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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR DEUTETRABENAZINE


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All Clinical Trials for Deutetrabenazine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01795859 ↗ First Time Use of SD-809 in Huntington Disease Completed Teva Branded Pharmaceutical Products R&D, Inc. Phase 3 2013-08-05 The purpose of this study is to determine whether SD-809 tablets are effective in the treatment of chorea associated with Huntington's Disease.
NCT01795859 ↗ First Time Use of SD-809 in Huntington Disease Completed Teva Pharmaceutical Industries Phase 3 2013-08-05 The purpose of this study is to determine whether SD-809 tablets are effective in the treatment of chorea associated with Huntington's Disease.
NCT01897896 ↗ Alternatives for Reducing Chorea in Huntington Disease Completed Auspex Pharmaceuticals, Inc. Phase 3 2013-11-12 The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of SD-809 extended release (ER) in participants switching from tetrabenazine to SD-809 ER. In addition, the safety and tolerability of long-term treatment with SD-809 ER will be assessed in "Switch" participants as well as "Rollover" participants completing a randomized, double blind, placebo-controlled study of SD-809 ER.
NCT02195700 ↗ Aim to Reduce Movements in Tardive Dyskinesia Completed Auspex Pharmaceuticals, Inc. Phase 2/Phase 3 2014-06-01 The purpose of this study is to determine whether an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.
NCT02198794 ↗ Reducing Involuntary Movements in Participants With Tardive Dyskinesia Completed Auspex Pharmaceuticals, Inc. Phase 3 2014-10-20 The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809.
NCT02291861 ↗ Addressing Involuntary Movements in Tardive Dyskinesia Completed Auspex Pharmaceuticals, Inc. Phase 3 2014-10-31 The purpose of this study is to determine whether fixed-doses of an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Deutetrabenazine

Condition Name

Condition Name for Deutetrabenazine
Intervention Trials
Tourette Syndrome 4
Huntington Disease 3
Tardive Dyskinesia 3
Cerebral Palsy, Dyskinetic 2
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Condition MeSH

Condition MeSH for Deutetrabenazine
Intervention Trials
Huntington Disease 5
Tourette Syndrome 4
Syndrome 4
Dyskinesias 4
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Clinical Trial Locations for Deutetrabenazine

Trials by Country

Trials by Country for Deutetrabenazine
Location Trials
United States 189
Poland 7
Canada 7
Australia 4
Slovakia 4
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Trials by US State

Trials by US State for Deutetrabenazine
Location Trials
Texas 10
Tennessee 10
Alabama 9
Missouri 9
Florida 9
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Clinical Trial Progress for Deutetrabenazine

Clinical Trial Phase

Clinical Trial Phase for Deutetrabenazine
Clinical Trial Phase Trials
Phase 3 8
Phase 2/Phase 3 3
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Deutetrabenazine
Clinical Trial Phase Trials
Completed 8
Recruiting 5
Terminated 1
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Clinical Trial Sponsors for Deutetrabenazine

Sponsor Name

Sponsor Name for Deutetrabenazine
Sponsor Trials
Teva Branded Pharmaceutical Products R&D, Inc. 8
Teva Branded Pharmaceutical Products, R&D Inc. 6
Auspex Pharmaceuticals, Inc. 5
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Sponsor Type

Sponsor Type for Deutetrabenazine
Sponsor Trials
Industry 23
Other 4
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Deutetrabenazine: Clinical Trials, Market Analysis, and Projections

Introduction

Deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, has been approved by the US Food and Drug Administration (FDA) for the treatment of chorea associated with Huntington's disease and tardive dyskinesia. Here, we delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Efficacy and Safety in Tourette Syndrome

A recent phase 3 clinical trial, known as the ARTISTS 2 study, evaluated the efficacy and safety of deutetrabenazine in children and adolescents with Tourette syndrome. This randomized, double-blind, placebo-controlled trial involved 158 participants who were randomized to receive either high-dose deutetrabenazine (up to 48 mg/day), low-dose deutetrabenazine (up to 36 mg/day), or a matching placebo. The primary efficacy endpoint was the change from baseline to week 8 in the Yale Global Tic Severity Scale–Total Tic Score (YGTSS-TTS). Although the trial showed that deutetrabenazine was generally well tolerated, it did not meet the primary efficacy endpoint, with no significant difference in tic severity compared to the placebo group[1].

Safety Profile in Tardive Dyskinesia and Huntington's Disease

Safety data from clinical studies on deutetrabenazine for the treatment of tardive dyskinesia (TD) and Huntington's disease (HD) indicate that the drug is generally well tolerated. Integrated safety data from pivotal studies and open-label extension studies showed that common adverse events included headache, somnolence, nausea, anxiety, fatigue, dry mouth, and diarrhea. Serious adverse events were reported in a small percentage of patients, and the overall safety profile was favorable compared to placebo[5].

Market Analysis

Market Size and Growth

The deutetrabenazine market is projected to experience significant growth. As of 2023, the market size was valued at USD 79.58 million and is expected to reach USD 419.58 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 21.4% during the forecast period of 2024-2030[2].

