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. First approved in 2017.
Drug data last refreshed 12h ago · AI intelligence enriched 17h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INGREZZA (valbenazine) is an oral small-molecule capsule approved by FDA in April 2017 for the treatment of tardive dyskinesia, a hyperkinetic movement disorder associated with antipsychotic or metoclopramide use. It works through reversible inhibition of vesicular monoamine transporter 2 (VMAT2), reducing cytoplasmic monoamine levels available for synaptic release. The mechanism represents a novel, non-dopamine-blocking approach to managing involuntary movements.
$1.7BPart D
Peak13.9 years to LOEAt peak lifecycle with $1.7B in Part D spending and 225K claims in 2023, indicating a mature commercial franchise with stable field and marketing infrastructure.
Mechanism 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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (15)
Valbenazine in Obsessive Compulsive Disorder
Started Jun 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
100 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.