Deutetrabenazine

also known as SD-809 · Austedo

Developed for: Huntington disease · tardive dyskinesia · choreatic disease · dystonic disorder · Tourette syndrome
Investigated by: Auspex Pharmaceuticals, Inc. · Teva Branded Pharmaceutical Products R&D, Inc. · Fundacion Huntington Puerto Rico · Second Affiliated Hospital, School of Medicine, Zhejiang University · Teva Pharmaceuticals USA · University Hospitals Cleveland Medical Center
+2 more
· University of Pennsylvania · Vanderbilt University Medical Center

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	EU (EMA)	Austedo	—	2026-01-08	europa.eu ↗
Label expansion	US (FDA)	AUSTEDO	—	2021-06-24	fda.gov ↗
Approved	US (FDA)	AUSTEDO	—	2017-04-03	fda.gov ↗

Trials 12 · a red edge is where a trial was stopped

today

US approved 2017

EU approved 2026

NCT06997198 · Ph 4 NCT07601516 · Ph 4 NCT04301726 · Ph 1 NCT04713982 · Ph 2/3 NCT04173260 · Ph 1/2 NCT04071639 · Ph 1 NCT02291861 · Ph 3 NCT02198794 · Ph 3 NCT02674321 · Ph 1 NCT02195700 · Ph 2/3 NCT01897896 · Ph 3 NCT01795859 · Ph 3

201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 13 trials
Phase 1	NCT04301726	Jan 2022 → Aug 2023	Huntington disease	Fundacion Huntington Puerto Rico	Terminated	No outcome recorded
Phase 1	NCT04071639	Mar 2020 → Dec 2024	Huntington disease	Second Affiliated Hospital, School of Medicine, Zhejiang University	Unknown	No outcome recorded
Phase 1	NCT02674321	Jul 2014 → Jun 2015	Tourette syndrome	Auspex Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT04173260	Apr 2021 → Mar 2024	dystonic disorder	University of Pennsylvania	Completed	No outcome recorded
Phase 2/32 trials
Phase 2/3	NCT04713982	Nov 2021 → Jun 2026 overdue	Huntington disease	Vanderbilt University Medical Center	Active not recruiting	No outcome recorded
Phase 2/3	NCT02195700	Jun 2014 → May 2015	tardive dyskinesia	Auspex Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 34 trials
Phase 3	NCT02291861	Oct 2014 → Aug 2016	tardive dyskinesia	Auspex Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT02198794	Oct 2014 → Dec 2019	tardive dyskinesia	Auspex Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT01897896	Nov 2013 → Aug 2017	Huntington disease	Auspex Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT01795859	Aug 2013 → Dec 2014	choreatic disease	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	No outcome recorded
Phase 42 trials
Phase 4	NCT06997198	Jun 2026 → Oct 2027 expected	developmental disability, intellectual disability, tardive dyskinesia	University Hospitals Cleveland Medical Center	Recruiting	No outcome recorded
Phase 4	NCT07601516	Feb 2024 → Oct 2025	Huntington disease, choreatic disease	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	No outcome recorded

