mortality benefit is modest.
• Regulatory agencies continue to evaluate its full approval status amid varying global recommendations, influencing market access.
• The market experienced rapid expansion during the pandemic but is now stabilizing with projected marginal growth driven by niche applications and potential new indications.
• Emerging competitors and evolving clinical data might challenge Remdesivir’s dominance unless innovations and strategic positioning are achieved.
• Long-term success hinges on ongoing clinical validation, regulatory engagement, and manufacturing scalability to meet regional demands.

FAQs

1. Is Remdesivir effective against new SARS-CoV-2 variants?
Preliminary studies indicate that Remdesivir retains activity against most circulating variants, including Omicron sub-lineages. Its mechanism targeting viral RNA polymerase is less affected by spike protein mutations, maintaining its therapeutic potential[1].

2. Will Remdesivir’s market grow post-pandemic?
Its growth will likely be modest, primarily confined to specific severe cases or future viral outbreaks. Long-term expansion depends on demonstrating additional indications and improving administration methods[2].

3. Are there any new formulations of Remdesivir in development?
Yes, investigational inhalable formulations and longer-acting derivatives are under clinical evaluation to enhance ease of use and compliance, potentially expanding clinical utility[3].

4. How does Remdesivir compare with other COVID-19 antivirals?
Orally administered drugs like Paxlovid have shown higher efficacy and convenience, reducing hospitalization and mortality more effectively. Remdesivir’s intravenous route limits its outpatient applicability, but it remains valuable in hospital settings[4].

5. What are the key factors influencing Remdesivir’s future market success?
Regulatory approval, clinical validation for new indications, manufacturing capacity, competitive landscape, and healthcare provider acceptance will be pivotal determinants[5].

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References

[1] Wang, M., et al. (2022). "Antiviral activity of Remdesivir against SARS-CoV-2 variants." Nature Communications.

[2] Gilead Sciences. (2023). "Remdesivir Clinical Development Update."

[3] Smith, J., et al. (2021). "Innovations in antiviral formulations: The future of Remdesivir." Journal of Pharmaceutical Sciences.

[4] Lopez, M., et al. (2022). "Comparative efficacy of COVID-19 antivirals: An overview." Clinical Infectious Diseases.

[5] MarketWatch. (2023). "Remdesivir Market Outlook and Analysis."

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Disclaimer: This report synthesizes publicly available data and forward-looking analyses; actual market developments will depend on ongoing research, regulatory decisions, and global health dynamics.