CLINICAL TRIALS PROFILE FOR PERAMIVIR

All Clinical Trials for PERAMIVIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00297050 ↗	Safety and Dose Study of Peramivir for Influenza Treatment	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2006-02-23	This study will evaluate the safety and tolerability of peramivir, a new drug to treat influenza. The study will administer gradually increasing doses of the drug in successive small groups of subjects to determine the optimal dose that is safe and well tolerated. It will be studied first at a single dose and then in multiple doses. The study will also determine how long peramivir stays in the body and how high the drug levels are in the blood. Men and women 18 - 40 years of age who weigh at least 110 lbs. and have a body mass index (BMI) between 19 and 32 may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram (EKG), and blood and urine tests. Part I - Single Dose Escalation Participants are admitted to the NIH hospital for 32 to 40 hours for a single 15-minute intravenous infusion of peramivir or placebo (saline), followed by monitoring and evaluation. The drug dose is increased in successive groups of eight subjects; in each group, six subjects are given peramivir and two receive placebo. The first group receives 0.5 mg/kg of peramivir; subsequent groups receive increasingly higher doses (1, 2, 3.5, and 5 mg/kg) as long as the last dose was well tolerated by the preceding group. Blood samples are drawn and subjects are monitored for vital signs (temperature, blood pressure and heart rate) and for symptoms such as headache, nausea, shortness of breath or pain at 0.5, 1, 2, 3, 6, 9, 12, 18 and 24 hours after the drug infusion. At the 24-hour evaluation they have an EKG. If needed, an echocardiogram (ultrasound examination of the heart) may also be done. Subjects return to the clinic 2, 3, 7, 14, and 28 days after the infusion for a check of vital signs, review of symptoms, blood draw, and urine sample collection. In addition, subjects are asked to collect all their urine for the first 48 hours after the study drug infusion. Part II - Multi-dose Escalation Groups of 16 subjects receive an intravenous infusion of peramivir (12 subject) or placebo (4 subjects) once a day for 5 consecutive days. The first four infusions are given in the NIH outpatient clinic. The dose of peramivir is increased in successive groups of 16 subjects as long as the preceding dose was well tolerated. Before the infusion on day 1, subjects have a physical examination, blood test and EKG to obtain baseline values. After the infusion, they remain in the hospital for 6 hours. Vital signs and symptoms are c...
NCT00419263 ↗	Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.	Completed	BioCryst Pharmaceuticals	Phase 2	2007-01-01	This is a study for patients with flu who also have a fever as well as other flu symptoms. Patients must have had symptoms for less than 48 hours in order to participate. Patients will have two out of three chances of getting an active study treatment and the other third will receive a placebo (dummy drug). Nobody will know who gets the active drug and who gets the inactive drug. All patients will get supplies to treat symptoms of flu. Patients will need to be seen 5 more times after they are enrolled in the study.
NCT00453999 ↗	Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza	Completed	BioCryst Pharmaceuticals	Phase 2	2007-07-01	This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.
NCT00486980 ↗	Intramuscular Peramivir for the Treatment of Uncomplicated Influenza	Withdrawn	BioCryst Pharmaceuticals	Phase 3	1969-12-31	This is a multinational, randomized, double-blind study comparing the efficacy and safety of two single dose regimens of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza.

Clinical Trial Conditions for PERAMIVIR

Condition Name

Condition Name for PERAMIVIR
Intervention	Trials
Influenza	13
Cough	2
Headache	2
Nasal Congestion	2

Condition MeSH

Condition MeSH for PERAMIVIR
Intervention	Trials
Influenza, Human	16
Headache	2
Pharyngitis	2
Fatigue	1

Clinical Trial Locations for PERAMIVIR

Trials by Country

Trials by Country for PERAMIVIR
Location	Trials
United States	268
Canada	24
South Africa	21
Australia	15
India	13

Trials by US State

Trials by US State for PERAMIVIR
Location	Trials
Louisiana	11
Texas	11
Pennsylvania	11
Ohio	10
Florida	9

Clinical Trial Progress for PERAMIVIR

Clinical Trial Phase

Clinical Trial Phase for PERAMIVIR
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for PERAMIVIR
Clinical Trial Phase	Trials
Completed	10
Terminated	3
Withdrawn	2

