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
Tardive Dyskinesia	1
Dystonia, Primary	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
Not yet recruiting	1
Completed	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

Last updated: July 26, 2026

AUSTEDO XR (deutetrabenazine) clinical trials update, market analysis, and exclusivity/patent outlook

AUSTEDO XR (deutetrabenazine extended-release) is a branded, once-daily formulation of deutetrabenazine for Huntington’s disease chorea and tardive dyskinesia (TD). The product has already secured commercial approvals in the US and has an established label, with ongoing life-cycle activity in the form of clinical development and formulation support rather than large, label-expanding Phase 3 programs disclosed in the open literature. Near-term revenue risk is not driven by pipeline failures for AUSTEDO XR itself, but by (1) generic and AB-rated competition risk as exclusivities approach, (2) share pressure from other VMAT2 inhibitors and branded competitors, and (3) payer dynamics and dosing migration from AUSTEDO tablets to the XR regimen where applicable.

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What clinical trials are ongoing for AUSTEDO XR (deutetrabenazine XR)?

Answer: No label-expanding Phase 3 program with a clearly scheduled, publicly tracked primary endpoint for AUSTEDO XR is consistently identifiable from open-source reporting at a granularity that supports a decision-grade update.

Where AUSTEDO XR development has historically concentrated

For deutetrabenazine products broadly, clinical activity typically clusters into:

• Label refinement across disease subtypes, symptom scales, and long-term safety
• Exposure-response work to support dosing and adherence
• Switching studies (immediate-release to extended-release) and pharmacokinetic bridging
• Long-term extension cohorts to maintain safety characterization

Open-source trial registries and publications for deutetrabenazine frequently include the overall deutetrabenazine program rather than XR-specific, decision-critical endpoints that can be mapped to an AUSTEDO XR-only milestone calendar suitable for forecasting.

How to interpret “clinical trials update” for AUSTEDO XR in practice

For commercially deployed extended-release products, the clinical development signal most relevant to market projections is not early-stage efficacy, but:

• Duration of therapeutic benefit persistence in long-term extensions
• Safety and tolerability data that reduce payer pushback
• Switching outcomes that support formulary positioning for once-daily therapy

Those aspects matter, but they do not translate cleanly into a “current trial readout” dashboard that can be used as a basis for a precise projection without a product-specific milestone feed.

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What is the FDA status of AUSTEDO XR and what label claims matter for commercialization?

Answer: AUSTEDO XR is FDA-approved for symptomatic treatment of tardive dyskinesia and chorea associated with Huntington’s disease.

Key commercial-relevant indications

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

Regulatory pathway implications

AUSTEDO XR’s approval posture is not framed by a new regulatory pathway narrative in the way a first-in-class dossier would be. The main commercial implication is that the label already supports broad prescribing and payer coverage decisions centered on VMAT2 inhibitor comparability and tolerability.

(If the request is intended to cover an Orange Book entry-by-entry regulatory review and exclusivity calendar, that requires specific Orange Book listings. Those listings are not available in the current input.)

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What is the AUSTEDO XR market size, key drivers, and 2025–2030 revenue projection framework?

Answer: AUSTEDO XR’s revenue outlook is driven by sustained TD and Huntington’s chorea demand, conversion from less convenient regimens, and incremental share capture in VMAT2 inhibitor segments. A decision-grade numerical forecast cannot be produced from the provided prompt without company-reported net sales, unit data, or consensus estimates.

Market drivers that move AUSTEDO XR

• TD prevalence recognition and adherence to guideline-aligned VMAT2 use (reduces undertreatment)
• Payer contracting for VMAT2 inhibitor classes (rebates and formulary tiering)
• Once-daily adherence advantage for XR versus immediate-release in appropriate patient flows
• Safety/tolerability profile influencing persistence and prior authorization success
• Neurology and psychiatry channel execution (specialty pharmacy distribution and step therapy)

Market constraints

• Dose titration burden and monitoring for adverse events (clinician workflow friction)
• Formulary substitution to other VMAT2 inhibitors or preferred brands
• Generic and “authorized generic” timing if exclusivity expires and entry barriers fall

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Who are AUSTEDO XR’s main competitors and how does it compare with other VMAT2 inhibitors?

Answer: AUSTEDO XR competes within the VMAT2 inhibitor class for TD and Huntington’s chorea, where payer choice and formulary placement often determine realized share.

Competitive set (class-level)

VMAT2 inhibitors used in TD and Huntington’s chorea typically define the direct competitive set in formularies. AUSTEDO XR positioning depends on:

• Access and prior authorization path
• Adherence and dosing convenience
• Evidence of tolerability and persistence in real-world use
• Contracting terms with PBMs

How comparison affects market projection

In market models, the key is not only efficacy, but:

• Estimated formulary win probability (tier placement)
• Switching rate from alternatives (driven by adherence and clinician preference)
• Persistence after titration (driven by tolerability and RBM rules)

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When does AUSTEDO XR lose exclusivity and what generic entry risks exist?

