TheraRadar
Data updated: May 26, 2026

Ixiaro (japanese encephalitis vaccine, inactivated, adsorbed)

Approved 2009-03-29
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2009-03-29
Patent Cliff
2020

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Patent cliff and revenue data

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Routes
Intramuscular
Dosage Forms
Injection

Companies

Valneva Austria GmbH
Active Ingredient: Japanese Encephalitis Vaccine, Inactivated, Adsorbed

Ixiaro Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2009 to 2009
Mar 2009 ORIGINAL
Update · CBER biologic (Purple Book)

What Ixiaro Treats

1 FDA approvals

Originally approved for its first indication in 2009 .

  • Other (1)
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Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT06680128 GBP560_001 Ph 1, Ph 2 recruiting A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy Adults
NCT02963909 16-0062 Ph 1 completed A Phase 1, First-in-human, Double-blinded, Randomized, Placebo-controlled Trial of a Zika Virus Purified Inactivated Vaccine (ZPIV) With Alum Adjuvant in Healthy Flavivirus-naive and Flavivirus-Primed Subjects.
NCT01398540 IX-sensesc 1.2 Ph 4 completed Cellular and Humoral Immunity in Elderly After Immunization With a Japanese Encephalitis Vaccine
NCT01296360 results posted IC51-325 Ph 3 completed Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country
NCT01559831 IC51-319 Ph 1 withdrawn Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

Ixiaro FDA Label Details

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Data Sources

FDA Approval: BLA125280 → Trials: ClinicalTrials.gov →

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