Drugs / Deutetrabenazine
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Huntington disease 3 milestones | |||||
| Filed | US (FDA) | — | Huntington disease | 2016-10-20 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for SD-809 (deutetrabenazine)” tevapharm.com ↗ |
| Rejected (CRL) | US (FDA) | — | Huntington disease | 2016-05-31 | “today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for SD-809” tevapharm.com ↗ |
| Filed | US (FDA) | — | Huntington disease | 2015-08-12 | “today announced that the New Drug Application (NDA) for SD-809 (deutetrabenazine) has been accepted by the U.S. Food and Drug Administration (FDA)” tevapharm.com ↗ |
| Filed tardive dyskinesia 1 milestone | |||||
| Filed | US (FDA) | — | tardive dyskinesia | 2017-02-28 | “today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for SD-809 (deutetrabenazine) for the...” tevapharm.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| Phase 34 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT02291861 | Oct 2014 → Aug 2016 | tardive dyskinesia | Auspex Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT02198794 | Oct 2014 → Dec 2019 | tardive dyskinesia | Auspex Pharmaceuticals, Inc. | Completed | Missed primary |
| 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 | Met primary |
| 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 |
News releases announcing trial results or a regulatory action · 34
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Teva Study Identifies the Attributes that Healthcare Providers Prioritize when Selecting a Treatment for Tardive Dyskinesia in Older Patients tevapharm.com ↗
Across all four patient profiles, AUSTEDO® (deutetrabenazine) was most closely related to the attributes most valued by healthcare providers |
| 2026-06-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
New analysis from the IMPACT-TD Registry demonstrates that treatment with AUSTEDO and AUSTEDO XR led to reductions in Abnormal Involuntary Movement Scale (AIMS) scores in all participants, which were associated with improved activities of daily living. |
| 2026-06-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
The findings demonstrate that treating chorea with AUSTEDO or AUSTEDO XR led to symptom improvement and, as a result, showed improvements across multiple quality of life measures. |
| 2025-11-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
The findings demonstrate that treatment with AUSTEDO (deutetrabenazine) tablets or AUSTEDO XR (deutetrabenazine) extended-release tablets for tardive dyskinesia (TD) led to reductions in the severity of involuntary movements and improvements in patient-reported quality of life. |
| 2025-09-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Patients Taking AUSTEDO XR® (deutetrabenazine) extended-release tablets Reported Symptom Improvement and High Satisfaction tevapharm.com ↗
Of the 209 patients with tardive dyskinesia (TD) that were surveyed, >94% reported movement improvement once treated with AUSTEDO XR® (deutetrabenazine) extended-release tablets |
| 2024-11-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents New Tardive Dyskinesia Data at Psych Congress 2024 from the IMPACT-TD Registry, Revealing Differences in Patient Experience Based on Underlying Psychiatric Condition tevapharm.com ↗
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new patient- and physician-reported interim results from the Phase 4 IMPACT-TD Registry study, revealing differences between TD patients with a psychotic disorder and those with a mood disorder. |
| 2024-09-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Long Term Efficacy and Safety of Deutetrabenazine in European Patients with Debilitating Movement Disorder Tardive Dyskinesia tevapharm.com ↗
The improvement in symptoms was sustained throughout the three-year study, and deutetrabenazine was well tolerated. |
| 2024-06-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents First Real-World Data from the IMPACT-TD Registry Study at Psych Congress Elevate 2024 tevapharm.com ↗
Nearly 98% of patients experience quality of life impact as a result of tardive dyskinesia (TD) including social, psychological, physical and recreational aspects of daily living |
| 2024-05-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory 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 ↗
U.S. FDA approves new one pill, once-daily AUSTEDO XR tablets (30, 36, 42, 48 mg/day) |
| 2024-04-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
Almost 80% of patients with Huntington's disease (HD) chorea were able to achieve optimal dosing within four weeks with the 4-week Titration Kit in final START study results |
| 2023-11-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present New Data Supporting Safety, Efficacy and Real-World Effectiveness of AUSTEDO® (deutetrabenazine) Tablets at the 2023 HSG Annual Meeting tevapharm.com ↗
TMC scores mostly improved with AUSTEDO treatment, and the safety profile was consistent with AUSTEDO’s known safety profile. |
| 2023-06-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents Real-World Data for AUSTEDO® (deutetrabenazine) Tablets with 4-Week Patient Titration Kit at Psych Congress Elevate 2023 tevapharm.com ↗
Data presented will include interim findings from the START trial, a Phase 4 study investigating real-world utilization of AUSTEDO with a 4-week patient titration kit along with treatment success as measured at the end of treatment. |
| 2023-04-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
Bioequivalence and relative bioavailability were established between the once-daily and twice-daily tablet formulations, with no new safety findings emerging. |
| 2023-02-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, a New Once-Daily Formulation of AUSTEDO® (deutetrabenazine) Tablets tevapharm.com ↗
New once-daily AUSTEDO XR regimen now approved in 6, 12, and 24 mg tablet strengths |
| 2022-10-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
ARC-HD results showed that treatment with AUSTEDO had a safety and tolerability profile comparable with the First-HD randomized, double-blind, placebo-controlled, 12-week study. |
| 2022-05-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents New Long-Term AUSTEDO® (deutetrabenazine) Tablets Data at 2022 American Psychiatric Association Annual Meeting tevapharm.com ↗