Press releases naming this drug 54 releases

Date	Issuer	Release
2026-06-08	Teva Branded Pharmaceutical Products R&D, Inc.	Teva’s Data on AUSTEDO® (deutetrabenazine) tablets and AUSTEDO XR® (deutetrabenazine) extended-release tablets Highlight Long-Term Advances in Tardive Dyskinesia Treatment and Care tevapharm.com ↗
2026-06-08	Teva Branded Pharmaceutical Products R&D, Inc.	Teva’s Data on AUSTEDO® (deutetrabenazine) tablets and AUSTEDO XR® (deutetrabenazine) extended-release tablets Highlight Long-Term Advances in Tardive Dyskinesia Treatment and Care tevapharm.com ↗
2026-06-05	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Presents New Data on AUSTEDO® (deutetrabenazine) tablets and AUSTEDO XR® (deutetrabenazine) extended-release tablets that Show Patient- and Caregiver-Reported Improvements in Huntington's Disease Chorea tevapharm.com ↗
2026-06-05	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Presents New Data on AUSTEDO® (deutetrabenazine) tablets and AUSTEDO XR® (deutetrabenazine) extended-release tablets that Show Patient- and Caregiver-Reported Improvements in Huntington's Disease Chorea tevapharm.com ↗
2025-11-07	Teva Branded Pharmaceutical Products R&D, Inc.	AUSTEDO® (deutetrabenazine) tablets and AUSTEDO XR® (deutetrabenazine) extended-release tablets Demonstrate Positive Real-world Impact, with Patients Reporting Improvement in Involuntary Movements and Activities of Daily Living tevapharm.com ↗
2025-11-07	Teva Branded Pharmaceutical Products R&D, Inc.	AUSTEDO® (deutetrabenazine) tablets and AUSTEDO XR® (deutetrabenazine) extended-release tablets Demonstrate Positive Real-world Impact, with Patients Reporting Improvement in Involuntary Movements and Activities of Daily Living tevapharm.com ↗
2025-11-05	Teva Branded Pharmaceutical Products R&D, Inc.	Teva's Innovative Portfolio Drives 11th Consecutive Quarter of Growth in Q3 2025; Increases 2025 Outlook for Austedo® and Non-GAAP EPS tevapharm.com ↗
2025-11-05	Teva Branded Pharmaceutical Products R&D, Inc.	Teva's Innovative Portfolio Drives 11th Consecutive Quarter of Growth in Q3 2025; Increases 2025 Outlook for Austedo® and Non-GAAP EPS tevapharm.com ↗
2025-09-21	Teva Branded Pharmaceutical Products R&D, Inc.	Patients Taking AUSTEDO XR® (deutetrabenazine) extended-release tablets Reported Symptom Improvement and High Satisfaction tevapharm.com ↗
2025-09-20	Teva Branded Pharmaceutical Products R&D, Inc.	Patients Taking AUSTEDO XR® (deutetrabenazine) extended-release tablets Reported Symptom Improvement and High Satisfaction tevapharm.com ↗
2024-09-23	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Long Term Efficacy and Safety of Deutetrabenazine in European Patients with Debilitating Movement Disorder Tardive Dyskinesia tevapharm.com ↗
2024-07-31	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Strong Growth in Second Quarter Revenues mainly driven by Generics Products in All Regions and AUSTEDO®; Raises 2024 Financial Guidance tevapharm.com ↗
2024-05-29	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets Now U.S. FDA Approved as a One Pill, Once-Daily Treatment Option for Clinically Therapeutic Doses (24–48 mg/day) tevapharm.com ↗
2024-04-16	Teva Branded Pharmaceutical Products R&D, Inc.	Teva’s New Real-World Evidence Presented at the 2024 AAN Annual Meeting Confirms Effectiveness and Patient Satisfaction for HD Chorea with the 4-week Titration Kit for AUSTEDO® (deutetrabenazine) Tablets tevapharm.com ↗
2024-02-26	Teva Branded Pharmaceutical Products R&D, Inc.	Teva and Jiangsu Nhwa Forge Strategic Partnership to Promote Patient Access to AUSTEDO® in China tevapharm.com ↗
2023-11-02	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present New Data Supporting Safety, Efficacy and Real-World Effectiveness of AUSTEDO® (deutetrabenazine) Tablets at the 2023 HSG Annual Meeting tevapharm.com ↗
2023-09-06	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present Data for AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, AUSTEDO® (deutetrabenazine) Tablets and UZEDY™ (risperidone) Extended-Release Injectable Suspension at Psych Congress 2023 tevapharm.com ↗
