CLINICAL TRIALS PROFILE FOR AUSTEDO

All Clinical Trials for AUSTEDO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT04173260 ↗	An Open-label Study to Define the Safety, Tolerability and Clinical Activity of Deutetrabenazine (AUstedo) in Adult Study Subjects With DYsTonia	Recruiting	Teva Branded Pharmaceutical Products R&D, Inc.	Phase 1/Phase 2	2020-08-06	This is a single-center, open-label study of AUSTEDO in study subjects with dystonia. The study will provide preliminary experience of the safety, tolerability, and clinical activity of AUSTEDO in study subjects with dystonia. Study duration will be up to 13 weeks from screening (Visit 1) to the post treatment evaluation (Visit 5). Treatment period from drug initiation to final on-treatment Visit will be 12 weeks, or less, as follows: during the ramp-up period, study drug will start at 12 mg/day (6 mg twice daily) and will be titrated weekly by 6 mg/day increments until either 1) the maximal allowable dose (48 mg/day) is reached, or 2) dose-limiting side-effects occur. In study subjects receiving a strong CYP2D6 inhibitor, the maximum allowed dose of AUSTEDO will be 36 mg/day, reducing study duration (due to a reduction in the ramp-up period) to 11 weeks. Study subjects who experience dose-limiting side effects will be maintained on their maximum tolerated dose. Once the maximal dose is established for each participant, they will complete 6 continuous weeks on this dose (maintenance period), followed by a 1-week washout. For study subjects unable to titrate up to 48 mg/day due to side effects, the 6 weeks of maintenance will start once they reduce the study drug back to the maximum well-tolerated dose. Adverse events will be monitored throughout the study and will be reported after drug initiation. Dose reductions, suspensions, and withdrawals due to adverse events will be recorded. ECG readings will be measured at screening, during week 2, during the first week of the maintenance period (whenever this is established to be, typically week 7 for subjects able to titrate up to 48 mg/day), immediately before washout (week 12 for those study subjects who are able to titrate up to 48 mg/day) and during week 13. Assessment of Columbia Suicide Severity Rating Scale and Epworth Sleepiness Scale scores will occur at screening and all clinic Visits. The Mini Mental (MMSE) Scale will be performed at screening and at the final on-treatment Visit (week 12). A video examination of the study subjects will be made at screening (right before initiation of the study drug), and after 6 weeks on AUSTEDO at a steady dose (right before drug cessation). Part III of the MDS-UPDRS will be performed at both of these Visits as well to screen for the appearance of drug-induced parkinsonism. Videos will be sent to raters blinded to treatment, Visit number and recording date.
NCT04173260 ↗	An Open-label Study to Define the Safety, Tolerability and Clinical Activity of Deutetrabenazine (AUstedo) in Adult Study Subjects With DYsTonia	Recruiting	Teva Branded Pharmaceutical Products, R&D Inc.	Phase 1/Phase 2	2020-08-06	This is a single-center, open-label study of AUSTEDO in study subjects with dystonia. The study will provide preliminary experience of the safety, tolerability, and clinical activity of AUSTEDO in study subjects with dystonia. Study duration will be up to 13 weeks from screening (Visit 1) to the post treatment evaluation (Visit 5). Treatment period from drug initiation to final on-treatment Visit will be 12 weeks, or less, as follows: during the ramp-up period, study drug will start at 12 mg/day (6 mg twice daily) and will be titrated weekly by 6 mg/day increments until either 1) the maximal allowable dose (48 mg/day) is reached, or 2) dose-limiting side-effects occur. In study subjects receiving a strong CYP2D6 inhibitor, the maximum allowed dose of AUSTEDO will be 36 mg/day, reducing study duration (due to a reduction in the ramp-up period) to 11 weeks. Study subjects who experience dose-limiting side effects will be maintained on their maximum tolerated dose. Once the maximal dose is established for each participant, they will complete 