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA),today announced new efficacy and safety data from a 3-year open-label extension (OLE) study on AUSTEDO® (deutetrabenazine) tablets in postmenopausal women with tardive dyskinesia (TD). |
| 2021-08-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Post Hoc Analysis of Long-Term Data Examining Treatment with AUSTEDO® (deutetrabenazine) Tablets in Adult Patients with Tardive Dyskinesia tevapharm.com ↗
The findings, published online in The American Journal of Geriatric Psychiatry, evaluated the long-term use of AUSTEDO with the total motor Abnormal Involuntary Movements Scale (AIMS) score, and measures of treatment success and quality of life. |
| 2020-09-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
The open-label extension of the pivotal ARM-TD and AIM-TD studies evaluated the long-term efficacy and safety of AUSTEDOfor the treatment of TD. |
| 2020-05-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory China Approves AUSTEDO® For Treating Chorea Associated with Huntington's Disease and Tardive Dyskinesia in Adults tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the China National Medical Products Administration (NMPA) has approved AUSTEDO® (Deutetrabenazine Tablets) for the treatment of chorea associated with Huntington's disease (HD) and Tardive Dyskinesia (TD) in adults, after a priority review. |
| 2020-02-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Registration Trials of Deutetrabenazine in Pediatric Patients with Tourette Syndrome Did Not Meet the Primary Endpoint tevapharm.com ↗ |
| 2017-08-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of AUSTEDO® (deutetrabenazine) Tablets for the Treatment of Tardive Dyskinesia in Adults tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved AUSTEDO® (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults. |
| 2017-07-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
Results from the study showed patients with chorea associated with Huntington disease (HD) were able to safely switch overnight from three times daily tetrabenazine to twice daily AUSTEDO™ (deutetrabenazine) tablets. |
| 2017-06-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Publication of AIM-TD Study Results in The Lancet Psychiatry for the Investigational Use of Deutetrabenazine in Tardive Dyskinesia tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the publication of results from the Phase III study, AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia), in the medical journal, The Lancet Psychiatry. |
| 2017-04-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Publication of ARM-TD Study Results in Neurology® for the Investigational Use of Deutetrabenazine in Tardive Dyskinesia tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced the publication of results from the Phase II/III study ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) in Neurology®, the medical journal of the American Academy of Neurology. |
| 2017-04-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of AUSTEDO™ (deutetrabenazine) Tablets for the Treatment of Chorea Associated with Huntington’s Disease tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved AUSTEDO™ (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease (HD). |
| 2017-02-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Priority Review Granted by FDA for SD-809 for Treatment of Tardive Dyskinesia tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for SD-809 (deutetrabenazine) for the treatment of tardive dyskinesia (TD). |
| 2016-10-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Acceptance of Resubmitted New Drug Application for SD-809 for Treatment of Chorea Associated with Huntington Disease tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD). |
| 2016-09-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Positive Top-Line Data from Second Phase III Study of SD-809 in Tardive Dyskinesia (TD) tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced SD-809 (deutetrabenazine) showed statistically significant results in the second Phase III registration trial studying the potential of SD-809 for the treatment of tardive dyskinesia (TD). |
| 2016-07-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and the Huntington Study Group (HSG) today announced the publication of data from the Phase III, placebo-controlled and randomized First-HD (First Time Use of SD-809 in Huntington Disease) study evaluating the efficacy and safety of SD-809 (deutetrabenazine) tablets for the treatment of chorea associated with Huntington disease (HD). |
| 2016-05-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives Complete Response Letter for NDA for SD-809 for the Treatment of Chorea Associated with Huntington Disease tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease (HD). |
| 2016-04-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
In the Phase III First-HD study, data showed deutetrabenazine significantly improved swallowing as measured by the Swallowing Disturbance Questionnaire (SDQ). |
| 2015-11-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory 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. | Regulatory Teva Announces FDA Acceptance of NDA for SD-809 for Treatment in Huntington Disease tevapharm.com ↗ |
| 2015-06-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Advances Pipeline of Movement Disorder Assets with Announcement of Positive Top-Line Data from the First Pivotal Study of Investigational Treatment for Patients with Tardive Dyskinesia tevapharm.com ↗
The study results show patients taking SD-809 achieved an improvement of 3.0 points on the AIMS score from baseline to end of therapy compared to 1.6 points in placebo (p = 0.0188) for a clinically meaningful effect. |
All press releases naming this drug 58 releases
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 ↗ |
| Known as | Austedo | “Deutetrabenazine Oral Tablet [Austedo]” NCT04071639 ↗ |
| Known as | SD-809 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01897896 ↗ |
| Action | Inhibit | “Deutetrabenazine, a selective vesicular monoamine transporter 2 inhibitor” NCT06997198 ↗ |
| Route | Oral | “Participants will receive SD-809 orally twice daily (BID)” NCT02198794 ↗ |