Objective: Assess real-world effectiveness and safety of deutetrabenazine (DTBZ) in Chinese adults with tardive dyskinesia (TD).

Background: TD is a movement disorder associated with prolonged dopamine receptor antagonist use [1]. DTBZ, a vesicular monoamine transporter 2 inhibitor, is an approved TD treatment [2,3], but real-world evidence in Chinese populations is limited.

Method: This was a multicenter, prospective, observational Phase 4 study (TV50717-CNS-40183) conducted in China. DTBZ-naïve adults with TD and baseline Abnormal Involuntary Movement Scale (AIMS) score ≥6 were enrolled. Physician-directed titration was followed by a maintenance period. Visits occurred monthly through Week 16. The primary endpoint was AIMS score change (baseline–Week 16 in patients receiving DTBZ ≥24 mg/day for ≥6 weeks). Secondary endpoints included AIMS score change and safety in all patients. Analyses used descriptive statistics, paired t-tests, and linear mixed models.

Results: Fifty patients were enrolled; 49 had ≥1 post-baseline AIMS score (effectiveness set) and 50 comprised the safety set. Forty patients (80%) completed Week 16: 27 received DTBZ ≥24 mg/day and 13 <24 mg/day. Mean (SD) age was 53.5 (15.5) years; 34.7% were male. Most common psychiatric diagnoses were schizophrenia (51.0%) and bipolar disorder (14.3%). Mean (SD) treatment duration was 15.7 (1.8), 12.8 (5.2), and 14.5 (3.8) weeks in the ≥24 mg/day, <24 mg/day, and overall groups, respectively. Mean AIMS score change was −6.50 (95% CI: −8.18, −4.82; P<0.0001; −60.1% [SD: 24.4%]) with DTBZ ≥24 mg/day (n=24) and −3.69 (95% CI: −4.78, −2.61; P<0.0001; −42.2% [SD: 20.6%]) with DTBZ <24 mg/day (n=13). For all patients (n=37), mean AIMS score change was −5.51 (95% CI: −6.72, −4.31; P<0.0001; −53.8% [SD: 24.4%]). Overall, 25 (50.0%) patients reported 56 adverse events (AEs); 12 (24.0%) had 20 treatment-related AEs. AEs occurred in 36.0% and 31.4% of patients during titration and maintenance. Five patients (10.0%) experienced 5 serious AEs (SAEs) with only 1 SAE (depression) considered treatment related. Three patients withdrew due to AEs.

Conclusion: In this first prospective, multicenter Chinese real-world study, DTBZ produced clinically meaningful symptom improvement with a favorable safety profile consistent with clinical trials. Numerically greater improvement with DTBZ ≥24 mg/day supports potential dose optimization in practice.

References: Additional Authors
Shimin Bi: Beijing Analysis International Consulting Co., Ltd., Beijing, China
Gang Wang: Beijing Anding Hospital, Capital Medical University, Beijing, China

Previous presentation:
Presented at the 8th Annual Schizophrenia International Research Society Conference, March 25–29, 2026 in Florence, Italy.

1. Carbon M, et al. Tardive dyskinesia risk with first- and second-generation antipsychotics in comparative randomized controlled trials: a meta-analysis. World Psychiatry. 2018;17(3):330–40.

2. China Approves AUSTEDO® For Treating Chorea Associated with Huntington’s Disease and Tardive Dyskinesia in Adults. Updated May 18, 2020. Accessed February 25, 2026. https://www.tevapharm.com/news-and-media/latest-news/china-approves-austedo-for-treating-chorea-associated-with-huntingtons-disease-and-tardive-dyskinesia

AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine)
tablets. Prescribing information. Teva Neuroscience, Inc.; 2025.

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