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APR 27 2026
APPROVED · 155 DAYS AGO

Johnson & Johnson — Caplyta (lumateperone) $JNJ

for schizophrenia

NDA

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 marked by hallucinations, delusions, disorganized thinking, and flat or inappropriate affect — symptoms that usually emerge in young adulthood and can disrupt a person's relationships, work, and daily life. Caplyta (lumateperone) is a once-daily oral medicine that calms overactive signaling in the brain. By steadying that brain activity, Caplyta may help ease symptoms and lower the chance they return, though how well it works varies from person to person.

Pivotal trial

NCT02469155 Phase 3 completed NCT02469155

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