NDAINHALATIONPOWDERPriority Review
Approved
Jul 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
17
Data completeness
5/8 — Partial
Priority Review
RELENZA (zanamivir) by GSK is neuraminidase inhibitors [moa]. Approved for neuraminidase inhibitor [epc]. First approved in 1999.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RELENZA (zanamivir) is an inhaled powder neuraminidase inhibitor approved in 1999 for treatment of influenza A and B. It works by blocking viral neuraminidase, preventing viral release from infected cells and reducing symptom duration. The drug is administered via oral inhalation and is indicated for both treatment and prophylaxis of seasonal influenza.
$0.013BPart D
LOE ApproachingDeclining
Mature product in decline with minimal Part D utilization; commercial team likely focused on defending market share against generic zanamivir and alternative antivirals.
Mechanism of Action
Neuraminidase Inhibitors
Pharmacologic Class:
Neuraminidase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (17)
An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection
Started Nov 2022
12 enrolled
Influenza, HumanArthralgia
Pharmacokinetics of Zanamivir After Single and Repeated Dose Infusion Administration in Healthy Chinese Adults
Started Apr 2015
24 enrolled
Influenza, Human
A Study of Intravenous Zanamivir in the Treatment of Hospitalized Patients With Influenza Infection
Started Jan 2012
21 enrolled
Influenza, Human
Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study
Started Jul 2011
113 enrolled
Infections, Respiratory Tract
Safety of Inhaled Zanamivir in Pregnancy
Started Jul 2011
1 enrolled
Influenza, Human
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.