2023-06-02	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Presents Real-World Data for AUSTEDO® (deutetrabenazine) Tablets with 4-Week Patient Titration Kit at Psych Congress Elevate 2023 tevapharm.com ↗
2023-05-15	Teva Branded Pharmaceutical Products R&D, Inc.	AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, New Once-Daily Formulation of AUSTEDO®, Now Available in the U.S. tevapharm.com ↗
2023-04-11	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present New Data on Once-Daily AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets at the 2023 American Academy of Neurology Annual Meeting tevapharm.com ↗
2023-02-17	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces FDA Approval of AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, a New Once-Daily Formulation of AUSTEDO® (deutetrabenazine) Tablets tevapharm.com ↗
2022-10-18	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Results from 3-Year Study Assessing the Safety and Tolerability of AUSTEDO® (deutetrabenazine) Tablets for the Treatment of Chorea Associated with Huntington’s Disease tevapharm.com ↗
2022-06-09	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Settlement with Aurobindo Resolving AUSTEDO® (deutetrabenazine) Patent Dispute tevapharm.com ↗
2022-05-23	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Presents New Long-Term AUSTEDO® (deutetrabenazine) Tablets Data at 2022 American Psychiatric Association Annual Meeting tevapharm.com ↗
2022-05-02	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Settlement with Lupin Resolving AUSTEDO® (deutetrabenazine) Patent Dispute tevapharm.com ↗
2022-04-01	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present New Analyses of AJOVY® (fremanezumab-vfrm) Injection and AUSTEDO® (deutetrabenazine) Tablets at 2022 American Academy of Neurology Annual Meeting tevapharm.com ↗
2021-08-20	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Post Hoc Analysis of Long-Term Data Examining Treatment with AUSTEDO® (deutetrabenazine) Tablets in Adult Patients with Tardive Dyskinesia tevapharm.com ↗
2021-05-03	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present New Long-Term AUSTEDO® (deutetrabenazine) Tablets Data at American Psychiatric Association Annual Meeting tevapharm.com ↗
2021-04-27	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present New Analyses of AUSTEDO® (deutetrabenazine) Tablets and Assessment of Schizophrenia Clinical Outcomes at Upcoming 2021 American Psychiatric Association Annual Meeting tevapharm.com ↗
2021-04-15	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present New Analyses of AJOVY® (fremanezumab-vfrm) Injection and AUSTEDO® (deutetrabenazine) Tablets at Upcoming 2021 American Academy of Neurology Virtual Annual Meeting, Highlighting Teva’s Ongoing Commitment to Neurology tevapharm.com ↗
2020-09-14	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present New Data at The MDS Virtual Congress 2020 and Psych Congress 2020 Virtual Experience Evaluating Long-Term Treatment with AUSTEDO® (deutetrabenazine) Tablets tevapharm.com ↗
2020-09-08	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present New Data on AUSTEDO® (deutetrabenazine) Tablets at the MDS Virtual Congress 2020 and Psych Congress 2020 Virtual Experience tevapharm.com ↗
2020-05-18	Teva Branded Pharmaceutical Products R&D, Inc.	China Approves AUSTEDO® For Treating Chorea Associated with Huntington's Disease and Tardive Dyskinesia in Adults tevapharm.com ↗
2020-05-01	Teva Branded Pharmaceutical Products R&D, Inc.	New Data For Teva AJOVY® (fremanezumab-vfrm) Injection and AUSTEDO® (deutetrabenazine) Tablets Included in Neurology tevapharm.com ↗
2020-02-19	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Registration Trials of Deutetrabenazine in Pediatric Patients with Tourette Syndrome Did Not Meet the Primary Endpoint tevapharm.com ↗
2019-10-02	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present New Data on AUSTEDO® (deutetrabenazine) Tablets at Psych Congress 2019 tevapharm.com ↗
2018-05-02	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present AUSTEDO® (deutetrabenazine) Tablets Data at the American Psychiatric Association 2018 Annual Meeting tevapharm.com ↗
