Ingrezza

(Valbenazine)

ApprovedSmall molecule

Valbenazine is used to treat involuntary repetitive movements and tics, particularly tardive dyskinesia, which is a condition that can develop as a side effect of certain psychiatric medications.[2] Ingrezza is currently approved and in use across 11 indications[4].[1]

Ingrezza is one of 142 small molecule programs targeting Tardive Dyskinesia. It is currently in Approved.

Indications

Total Trials

Active Trials

141

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Tardive DyskinesiaCompleted

Parkinson's DiseaseApproved

SchizophreniaRecruiting

Huntington's DiseaseApproved

Movement DisorderApproved

Obsessive-Compulsive DisorderApproved

Hair-PullingApproved

Cerebral PalsyActive, not recruiting

TrichotillomaniaRecruiting

Huntington DiseaseActive, not recruiting

Tardive DyskinesiaApproved

Completed

Parkinson's DiseaseApproved

Approved

SchizophreniaApproved

Recruiting

Huntington's DiseaseApproved

Approved

Movement DisorderApproved

Approved

Obsessive-Compulsive DisorderApproved

Approved

Hair-PullingApproved

Approved

Cerebral PalsyPhase 3

Active, not recruiting

TrichotillomaniaPhase 2

Recruiting

Huntington DiseasePhase 3

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Ingrezza

Neurocrine Biosciences

Approved

3 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Luvox

SSolvay Pharmaceuticals

Preclinical

1 9

Catapres

Boehringer Ingelheim

Preclinical

1 10

Rapamune

PPrism Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Trichotillomania

NCT05207085

Q4 2027

Phase 2Not yet recruiting

Obsessive-Compulsive Disorder

NCT07111988

Q2 2028

ApprovedRecruiting

Schizophrenia

NCT07105111

Clinical

Trials by Indication[1]

Tardive Dyskinesia5 trials

Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities

Withdrawn·SStephen Ruedrich·Phase 4·NCT06107829

Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia

Completed· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 4·NCT03891862·135 enrolled

Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

Completed· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 3·NCT02736955·161 enrolled

Show 2 more trials

Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine

Withdrawn·YYale University·Phase 1·NCT05053321

Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia

Completed· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 4·NCT05859698·59 enrolled

Tourette syndrome4 trials

Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

Completed· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 2·NCT03444038·85 enrolled

Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome

Completed· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 2·NCT02879578·155 enrolled

Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome

Terminated· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 2·NCT03530293·81 enrolled

Show 1 more trial

Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

Completed· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 2·NCT03325010·127 enrolled

Huntington disease3 trials

Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease

Completed· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 3·NCT04102579·128 enrolled

Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease

Active, not recruiting· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 3·NCT04400331·154 enrolled

Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada

Enrolling by invitation· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 3·NCT06312189·7 enrolled

Schizophrenia3 trials

Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia

Completed· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 3·NCT05110157·442 enrolled

Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia

Terminated· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 3·NCT05654870·8 enrolled

A Phase 4, Open-Label Study to Evaluate the Efficacy of Valbenazine on Clinician- and Patient-Reported Outcomes in Patients With Tardive Dyskinesia (TD) Who Remain Symptomatic While on Deutetrabenazine or After Discontinuing Prior TD Treatment With a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Recruiting· Neurocrine Biosciences logo

Neurocrine Biosciences·Approved·NCT07105111·100 enrolled

Obsessive-Compulsive Disorder1 trial

Valbenazine in Obsessive Compulsive Disorder

Not yet recruiting·UUniversity of Chicago·Phase 2·NCT07111988·30 enrolled

4 more indications

Trichotillomania1 trial

Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults

Recruiting·YYale University·Phase 2·NCT05207085·20 enrolled

Cerebral Palsy1 trial

Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy

Active, not recruiting· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 3·NCT05206513·86 enrolled

Cervical Dystonia1 trial

Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia

Recruiting·VVirginia Commonwealth University·Phase 2·NCT06771323·20 enrolled

Withdrawal1 trial

The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

Completed· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 4·NCT03698331·89 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 11, 2017

