NDAORALTABLET
Approved
Apr 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
6/8 — Strong
AUSTEDO (deutetrabenazine) by Teva is huntington's disease is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. First approved in 2017.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUSTEDO (deutetrabenazine) is an oral small-molecule therapeutic approved in 2017 for Huntington's disease, a rare neurological disorder characterized by involuntary movements. It works as a reversible monoamine depleter via VMAT2 inhibition, reducing dopamine and other neurotransmitters in synaptic vesicles to suppress chorea symptoms. The drug represents the first FDA-approved treatment specifically targeting the involuntary movements associated with this genetic disease.
$1.1BPart D
Peak12.2 years to LOEThe product is in peak commercial phase with stable revenue and large claims volume, indicating a mature team focused on maximizing penetration in the Huntington's disease market.
Mechanism of Action
Huntington's disease is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (α-dihydrotetrabenazine [HTBZ] and β-HTBZ) of deutetrabenazine, are…
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 May 2026
25 enrolled
Tardive DyskinesiaIntellectual DisabilityDevelopmental Disabilities
Real World Effectiveness and Safety of Deutetrabenazine in Adult Chinese Patients 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.