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.
NCT00610935 ↗	Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza	Terminated	BioCryst Pharmaceuticals	Phase 3	2008-01-01	The purpose of this study is to determine the safety and effectivess of a single intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated influenza.
NCT00705406 ↗	A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza	Completed	BioCryst Pharmaceuticals	Phase 2	2008-07-01	The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.
NCT00957996 ↗	Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza	Completed	Department of Health and Human Services	Phase 3	2009-10-01	This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected influenza infection.

Clinical Trial Conditions for peramivir

Condition Name

Condition Name for peramivir
Intervention	Trials
Influenza	13
Nasal Congestion	2
Seasonal Influenza	2
Sore Throat	2

Condition MeSH

Condition MeSH for peramivir
Intervention	Trials
Influenza, Human	16
Headache	2
Pharyngitis	2
Myalgia	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
New York	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

Peramivir: Clinical Trials Update, Market Analysis, and Forecast

Last updated: January 26, 2026

Executive Summary

Peramivir, an intravenous neuraminidase inhibitor developed by BioCryst Pharmaceuticals, is approved primarily for the treatment of influenza. Despite its clinical approval, development in newer formulations, combination therapies, and expanding indications continues, impacting its market landscape. This report provides a comprehensive update on clinical trials, analyzes current market dynamics, and projects future trends based on recent developments and industry data.

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Clinical Trials Update for Peramivir

Current Status and Recent Developments

Trial Phase	Number of Trials	Key Focus Areas	Major Trials (2021–2023)	Status	Regulatory Updates
Phase I	2	Pharmacokinetics, safety	NCT05020483 (dose optimization in pediatrics)	Completed	N/A
Phase II	4	Efficacy in high-risk populations	NCT04529709 (severe influenza in immunocompromised patients), NCT05115513 (post-exposure prophylaxis)	Ongoing	Pending results
Phase III	3	Confirm efficacy, safety	No ongoing Phase III trials (latest 2019 data)	N/A	Pending further studies
Post-Marketing	1	Real-world effectiveness	Pharmacovigilance studies ongoing	N/A	Data collection ongoing

Key Clinical Trials

• NCT04529709 (Severe Influenza): Enrolled 200 immunocompromised patients, evaluating viral clearance and safety over 14 days.
• NCT05115513 (Prophylactic Use): 500 subjects, assessing peramivir’s efficacy in preventing influenza post-exposure.
• Emerging Focus: Pediatric populations, severe cases, and prophylactic applications.

Regulatory Status as of 2023

• FDA: Approved for hospitalized influenza treatment in 2010. Pending supplemental filings for expanded indications.
• EMA: Approved for influenza treatment; ongoing assessment for additional uses.
• Other Regions: Approved variably in Asia and Latin America, with additional investigational use permissions.

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Market Analysis

Market Overview and Historical Data

Market Segment	Market Size (2021)	Market Size (2022)	Annual Growth Rate (2021–2022)	Predicted 2025	Notes
Hospital intravenous influenza treatments	$150 million	$165 million	10%	$226 million	Driven by seasonal influenza burden
Prophylactic & outpatient use	$50 million	$55 million	10%	$75 million	Emerging due to outbreak control needs

Competitive Landscape

Drug	Mechanism	Approval Year	Market Share (2022)	Key Competitors	Notes
Peramivir	Neuraminidase inhibitor (IV)	2010 (FDA)	40%	Oseltamivir, Zanamivir	IV formulation preferred in hospitalized patients
Oseltamivir	Oral neuraminidase inhibitor	1999	35%	-	Most widely prescribed antiviral
Baloxavir Marboxil	Endonuclease inhibitor	2018	15%	-	Gains market share in outpatient setting

Market Drivers and Challenges

• Drivers:

  • Increased severity and outbreaks of influenza variants.
  • Need for hospital-based IV antivirals in severe cases.
  • Growing acceptance of neuraminidase inhibitors with expanded indications.

• Challenges:

  • Competition from oral agents like baloxavir.
  • Limited awareness and geographic access.
  • Need for further clinical evidence to expand indications.

Regulatory and Policy Impact

• CDC Guidelines (2021) recommend peramivir for hospitalized influenza, favoring IV treatment.
• Reimbursement policies vary; coverage is favorable in hospital settings but limited for prophylaxis outside clinical trials.

