NDAORALTABLETPriority Review
Approved
Aug 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
5/8 — 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. Approved for tardive dyskinesia, huntington disease. First approved in 2017.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUSTEDO (deutetrabenazine) is an oral tablet approved by the FDA in August 2017 for the treatment of Huntington's disease. It is a reversible monoamine depleter that works by inhibiting VMAT2, reducing the uptake of monoamines (dopamine, serotonin, norepinephrine, histamine) into synaptic vesicles and depleting monoamine stores in nerve terminals. The mechanism is believed to address the underlying pathophysiology of involuntary movements associated with Huntington's disease. AUSTEDO represents a deuterated reformulation of tetrabenazine, offering potential pharmacokinetic advantages.
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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 (2)
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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.