6 continuous weeks on this dose (maintenance period), followed by a 1-week washout. For study subjects unable to titrate up to 48 mg/day due to side effects, the 6 weeks of maintenance will start once they reduce the study drug back to the maximum well-tolerated dose. Adverse events will be monitored throughout the study and will be reported after drug initiation. Dose reductions, suspensions, and withdrawals due to adverse events will be recorded. ECG readings will be measured at screening, during week 2, during the first week of the maintenance period (whenever this is established to be, typically week 7 for subjects able to titrate up to 48 mg/day), immediately before washout (week 12 for those study subjects who are able to titrate up to 48 mg/day) and during week 13. Assessment of Columbia Suicide Severity Rating Scale and Epworth Sleepiness Scale scores will occur at screening and all clinic Visits. The Mini Mental (MMSE) Scale will be performed at screening and at the final on-treatment Visit (week 12). A video examination of the study subjects will be made at screening (right before initiation of the study drug), and after 6 weeks on AUSTEDO at a steady dose (right before drug cessation). Part III of the MDS-UPDRS will be performed at both of these Visits as well to screen for the appearance of drug-induced parkinsonism. Videos will be sent to raters blinded to treatment, Visit number and recording date.
NCT04173260 ↗	An Open-label Study to Define the Safety, Tolerability and Clinical Activity of Deutetrabenazine (AUstedo) in Adult Study Subjects With DYsTonia	Recruiting	University of Pennsylvania	Phase 1/Phase 2	2020-08-06	This is a single-center, open-label study of AUSTEDO in study subjects with dystonia. The study will provide preliminary experience of the safety, tolerability, and clinical activity of AUSTEDO in study subjects with dystonia. Study duration will be up to 13 weeks from screening (Visit 1) to the post treatment evaluation (Visit 5). Treatment period from drug initiation to final on-treatment Visit will be 12 weeks, or less, as follows: during the ramp-up period, study drug will start at 12 mg/day (6 mg twice daily) and will be titrated weekly by 6 mg/day increments until either 1) the maximal allowable dose (48 mg/day) is reached, or 2) dose-limiting side-effects occur. In study subjects receiving a strong CYP2D6 inhibitor, the maximum allowed dose of AUSTEDO will be 36 mg/day, reducing study duration (due to a reduction in the ramp-up period) to 11 weeks. Study subjects who experience dose-limiting side effects will be maintained on their maximum tolerated dose. Once the maximal dose is established for each participant, they will complete 6 continuous weeks on this dose (maintenance period), followed by a 1-week washout. For study subjects unable to titrate up to 48 mg/day due to side effects, the 6 weeks of maintenance will start once they reduce the study drug back to the maximum well-tolerated dose. Adverse events will be monitored throughout the study and will be reported after drug initiation. Dose reductions, suspensions, and withdrawals due to adverse events will be recorded. ECG readings will be measured at screening, during week 2, during the first week of the maintenance period (whenever this is established to be, typically week 7 for subjects able to titrate up to 48 mg/day), immediately before washout (week 12 for those study subjects who are able to titrate up to 48 mg/day) and during week 13. Assessment of Columbia Suicide Severity Rating Scale and Epworth Sleepiness Scale scores will occur at screening and all clinic Visits. The Mini Mental (MMSE) Scale will be performed at screening and at the final on-treatment Visit (week 12). A video examination of the study subjects will be made at screening (right before initiation of the study drug), and after 6 weeks on AUSTEDO at a steady dose (right before drug cessation). Part III of the MDS-UPDRS will be performed at both of these Visits as well to screen for the appearance of drug-induced parkinsonism. Videos will be sent to raters blinded to treatment, Visit number and recording date.

