Chemically, deutetrabenazine is anisotopic isomer oftetrabenazine in which six hydrogen atoms have been replaced bydeuterium atoms. The incorporation of deuterium slows the rate ofdrug metabolism, allowing less frequent dosing.[5][6]
A study published in June 2017 carried out a review between October 2014 and August 2016 where 298 participants were randomly assigned to receive at least one of the following: one dose of placebo per day, one dose of deutetrabenazine 12 mg/day, one dose of deutetrabenazine 24 mg/day, or one dose of deutetrabenazine 36 mg/day.[7]
From baseline to week 12, the least-squares mean AIMS (Abnormal Involuntary Movement Scale) score improved by −3.3 points in the deutetrabenazine 36 mg/day group, −3.2 points in the 24 mg/day group, −2.1 points in the 12 mg/day group, and −1.4 points in the placebo group. Deutetrabenazine 24 mg/day and 36 mg/day provided a significant reduction in tardive dyskinesia, with favourable safety and tolerability. These findings suggest that dosing regimens could be individualized and tailored for patients on the basis of dyskinesia control and tolerability.[8]
In June 2025, theCommittee for Medicinal Products for Human Use of theEuropean Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Austedo, intended for the treatment of adults with moderate to severe tardive dyskinesia.[14] The applicant for this medicinal product is TEVA GmbH.[14]
^Anderson KE, Stamler D, Davis MD, Factor SA, Hauser RA, Isojärvi J, et al. (August 2017). "Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial".The Lancet. Psychiatry.4 (8):595–604.doi:10.1016/S2215-0366(17)30236-5.PMID28668671.
^ab"Austedo EPAR".European Medicines Agency (EMA). 20 June 2025. Retrieved26 June 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
