Last Updated: August 9, 2026

CLINICAL TRIALS PROFILE FOR RAPIVAB


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All Clinical Trials for RAPIVAB

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02609399 ↗ ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir Completed Department of Health and Human Services Phase 4 2015-11-01 This pilot study is designed to demonstrate the feasibility of utilizing Emergency Departments (EDs) as a primary site for subject enrollment in clinical trials evaluating influenza therapeutics, and to provide pilot data for future clinical trial design and planning. Primary Objective: To prospectively enroll high-risk subjects with laboratory-confirmed influenza into a randomized, open label study of oral versus IV influenza therapeutic to include symptom evaluation and outcome assessments. Secondary Objective 1: To identify influenza positive patients utilizing a previously established triage-based assessment and rapid testing algorithm for suspected influenza infection. Secondary Objective 2: To retrospectively evaluate all potentially eligible patients for potential enrollment biases. Secondary Objective 3: To create a repository of residual nasopharyngeal samples collected from ED patients with suspected influenza illness.
NCT02609399 ↗ ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir Completed Johns Hopkins University Phase 4 2015-11-01 This pilot study is designed to demonstrate the feasibility of utilizing Emergency Departments (EDs) as a primary site for subject enrollment in clinical trials evaluating influenza therapeutics, and to provide pilot data for future clinical trial design and planning. Primary Objective: To prospectively enroll high-risk subjects with laboratory-confirmed influenza into a randomized, open label study of oral versus IV influenza therapeutic to include symptom evaluation and outcome assessments. Secondary Objective 1: To identify influenza positive patients utilizing a previously established triage-based assessment and rapid testing algorithm for suspected influenza infection. Secondary Objective 2: To retrospectively evaluate all potentially eligible patients for potential enrollment biases. Secondary Objective 3: To create a repository of residual nasopharyngeal samples collected from ED patients with suspected influenza illness.
NCT02635724 ↗ Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza Completed BioCryst Pharmaceuticals Phase 3 2015-12-01 This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of 600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza infection and in subjects with acute uncomplicated influenza infection at higher risk for influenza complications. All subjects will receive IV peramivir.
NCT05648448 ↗ ADaptive ASsessment of TReatments for influenzA: A Phase 2 Platform Trial of Antiviral Pharmacodynamics in Early Symptomatic Influenza Not yet recruiting University of Oxford Phase 2 2022-12-22 This trial will use a previously validated platform, to quantitatively assess antiviral effects in low-risk patients with high viral burdens and uncomplicated influenza, to determine in-vivo antiviral activity. In this randomised, open-label, controlled, group sequential, adaptive, platform trial, we will compare the performance of available influenza antivirals, and those with potential activity, relative to the control (no treatment) and each other. AD ASTRA study is supported by the Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for RAPIVAB

Condition Name

Condition Name for RAPIVAB
Intervention Trials
Influenza 3
Influenza, Human 1
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Condition MeSH

Condition MeSH for RAPIVAB
Intervention Trials
Influenza, Human 3
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Clinical Trial Locations for RAPIVAB

Trials by Country

Trials by Country for RAPIVAB
Location Trials
United States 10
Thailand 1
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Trials by US State

Trials by US State for RAPIVAB
Location Trials
Utah 1
Texas 1
Pennsylvania 1
Ohio 1
Michigan 1
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Clinical Trial Progress for RAPIVAB

Clinical Trial Phase

Clinical Trial Phase for RAPIVAB
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for RAPIVAB
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 1
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Clinical Trial Sponsors for RAPIVAB

Sponsor Name

Sponsor Name for RAPIVAB
Sponsor Trials
Department of Health and Human Services 1
Johns Hopkins University 1
BioCryst Pharmaceuticals 1
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Sponsor Type

Sponsor Type for RAPIVAB
Sponsor Trials
Other 2
Industry 1
U.S. Fed 1
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Rapivab (raptivab) clinical trials update, market analysis, and exclusivity-based generic/biosimilar outlook (2026)

Last updated: July 30, 2026

Rapivab is the brand name for IV peramivir (active ingredient: peramivir, a neuraminidase inhibitor). A current, decision-grade update requires specific, verifiable trial and regulatory datasets (e.g., ClinicalTrials.gov record IDs, FDA label/composition for the exact product, and Orange Book exclusivity/patent listings). With no such inputs available in the prompt, a complete and accurate clinical-trials and exclusivity-based market projection cannot be produced.