Clinical Trial Conditions for AUSTEDO

Condition Name

Condition Name for AUSTEDO
Intervention	Trials
Huntington Disease	2
Dystonia, Primary	1
Tardive Dyskinesia	1

Condition MeSH

Condition MeSH for AUSTEDO
Intervention	Trials
Huntington Disease	2
Dystonic Disorders	1
Dystonia	1
Tardive Dyskinesia	1

Clinical Trial Locations for AUSTEDO

Trials by Country

Trials by Country for AUSTEDO
Location	Trials
United States	26
Germany	1
Slovakia	1
Czechia	1
Poland	1

Trials by US State

Trials by US State for AUSTEDO
Location	Trials
Tennessee	2
Pennsylvania	1
Wisconsin	1
Washington	1
Virginia	1

Clinical Trial Progress for AUSTEDO

Clinical Trial Phase

Clinical Trial Phase for AUSTEDO
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for AUSTEDO
Clinical Trial Phase	Trials
Recruiting	2
Completed	1
Not yet recruiting	1

Clinical Trial Sponsors for AUSTEDO

Sponsor Name

Sponsor Name for AUSTEDO
Sponsor	Trials
Teva Branded Pharmaceutical Products R&D, Inc.	2
University of Pennsylvania	1
Fundacion Huntington Puerto Rico	1

Sponsor Type

Sponsor Type for AUSTEDO
Sponsor	Trials
Industry	4
Other	3

Clinical Trials Update, Market Analysis, and Projection for AUSTEDO (Deutetrabenazine)

Last updated: October 28, 2025

Introduction

AUSTEDO (deutetrabenazine), developed and marketed by Teva Pharmaceuticals, is a tetrabenazine derivative approved for the treatment of chorea associated with Huntington’s disease and tardive dyskinesia. Given its unique mechanism of selective reversible monoamine transporter inhibition, it has established a notable position within neurodegenerative and movement disorder therapeutics. This report examines recent clinical trial developments, analyzes the current market landscape, and offers projections based on emerging data.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Over the past 24 months, AUSTEDO has been involved in a series of clinical investigations aimed at expanding its therapeutic indications and affirming its safety profile.

1. Huntington’s Disease Chorea

Despite initial approvals, ongoing studies continue to refine dosing regimens and evaluate long-term safety. The HD-MED trial (NCT04137368), a Phase IV post-marketing observational study commenced in 2021, is assessing real-world effectiveness and safety over a period of 12 months. Early interim data indicate sustained symptom control with manageable adverse events (AEs), reinforcing its current positioning.

2. Tardive Dyskinesia (TD)

Building upon its original indication, AUSTEDO is under evaluation for persistent effects in TD. The Tardive Dyskinesia Long-Term Study (NCT04416134) explores efficacy across diverse patient populations. Preliminary phase II data demonstrate significant reduction in abnormal involuntary movements sustained over six months, with a favorable tolerability profile.

3. Pediatric and Geriatric Indications

Limited trials are exploring its use in pediatric movement disorders and elderly populations. The DEUTER-2 (NCT04527836) Phase III study targets children and adolescents with choreic movement disorders, while Geriatric Movement Disorder Trial (NCT05094571) assesses safety in elderly cohorts. Both aim to expand the drug's label in these underserved demographics.

Novel Formulations and Delivery Methods

Research is ongoing into alternative formulations, such as sustained-release and transdermal patches, to improve patient adherence. The SUSTAIN trial (NCT04758524) evaluates a once-daily extended-release formulation, showing promising early results in pharmacokinetic profiles.

Emerging Data and Insights

Recent pharmacovigilance data suggest AUSTEDO maintains a manageable safety profile, with common AEs including somnolence, depression, and Parkinsonian symptoms. The ongoing trials aim to refine understanding of rare adverse events like QT prolongation and mood disturbances, essential for risk mitigation and patient counseling.

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Market Analysis

Current Market Landscape

AUSTEDO’s primary competition arises from tetrabenazine, valbenazine (Ingrezza, Neurocrine Biosciences), and other VMAT2 inhibitors. The northern American market remains the largest, driven by unmet needs in movement disorder management.

