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.
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
NCT04713982 ↗	Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease	Recruiting	Vanderbilt University Medical Center	Phase 2/Phase 3	2021-07-30	Examine the effects of deutetrabenazine on functional speech and gait impairment

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
Movement Disorders	1
Dyskinesias	1
Dystonic Disorders	1

Clinical Trial Locations for AUSTEDO

Trials by Country

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

Trials by US State

Trials by US State for AUSTEDO
Location	Trials
Tennessee	2
Maryland	1
Kansas	1
Illinois	1
Georgia	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
Auspex Pharmaceuticals, Inc.	1
Teva Branded Pharmaceutical Products, R&D Inc.	1

Sponsor Type

Sponsor Type for AUSTEDO
Sponsor	Trials
Industry	4
Other	3

AUSTEDO (deutetrabenazine) Clinical Trials Update, Market Analysis, and 2025–2035 Projection

Last updated: July 27, 2026

Executive summary

• AUSTEDO (deutetrabenazine) is an oral, vesicular monoamine transporter 2 (VMAT2) inhibitor approved for Huntington’s disease chorea (HD chorea) and tardive dyskinesia (TD). The clinical pipeline focus is on incremental label expansion, longer-term safety/tolerability, and formulation or regimen optimization rather than a near-term replacement product.
• Commercially, AUSTEDO has shifted from early growth into a more mature market with brand longevity driven by ongoing neurologic use, titration/maintenance adherence, and payor dynamics that can pressure price but not necessarily units quickly.
• A realistic 2025–2035 projection for AUSTEDO depends on TD and HD chorea penetration, prescriber inertia, and generic/biosimilar risk. AUSTEDO’s core value is durability of use in chronic disorders and resistance to rapid substitution due to clinical workflow and dosing titration.

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What is the latest clinical trial update for AUSTEDO (deutetrabenazine)?

Core status snapshot (what matters for investors)

• AUSTEDO’s clinical activity over the last several years has emphasized:
  • long-term safety in chronic treatment (TD and HD chorea),
  • sustained symptom control with ongoing dosing,
  • comparative tolerability and real-world alignment of titration strategies.
• The highest-yield readouts for commercial impact are typically maintenance endpoints (durability of chorea reduction, TD symptom persistence), adherence/titration feasibility, and safety in broader populations.

Which trial programs most affect AUSTEDO’s label durability?

HD chorea (deutetrabenazine)

• Trials and follow-on studies track durability of chorea reduction and adverse event rates over extended exposure.
• HD chorea is a chronic indication, so trials that confirm stable benefit and manageable discontinuation rates have the most downstream impact on market size and payer acceptance.

Tardive dyskinesia (deutetrabenazine)

• TD programs focus on sustained AIMS improvement, tolerability across titration, and behavior around real-world dosing cadence.
• TD is also chronic. For a brand, the strategic clinical question is whether long-term data supports continued prescribing and minimizes discontinuation.

What do recent safety signals typically target?

• VMAT2 class monitoring concentrates on depression/suicidality risk, parkinsonism, sedation, and QT considerations per label.
• Trial updates that reduce discontinuations or show stable event rates across time are commercially relevant because they improve physician confidence and payer authorization likelihood.

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Which endpoints and outcomes matter most in AUSTEDO studies for market uptake?

Featured-snippet answer: Durable symptom control, low discontinuation, and manageable depression/sedation and parkinsonism profiles.

Primary efficacy outcomes

• HD chorea: reduction in chorea severity scales (commonly UHDRS-derived measures).
• TD: improvement on AIMS, plus responder analyses that correlate with clinician decision-making.

Secondary endpoints that affect uptake

• time to response and dose-response curves,
• maintenance of effect after titration,
• functional or patient-reported outcomes when present,
• discontinuation rate and reasons for stopping.

Safety endpoints linked to payer and clinician behavior

• treatment-emergent adverse events by category,
• depression-related events and suicidality monitoring metrics,
• sedation rates,
• parkinsonism-related events,
• lab monitoring and ECG-related outcomes where applicable.

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What is AUSTEDO’s current market position by indication (TD vs HD chorea)?

Executive summary: TD drives broad chronic prevalence and steady demand; HD chorea contributes higher acuity neurologist prescribing concentration.

TD vs HD chorea commercial dynamics

• TD
  • wider distribution across psychiatry and neurology care settings,
  • higher importance of prior authorization, dosing initiation support, and durable maintenance.
• HD chorea
  • smaller patient pool but more consistent neurologist follow-through,
  • benefit persistence and safety profile are key to long-term retention.

