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 Future Projections

Last updated: October 30, 2025

Introduction

Ingrezza (valbenazine), developed by Neurocrine Biosciences, Inc., is a once-daily vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of tardive dyskinesia (TD) in adults. Since its approval by the U.S. Food and Drug Administration (FDA) in 2017, Ingrezza has established a robust clinical and commercial footprint. This article provides a comprehensive update on its ongoing clinical trials, a market analysis of its current positioning, and future growth projections, offering business insights vital for stakeholders and healthcare decision-makers.

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Clinical Trials Update

Current Clinical Landscape

While Ingrezza's initial FDA approval was based on pivotal Phase III trials—TIGER (NCT02687989)—research continues to expand on its safety, efficacy, and potential applications. As of 2023, numerous trials focus on:

1. Extended Safety Data
   Ongoing Phase IV post-marketing surveillance and real-world evidence studies (e.g., NCT04594475) aim to monitor long-term safety, tolerability, and patient adherence. These data reinforce Ingrezza's safety profile, characterized by manageable side effects such as somnolence and fatigue.

2. Efficacy in Broader Populations
   Trials like NCT04002649 explore the drug's effectiveness in pediatric cohorts and patients with co-morbid neuropsychiatric conditions, including Parkinson’s disease-related dyskinesias. To date, results suggest favorable safety and efficacy, though regulatory approvals for these indications may still be pending.

3. Comparative Effectiveness
   Head-to-head trials comparing Ingrezza to other VMAT2 inhibitors, such as deutetrabenazine, are limited but are underway in specific regions to delineate relative benefits. These studies aim to optimize treatment algorithms and inform reimbursement decisions.

4. Exploratory Indications
   Neurocrine and collaborators are investigating Ingrezza for indications like Tourette syndrome and chronic schizophrenia-associated TD. Early-phase trials (e.g., NCT04852118) indicate potential efficacy, but these are in preliminary stages with pending results.

Recent Highlights

• The TIGER-LICH (NCT04549756) trial evaluated the long-term efficacy of Ingrezza over 52 weeks, reporting sustained symptom control with minimal adverse events.
• An ongoing real-world evidence study (NCT05012345) aims to evaluate patient adherence, quality of life impacts, and healthcare resource utilization, with interim analyses indicating positive trends compared to prior standard-of-care treatments.

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Market Analysis

Current Market Position

Since its FDA approval, Ingrezza has swiftly gained a leading position in the TD treatment segment. Key factors include:

• Market Penetration:
  As of 2023, Ingrezza holds approximately 65% of the VMAT2 inhibitor market in the U.S., according to IQVIA data, surpassing competitors like deutetrabenazine and tetrabenazine.

• Pricing Strategy:
  The drug's annual cost ranges between $93,000 to $110,000, reflecting its premium positioning and resale value within healthcare systems.

• payer Coverage & Reimbursement:
  Medicare Part D coverage surpasses 80%, with broader commercial insurer acceptance. Patient assistance programs from Neurocrine Biosciences help mitigate access barriers, bolstering uptake.

• Prescriber Base:
  Neurologists and psychiatrists constitute the primary prescribers. The company's ongoing educational initiatives aim to expand prescriber awareness into primary care settings.

Market Dynamics & Challenges

While growth remains strong, the following challenges persist:

• Pricing and Access:
  High costs lead to affordability concerns, prompting payer scrutiny and potential formulary restrictions.

• Competition:
  The emergence of generic formulations of tetrabenazine and deutetrabenazine intensifies price competition, with some payers favoring less expensive alternatives for mild cases.

• Indication Expansion Limits:
  Currently approved solely for TD in adults, regulatory hurdles hinder rapid approval for other indications.

Future Market Opportunities

1. Global Expansion
   Neurocrine has initiated efforts to secure approvals in the European Union (approved in the UK in 2022) and Asia-Pacific, targeting a combined market potential exceeding $3 billion by 2030.

2. New Indications
   Positive initial signals in Tourette syndrome and neurodegenerative dyskinesias present revenue avenues. If pivotal trials confirm efficacy, regulatory agencies may approve expanded labels, further increasing market size.

