AUSTEDO

Peak

deutetrabenazine

NDAORALTABLETPriority Review
Approved
Aug 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
7

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…

Clinical Trials (5)

NCT06997198Phase 4Not Yet Recruiting

Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities

Started Mar 2026
25 enrolled
Tardive DyskinesiaIntellectual DisabilityDevelopmental Disabilities
NCT04713982Phase 2/3Active Not Recruiting

Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease

Started Nov 2021
30 enrolled
Huntington Disease
NCT04173260Phase 1/2Completed

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
NCT03813238Phase 3Completed

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
NCT03567291Phase 3Terminated

Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents

Started May 2018
228 enrolled
Tourette Syndrome