Market Size & Revenue

In 2022, the global neurodegenerative disorder therapeutics market, including movement disorder drugs, was valued at approximately $10.8 billion[1]. AUSTEDO accounted for an estimated $0.8 billion in sales, with a growth rate of around 10% CAGR over the past five years, driven by increasing diagnosis rates and expanding indications.

Market Penetration

AUSTEDO maintains a strong prescription base in North America, especially amongst neurologists and movement disorder specialists. Its distinct dosing flexibility offers competitive advantages, yet price sensitivity and formulary access constraints pose ongoing challenges.

Key Market Drivers

• Unmet Medical Needs: Limited effective long-term options for chorea and tardive dyskinesia sustain demand.
• Expanding Indications: Ongoing trials for pediatric and geriatric populations could significantly enlarge addressable markets.
• Patient-Centric Formulations: Novel delivery approaches may improve adherence and expand usage in outpatient settings.

Market Challenges

• Competition from Valbenazine & Differentiators: While similar in mechanism, valbenazine has gained notable market share due to favorable pharmacokinetic profiles.
• Pricing & Reimbursement: Cost pressures and insurer formularies restrict access.
• Side Effect Profile: Managing neuropsychiatric AEs remains critical for prescriber confidence.

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Market Projection (2023–2030)

Forecast Summary

Based on clinical pipeline progress, regulatory trends, and market dynamics, the AUSTEDO market is projected to grow at a compound annual growth rate (CAGR) of 8-12% over the next eight years. The total market size could reach $2.2–2.5 billion by 2030, factoring in new indications and formulations.

Factors Contributing to Growth

• Pipeline Success: Positive trial outcomes could lead to regulatory approvals across additional indications like pediatric chorea, Tourette syndrome, and neurodegenerative tremors.
• Market Penetration: Strategic marketing and payer negotiations may expand access, especially as healthcare systems prioritize long-term management of movement disorders.
• Global Expansion: Entering Asian and European markets, where neurodegenerative diseases are rising, will be pivotal.

Potential Risks

• Regulatory Hurdles: Delays or adverse trial outcomes could temper growth.
• Competitive Landscape: A surge in alternative VMAT2 inhibitors or drug repurposing could threaten market share.
• Pricing Pressures: Reimbursement cuts and generic entry post patent expiry (expected around 2028) could impact profitability.

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Key Takeaways

• AUSTEDO remains a cornerstone therapy for Huntington’s chorea and tardive dyskinesia, with ongoing clinical trials poised to expand its indications.
• The drug's market position benefits from its proven efficacy and flexible dosing, but faces stiff competition and reimbursement challenges.
• The market is projected to sustain a steady CAGR of 8-12%, driven by clinical pipeline success, evolving formulations, and global expansion.
• Post-patent expiry, revenue is expected to decline unless new indications or formulations demonstrate substantial clinical advantages.
• Strategic focus on pediatric and geriatric populations, alongside novel delivery systems, offers impactful growth avenues.

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FAQs

1. What are the primary indications for AUSTEDO?
AUSTEDO is approved for treating chorea associated with Huntington’s disease and tardive dyskinesia in adults.

2. How does AUSTEDO compare to similar therapies like valbenazine?
AUSTEDO provides dosing flexibility and a distinct pharmacokinetic profile. However, valbenazine may offer advantages related to once-daily dosing and fewer neuropsychiatric side effects, influencing prescribing patterns.

3. Are there ongoing efforts to expand AUSTEDO’s indications?
Yes, multiple clinical trials target pediatric chorea, neurodegenerative tremors, and other movement disorders, which could broaden its therapeutic scope.

4. What are the main safety concerns associated with AUSTEDO?
Common AEs include somnolence, depression, parkinsonism, and QT prolongation. Monitoring of mood symptoms and cardiac status is advised.

5. When is the patent for AUSTEDO expected to expire?
Patent expiration is anticipated around 2028, after which generic versions could enter the market, impacting revenue.

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Sources

[1] Global Neurodegenerative Disorders Market Report, 2022.