CLINICAL TRIALS PROFILE FOR INGREZZA

All Clinical Trials for ingrezza

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03325010 ↗	Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome	Completed	Neurocrine Biosciences	Phase 2	2017-10-05	This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's optimal dose administered once daily (qd) for a total of 12 weeks of treatment in pediatric subjects with TS.
NCT03444038 ↗	Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome	Completed	Neurocrine Biosciences	Phase 2	2018-02-08	This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.
NCT03530293 ↗	Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome	Terminated	Neurocrine Biosciences	Phase 2	2018-04-16	This is a Phase 2, double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety and maintenance of efficacy of an optimized once-daily (qd) dose of NBI-98854 in pediatric subjects with TS.
NCT03732534 ↗	Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome	Terminated	Neurocrine Biosciences	Phase 2	2018-10-17	This is an open-label, rollover study to collect long-term safety, tolerability, and investigator- and participant-reported pharmacodynamic (PD) data after chronic administration of NBI-98854 in pediatric participants with Tourette Syndrome (TS), as well as to provide open-label access to NBI-98854 for the treatment of TS for pediatric participants who have taken part in a Phase 2 NBI-98854 study.
NCT05157100 ↗	Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia	Enrolling by invitation	The Orthopedic Foundation	Phase 4	2021-10-19	STUDY OF INGREZZA (VALBENAZINE) FOR THE TREATMENT OF CERVICAL DYSTONIA
NCT05207085 ↗	Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults	Not yet recruiting	Neurocrine Biosciences	Phase 2	2022-02-01	This trial aims to evaluate the efficacy, safety and tolerability of valbenazine, titrated to the subject's optimal dose of 40mg or 80mg, administered once daily, for 12 weeks, for the treatment of trichotillomania (TTM) in a double blind placebo controlled design study. After week 12, subjects will begin a 12-week, open-label portion of the study. During the open-label portion of the study, all subjects will receive the study drug at their optimal dose. The primary endpoint of these studies will be the change from baseline of placebo vs. active scores utilizing the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) at the end of Week 12.
NCT05207085 ↗	Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults	Not yet recruiting	Michael Bloch	Phase 2	2022-02-01	This trial aims to evaluate the efficacy, safety and tolerability of valbenazine, titrated to the subject's optimal dose of 40mg or 80mg, administered once daily, for 12 weeks, for the treatment of trichotillomania (TTM) in a double blind placebo controlled design study. After week 12, subjects will begin a 12-week, open-label portion of the study. During the open-label portion of the study, all subjects will receive the study drug at their optimal dose. The primary endpoint of these studies will be the change from baseline of placebo vs. active scores utilizing the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) at the end of Week 12.

Clinical Trial Conditions for ingrezza

Condition Name

Condition Name for ingrezza
Intervention	Trials
Tourette Syndrome	4
Cervical Dystonia	1
Developmental Disabilities	1
Intellectual Disability	1

Condition MeSH

Condition MeSH for ingrezza
Intervention	Trials
Tourette Syndrome	4
Syndrome	4
Dyskinesias	1
Developmental Disabilities	1

Clinical Trial Locations for ingrezza

Trials by Country

Trials by Country for ingrezza
Location	Trials
United States	66
Puerto Rico	4

Trials by US State

Trials by US State for ingrezza
Location	Trials
Illinois	4
Florida	4
Connecticut	4
California	4
Ohio	4

Clinical Trial Progress for ingrezza

Clinical Trial Phase

Clinical Trial Phase for ingrezza
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	5

Clinical Trial Status

Clinical Trial Status for ingrezza
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	2
Terminated	2

Clinical Trial Sponsors for ingrezza

Sponsor Name

Sponsor Name for ingrezza
Sponsor	Trials
Neurocrine Biosciences	6
The Orthopedic Foundation	1
Michael Bloch	1

Sponsor Type

Sponsor Type for ingrezza
Sponsor	Trials
Industry	6
Other	3

INGREZZA (valbenazine): Clinical Trials Update, Market Analysis, and Projection

Last updated: May 1, 2026

What is INGREZZA’s current clinical and regulatory footprint?

INGREZZA (valbenazine) is approved for treatment of tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD chorea) in the US. The commercial life-cycle now hinges on (1) incremental evidence in newer subpopulations and (2) sustaining uptake and payer support amid branded competition in movement-disorder CNS.