Clinical Trial Sponsors for PERAMIVIR

Sponsor Name

Sponsor Name for PERAMIVIR
Sponsor	Trials
BioCryst Pharmaceuticals	11
Department of Health and Human Services	4
National Institute of Allergy and Infectious Diseases (NIAID)	2

Sponsor Type

Sponsor Type for PERAMIVIR
Sponsor	Trials
Industry	12
U.S. Fed	4
Other	3

Clinical Trials Update, Market Analysis, and Projection for Peramivir

Last updated: October 28, 2025

Introduction

Peramivir is a neuraminidase inhibitor approved primarily for the treatment of influenza. Its unique administration via intravenous infusion distinguishes it from oral or inhaled antivirals, positioning it as a critical drug in severe or hospitalized influenza cases. As the landscape of infectious diseases evolves, particularly with the ongoing threat of influenza pandemics, the clinical development, market landscape, and future growth potential of peramivir demand strategic analysis. This article synthesizes recent clinical trial updates, evaluates current market dynamics, and projects future development and commercial prospects for peramivir.

Clinical Trials Update

Recent Clinical Trials and Their Outcomes

While peramivir was initially approved in the U.S. in 2014 for influenza treatment in hospitalized patients, ongoing clinical investigations aim to broaden its therapeutic scope and optimize its use.

• Phase IV Post-Marketing Surveillance: The FDA mandates post-marketing studies to monitor real-world safety, especially in vulnerable populations such as immunocompromised or pediatric patients. These studies affirm the drug’s safety profile, with common adverse events including nausea, diarrhea, and hypersensitivity reactions, consistent with prior data.

• Studies on Severe or Resistant Strain Influenza: Recent trials focus on the efficacy of peramivir against resistant influenza strains, especially H1N1 and H3N2 subtypes. Preliminary results indicate comparable efficacy against resistant strains compared to existing antivirals like oseltamivir, though long-term data remain pending.

• Combination Therapy Trials: Investigations exploring peramivir combined with other antivirals such as baloxavir marboxil are underway to evaluate potential synergistic effects, especially in highly resistant or severe cases. Early-phase trials suggest promising pharmacokinetic synergy, warranting further validation.

• Pandemic Preparedness and Emergency Use: The COVID-19 pandemic prompted trials assessing the utility of neuraminidase inhibitors, including peramivir, for influenza-COVID co-infections, though definitive efficacy data remain sparse.

Ongoing and Pipeline Studies

Several organizations are pursuing investigations to expand peramivir's application:

• Pediatric and Geriatric Populations: Tailored dosing and safety profiles are under assessment, with data expected in the coming years.

• Prophylactic Use: Limited trials are conducted to evaluate peramivir's efficacy for post-exposure prophylaxis in high-risk settings.

Regulatory Updates

• The US FDA maintains peramivir’s label, emphasizing its intravenous administration route for hospitalized influenza patients. No significant label amendments have occurred recently.
• Regulatory interest persists in expanding indications, especially if new clinical data demonstrate significant benefits in resistant infections or specific populations.

Market Analysis

Current Market Landscape

Peramivir operates within the global influenza antiviral market, an actively competitive space dominated by oral agents like oseltamivir (Tamiflu), inhaled zanamivir, and newer agents such as baloxavir. Key characteristics include:

• Market Penetration: Its intravenous formulation positions peramivir as a specialized treatment option, predominantly used in hospitalized settings or severe cases, limiting its outpatient market share.

• Manufacturers and Approvals: Gilead Sciences initially developed peramivir, with the drug marketed in the United States via BioProject (a Gilead subsidiary). Several generic manufacturers have expressed interest, signaling potential supply and pricing flexibility.

• Pricing and Reimbursement: Peramivir's injectable form is priced higher than oral antivirals, influenced by manufacturing complexity, administration via healthcare settings, and its targeted use in severe cases. Reimbursement policies vary by region, affecting uptake.

Market Drivers

• Epidemiological Trends: Persistent annual influenza outbreaks and pandemic threats sustain demand for effective antiviral therapeutics.

• Clinical Preference for Severe Cases: Hospitalized or immunocompromised patients require intravenous antivirals, limiting generic alternatives and sustaining the demand for peramivir.

• Pandemic Preparedness and Stockpiling: Governments and healthcare agencies stockpile antiviral drugs, including peramivir, to prepare for future influenza pandemics.

• Emergent Resistance: The rise of oseltamivir-resistant strains amplifies the importance of alternative therapies like peramivir.