2017-09-19	Teva Branded Pharmaceutical Products R&D, Inc.	Teva and Nuvelution Pharma Partner to Accelerate Development of AUSTEDO® (deutetrabenazine) Tablets for Use in Tourette Syndrome in the United States tevapharm.com ↗
2017-09-14	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present Data for AUSTEDO® (deutetrabenazine) Tablets and Other Research at the 2017 Psych Congress tevapharm.com ↗
2017-08-30	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces FDA Approval of AUSTEDO® (deutetrabenazine) Tablets for the Treatment of Tardive Dyskinesia in Adults tevapharm.com ↗
2017-07-11	Teva Branded Pharmaceutical Products R&D, Inc.	Teva and the Huntington Study Group Announce Publication of Data for AUSTEDO™ (deutetrabenazine) Tablets in Huntington Disease from ARC-HD Study in JAMA Neurology tevapharm.com ↗
2017-06-29	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Publication of AIM-TD Study Results in The Lancet Psychiatry for the Investigational Use of Deutetrabenazine in Tardive Dyskinesia tevapharm.com ↗
2017-05-17	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present Data for Deutetrabenazine in Tardive Dyskinesia at the American Psychiatric Association 2017 Annual Meeting tevapharm.com ↗
2017-04-27	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Publication of ARM-TD Study Results in Neurology® for the Investigational Use of Deutetrabenazine in Tardive Dyskinesia tevapharm.com ↗
2017-04-03	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces FDA Approval of AUSTEDO™ (deutetrabenazine) Tablets for the Treatment of Chorea Associated with Huntington’s Disease tevapharm.com ↗
2017-02-28	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Priority Review Granted by FDA for SD-809 for Treatment of Tardive Dyskinesia tevapharm.com ↗
2016-10-20	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces FDA Acceptance of Resubmitted New Drug Application for SD-809 for Treatment of Chorea Associated with Huntington Disease tevapharm.com ↗
2016-09-22	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Positive Top-Line Data from Second Phase III Study of SD-809 in Tardive Dyskinesia (TD) tevapharm.com ↗
2016-07-05	Teva Branded Pharmaceutical Products R&D, Inc.	Teva and the Huntington Study Group Announce Publication of Pivotal Phase III Data on Deutetrabenazine (SD-809) in Huntington Disease from First-HD Trial in JAMA tevapharm.com ↗
2016-06-20	Teva Branded Pharmaceutical Products R&D, Inc.	Teva to Present Data Highlighting SD-809 at 20th International Congress of Parkinson’s Disease and Movement Disorders tevapharm.com ↗
2016-05-31	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Receives Complete Response Letter for NDA for SD-809 for the Treatment of Chorea Associated with Huntington Disease tevapharm.com ↗
2016-04-18	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Presents New Data for SD-809 in Huntington Disease at 68th American Academy of Neurology (AAN) Annual Meeting in Vancouver, B.C. tevapharm.com ↗
2015-11-09	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Breakthrough Therapy Designation for SD-809 Granted by FDA for the Treatment of Tardive Dyskinesia tevapharm.com ↗
2015-08-12	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces FDA Acceptance of NDA for SD-809 for Treatment in Huntington Disease tevapharm.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 12 sources stand behind the page.

Field	Value	Cited text
Known as	Deutetrabenazine	“A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS)” NCT02674321 ↗ 6 NCT04071639 ↗ NCT04713982 ↗ NCT04301726 ↗ NCT07601516 ↗ NCT06997198 ↗ NCT04173260 ↗
Known as	Austedo	“Deutetrabenazine Oral Tablet [Austedo]” NCT04071639 ↗
Known as	SD-809	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02195700 ↗ 5 NCT02198794 ↗ NCT02674321 ↗ NCT01795859 ↗ NCT01897896 ↗ NCT02291861 ↗
Action	Inhibit	“Deutetrabenazine, a selective vesicular monoamine transporter 2 inhibitor” NCT06997198 ↗
Route	Oral	“Participants will receive SD-809 orally twice daily (BID)” NCT02198794 ↗