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. First approved in 2019.
Drug data last refreshed 7h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAPLYTA (lumateperone) is an oral atypical antipsychotic approved for treating depressive episodes in bipolar disorder (as monotherapy or adjunctive therapy) and major depressive disorder (as adjunctive therapy with antidepressants). It works through a combination of 5-HT2A receptor antagonism and D2 receptor partial agonism, offering a differentiated mechanism within the antipsychotic class.
$0.195BPart D
Peak14.2 years to LOEProduct is in peak lifecycle phase with $195M in Part D spending and 118,753 claims in 2023, indicating an actively scaled commercial team with room for market expansion.
Mechanism 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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder
Started Oct 2026
585 enrolled
Depressive Disorder, Major
The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression
Started Sep 2026
25 enrolled
Bipolar Depression Depressed PhaseObesity & Overweight
Lumateperone for Late-Life Depression
Started Sep 2026
100 enrolled
Treatment Resistant Depression (TRD)Late Life Depression (LLD)Depression / Major Depressive Disorder
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
Started Dec 2024
160 enrolled
Irritability Associated With Autism Spectrum Disorder
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
Started Nov 2024
160 enrolled
Irritability Associated With Autism Spectrum 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.