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Austedo

(Deutetrabenazine)

ApprovedSmall molecule

This medication is used to reduce involuntary movements (like sudden jerking or twisting motions) caused by Huntington's disease and a movement disorder called tardive dyskinesia. It works by adjusting brain chemicals that control nerve and muscle activity.[2] Austedo is currently approved and in use across 3 indications[4].[1]

Austedo is one of 23 small molecule programs targeting Huntington's Disease. It is currently in Approved.

3

Indications

6

Total Trials

2

Active Trials

22

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

31

Patents

Pipeline

Status by Indication[4][1]

Indication

Huntington's DiseaseCompleted

Huntington DiseaseActive, not recruiting

Tardive DyskinesiaRecruiting

Huntington's DiseaseApproved

Completed

Huntington DiseasePhase 3

Active, not recruiting

Tardive DyskinesiaApproved

Recruiting

Competition

Competitive Landscape

19 competitors in Huntington Disease

#DrugCompanyPhaseTrials

Epidiolex

Jazz Pharmaceuticals

Dojolvi

Actigall

Minocin

Glucophage

Risperdal

Tricor

Acetadote

AArbor Pharmaceuticals, Inc.

Rilutek

AAzurity Pharmaceuticals

Lithobid

SSolvay Pharmaceuticals

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

PreclinicalActive, not recruiting

Huntington Disease

NCT04713982

ApprovedRecruiting

Tardive Dyskinesia

NCT06997198

Clinical

Trials by Indication[1]

Huntington's Disease2 trials

Symptomatic Therapy for Patients With Huntington's Disease

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 1·NCT04071639·60 enrolled

Real-World Effectiveness and Safety of Deutetrabenazine in Chinese Patients With Chorea Associated With Huntington's Disease.

Completed· Teva logo

Teva·Approved·NCT07601516·50 enrolled

Dysphagia1 trial

Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated with HD

Terminated·FFundacion Huntington Puerto Rico·Phase 1·NCT04301726·36 enrolled

Dystonia1 trial

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

Completed·UUniversity of Pennsylvania·Phase 1/2·NCT04173260·15 enrolled

Huntington disease1 trial

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

Active, not recruiting·VVanderbilt University Medical Center·Preclinical·NCT04713982·30 enrolled

Tardive Dyskinesia1 trial

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

Recruiting·UUniversity Hospitals Cleveland Medical Center·Approved·NCT06997198·25 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 3, 2017

AUSTEDO

NDA NDA208082

Feb 17, 2023

AUSTEDO XR

NDA NDA216354

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Deutetrabenazine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Austedo drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Deutetrabenazine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Deutetrabenazine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216354). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Austedo. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Teva company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Teva

Patent Landscape[6]

Patent Cliff

Apr 3, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8524733Apr 3, 2031

8524733*PEDOct 3, 2031

9233959Sep 18, 2033

9296739Sep 18, 2033

9814708Sep 18, 2033

26 more patents

11666566Sep 18, 2033

9550780Sep 18, 2033

9233959*PEDMar 18, 2034

9296739*PEDMar 18, 2034

9550780*PEDMar 18, 2034

9814708*PEDMar 18, 2034

11666566*PEDMar 18, 2034

11648244Mar 7, 2036

11446291Mar 7, 2036

11357772Mar 7, 2036

11564917Mar 7, 2036

10959996Mar 7, 2036

12016858Mar 7, 2036

12016858*PEDSep 7, 2036

10959996*PEDSep 7, 2036

11564917*PEDSep 7, 2036

11648244*PEDSep 7, 2036

11446291*PEDSep 7, 2036

11357772*PEDSep 7, 2036

11179386Mar 15, 2038

11813232Mar 15, 2038

11813232*PEDSep 15, 2038

11179386*PEDSep 15, 2038

12599598Jun 10, 2041

11311488Jun 10, 2041

12589075Jun 10, 2041

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