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Last Updated: February 9, 2025

CLINICAL TRIALS PROFILE FOR INGREZZA


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ingrezza

Condition Name

Condition Name for Ingrezza
Intervention Trials
Tourette Syndrome 4
Developmental Disabilities 1
Intellectual Disability 1
Tardive Dyskinesia 1
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Condition MeSH

Condition MeSH for Ingrezza
Intervention Trials
Tourette Syndrome 4
Syndrome 4
Dystonia 1
Intellectual Disability 1
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Clinical Trial Locations for Ingrezza

Trials by Country

Trials by Country for Ingrezza
Location Trials
United States 66
Puerto Rico 4
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Trials by US State

Trials by US State for Ingrezza
Location Trials
Nebraska 4
Illinois 4
Florida 4
Connecticut 4
California 4
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Clinical Trial Progress for Ingrezza

Clinical Trial Phase

Clinical Trial Phase for Ingrezza
Clinical Trial Phase Trials
Phase 4 2
Phase 2 5
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Clinical Trial Status

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

Sponsor Name

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

Sponsor Type for Ingrezza
Sponsor Trials
Industry 6
Other 3
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INGREZZA: Clinical Trials Update, Market Analysis, and Projections

Introduction to INGREZZA

INGREZZA, also known as valbenazine, is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor developed by Neurocrine Biosciences. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD)[2][3][4].

Clinical Trials Update

KINECT-4 Study for Tardive Dyskinesia

The KINECT-4 study, a Phase 3 open-label trial, has provided significant insights into the efficacy and safety of INGREZZA in treating tardive dyskinesia. The study involved 163 participants with moderate to severe TD and underlying schizophrenia, schizoaffective disorder, or mood disorders. Participants received 48 weeks of open-label treatment with INGREZZA at doses of 40 mg or 80 mg per day, followed by a four-week washout period.

Key findings from the study include:

  • Nearly 60% of participants achieved remission of TD symptoms, with 59.2% having a score of 1 or less in each Abnormal Involuntary Movement Scale (AIMS) item at Week 48[2][4].
  • The remission rates varied slightly between the two dosage groups, with 65.0% in the 40 mg dose group and 57.8% in the 80 mg dose group[2].
  • Complete resolution of symptoms, with a total AIMS score of 0, was observed in 10% of participants[2].

The study also demonstrated that INGREZZA was generally well tolerated, with treatment-emergent adverse events (TEAEs) such as urinary tract infections (8.5%) and headaches (5.2%) occurring in more than 5% of participants. Changes in psychiatric stability, vital signs, electrocardiogram parameters, and laboratory test values were minor and not clinically significant[1][2][4].

KINECT-HD Study for Huntington’s Disease

The KINECT-HD study, a Phase III randomized, double-blind, placebo-controlled trial, evaluated the efficacy, safety, and tolerability of INGREZZA in treating chorea associated with Huntington’s disease. The study involved 120 patients and showed that INGREZZA significantly reduced the symptoms of chorea, as assessed by the Unified Huntington’s Disease Rating Scale (UHDRS) and the total maximal chorea (TMC) score. Patients on INGREZZA achieved a placebo-adjusted mean reduction in the TMC score by 3.2 units at weeks 10 and 12[3].

Additional Research

Neurocrine Biosciences has also presented data on INGREZZA’s impact on patients with dysphagia and the quality of life improvements in patients treated with the drug. These findings further support the drug’s effectiveness and safety profile[2].

Market Analysis

Current Market Performance

INGREZZA has shown strong market performance, particularly in the treatment of tardive dyskinesia. In the third quarter of 2024, sales of INGREZZA reached $613 million, leading to an updated annual revenue guidance of $2.3 to $2.32 billion, representing a 25% growth compared to the previous year[2].

Financial Health

Neurocrine Biosciences' financial health is robust, with a gross profit margin of 68.07% and an operating income margin of 26.85% over the last twelve months. This financial stability allows the company to continue investing in research and development for treatments like INGREZZA[2].

