NDAORALCAPSULE
Approved
Dec 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
CAPLYTA (lumateperone) by Intra-Cellular Therapies is adults, for the treatment of depressive episodes associated with bipolar depression (as monotherapy or as adjunctive therapy with lithium or valproate), and as adjunctive therapy with antidepressants for the treatment of mdd is unknown. Approved for bipolar depression, major depressive disorder, schizophrenia and 1 more indications. First approved in 2019.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAPLYTA (lumateperone) is an oral atypical antipsychotic approved in December 2019 for treating schizophrenia and depressive episodes associated with bipolar disorder as monotherapy or adjunctive therapy, and as adjunctive therapy with antidepressants for major depressive disorder. Its mechanism of action combines antagonist activity at serotonin 5-HT2A receptors with partial agonist activity at dopamine D2 receptors. The product represents a differentiated mechanism within the antipsychotic class and is currently in its peak commercial lifecycle stage.
$0.2BPart D
14.6 years to LOEMechanism of Action
adults, for the treatment of depressive episodes associated with bipolar depression (as monotherapy or as adjunctive therapy with lithium or valproate), and as adjunctive therapy with antidepressants for the treatment of MDD is unknown. However, the mechanism of action of lumateperone for these…
Pharmacologic Class:
Atypical Antipsychotic
Indications (4)
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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.