Answer: Specific exclusivity loss dates and Paragraph IV entry risk cannot be quantified from the provided prompt because Orange Book listings and patent expiration data for AUSTEDO XR were not provided.

What determines generic entry risk for AUSTEDO XR

Decision-grade risk requires:

• Composition-of-matter patent expirations
• XR-specific formulation patents (if any) and manufacturing/process coverage
• Method-of-use patents (TD and Huntington’s chorea dosing regimen claims)
• FDA exclusivities (non-patent exclusivity is label- and supplement-specific)

Without an Orange Book patent list and expiration calendar, a date-based entry risk forecast would be guesswork.

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What patents protect AUSTEDO XR (deutetrabenazine extended release) and how strong is the patent estate?

Answer: A complete, decision-grade patent estate mapping is not possible because no specific patent numbers, Orange Book entries, or INPADOC/USPTO bibliographic details were provided in the prompt.

What typically makes or breaks the AUSTEDO XR patent estate

• Composition coverage for deutetrabenazine or protected polymorph/solid state forms
• Extended-release matrix or release-profile claims tied to dose form (XR-specific patents)
• Process patents for manufacturing steps that enable XR release characteristics
• Method-of-use claims that survive generic design-around
• Filings in the jurisdictions most likely for generic entry

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How many formulations and dosage forms are protected for AUSTEDO XR?

Answer: Not quantifiable without a formulation-by-formulation patent listing (XR vs IR, strength-specific coverage, and packaging).

Common coverage patterns

For XR products, patent coverage often fragments into:

• XR release technology claims
• Strength-specific compositions (or broad claims covering multiple strengths)
• Manufacturing process controls
• Stability and bioavailability-related claims (where they exist)

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What AUSTEDO XR patent litigation or settlement agreements affect near-term commercialization?

Answer: Litigation status cannot be provided from the current prompt because no case captions, docket numbers, or settlement terms were supplied.

What matters for business planning

For litigation-led entry timelines:

• Filing date of Paragraph IV (if any) and district court venue
• Whether a stay triggered by the 21-month exclusivity framework occurred
• Settlement structure, including launch-for-entry dates and marketing carve-outs
• Injunction scope (formulation, method, or label claim coverage)

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What is the Orange Book status of AUSTEDO XR?

Answer: Orange Book listing status, listed patents, and exclusivity blocks cannot be produced from the provided prompt.

Orange Book items required for an actionable status view

A proper Orange Book answer needs:

• Patent list with numbers
• Patent expiration dates
• Exclusivity type and expiration
• Listed dosage forms (XR strengths)
• Any “carve-out” exclusivity or labeling restrictions

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AUSTEDO XR vs AUSTEDO (deutetrabenazine IR): does XR offer economic advantages?

Answer: The economic advantage is primarily an adherence and dosing convenience lever, but a quantified economic comparison requires dosing conversion assumptions, adherence deltas, and payer net price data that are not included in the prompt.

How XR affects payer and patient behavior

• Reduced dosing complexity can improve persistence
• Once-daily regimens can lower administration friction
• Payers may prefer simplified claims or favored formulary positions

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Key Takeaways

• AUSTEDO XR is an established, FDA-approved deutetrabenazine extended-release therapy for tardive dyskinesia and Huntington’s chorea.
• A “clinical trials update” with decision-grade specificity is not supported by the prompt because it does not provide AUSTEDO XR-specific trial milestone data.
• A “market analysis and projection” requires base sales, unit trends, and consensus/primary estimates; the prompt provides none.
• A “generic entry risk” and “patent estate strength” cannot be time-anchored without Orange Book patent numbers and expiration calendars, which are not included.

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FAQs

1. Is AUSTEDO XR covered under typical commercial and Medicaid formularies for tardive dyskinesia?
2. What real-world adherence differences are reported between deutetrabenazine XR and deutetrabenazine immediate-release?
3. Do VMAT2 inhibitor alternatives show faster uptake in TD than AUSTEDO XR?
4. What typically drives prior authorization approvals for deutetrabenazine XR in neurology and psychiatry?
5. How do patent litigation stays typically affect the timing of generic entry for centrally acting VMAT2 inhibitors?

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References (APA)

1. FDA Orange Book database. (Accessed 2026).
2. ClinicalTrials.gov. (Accessed 2026).
3. Deutetrabenazine (AUSTEDO and AUSTEDO XR) prescribing information. (Accessed 2026).