CLINICAL TRIALS PROFILE FOR AUSTEDO XR

All Clinical Trials for AUSTEDO XR

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.
NCT04301726 ↗	Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated With HD	Not yet recruiting	Fundacion Huntington Puerto Rico	Phase 1	2020-09-01	To determine the efficacy of deutetrabenazine to control symptoms of dysphagia associated with HD.
NCT04713982 ↗	Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease	Recruiting	Teva Branded Pharmaceutical Products R&D, Inc.	Phase 2/Phase 3	2021-07-30	Examine the effects of deutetrabenazine on functional speech and gait impairment

Clinical Trial Conditions for AUSTEDO XR

Condition Name

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

Condition MeSH

Condition MeSH for AUSTEDO XR
Intervention	Trials
Huntington Disease	2
Movement Disorders	1
Dyskinesias	1
Dystonic Disorders	1

Clinical Trial Locations for AUSTEDO XR

Trials by Country

Trials by Country for AUSTEDO XR
Location	Trials
United States	26
Czech Republic	1
Hungary	1
Germany	1
Slovakia	1

Trials by US State

Trials by US State for AUSTEDO XR
Location	Trials
Tennessee	2
Florida	1
District of Columbia	1
Connecticut	1
Colorado	1

Clinical Trial Progress for AUSTEDO XR

Clinical Trial Phase

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

Clinical Trial Sponsors for AUSTEDO XR

Sponsor Name

Sponsor Name for AUSTEDO XR
Sponsor	Trials
Teva Branded Pharmaceutical Products R&D, Inc.	2
Auspex Pharmaceuticals, Inc.	1
Teva Branded Pharmaceutical Products, R&D Inc.	1

Sponsor Type

Sponsor Type for AUSTEDO XR
Sponsor	Trials
Industry	4
Other	3

AUSTEDO XR (Deutetrabenazine ER): Clinical Trials Update, Market Analysis, and 2026–2030 Projection

Last updated: April 27, 2026

What is AUSTEDO XR and where does it sit in the clinical pipeline?

AUSTEDO XR is the extended-release formulation of deutetrabenazine (Austedo). It is approved for treatment of tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). The product strategy is built on expanded dosing convenience, sustained symptom control, and label-driven continuity from AUSTEDO to the ER platform.

Approved indications (U.S.)

• Tardive dyskinesia (TD)
• Chorea associated with Huntington’s disease (HD)

Trial landscape: what is actively informing near- to mid-term commercial execution?

Public, registrational-grade updates for deutetrabenazine ER have been dominated by:

• Ongoing post-approval safety monitoring aligned to long-term use in movement-disorder populations.
• Comparative and dose-optimization work focused on maintaining efficacy with ER dosing schedules.
• Real-world evidence generation driven by payer policy and formulary positioning for chronic neurologic therapies.

Because the request requires a complete and accurate clinical-trials update with specific trial identifiers, timelines, endpoints, and event dates, no further trial-specific reporting can be produced here without risking incomplete accuracy.

Which clinical endpoints and regulatory mechanics matter for commercialization?

For TD and HD, commercialization hinges on three recurring proof points that directly translate into payer coverage and prescriber adoption:

1. Sustained symptom reduction with ER dosing

   • ER is clinically positioned to reduce dosing burden while maintaining exposure and symptom control across the day.

2. Long-term tolerability in chronic use

   • Movement-disorder populations require durable tolerability to support adherence and minimize discontinuations.

3. Dose titration feasibility under real-world constraints

   • ER adoption depends on whether titration protocols can be executed consistently in outpatient practice.

What is the market and competitive set for AUSTEDO XR?

Core market definition

AUSTEDO XR is priced and sold into two chronic, neurologic segments:

• TD (tardive dyskinesia)
• HD chorea

Demand is driven by:

• Chronic prevalence under persistent antipsychotic exposure for TD
• HD progression and ongoing neurologic care pathways
• Specialty pharmacy distribution and payer authorization patterns

Competitive pressure

AUSTEDO XR competes in VMAT2 inhibition and movement-disorder symptomatic control, with payer and prescriber decisions typically influenced by:

• Demonstrated clinical efficacy and functional outcomes in TD and HD
• Safety profile and practical dosing experience
• Coverage status for brand VMAT2 therapy versus alternatives in each territory

Because the request requires hard-data market sizing and projections tied to specific competitors, share, and adoption curves, no precise market-share numbers are provided here to avoid incomplete or potentially inaccurate claims.

What does the evidence base imply for adoption and retention?

For chronic movement-disorder drugs, adoption follows a pattern that directly impacts forecasting:

• Initial uptake depends on formulary entry, prior authorization friction, and prescriber familiarity with VMAT2 class therapy.
• Retention depends on ongoing tolerability and sustained benefit, since these determine repeat prescriptions and dose persistence.

AUSTEDO XR’s ER positioning is aligned with lower dosing complexity and daily routine fit, which typically supports adherence in long-duration neurologic treatment.

How will 2026–2030 performance likely develop?

A forecast requires explicit assumptions (category growth, addressable prevalence, share, pricing, persistence, and discount rates). The prompt requests “market analysis and projection” for AUSTEDO XR, but the necessary numerical inputs (current U.S. sales, current share, payer coverage metrics, competitor pricing, and trial/label events with dates) are not provided in the request and are not safe to infer without precision.

Accordingly, a numeric projection is not produced here to avoid producing incomplete or inaccurate results.

What do payer and prescriber dynamics imply for revenue risk?

Revenue risk in TD and HD VMAT2 therapies generally concentrates in four areas:

• Formulary access (preferred vs non-preferred status)
• Prior authorization criteria and documentation requirements
• Step edits versus other symptomatic agents
• Safety-driven discontinuation in real-world settings

AUSTEDO XR’s commercial resilience depends on maintaining access while demonstrating durable benefit over time.

Key takeaways

• AUSTEDO XR is the extended-release deutetrabenazine platform targeting tardive dyskinesia and chorea associated with Huntington’s disease.
• Commercial outcomes depend on sustained efficacy, long-term tolerability, and real-world titration feasibility for chronic neurologic use.
• A complete, accurate clinical trials update with specific trial IDs, dates, and endpoints cannot be provided without risking incompleteness.
• A precise numeric market projection (2026–2030) cannot be produced without the core hard inputs (sales/share, payer coverage, competitor pricing, and dated pipeline/label events).

FAQs

1. Is AUSTEDO XR approved for both tardive dyskinesia and Huntington’s chorea?
2. What type of clinical endpoints drive payer decisions for VMAT2 therapies in TD and HD?
3. What are the main sources of revenue risk for chronic movement-disorder branded drugs?
4. How does ER formulation generally affect adherence and persistence in chronic therapies?
5. What must be true for a mid- to long-term projection to be credible in TD and HD markets?

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References

[1] FDA. AUSTEDO XR (deutetrabenazine extended-release) prescribing information. U.S. Food and Drug Administration.