Distribution, channel, and prescribing pattern

• Oral chronic neuropsychiatry drugs typically sell through specialty pharmacy channels with authorization and patient support programs.
• AUSTEDO’s clinical routine (start low, titrate) influences fulfillment patterns and may slow rapid unit expansion but improves persistence once on therapy.

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How has AUSTEDO performed in sales, and what are the drivers of growth or decline?

Key drivers

• TD and HD chorea prevalence treated with VMAT2 inhibitors,
• new patient starts versus continuation,
• payor coverage changes and step therapy,
• competition effects in the VMAT2 class,
• net price vs list price discounts and rebates.

What typically drives unit changes in chronic VMAT2 therapy

• physician familiarity with titration and side effect management,
• patient persistence over multiple quarters,
• switching behavior among VMAT2 options,
• geographic and payer-specific coverage.

What typically drives revenue volatility

• contract renegotiations,
• uptake of competing VMAT2 therapies,
• exclusivity and generic timing for competing products (noting this analysis focuses on AUSTEDO’s own forward pricing risk).

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What generic entry risks exist for AUSTEDO (deutetrabenazine) and how do they affect projections?

Featured-snippet answer: The biggest forecast lever is whether market access can sustain demand if equivalent alternatives launch. For VMAT2-class drugs, payer behavior often shifts toward lowest-cost covered option once equivalence and label alignment are accepted.

How to model generic risk in a brand projection

• Use three layers:
  1. coverage disruption risk (formulary exclusion probability),
  2. switching elasticity (share loss post-entry),
  3. persistence decline (continuation rates after substitution).
• For chronic neurologic therapy, share loss typically depends more on payer rules and prescriber comfort than on pharmacologic substitution alone.

What would accelerate share loss

• aggressive step therapy for TD or HD chorea,
• near-cost parity with a broader set of covered generics,
• safety equivalence concerns in real-world practice that trigger switching delays.

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When does AUSTEDO lose exclusivity and what does that mean for market timing?

Featured-snippet answer: Exclusivity and patent term timing determines when biosubstitution-like behavior for a small molecule can begin via generics; commercial impact usually follows actual ANDA launches and payor formulary updates rather than the mere passage of years.

How to translate patent and exclusivity milestones into a sales curve

• Pre-launch: pricing leverage may weaken as generics approach.
• Launch year: share shifts depend on speed of coverage, pharmacy stocking, and physician switching.
• Post-launch: net price compresses while units can remain stable or decline depending on persistence.

(Austedo-specific exclusivity and patent term dates were not provided in the input content. Without a sourced term list, no exact launch timing or expiration dates should be stated.)

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Which companies are challenging AUSTEDO and what is the litigation landscape likely to look like?

Featured-snippet answer: Generic challengers typically target Orange Book-listed patents tied to drug substance, formulation, or method-of-use claims; disputes focus on patent validity and infringement.

How Paragraph IV litigation affects forecasts

• If a Paragraph IV is filed, market forecasts often incorporate:
  • delayed launch if a court injunction issues,
  • settlement-driven launch timing,
  • risk of “design-around” formulations that still capture the therapeutic category.

(No specific court docket or Orange Book listing details were supplied in the input content, so litigation names and dates are not stated.)

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What is the Orange Book status of AUSTEDO and how many patents cover it?

Featured-snippet answer: Orange Book listings map to the legal risk profile and generic entry barrier. The number and type of patents (drug substance, drug product, method of use) determine the strength and breadth of protection.

(No Orange Book patent count or listing table was provided in the input content. Without sourced listings, patent numbers or expiration dates are not provided.)

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What formulations are protected for AUSTEDO and can generics “design around” easily?

Featured-snippet answer: For an oral tablet/capsule brand like AUSTEDO, generic design-around is usually constrained by:

• bioequivalence requirements,
• patent coverage for specific formulations or dosing regimens,
• method-of-use claims that can be avoided only if label carve-outs are accepted.

Formulation vs regimen risk

• Drug product patents (excipient systems, coating, release profile) can delay approval or limit market entry even if substance patents expire.
• Method-of-use patents can slow prescribing if label carve-outs restrict substitution.

(Specific AUSTEDO formulation patent claims are not provided in the input content.)

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How does AUSTEDO compare with competing VMAT2 inhibitors for TD and HD chorea?

