TheraRadar
Data updated: May 26, 2026

Vaxchora (cholera vaccine, live, oral)

Approved 2016-06-09
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2016-06-09
Routes
Oral
Dosage Forms
Suspension

Companies

Bavarian Nordic
Active Ingredient: Cholera Vaccine, Live, Oral , Cholera Vaccine, Live, Oral , Cholera Vaccine, Live, Oral

Vaxchora Approval History

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

What Vaxchora Treats

1 FDA approvals

Originally approved for its first indication in 2016 .

  • Other (1)
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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT03251495 results posted IRB00097012 R01AI137127 Ph 2 completed Immunologic Responses to a Live Attenuated Oral Cholera Vaccine
NCT03705585 HP-00081568 Ph 4 recruiting CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
NCT03724357 results posted HP-00082377 Ph 4 terminated Blood Donor CVD 9000
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

Vaxchora FDA Label Details

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Data Sources

FDA Approval: BLA125597 → Trials: ClinicalTrials.gov →

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