Competitive Landscape

INGREZZA competes in the market against other VMAT2 inhibitors, such as Teva’s Austedo (deutetrabenazine). However, INGREZZA has several competitive advantages, including a convenient once-daily dosing regimen and a better safety profile, particularly regarding the risk of depression and suicidality. This positions INGREZZA to gain significant market share in the treatment of HD chorea[3].

Market Projections

Sales Projections

INGREZZA is forecast to generate strong sales, particularly in the Huntington’s disease market. GlobalData expects INGREZZA to generate $326 million in sales for HD in the US from its approval until 2030. This projection is based on the drug’s clinical advantages and the sparseness of the US HD therapeutics market[3].

Market Share

Given its competitive advantages, INGREZZA is likely to seize significant market share from its main competitor, Austedo. The convenience of once-daily dosing and the absence of a boxed warning for depression and suicidality are key factors that will drive its adoption[3].

Future Growth

The positive clinical outcomes and strong financial performance of Neurocrine Biosciences suggest continued growth for INGREZZA. Analysts have revised their earnings upwards for the upcoming period, indicating optimism about the drug’s future market performance[2].

Quality of Life Improvements

Patient Outcomes

Studies have shown that INGREZZA not only reduces the symptoms of TD and HD chorea but also improves the quality of life for patients. The reduction in involuntary movements and the absence of significant adverse effects contribute to better patient outcomes and improved quality of life[2][3].

Impact on Dysphagia

Additional research presented at the 2024 Psych Congress highlighted INGREZZA’s impact on patients with dysphagia, further underscoring its benefits beyond just symptom reduction[2].

Safety and Tolerability

Adverse Events

INGREZZA has been consistently shown to be well tolerated in clinical trials. The most common treatment-emergent adverse events include urinary tract infections and headaches, which occur in more than 5% of participants. Other safety parameters, such as psychiatric stability, vital signs, electrocardiogram parameters, and laboratory test values, remain generally stable and not clinically significant[1][2][4].

Long-Term Safety

The long-term safety profile of INGREZZA has been supported by the KINECT-4 study, which demonstrated that the drug remains safe and effective over an extended treatment period[1][2][4].

Key Takeaways

  • INGREZZA has demonstrated significant efficacy in treating tardive dyskinesia and chorea associated with Huntington’s disease.
  • The drug has shown a strong safety profile with minimal adverse events.
  • Market performance is robust, with sales reaching $613 million in the third quarter of 2024.
  • INGREZZA is projected to gain significant market share in the HD market due to its competitive advantages.
  • The drug improves quality of life for patients by reducing symptoms and minimizing adverse effects.

FAQs

What is INGREZZA used for?

INGREZZA (valbenazine) is used for the treatment of adults with tardive dyskinesia and chorea associated with Huntington’s disease[2][3][4].

What are the common side effects of INGREZZA?

Common side effects of INGREZZA include urinary tract infections and headaches, occurring in more than 5% of participants[1][2][4].

How effective is INGREZZA in treating tardive dyskinesia?

INGREZZA has shown that nearly 60% of participants achieved remission of TD symptoms in the KINECT-4 study[2][4].

What is the competitive advantage of INGREZZA over other VMAT2 inhibitors?

INGREZZA has a convenient once-daily dosing regimen and does not pose the risk of increased depression and suicidality, unlike some of its competitors[3].

What are the projected sales for INGREZZA in the Huntington’s disease market?

INGREZZA is forecast to generate $326 million in sales for HD in the US from its approval until 2030[3].

Sources

  1. Neurocrine Biosciences Presents New Data on INGREZZA (valbenazine) Capsules at Psych Congress 2024. Neurocrine Biosciences.
  2. INGREZZA shows tardive dyskinesia remission in study. Investing.com.
  3. Positive Phase III data push Neurocrine's Ingrezza closer to dominant position in Huntington's disease market. Clinical Trials Arena.
  4. Neurocrine Biosciences Presents New Data on INGREZZA (valbenazine) Capsules at Psych Congress 2024. PR Newswire.
  5. Neurocrine Biosciences Reports Fourth Quarter and Fiscal 2023 Financial Results. Neurocrine Biosciences.

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