NDAORALCAPSULE
Approved
Dec 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
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 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAPLYTA (lumateperone) is an oral atypical antipsychotic approved in 2019 for bipolar depression as monotherapy or adjunct, and for major depressive disorder as adjunctive therapy with antidepressants. It works through serotonin 5-HT2A receptor antagonism and dopamine D2 partial agonism. The unique mechanism differentiates it from first-generation and some second-generation antipsychotics in the mood disorder space.
$0.195BPart D
Peak14.5 years to LOEProduct is in peak revenue phase with $195M annual spending and 118K+ prescriptions, suggesting established commercial infrastructure and stable-to-growing team requirements.
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)
Lumateperone for Late-Life Depression
Started Jun 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
174 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
174 enrolled
Irritability Associated With Autism Spectrum Disorder
Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
Started Aug 2024
52 enrolled
Schizophrenia or Schizoaffective
Study of Lumateperone in the Treatment of Patients With Bipolar Mania
Started Jul 2024
350 enrolled
Bipolar Disorder, Manic
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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.