NDAORALCAPSULE
Approved
Sep 2015
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug data last refreshed 2d ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VRAYLAR (cariprazine) is an oral atypical antipsychotic approved in 2015 for schizophrenia and bipolar disorder. It works through dopamine D2/D3 receptor partial agonism with preferential D3 binding. The mechanism provides efficacy in psychotic and mood disorders with a differentiated side-effect profile compared to first-generation agents.
$0.936BPart D
Peak3.7 years to LOEPeak-cycle product with substantial Medicare utilization ($936M Part D spending) indicates stable commercial infrastructure and mid-sized team operations.
Mechanism of Action
Pharmacologic Class:
Atypical Antipsychotic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
Started Apr 2024
120 enrolled
Bipolar I Disorder
Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
Started Aug 2022
34 enrolled
Schizophrenia
Cariprazine Versus Placebo for Social Anxiety Disorder
Started Jul 2022
40 enrolled
Social Anxiety Disorder
Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD
Started Jul 2022
161 enrolled
Autism Spectrum Disorder
Adjunct Treatment With Cariprazine for Adults With Attention-deficit/Hyperactivity Disorder
Started Dec 2021
15 enrolled
Attention Deficit Hyperactivity Disorder
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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.