DEUTETRABENAZINE · Aurobindo Pharma
DEUTETRABENAZINE is FDA-approved to treat 3 conditions (same as AUSTEDO XR).
Details
- Status
- Prescription
- First Approved
- 2017-04-03
- Routes
- ORAL
- Dosage Forms
- TABLET
DEUTETRABENAZINE Approval History
What DEUTETRABENAZINE Treats
3 indicationsDEUTETRABENAZINE is approved for 3 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chorea
- Huntington's Disease
- Tardive Dyskinesia
Same approved indications as AUSTEDO XR (same active ingredient).
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04713982 | 200069 | Ph 2, Ph 3 | active not recruiting | Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease |
| NCT07601516 results posted | TV50717-NDG-40182 | Ph 4 | completed | Real World Effectiveness and Safety of Deutetrabenazine in Adult Chinese Participants With Huntington's Disease (HD) Chorea in China |
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.
DEUTETRABENAZINE FDA Label Details
Indications & Usage
DEUTETRABENAZINE is FDA-approved to treat 3 conditions — same approved indications as AUSTEDO XR.
Looking for the branded version?
AUSTEDO XR
Full clinical data, patents, trials, and competitive landscape for deutetrabenazine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.