APR 27 2026
Johnson & Johnson — Caplyta (lumateperone) $JNJ
for schizophrenia
FDA approved a supplemental New Drug Application for Caplyta (lumateperone) based on long-term data supporting reduced relapse risk in schizophrenia.
About
Schizophrenia is a mental disorder that causes hallucinations, delusions, and disorganized thinking, typically beginning in young adulthood. Caplyta (lumateperone) is an antipsychotic that works by modulating key brain signaling pathways. This mechanism may help control symptoms and reduce the risk of relapse for people with this condition.
Pivotal trial
The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on Caplyta
- Intra-Cellular Therapies highlights its psychiatry focus. The Nasdaq-listed biotech leans on Caplyta - AD HOC NEWS
- CAPLYTA Data Highlights Johnson & Johnson Valuation And Mental Health Story - Yahoo Finance
- Lumateperone Ranks Highest Among Adjunctive MDD Therapies in First Network Meta-Analysis - Psychiatric Times
- Lumateperone (Caplyta) Gains FDA Approval for Relapse Prevention in Schizophrenia - Consultant360
- Electric Shock Ban? FDA Expands Caplyta Label; Bipolar Disorder Strategies - MedPage Today