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deutetrabenazine

Generic: DEUTETRABENAZINE·Brand: AUSTEDO, AUSTEDO XR, DEUTETRABENAZINE

deutetrabenazine: developed by 1 company · 2 clinical trials tracked · 2 FDA decisions.

deutetrabenazine evidence translation

What we can confirm

2 FDA records · 2 tracked trials

What it means

Source-backed records connect deutetrabenazine to TEVA; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could deutetrabenazine → TEVA affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 0 study sponsors

Related indications

Huntington's DiseaseIntellectual DisabilityTardive Dyskinesia

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (2)
CompanyPhase
Teva Pharmaceutical Industries Limited (TEVA)Approved
Teva Pharmaceutical Industries Limited (TEVA)
Huntington's Disease
Phase 4
Clinical Trials (2)

Identification, Assessment, and Treatment of Tardive Dyskinesia With Deutetrabenazine in Adults With Intellectual/Developmental Disabilities and Co-occurring Psychiatric and/or Behavioral Disorders

NCT06997198·Phase 4
Recruiting

Primary endpoint: Change in AIMS total scores of items 1-7

Interventionalopen25 targetStarted 2026-06Completion 2027-101 site · United StatesUniversity Hospitals Cleveland Medical Center

Real-World Effectiveness and Safety of Deutetrabenazine in Chinese Patients With Chorea Associated With Huntington's Disease.

NCT07601516·Phase 4·TEVA
Completed

Primary endpoint: Change From Baseline in TMC Score in Participants Receiving ≥24 mg/Day

Interventionalopen50 enrolledStarted 2024-02Completion 2025-103 sites · ChinaTeva Branded Pharmaceutical Products R&D LLC
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE AUSTEDO XR ® and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease [see Clinical Studies ( 14.1 )] tardive dyskinesia [see Clinical Studies ( 14.2 )] AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease ( 1 ) Tardive dyskinesia ( 1 )(TEVA)FDA ↗
NDA216354Type 3 - New Dosage FormOrphan DrugStandardOralTablet, Extended Release
Approval1 INDICATIONS AND USAGE AUSTEDO XR ® and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease [see Clinical Studies ( 14.1 )] tardive dyskinesia [see Clinical Studies ( 14.2 )] AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease ( 1 ) Tardive dyskinesia ( 1 )(TEVA)FDA ↗
NDA208082Type 1 - New Molecular EntityOrphan DrugStandardOralTablet

Frequently asked questions

Who is developing deutetrabenazine?

deutetrabenazine is being developed by Teva Pharmaceutical Industries Limited.

How many clinical trials involve deutetrabenazine?

BioSniper tracks 2 clinical trials involving deutetrabenazine.

What is deutetrabenazine's latest FDA decision?

The most recent tracked FDA decision for deutetrabenazine is Approval for 1 INDICATIONS AND USAGE AUSTEDO XR ® and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease [see Clinical Studies ( 14.1 )] tardive dyskinesia [see Clinical Studies ( 14.2 )] AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease ( 1 ) Tardive dyskinesia ( 1 ), dated February 17, 2023.