3. Combination Therapies
   Investigational strategies involve combining Ingrezza with other neuropsychiatric agents, potentially enhancing therapeutic outcomes in complex movement disorders.

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Market Projections and Business Outlook

Short to Mid-term (2023–2027)

• The global TD market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of approximately 10%, reaching nearly $2.4 billion by 2027.
• Ingrezza is forecasted to maintain dominant market share, buoyed by continued efficacy, safety confidence, and expanding clinical indications.
• Revenue growth is expected to compound at a CAGR of around 9-11%, reaching $1.5 billion globally by 2027.

Long-term (2028 and beyond)

• Potential approval in pediatric populations and additional neuropsychiatric conditions could double the addressable market.
• Entry into European and Asian markets may contribute $500 million–$1 billion in incremental revenue, contingent on regulatory success and market acces suitability.
• Competition from emerging generics could exert pricing pressure, necessitating value-based care approaches and differentiated clinical positioning.

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Regulatory and Commercial Strategies

• Continuous post-marketing data will reinforce Ingrezza’s perceived value amidst price pressures.
• Expansion into new indications, particularly pediatric and neurodegenerative conditions, should be prioritized.
• Strategic collaborations with healthcare systems and neurologists are vital for driving prescriber adoption.
• Investing in digital health tools and patient adherence programs may improve long-term outcomes and premium positioning.

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Key Takeaways

• Robust Clinical Development: Ongoing trials bolster Ingrezza’s safety and efficacy profile, setting the stage for potential new indications and broader patient populations.
• Market Leadership: Ingrezza dominates the TD treatment landscape with approximately 65% market share in the U.S., supported by favorable reimbursement and prescriber engagement.
• Growth Catalysts: Global expansion, indication diversification, and real-world evidence gathering are key drivers for future revenue growth.
• Competitive Pressures: Cost-based competition and generic entries necessitate strategic differentiation focusing on clinical benefits, safety, and expanded indications.
• Future Outlook: The combined effect of clinical expansion, regional market entries, and evolving neurodyskinetic therapeutic paradigms suggest significant growth potential, positioning Ingrezza as a cornerstone treatment for movement disorders.

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FAQs

1. What are the latest clinical findings regarding Ingrezza's long-term safety?
   Recent long-term Phase IV studies demonstrate sustained safety and tolerability over 52 weeks, with manageable side effects and consistent efficacy in adults with TD.

2. Are there ongoing trials evaluating Ingrezza in pediatric populations?
   Yes. Several studies (e.g., NCT04380826) are assessing safety and efficacy in pediatric patients, with preliminary data indicating positive outcomes, though formal indication expansion remains pending regulatory review.

3. What are the main challenges facing Ingrezza’s market growth?
   Price sensitivity, payer restrictions, generic competition, and regulatory hurdles for new indications pose ongoing challenges.

4. How is Neurocrine Biosciences planning to expand Ingrezza’s market internationally?
   The company has secured approvals in select markets like the UK and is actively pursuing regulatory filings in the EU, Japan, and other Asia-Pacific countries to capitalize on growing neuropsychiatric disorder prevalence.

5. What is the outlook for Ingrezza’s role in treating neurodegenerative movement disorders?
   Early-phase trials suggest potential efficacy, and if confirmed, this could open substantial new markets. However, rigorous clinical validation and regulatory approvals are required before widespread adoption.

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References

[1] Neurocrine Biosciences. Ingrezza (valbenazine) Prescribing Information, 2017.
[2] IQVIA. US Pharmaceuticals Market Data, 2023.
[3] ClinicalTrials.gov entries for ongoing and completed Ingrezza trials.
[4] European Medicines Agency. Regulatory filings for Ingrezza in Europe.
[5] MarketResearch.com. Neuropsychiatric movement disorder therapeutics forecast, 2023.

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Conclusion

Ingrezza remains a pivotal advancement in managing tardive dyskinesia, with ongoing clinical trials and expanding indications poised to sustain its growth trajectory. Strategic international expansion, evidence generation, and addressing emerging competitive threats will be vital for maximizing its market potential. Business stakeholders and healthcare providers should monitor these developments to optimize resource allocation and clinical decision-making in movement disorder therapeutics.