Key Drivers

Several factors are driving the growth of the deutetrabenazine market:

  • Growing Prevalence of Huntington’s Disease: The increasing prevalence of Huntington’s disease, a neurodegenerative illness characterized by involuntary movements, is driving the demand for effective treatments like deutetrabenazine[2].
  • Unmet Medical Need: The scarcity of specific therapies for chorea associated with Huntington’s disease creates a significant medical need that deutetrabenazine can address[2].
  • Clinical Efficacy and Safety Profile: Favorable clinical trial results demonstrating the safety and efficacy of deutetrabenazine in treating chorea symptoms are boosting market demand[2].
  • Patient-Centric Drug Development: The focus on patient-centric drug development, which includes improvements in quality of life and symptom management, is propelling the creation and uptake of deutetrabenazine[2].

Market Segments

The deutetrabenazine market can be segmented by distribution channel, end-user, and age group:

  • Distribution Channels: Hospital pharmacies, retail pharmacies, and online pharmacies are key distribution channels. Online pharmacies are emerging as a new market niche, enhancing market penetration[2].
  • End-Users: Hospitals and clinics, specialty neurology centers, and homecare settings are the primary end-users. Specialty neurology centers play a crucial role in managing prescriptions for deutetrabenazine[2].
  • Age Group: Adults are the main target demographic since Huntington’s disease typically first appears in adulthood. There is potential for future growth in the pediatric market if deutetrabenazine is approved for use in young patients[2].

Market Projections

Geographic Markets

The deutetrabenazine market is expected to grow across various geographic regions:

  • North America: This region includes the United States and Canada, where there is a high prevalence of Huntington’s disease and strong healthcare infrastructure[2].
  • Europe: Regional differences in disease prevalence, healthcare practices, and regulatory environments will influence market dynamics in Europe[2].
  • Asia-Pacific: Variations in healthcare infrastructure and disease awareness will shape the market in Asia-Pacific countries[2].
  • Latin America and Middle East & Africa: These regions will also see growth, though it will be influenced by geographical variables affecting healthcare accessibility and disease awareness[2].

Regulatory Approvals and Designations

Regulatory approvals, such as the FDA approval of Austedo XR (deutetrabenazine) as extended-release tablets in February 2023, are crucial for market growth. Orphan drug status and other designations accelerate the development and market access of deutetrabenazine[4].

Competitive Landscape

Major players in the deutetrabenazine market include Viatris Inc., Glenmark Pharmaceuticals Ltd., Alembic Pharmaceuticals Ltd., Teva Pharmaceutical Industries Ltd., and others. These companies are driving the market through research and development activities and strategic partnerships[2].

Challenges and Limitations

Restricted Indications and Patient Population

The main indication for deutetrabenazine is the treatment of chorea associated with Huntington’s disease, which limits its market potential due to the narrow range of indications and small patient base[2].

High Treatment Costs

Deutetrabenazine and similar drugs can be expensive, presenting a financial hardship for individuals and healthcare systems, particularly in areas with constrained funding for medical care[2].

Competition from Alternative Therapies

The market share of deutetrabenazine may be impacted by competition from currently available drugs or new treatments for the symptomatic treatment of Huntington’s disease[2].

Adverse Effects and Safety Concerns

While deutetrabenazine has a favorable safety profile, adverse effects such as headache, somnolence, and nausea can affect patient compliance and market growth[5].

Key Takeaways

  • Deutetrabenazine has shown mixed results in clinical trials, with significant efficacy in treating chorea associated with Huntington’s disease and tardive dyskinesia but limited efficacy in Tourette syndrome.
  • The market for deutetrabenazine is projected to grow significantly, driven by the growing prevalence of Huntington’s disease and favorable clinical trial results.
  • Regulatory approvals and patient-centric drug development are key factors driving market growth.
  • Despite the potential, the market faces challenges such as high treatment costs, competition from alternative therapies, and restricted indications.

FAQs

What is deutetrabenazine used for?

Deutetrabenazine is used for the treatment of chorea associated with Huntington's disease and tardive dyskinesia. It is a vesicular monoamine transporter 2 (VMAT2) inhibitor that suppresses dopamine activity in the brain[3].

What were the results of the ARTISTS 2 clinical trial for deutetrabenazine in Tourette syndrome?

The ARTISTS 2 trial showed that deutetrabenazine was generally well tolerated but did not meet the primary efficacy endpoint, with no significant difference in tic severity compared to the placebo group[1].

What is the projected market size of deutetrabenazine by 2030?

The deutetrabenazine market is projected to reach USD 419.58 million by 2030, growing at a CAGR of 21.4% during the forecast period of 2024-2030[2].

What are the common adverse effects of deutetrabenazine?

Common adverse effects of deutetrabenazine include headache, somnolence, nausea, anxiety, fatigue, dry mouth, and diarrhea[5].

Which companies are major players in the deutetrabenazine market?

Major players include Viatris Inc., Glenmark Pharmaceuticals Ltd., Alembic Pharmaceuticals Ltd., Teva Pharmaceutical Industries Ltd., and others[2].

Sources

  1. JAMA Network Open: "Efficacy and Safety of Fixed-Dose Deutetrabenazine in Children and Adolescents With Tourette Syndrome: A Randomized Clinical Trial."
  2. Verified Market Research: "Deutetrabenazine Market Size, Share, Scope & Forecast."
  3. QY Research: "Deutetrabenazine API - Global Market Insights and Sales Trends 2024."
  4. Research Nester: "Huntington's Disease Treatment Market Size & Share, Forecast."
  5. PubMed: "Safety of Deutetrabenazine for the Treatment of Tardive Dyskinesia and Huntington’s Disease."

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