NDAORALCAPSULEPriority Review
Approved
Apr 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
15
Data completeness
7/8 — Comprehensive
Priority Review
INGREZZA (valbenazine) by Neurocrine Biosciences is huntington's disease is unclear, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (vmat2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release. Approved for tardive dyskinesia. First approved in 2017.
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INGREZZA (valbenazine) is an oral capsule medication approved by the FDA on April 11, 2017, developed by Neurocrine Biosciences. It is indicated for the treatment of involuntary movement disorders, working through reversible inhibition of vesicular monoamine transporter 2 (VMAT2) to regulate monoamine storage and release in synaptic vesicles. The mechanism is thought to address the underlying neurobiological dysfunction in conditions like tardive dyskinesia and Huntington's disease. INGREZZA represents a novel mechanistic approach to treating movement disorders previously managed with limited pharmacological options.
$1.7BPart D
14.3 years to LOEMechanism of Action
Huntington's disease is unclear, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release.
Indications (1)
Clinical Trials (15)
Valbenazine in Obsessive Compulsive Disorder
Started Feb 2026
30 enrolled
Obsessive-Compulsive Disorder
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Started Aug 2025
50 enrolled
SchizophreniaSchizoaffective DisorderBipolar Disorder+2 more
Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities
Started Jan 2025
0Tardive DyskinesiaIntellectual DisabilityDevelopmental Disabilities
Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine
Started Oct 2024
0Tardive Dyskinesia
Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada
Started Apr 2024
7 enrolled
Chorea, Huntington
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.