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Drug

Deutetrabenazine

Approved medicine
ClassSynaptic vesicular amine transporter inhibitorResearchOngoing clinical research
Also known as Austedo, D6 tetrabenazine, D6-tetrabenazine, Tetrabenazine D6+1 more

Austedo, D6 tetrabenazine, D6-tetrabenazine, Tetrabenazine D6, Tetrabenazine-D6.

RxNorm1876905ChEMBLCHEMBL3137326ATCN07XX16UNIIP341G6W9NB
2
Active clinical trials
SLC18A2
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Identification, Assessment, and Treatment of Tardive Dyskinesia With Deutetrabenazine in Adults With Intellectual/Developmental Disabilities and Co-occurring Psychiatric and/or Behavioral Disorders

Clinical trial2026-07-06Results expected Q4 2027 · ClinicalTrials.gov

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

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Approval: Austedo (EMA)

Regulatory2026-01-08EMA

Real World Effectiveness and Safety of Deutetrabenazine in Chinese Patients With Huntington's Disease (HD) Chorea

Clinical trial2025-10-24Completed · ClinicalTrials.gov

Non-randomized Control Clinical Trial to Evaluate the Efficacy and Safety of Symptomatic Drug Therapy for Mild to Moderate Huntington's Disease Patients

Clinical trial2024-12-31Primary completion · ClinicalTrials.gov

The AUDYT Trial: An Open-label Study to Define the Safety, Tolerability and Clinical Activity of Deutetrabenazine (AUstedo) in Adult Study Subjects With DYsTonia

Clinical trial2024-09-20Results posted · ClinicalTrials.gov

Efficacy of Deutetrabenazine in Huntington's Disease Patients with Dysphagia: a Randomised, Placebo-controlled Pilot Study

Clinical trial2023-09-01Terminated · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Deutetrabenazine
Aliases & brands
AustedoD6 tetrabenazineD6-tetrabenazineTetrabenazine D6Tetrabenazine-D6
RxNorm CUI
1876905
ChEMBL ID
CHEMBL3137326
ATC codes
N07XX16
UNII
P341G6W9NB
Primary mechanism
Synaptic vesicular amine transporter inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Synaptic vesicular amine transporter
SLC18A2 · Q05940
INHIBITORSynaptic vesicular amine transporter inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2026-01-08
Latest approval
2026-01-08
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2026-01-08Approval
Approval: Austedo (EMA)

Indication: Treatment of moderate to severe tardive dyskinesia in adults.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

6 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
6
registered trials across all phases
LATEST COMPLETION 2025
2
Active studies
1
Recruiting
3
Late-stage (III+)
2
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 6
Phase 12Phase 1 / 21Phase 2 / 31Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Identification, Assessment, and Treatment of Tardive Dyskinesia With Deutetrabenazine in Adults With Intellectual/Developmental Disabilities and Co-occurring Psychiatric and/or Behavioral Disorders

RecruitingPH IVUniversity Hospitals Cleveland Medical Centern=252027

Real World Effectiveness and Safety of Deutetrabenazine in Chinese Patients With Huntington's Disease (HD) Chorea

CompletedPH IVTeva Branded Pharmaceutical Products R&D LLCn=502025

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

Active, not recruitingPH II/IIIVanderbilt University Medical Centern=302026

Recent completions

Trials that read out recently, adding to the completed evidence base.

Real World Effectiveness and Safety of Deutetrabenazine in Chinese Patients With Huntington's Disease (HD) Chorea

CompletedPH IVTeva Branded Pharmaceutical Products R&D LLCn=502025

The AUDYT Trial: An Open-label Study to Define the Safety, Tolerability and Clinical Activity of Deutetrabenazine (AUstedo) in Adult Study Subjects With DYsTonia

CompletedPH I/IIUniversity of Pennsylvanian=152024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.