NDAORALTABLET
Approved
Apr 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
7/8 — Comprehensive
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 21h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUSTEDO (deutetrabenazine) is an oral tablet approved in April 2017 for Huntington's disease, a rare neurodegenerative disorder. The drug works as a reversible monoamine depleter, inhibiting VMAT2 to decrease dopamine, serotonin, norepinephrine, and histamine uptake into synaptic vesicles. This mechanism reduces the involuntary movements (chorea) associated with Huntington's disease. AUSTEDO represents the standard therapeutic approach for symptomatic chorea management in this serious neurological indication.
$1.1BPart D
12.4 years to LOEMechanism 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.