Competitive lens

• Competing VMAT2 therapies create share pressure through:
  • perceived efficacy differences,
  • tolerability and titration convenience,
  • payer coverage and patient assistance availability.

What to compare when modeling share

• responder rates and average dose requirements,
• discontinuation due to depression/sedation,
• time to stable dosing,
• total therapy cost at net price levels.

(Drug-by-drug comparisons require product-specific sales, coverage, and trial head-to-head data not included in the input content.)

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What is the forward clinical and regulatory path for AUSTEDO through 2025–2028?

Featured-snippet answer: For established oral neuropsychiatric agents, forward value usually comes from:

• label expansion if new subpopulations show improved outcomes,
• additional long-term exposure data supporting persistence,
• manufacturing/CMC updates that keep supply stable.

Regulatory execution factors that can affect commercial continuity

• inspection readiness and manufacturing capacity stability,
• changes in distribution or packaging that can affect refill reliability,
• label updates tied to safety.

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Market projection for AUSTEDO (2025–2035): scenarios and drivers

Executive summary: Build projections around three scenario levers: TD vs HD penetration, net price trend from competition, and generic-entry timing for alternatives that shift payer coverage. Without specific exclusivity dates and current sales baseline in the input, this section is expressed as a framework rather than a numeric forecast.

Projection framework

Revenue = Units × Net price

• Units drivers:
  • new starts in TD and HD,
  • persistence (treatment duration distribution),
  • switch-in and switch-out between VMAT2 options.
• Net price drivers:
  • formulary position and rebate structure,
  • contract cycles and pharmacy benefit manager (PBM) dynamics,
  • generic substitution and step therapy.

Scenario design for business planning

• Base case (steady maturity):
  • modest unit growth driven by continued diagnosis and specialist prescribing,
  • net price compression from competitive contracting,
  • limited disruption without major label or exclusivity shocks.
• Bull case (faster uptake / better persistence):
  • stronger new start momentum and lower discontinuation,
  • stable payer coverage with fewer formulary exclusions,
  • net price decline slower than historical averages.
• Bear case (coverage pressure / substitution accelerates):
  • earlier-than-expected payer substitution into lower-cost covered options,
  • increased switching and lower persistence,
  • faster net price decline.

Key monitoring indicators (quarterly)

• TD and HD treated patient counts via prescription and specialty pharmacy sell-through data,
• prescription fill and persistence metrics,
• payer policy updates (formulary changes, PA tightening),
• competitor launch announcements and court outcomes for IP-linked entry.

(No AUSTEDO baseline sales, patient counts, or competitor launch schedule were included in the input content.)

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Key barriers that can slow AUSTEDO uptake

• Titration time and clinician workflow burden, particularly for TD initiations.
• Depression/suicidality monitoring requirements that can slow prescribing and PA approval.
• Prior authorization and step therapy friction that delays first fills.
• Switching hesitation if patients previously stabilized on an alternative VMAT2.

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Key Takeaways

• AUSTEDO’s clinical relevance continues to center on long-term maintenance, tolerability during titration, and chronic persistence for TD and HD chorea.
• The market outlook is shaped by chronic disease dynamics and payer coverage behavior more than by near-term breakthroughs.
• The highest impact risks to a 2025–2035 revenue projection are competitive coverage shifts and generic-entry timing for alternatives, which can trigger faster switching and net price compression.
• A numeric projection requires sourced baseline sales and sourced exclusivity/patent timelines, which were not provided in the input content.

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FAQs

1. What clinical endpoints are most predictive of AUSTEDO continuation for TD and HD chorea?
2. How do prior authorization rules affect AUSTEDO first-fill timing and persistence?
3. What safety monitoring elements most influence physician willingness to titrate AUSTEDO?
4. How should investors model net price compression risk for chronic VMAT2 inhibitor brands?
5. What competitive events typically cause the largest quarter-to-quarter share shifts in TD VMAT2 therapy?

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References (APA)

1. FDA. (n.d.). Drug approvals and labeling for deutetrabenazine (AUSTEDO). U.S. Food and Drug Administration.
2. Orange Book. (n.d.). Deutetrabenazine listings and patent information. U.S. FDA, Approved Drug Products with Therapeutic Equivalence Evaluations.
3. ClinicalTrials.gov. (n.d.). Deutetrabenazine (AUSTEDO) clinical studies. U.S. National Library of Medicine.