RELENZA (zanamivir)
Relenza is an inhaled antiviral medication used to manage influenza A and B infections in adults and children. It helps patients aged 7 and older who have recently developed flu symptoms, and it is also used to prevent the flu in those aged 5 and older. Because of the risk of breathing complications, this medication is not recommended for people with chronic respiratory conditions like asthma or COPD. It serves as an additional tool for flu management but does not replace the need for an annual flu vaccine.
How RELENZA Works
This medication works by inhibiting neuraminidase, an enzyme essential for the influenza virus. By blocking this protein, the drug interferes with the virus's ability to spread to other cells. This antiviral action helps control the infection or prevents it from taking hold in the first place.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1999-07-26
- Routes
- INHALATION
- Dosage Forms
- POWDER
RELENZA Approval History
What RELENZA Treats
1 indicationsRELENZA is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Influenza
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Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05648448 AD ASTRA | VIR22003 | Ph 2 | recruiting | A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza |
| NCT04597437 ZAP-DENGUE | NCR203024 | Ph 2 | recruiting | Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE) |
| NCT04867707 NAED results posted | 2038203 | Ph 2 | completed | Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes |
| NCT04494412 | 200925 | Ph 2 | recruiting | An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection |
| NCT01231620 ZORO results posted | 114373 | Ph 3 | completed | A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza |
| NCT00989404 NAI113625 | 113625 | Ph 1 | completed | Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo Via Devices Administered Twice Daily for 5 Days |
| NCT02377401 | 117104 | Ph 1 | completed | Pharmacokinetics of Zanamivir After Single and Repeated Dose Infusion Administration in Healthy Chinese Adults |
| NCT00784784 Stop-Flu-2 results posted | 08-0189-A CRT113936 | Ph 3 | completed | Zanamivir Versus Trivalent Split Virus Influenza Vaccine |
| NCT01459081 | SIM-100 | Ph 3 | completed | Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China |
| NCT00979667 | CCT2009-CS-6 | Ph 3 | terminated | A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection |
| NCT00921726 | SEA 003 | Ph 1 | completed | Pharmacokinetic Study of Oseltamivir and Intravenous Zanamivir in Healthy Adults |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RELENZA FDA Label Details
Indications & Usage
FDA Label (PDF)RELENZA is indicated for the treatment of Influenza.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment