NDAORALTABLET, EXTENDED RELEASE
Approved
Feb 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
5/8 — Partial
Drug data last refreshed 12h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUSTEDO XR (deutetrabenazine) is an oral extended-release small molecule approved in February 2023 for the treatment of involuntary movement disorders, specifically tardive dyskinesia and chorea associated with Huntington's disease. It is a vesicular monoamine transporter 2 (VMAT2) inhibitor that reduces the release of monoamines in the central nervous system. The extended-release formulation enables once-daily dosing, improving patient convenience and adherence compared to immediate-release alternatives.
$91MPart D
Peak14.6 years to LOEThe product is in peak commercial phase with $91M in annual spending and modest claim volume, indicating a stable niche market with focused sales and marketing team investment.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
Started Jun 2026
25 enrolled
Tardive DyskinesiaIntellectual DisabilityDevelopmental Disabilities
Real World Effectiveness and Safety of Deutetrabenazine in Adult Chinese Participants With Huntington's Disease (HD) Chorea in China
Started Feb 2024
50 enrolled
Huntington's DiseaseChorea
Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease
Started Nov 2021
30 enrolled
Huntington Disease
An Open-label Study to Define the Safety, Tolerability and Clinical Activity of Deutetrabenazine (AUstedo) in Adult Study Subjects With DYsTonia
Started Apr 2021
15 enrolled
Dystonia, Primary
A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
Started Aug 2019
63 enrolled
Cerebral Palsy, Dyskinetic
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.