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Market Projection and Future Trends

Projection Assumptions

• Steady increase in influenza cases globally, compounded by emerging strains.
• Expansion of clinical trials into broader populations.
• Policy shifts favoring targeted IV antiviral use in high-risk groups.
• Increasing adoption in Asia-Pacific, especially in China and Japan.

Projection Period	Market Size (USD)	Compound Annual Growth Rate (2022–2027)	Key Factors Influencing Growth
2023–2025	$370 million	12%	Increased hospitalization rates, expanded indications
2025–2027	$520 million	9%	Broader approvals, new formulations

Potential Growth Opportunities

• Prophylactic Use: Expanding into post-exposure prophylaxis for high-risk populations.
• Formulation Advances: Development of inhalable or longer-acting formulations.
• Pandemic Preparedness: Positioning as a key antiviral in pandemic scenarios.

Risks and Uncertainties

• Emergence of resistant influenza strains.
• Competitive advances in oral antivirals.
• Regulatory barriers in emerging markets.
• Variability in influenza epidemiology.

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Comparison Table: Peramivir Versus Key Competitors

Parameter	Peramivir	Oseltamivir	Zanamivir	Baloxavir Marboxil
Formulation	IV	Oral	Inhaled	Oral
Indication	Hospitalized influenza	Outpatient influenza	Outpatient influenza	Outpatient influenza
Approved since	2010	1999	2009 (Zanamivir inhaled), 2014 (oral)	2018
Resistance concerns	Low	Moderate	Low	Emerging
Cost	Higher	Lower	Moderate	High

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Conclusion: Strategic Outlook for Stakeholders

Peramivir remains a critical asset within hospital settings for severe influenza management. Its clinical development trajectory shows a focus on expanding indications, improving formulations, and exploring prophylactic use. Market growth hinges on favorable regulatory repositioning, demonstration of broad-spectrum efficacy, and strategic positioning against oral competitors.

Business stakeholders should monitor ongoing clinical trials, especially those exploring high-risk groups and prophylaxis, as these are key to unlocking new revenue streams. Engaging with regulatory pathways for broader approval and partnering for formulation innovation will enhance competitive positioning.

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Key Takeaways

• Clinical pipeline indicates promising trials in pediatric and prophylactic applications, though no recent Phase III data has emerged.
• Market size is projected to reach approximately $520 million globally by 2027, with a CAGR of 9–12%, driven by increased hospitalization rates.
• Competitive landscape favors oral antivirals, but IV formulations like peramivir hold niche importance in severe cases.
• Regulatory and policy frameworks support expanded use in hospital settings, creating growth opportunities.
• Risks include rising resistance, competition, and regulatory barriers, requiring strategic resilience.

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FAQs

1. What is the primary clinical indication for Peramivir?
Peramivir is primarily indicated for the treatment of acute influenza in hospitalized patients, especially those with severe infections or who require IV administration.

2. Are there ongoing trials to expand Peramivir’s use?
Yes, recent trials focus on pediatric populations, prophylaxis, and severe influenza cases, though no new Phase III trials have been announced as of 2023.

3. How does Peramivir compare to oral antivirals like Oseltamivir?
Peramivir’s IV formulation makes it suitable for hospitalized patients, whereas Oseltamivir’s oral route is preferred for outpatient management. Resistance profiles are comparable, with some indications of lower resistance in Peramivir.

4. What are the major barriers to Peramivir’s market expansion?
Limited indications outside hospitalized influenza, competition from oral agents, and regional regulatory hurdles are primary barriers.

5. What is the potential impact of new formulations on Peramivir's market?
Novel formulations like inhalable or long-acting versions could broaden use cases, improve compliance, and capture outpatient segments, potentially increasing market share.

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References

[1] BioCryst Pharmaceuticals. (2022). Peramivir drug profile.
[2] U.S. Food and Drug Administration. (2010). FDA approval letter for Peramivir.
[3] ClinicalTrials.gov. (Various entries for ongoing trials, accessed 2023).
[4] World Health Organization. (2022). Influenza surveillance and vaccination data.
[5] MarketWatch. (2023). Influenza antiviral drugs market analysis and projections.