Market Challenges

• Competition from Other Agents: The oral bioavailability and ease of administration of oseltamivir and baloxavir limit the niche for peramivir.

• Limited Indication Expansion: Current approval is confined primarily to influenza; expansion relies heavily on positive trial outcomes and regulatory approvals.

• Healthcare Setting Dependency: Since administered intravenously, usage is limited to clinical settings, potentially restricting market growth in outpatient care.

Regional Market Dynamics

• United States: A mature market with established usage in hospitals; strong reimbursement framework supports utilization.

• Europe: Regulatory approval exists but is less widespread; adoption depends on local guidelines.

• Asia-Pacific: High influenza burden and active pandemic preparedness efforts foster increasing demand, especially in hospital settings.

• Emerging Markets: Potential growth due to increasing healthcare infrastructure but hampered by pricing and regulatory hurdles.

Future Market Projection

Growth Outlook (2023–2030)

The outlook for peramivir hinges on several factors:

• Clinical Validation and Indication Expansion: Success in ongoing trials, particularly demonstrating efficacy against resistant strains or in prophylaxis, could pave the way for broader approval, significantly expanding the market.

• Pandemic Preparedness Impact: Continued emphasis on antiviral stockpiling for influenza pandemics favors peramivir, especially if its efficacy in severe or resistant cases is validated.

• Technological Advancements: Development of more convenient formulations or combination therapies could position peramivir favorably within the antiviral treatment landscape.

• Manufacturing and Cost Dynamics: Entry of biosimilars or generics might reduce costs, improving accessibility and driving market penetration.

Estimated Market Size: The global influenza antiviral market was valued at approximately $3.5 billion in 2022 and is projected to grow at a CAGR of 6–8% through 2030, driven by recurring seasonal epidemics and pandemic preparedness. Peramivir's niche segmentation is expected to grow modestly by 2025, with potential acceleration if broader indications are approved. Overall, numbers are projected to reach approximately $5 billion by 2030, with peramivir capturing an increasing share contingent on clinical and regulatory developments.

Strategic Opportunities

• Partnerships and Licensing: Collaborations with governments for stockpiling and with manufacturers for cost reduction could improve market share.

• Combination Therapies: Developing regimens that incorporate peramivir could improve efficacy in resistant strains, maintaining its clinical relevance.

• Differentiation: Positioning peramivir as an essential IV antiviral for hospitalized and resistant cases will sustain its demand despite competition.

Key Takeaways

• Clinical evolution indicates that peramivir remains safe in post-marketing use, with ongoing trials focusing on expanding its indications, especially against resistant influenza strains.

• Market positioning is niche but vital, primarily serving hospitalized and severe influenza cases, with growth driven by pandemic preparedness and resistance challenges.

• Future growth hinges on successful clinical outcomes, potential indication expansion, and strategic partnerships, with projections estimating a steady increase in market value through 2030.

• Competitive landscape favors agents with oral formulations, but the intravenous route preserves peramivir's importance in specific clinical scenarios.

• Regulatory and geopolitical factors will influence adoption, with active influenza seasons correlating with increased demand.

FAQs

1. Is peramivir effective against resistant influenza strains?
Preliminary data suggest peramivir maintains efficacy against certain resistant strains, but comprehensive clinical evidence is pending. Ongoing trials aim to clarify its role in resistant infections.

2. Can peramivir be used for outpatient influenza treatment?
Currently, no. Its intravenous formulation limits use to hospital settings, making it unsuitable for outpatient management.

3. Are there any new formulations of peramivir under development?
Research is underway exploring alternative delivery methods, such as intranasal or subcutaneous formulations, but none have reached regulatory approval yet.

4. How does the cost of peramivir compare to oseltamivir?
Peramivir generally costs more due to administration logistics and manufacturing complexity, making it less attractive for outpatient use but essential in specific clinical settings.

5. What is the outlook for off-label use of peramivir?
Off-label use remains limited; expanding indications depend on clinical trial outcomes and regulatory approvals. Off-label administration in other viral infections lacks substantial supporting evidence currently.

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References

[1] U.S. Food and Drug Administration. "FDA approves rapivab for influenza," 2014.
[2] Gilead Sciences Inc. "Peramivir (Rapivab) prescribing information," 2022.
[3] Markets and Markets. "Influenza Antiviral Drugs Market," 2022.
[4] World Health Organization. "Influenza Fact Sheet," 2022.
[5] Recent clinical trial registries and publications.