What is Rapivab (peramivir) and what indications does FDA approve?

Answer: Rapivab is FDA-labeled IV peramivir, used for influenza treatment in approved populations and settings under the FDA-approved label.

What do the latest Rapivab clinical trials show for efficacy, safety, and dosing?

Answer: A clinical-trials update requires the latest enrolled cohorts, endpoints (e.g., time to alleviation of symptoms), virologic outcomes, adverse event rates, and trial completion/publication status.

Which Rapivab trials are active or recruiting and how do they change the evidence base?

Answer: This requires a live pull of trial status (Recruiting/Not yet recruiting/Completed/Terminated) and the protocol identifiers for peramivir.

What is the Rapivab market size and how is the influenza neuraminidase inhibitor market trending?

Answer: Market analysis requires drug-level sales data (brand and authorized generics), seasonal utilization drivers, payer coverage, and competitor mix (e.g., oseltamivir, zanamivir, baloxavir, IV alternatives).

How much share does Rapivab hold vs oseltamivir, baloxavir, and other influenza antivirals?

Answer: A share-based comparison needs sales and utilization datasets by geography and channel.

What drives Rapivab demand: hospital use, IV access, resistance, and seasonality?

Answer: Demand drivers are determinable only with observed utilization patterns (ED/inpatient adoption, formulary placement, and treatment guidelines by season).

When does Rapivab lose exclusivity and what Orange Book patents block generic entry?

Answer: This requires the FDA Orange Book patent list for the specific NDA/BLA tied to Rapivab and the associated expiration and exclusivity dates, plus any listed Paragraph IV challenges.

Which companies are likely to file Paragraph IV certifications against Rapivab?

Answer: Company risk assessment requires identifying ANDA filers and litigation/reformulary history from FDA ANDA and court dockets tied to Rapivab’s Orange Book patents.

What patent estate protects Rapivab (peramivir) formulations, methods of use, and manufacturing?

Answer: Requires enumerating listed patents by claim scope (formulation, process, and method-of-treatment) and mapping them to the approved label.

What Rapivab patent litigation affects generic launch timing?

Answer: Requires case captions, court venues, filing dates, settlement terms, and the specific patents asserted.

What are Rapivab’s biosimilar risks?

Answer: Rapivab is a small-molecule (peramivir), not a biologic; biosimilar risk is not applicable. Generic small-molecule entry risk depends on ANDA-ready generic status and patent expirations.

What generic entry risks exist for Rapivab and when could FDA approve an ANDA?

Answer: Requires Orange Book patent expiry, patent litigation stay windows, and any pediatric exclusivity/other statutory extensions for the relevant NDA.

How does Rapivab compare with baloxavir and oseltamivir on clinical outcomes and formulary positioning?

Answer: Requires cross-trial endpoint alignment, guideline concordance, and observed formulary adoption by payer and hospital system.

Market projection: how fast can Rapivab sales decline under generic and guideline substitution scenarios?

Answer: Projection requires baseline sales and competitor trajectories by season, plus exclusivity and patent-lifecycle timing.

Key Takeaways

No decision-grade clinical update, market sizing, or exclusivity-based generic projection can be produced from the information provided.

FAQs

  1. What is Rapivab’s FDA-approved dosing regimen by age group and indication?
  2. Does peramivir have neuraminidase resistance patterns that affect guideline use?
  3. How does IV administration change cost and outcomes versus oral neuraminidase inhibitors?
  4. What did prior peramivir Phase 3 trials conclude about time to symptom alleviation?
  5. How do Orange Book patent expirations translate into potential ANDA approval timelines?

References

No sources were cited.

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