Approved indications (US)

• Tardive dyskinesia (TD)
• Chorea associated with Huntington’s disease (HD chorea)
  Source: FDA label for INGREZZA. [1]

Pivotal development baseline (context for current strategy)

• INGREZZA’s approval is grounded in randomized trials showing improvements on established dyskinesia and chorea endpoints, supported by long-term safety evaluation in post-approval programs (label safety framework includes monitoring requirements such as QT considerations). [1]

Which clinical trials are actively shaping the pipeline?

A complete “current trials update” requires live trial registry extraction (e.g., ClinicalTrials.gov status, enrollment, endpoints, and results dates). No such trial registry data was provided in the prompt, and an accurate update cannot be produced from memory alone without risking incorrect trial status or wrong endpoints.

What is the market context and demand structure for INGREZZA?

Category

INGREZZA sits in the movement-disorder CNS segment, specifically orofacial and limb TD and HD chorea. Demand is driven by:

• Diagnosis prevalence and symptom burden in specialist-treated populations
• Payer policy design (medical necessity criteria, step edits, and prior authorization)
• Tolerability and dosing convenience versus alternatives

Competitive and substitution dynamics

Valbenazine competes within a branded TD/HD chorea landscape that includes other vesicular monoamine transporter 2 (VMAT2) agents and other off-label or symptomatic approaches. In practice, substitution is driven by:

• Formulary placement and net price
• Clinician and patient familiarity
• Safety profile considerations (sedation, QT-related risk management, and monitoring burdens)

(Competition specifics and share cannot be quantified without market-share and pricing inputs.)

How does dosing and safety influence adoption?

Dosing in label

• TD and HD chorea dosing follows a titration and maintenance approach as described in the US prescribing information, with attention to patient factors relevant to safety monitoring. [1]

Safety framework that affects payer and clinician behavior

The label includes risk controls tied to CNS tolerability and cardiac rhythm considerations (QT-related precautions) that influence real-world prescribing workflows (screening and monitoring). [1]

Market analysis: commercial drivers, friction points, and unit economics indicators

Primary commercial drivers

1. Ongoing access expansion through managed care contracting and clinician channel penetration in neurology and psychiatry.
2. Treatment persistence supported by an established maintenance dosing pattern and tolerability profile.
3. Earlier treatment initiation as awareness of TD diagnostic frameworks and HD chorea management grows in specialty settings.

Primary friction points

1. Prior authorization friction for TD and HD chorea, where payers often require documentation of diagnosis and severity and may limit duration of coverage pending reassessment.
2. Monitoring burden that can slow uptake in primary-care-adjacent workflows and require referral routing.
3. Brand-to-brand and class competition that intensifies pricing pressure during formulary cycles.

Projection: base case commercial trajectory

A numeric projection (revenue, prescriptions, growth rates) requires at least one of the following: current sales, prescription volume, market-share estimates, or analyst baseline figures. None were included. With only the brand name and no quantitative market anchor, a complete and accurate numeric projection cannot be produced.

What matters most for investors and R&D decision-making in the next 12 to 36 months?

Near-term watch items

• Uptake durability: whether prescribing remains stable across payers after formulary reviews.
• Safety-driven access: how QT and CNS tolerability considerations translate into real-world prescribing patterns.
• Evidence generation: whether trial readouts support expanded positioning in subpopulations or reinforce payer comfort for continued coverage.

R&D watch items

• New clinical evidence that improves endpoint robustness, expands label-relevant subgroups, or clarifies optimal sequencing with competing therapies.
• Competitive differentiation in dosing convenience and tolerability in practice rather than only in trial settings.

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Key Takeaways

• INGREZZA (valbenazine) is approved in the US for tardive dyskinesia and HD chorea; its label includes safety controls that shape real-world access and monitoring workflows. [1]
• A full “clinical trials update” with current trial status cannot be produced from the provided inputs without risking inaccurate trial details.
• A quantified market projection cannot be produced without a sales/prescription baseline or published market-share inputs.

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FAQs

1. What conditions is INGREZZA approved to treat in the US?
   Tardive dyskinesia and chorea associated with Huntington’s disease. [1]

2. What is INGREZZA’s mechanism of action class?
   It is a VMAT2 inhibitor used for hyperkinetic movement disorders. [1]

3. What safety considerations influence prescribing?
   The label includes precautions tied to CNS tolerability and QT-related risk management. [1]

4. Does INGREZZA dosing involve titration?
   Yes. The US prescribing information specifies dosing and titration steps for maintenance treatment. [1]

5. Can you provide numeric sales and market projections from this request alone?
   Not with accuracy, because no sales, prescription, share, or market baseline was provided.

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References

[1] U.S. Food and Drug Administration. INGREZZA (valbenazine) prescribing information. Accessed via FDA label documentation.