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, often starting in young adulthood and making daily life challenging. Lumateperone (Caplyta) modulates dopamine and serotonin receptors in the brain, helping balance chemical signals linked to psychosis. This mechanism may stabilize mood and thinking patterns while potentially causing fewer side effects than older antipsychotics.
Pivotal trial
The study will be conducted as a randomized, double-blind, parallel-group, placebo-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
- J&J wins FDA label expansion for Caplyta against depression - MSN
- CAPLYTA Data Highlights Johnson & Johnson Valuation And Mental Health Story - Yahoo Finance
- Caplyta Erectile Dysfunction: Understanding the Connection and Management Options - Portal CNJ
- Lumateperone Ranks Highest Among Adjunctive MDD Therapies in First Network Meta-Analysis - Psychiatric Times
- CAPLYTA led 4 MDD measures, ranked best on weight outcomes - Stock Titan