INGREZZA

NDA NDA209241

Apr 11, 2017

INGREZZA

NDA NDA209241

Aug 10, 2018

INGREZZA

NDA NDA209241

Jan 10, 2019

INGREZZA

NDA NDA209241

Jul 15, 2019

INGREZZA

NDA NDA209241

Apr 9, 2020

INGREZZA

NDA NDA209241

Apr 23, 2021

INGREZZA

NDA NDA209241

Aug 11, 2022

INGREZZA

NDA NDA209241

Aug 18, 2023

INGREZZA

NDA NDA209241

Apr 30, 2024

INGREZZA SPRINKLE

NDA NDA218390

Apr 30, 2024

INGREZZA SPRINKLE

NDA NDA218390

Nov 22, 2024

INGREZZA

NDA NDA209241

Feb 4, 2025

INGREZZA

NDA NDA209241

Apr 8, 2026

INGREZZA SPRINKLE

NDA NDA218390

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Valbenazine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ingrezza drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Valbenazine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Valbenazine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA218390). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Ingrezza. U.S. Food & Drug Administration.
[7]
PubMed — 10 publications indexed for Valbenazine. U.S. National Library of Medicine.
[8]
SEC EDGAR — Neurocrine Biosciences company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: VMAT2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Neurocrine Biosciences

Patent Landscape[6]

Patent Cliff

Nov 8, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8357697Nov 8, 2027

8039627Apr 11, 2031

10844058Oct 28, 2036

10065952Oct 28, 2036

10851104Oct 28, 2036

17 more patents

10851103Oct 28, 2036

10919892Dec 22, 2036

10906902Dec 22, 2036

10906903Dec 22, 2036

10857137Oct 10, 2037

11040029Oct 10, 2037

10993941Oct 10, 2037

10874648Oct 10, 2037

10857148Oct 10, 2037

10952997Oct 10, 2037

11439629Oct 10, 2037

10912771Oct 10, 2037

11311532Sep 18, 2038

11026939Sep 18, 2038

11654142Nov 14, 2038

11026931Aug 14, 2039

10940141Aug 10, 2040

Key Publications[7]

Endoscopic Sphincterotomy Prior to Biliary Stenting for Malignant Biliary Obstruction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

J Gastroenterol HepatolSep 4, 2026DOI: 10.1111/jgh.70714

A Phase 1 study of subcutaneous toripalimab in recurrent or metastatic nasopharyngeal carcinoma.

Br J Clin PharmacolSep 4, 2026DOI: 10.1002/bcp.70796

The Potential Allergic Role of Mast Cells to Orthodontic Appliance in Orthodontic-Induced Gingival Enlargement.

Oral Health Prev DentSep 4, 2026DOI: 10.3290/j.ohpd.c_2801

A Retrospective Cohort Study of Medication-Related Osteonecrosis of the Jaw (MRONJ) Prevention.

Oral Health Prev DentSep 4, 2026DOI: 10.3290/j.ohpd.c_2794

Patients' Real-World Experiences With Pharmacologic Therapies for Irritable Bowel Syndrome With Constipation: A Mixed-Methods Analysis and Classification of Social Media and E-Forum Posts.

Neurogastroenterol MotilSep 1, 2026DOI: 10.1111/nmo.70432

Lunsotogene Parvec: First Approval.

DrugsAug 4, 2026DOI: 10.1007/s40265-026-02361-7

Targeting the NO-cGMP axis in age-related vascular dysfunction: a systematic review and meta-analysis of preclinical animal studies.

GeroscienceAug 4, 2026DOI: 10.1007/s11357-026-02427-0

Weight regain after obesity treatment: mechanisms, predictors, and real-world evidence from the IGOBE program.

Rev Endocr Metab DisordAug 4, 2026DOI: 10.1007/s11154-026-10070-5

Neural Stem Cells in Multiple Sclerosis: A Comprehensive Review of Preclinical and Clinical Evidence for CNS Repair and Translational Hurdles.

Appl Biochem BiotechnolAug 4, 2026DOI: 10.1007/s12010-026-05865-w

3D Contractile and Remodeling Behaviors of Functionally Normal and Prolapsed Human Mitral Valve Interstitial Cells.

Ann Biomed EngAug 3, 2026DOI: 10.1007/s10439-026-04319-y