NDAORALTABLETPriority Review
Approved
Aug 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
4/8 — Partial
Priority Review
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 7h ago · AI intelligence enriched 13h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUSTEDO (deutetrabenazine) is an oral small-molecule monoamine depleter approved for Huntington's disease, a rare neurodegenerative disorder characterized by involuntary choreic movements. It works by inhibiting VMAT2, reducing synaptic uptake and depleting monoamines (dopamine, serotonin, norepinephrine, histamine) from nerve terminals. The drug represents the first deuterated therapeutic approved by the FDA, incorporating deuterium chemistry for improved pharmacokinetics.
$1.1BPart D
PeakStable
Peak lifecycle stage with $1.1B in Part D spending indicates a mature, well-established commercial franchise supporting mid-sized field and marketing teams.
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 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.