TheraRadar
Data updated: May 26, 2026

Arepanrix (influenza a (h5n1) virus monovalent vaccine, adjuvanted)

Approved 2013-11-21
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
12
Years on Market

Details

Status
Disc
First Approved
2013-11-21
Routes
Intramuscular
Dosage Forms
Injection

Companies

ID Biomedical Corporation of Quebec
Active Ingredient: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Arepanrix Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2013 to 2013
Nov 2013 ORIGINAL
Update · CBER biologic (Purple Book)

What Arepanrix Treats

1 FDA approvals

Originally approved for its first indication in 2013 .

  • Other (1)
📋

Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT01416571 results posted 112691 Ph 2 completed Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults
NCT00742885 results posted 111756 Ph 2 completed Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine
NCT00616928 results posted 110464 Ph 3 completed Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
NCT01002040 H09-02820 Ph 4 completed Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV
NCT01001026 H09-02769 Ph 4 completed Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

Arepanrix FDA Label Details

Track Arepanrix with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: BLA125419 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.