CLINICAL TRIALS PROFILE FOR VEKLURY

All Clinical Trials for VEKLURY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04784559 ↗	Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection	Recruiting	PharmaMar	Phase 3	2021-06-04	Treatment of patients hospitalised for management of moderate COVID-19 infection
NCT04832880 ↗	Factorial Randomized Trial of Rendesivir and Baricitinib Plus Dexamethasone for COVID-19 (the AMMURAVID Trial)	Not yet recruiting	ASST Fatebenefratelli Sacco	Phase 3	2021-04-06	Background: In the current worldwide medical emergency, a rapid identification of effective therapeutic strategy is crucial. So far, therapy with dexamethasone, remdesivir and baricitinib have been associated with evidence of impact on the clinical impact on COVID-19, but the effect of baricitinib and remdesivir in combination with dexamethasone. The AAMMURAVID trial is endorced and supported by the Italian Regulatory agency (AIFA-Agenzia Italiana del Farmaco)
NCT04853901 ↗	Remdesivir Efficacy In Management Of COVID-19 Patients	Completed	Ain Shams University	Phase 3	2020-07-27	The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.
NCT04871633 ↗	Effectiveness of Remedesvir in COVID-19 Patients Presenting at Mayo Hospital Lahore	Completed	King Edward Medical University	N/A	2020-08-01	Currently, several drugs including Remdesivir, hydroxychloroquine, chloroquine, ritonavir+lopinavir, Tocilizumab, Arbidol and interferon are under randomised controlled trials (RCTs) for efficacy and/or safety evaluations in patients with COVID-19 in different countries. Remdesivir (GS-5734) is among these investigational drugs and some studies reported promising results. Remdesivir is a nucleotide analogue intravenous pro-drug developed by Gilead Sciences, an American biopharmaceutical company, for treatment of Ebola virus during the 2014 Ebola outbreak in Western Africa. Remdesivir shows broad-spectrum antiviral activity against many RNA viruses including SARS-CoV-2 through blocking RNA polymerase thereby terminating RNA transcription. Remdesivir was among the first treatments used in China as the outbreak emerges and it has been reported as potential treatment options for COVID-19 in the USA, China and Italy.
NCT05502081 ↗	Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients	Completed	Mansoura University Hospital	Phase 4	2021-11-01	Introduction: Corona Virus induced disease - 2019 (COVID-19) pandemic stimulates research works to find a solution to this crisis from starting 2020 year up to now. With ending of 2021 year, various advances in pharmacotherapy against COVID-19 have emerged. Regarding antiviral therapy, Casirivimab and imdevimab antibody combination is a type of new immunotherapy against COVID-19. Standard antiviral therapy against COVID-19 includes Remdesivir and Favipravir. Aim of Study: 1. To compare the efficacy of antibodies cocktail (casirivimab and imdevimab), Remdesivir and Favipravir in reducing 28-day mortality in hospitalized patients with moderate, severe or critical COVID19 2. To compare safety of antibodies cocktail (casirivimab and imdevimab), Remdesivir and Favipravir by monitoring hypersensitivity and infusion related reactions or other significant adverse effects Patients and Population: 265 COVID-19 Polymerase Chain Reaction (PCR) confirmed patients with indication for antiviral therapy is included in this study and will be divided into 3 groups (1:2:2): 1. Group A: REGN3048-3051(Antibodies cocktail (casirivimab and imdevimab)) 2. group B: Remdesivir 3. group C: Favipravir Methods: Study design is single blind non-Randomized Controlled Trial (non-RCT). The drugs of the study are owned by Mansoura University Hospital (MUH), and prescribed by chest diseases lectures of faculty of medicine-Mansoura University. The duration of study is about 6 months after ethical approval.

Clinical Trial Conditions for VEKLURY

Condition Name

Condition Name for VEKLURY
Intervention	Trials
COVID-19	3
Covid19	2
COVID-19 Infection	1
Respiratory Syncytial Virus (RSV)	1

Condition MeSH

Condition MeSH for VEKLURY
Intervention	Trials
COVID-19	6
Post-Acute COVID-19 Syndrome	2
Respiratory Syncytial Virus Infections	1
Respiration Disorders	1

Clinical Trial Locations for VEKLURY

Trials by Country

Trials by Country for VEKLURY
Location	Trials
Spain	8
Brazil	7
Mexico	6
Colombia	4
Argentina	4

Clinical Trial Progress for VEKLURY

Clinical Trial Phase

Clinical Trial Phase for VEKLURY
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	2

Clinical Trial Status

Clinical Trial Status for VEKLURY
Clinical Trial Phase	Trials
RECRUITING	3
Completed	3
Not yet recruiting	2

