NDAORALTABLET, EXTENDED RELEASE
Approved
Feb 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
7/8 — Comprehensive
AUSTEDO XR (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 huntington disease, tardive dyskinesia. First approved in 2023.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUSTEDO XR (deutetrabenazine) is an extended-release oral small molecule approved by FDA on February 17, 2023, for treatment of tardive dyskinesia, Huntington's disease, dystonia, and intellectual/developmental disability-associated movement disorders. The drug functions as a reversible VMAT2 inhibitor, depleting monoamine neurotransmitters (dopamine, serotonin, norepinephrine, histamine) from nerve terminals. This mechanism addresses hyperkinetic movement disorders by reducing excessive dopaminergic signaling. AUSTEDO XR represents the first extended-release formulation in the tetrabenazine class, offering potential dosing convenience advantages over immediate-release alternatives.
$0.1BPart D
15.1 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.