Clinical Trial Sponsors for VEKLURY

Sponsor Name

Sponsor Name for VEKLURY
Sponsor	Trials
Unity Health Toronto	1
ASST Fatebenefratelli Sacco	1
Mount Sinai Hospital, Canada	1

Sponsor Type

Sponsor Type for VEKLURY
Sponsor	Trials
Other	14
UNKNOWN	1
NETWORK	1

Clinical Trials Update, Market Analysis, and Projection for Veklury (Remdesivir)

Last updated: October 30, 2025

Introduction

Veklury (remdesivir) remains a pivotal antiviral agent utilized primarily in the treatment of COVID-19. As the world navigates post-pandemic healthcare landscapes, understanding the evolving clinical trial data, market dynamics, and future projections for Veklury is critical for pharmaceutical companies, healthcare providers, and investors. This report provides a comprehensive analysis of current clinical trial statuses, market performance, competitive positioning, and future outlook for Veklury.

Clinical Trials Update

Current Clinical Trial Landscape

Since its emergency use authorization (EUA) in 2020, Veklury has undergone extensive clinical evaluation to determine efficacy, safety, and optimal usage parameters. According to clinicaltrials.gov, over 130 studies involve remdesivir, with 35+ underway or recently completed as of Q1 2023. These studies span multiple phases, focusing on COVID-19 variants, severe cases, outpatient settings, and combination therapies. (1).

Key Recent Trials and Outcomes

• Dissemination of Phase 3 Results: The ACTT-1 trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), demonstrated that remdesivir shortened recovery time in hospitalized COVID-19 patients from 15 to 10 days compared to placebo. The trial also observed a mortality trend reduction, though not statistically significant. These findings established Veklury as a standard treatment for severe cases early in the pandemic (2).

• RECOVERY Trial Sub-analyses: While the randomized RECOVERY trial primarily evaluated dexamethasone, subsets of data explored remdesivir's utility. Results indicated marginal benefits in specific cohorts, leading to refined treatment guidelines.

• Emerging Variants Research: Recent Phase 2/3 trials assess remdesivir's efficacy against Omicron and other new variants. Preliminary data suggest maintained antiviral activity owing to the conserved nature of the viral polymerase targeted by remdesivir (3).

Ongoing and Future Clinical Studies

• Outpatient Use Trials: Multiple trials are evaluating remdesivir’s efficacy in early-stage outpatient settings to prevent progression to severe disease (4).

• Combination Therapies: Trials combining remdesivir with immunomodulators or monoclonal antibodies aim to optimize treatment regimens for high-risk groups.

• Long COVID Research: Investigations into remdesivir's role in addressing post-acute sequelae of COVID-19 are underway, though results remain inconclusive to date.

Safety Profile and Limitations

Clinical data affirm remdesivir's favorable safety profile with predominantly mild adverse effects such as nausea and elevated liver enzymes. However, concerns about hepatotoxicity and renal impairment in specific populations persist, underpinning ongoing trial safety assessments (5).

Market Analysis

Current Market Dynamics

The COVID-19 pandemic catalyzed Veklury’s rapid adoption, with global sales reaching approximately $3.5 billion in 2021. The demand peaked during initial waves but has tapered as vaccination rates increased and newer therapeutics emerged (6).

• Market Segmentation:

  • Hospitals & Healthcare Facilities: Main purchase point, accounting for 85% of orders.
  • Government Procurement: Significant government contracts in the US, Europe, and Asia facilitated supply during peak demand phases.
  • Emerging Markets: Growth areas due to expanding healthcare infrastructure.

• Pricing & Reimbursement:

  • Remdesivir’s pricing varies, with a retail price around $2,340 per 5-day treatment in the US. Reimbursement policies differ across countries, with government subsidies mitigating costs.

Competitive Landscape

• Direct Competitors:

  • Molnupiravir (Merck): Oral antiviral granted emergency use authorization in late 2021, offering advantages in ease of administration.
  • Paxlovid (Pfizer): Another oral agent with similar indications, rapidly gaining market share.
  • Other Approaches: Monoclonal antibodies and corticosteroids remain adjuncts but have different usage contexts.

• Remdesivir's Unique Position:

  • Remdesivir remains the only FDA-approved antiviral for hospitalized COVID-19 patients in the US.
  • Its intravenous administration limits outpatient and early-stage use.

Regulatory Status

• Global Approvals:

  • Approved or authorized in over 50 countries, including the US, European Union, Japan, and Australia.
  • Several countries have adopted Veklury as part of standard of care for severe COVID-19.

• Evolving Indications:

  • The FDA has expanded remdesivir's label to include outpatient use for high-risk populations.
  • The European Medicines Agency (EMA) continues to review new data for expanded indications.

Market Challenges

• Emergence of Oral Agents: As oral antivirals gain preference for early treatment, Veklury faces potential obsolescence in mild or moderate cases.
• Cost and Mode of Administration: Intravenous infusion limits outpatient accessibility, impacting overall market penetration.

Projected Market Trends

• Post-Pandemic Demand:

  • Expect a decline in COVID-19 specific sales as the pandemic wanes.
  • However, remdesivir’s potential utility in other viral infections (e.g., Ebola, due to its broad antiviral activity) maintains some relevance.
  • Continual research could reposition Veklury in pandemic preparedness stockpiles.

• Pipeline Opportunities:

  • Development of long-acting formulations or oral analogs could rejuvenate market prospects.
  • Combining Veklury with novel therapeutics to enhance efficacy and broaden indication scope is a strategic avenue.

Future Market Projections

Short-Term Outlook (2023–2025)

Veklury’s sales are projected to decline gradually but remain significant, estimated to hover around $1.2–1.5 billion annually by 2025. The declining COVID-19 cases and competition from oral antivirals will influence revenue. Nonetheless, sustained use in hospitalized patients and efforts to position remdesivir for other viral diseases could buffer declines.

Medium-to-Long Term Outlook (2026–2030)

• Market Stabilization:

  • Veklury may transition from a pandemic-centric drug to a niche antiviral agent.
  • Its role in potential future outbreaks of coronavirus strains or other polymerase-inhibiting viruses could be rediscovered.

• Alternative Markets & Indications:

  • Expanding clinical research into antiviral efficacy against other viruses, such as hepatitis or emerging pathogens, could diversify revenue streams.

• Reformulation and New Delivery Modalities:

  • Investment in oral or long-acting formulations could significantly alter its market trajectory.
  • Such innovations could re-establish Veklury as a frontline therapeutic across broader COVID-19 stages.

Key Takeaways

• Clinical Efficacy: Veklury demonstrates clear benefits in hospitalized, severe COVID-19 cases, supported by robust clinical trial data. Its safety profile remains favorable, although limitations tied to intravenous administration persist.

• Market Dynamics: The initial surge in demand has waned with pandemic containment and competition from oral antivirals. Remdesivir's survival hinges on its evolving clinical role and strategic repositioning.

• Regulatory and Commercial Strategies: Continued expansion of indications, especially outpatient use and combination therapies, and innovation in delivery methods are vital to maintain relevance.

• Future Outlook: While pandemic-driven sales decline, Veklury's potential in future viral outbreaks and broader antiviral applications positions it as a speculative yet potentially valuable asset in the antiviral pharmacopeia.

• Investment Implication: Stakeholders should monitor ongoing clinical trials and regulatory decisions, as these significantly influence potential market resurgence or obsolescence.

FAQs

1. Is Veklury effective against newer COVID-19 variants?
Preliminary data suggest that remdesivir retains activity against Omicron and other variants due to its target—the viral RNA polymerase—which remains conserved. However, ongoing trials are crucial to confirm its efficacy.

2. Will Veklury replace oral antivirals like Paxlovid or Molnupiravir?
Unlikely in early disease stages. Oral agents offer convenience for outpatient care and early intervention, whereas Veklury remains primarily for hospitalized or severe cases, limiting its competitive scope.

3. Are there ongoing trials exploring Veklury's use in pediatrics?
Yes. Several studies are assessing safety and efficacy in pediatric populations, which could expand its application but require regulatory approvals.

4. How might the future of Veklury be affected by emerging antiviral technologies?
Innovations like long-acting formulations, combination therapies, or more potent agents could challenge remdesivir’s market position, emphasizing the need for continuous development and adaptation.

5. Could Veklury have utility beyond COVID-19?
Potentially. Its mechanism targeting viral polymerase offers prospects for application against other RNA viruses, particularly in outbreak scenarios.

References

1. ClinicalTrials.gov. "Remdesivir studies." Accessed February 2023.
2. Beigel, J. H., et al. (2020). Remdesivir for the Treatment of Covid-19 — Final Report. New England Journal of Medicine.
3. Wang, M., et al. (2022). Remdesivir Activity Against the Omicron Variant. Nature Communications.
4. NCT04643674. Clinical trial evaluating outpatient remdesivir.
5. Grein, J., et al. (2020). Compassionate Use of Remdesivir for Patients with Severe Covid-19. NEJM.
6. IQVIA Institute. (2022). Global Outlook on Respiratory Disease Therapeutics.

Note: Data and projections are subject to change based on evolving clinical results, regulatory decisions, and market developments.