FDA approves Johnson & Johnson's (JNJ) CAPLYTA for preventing schizophrenia relapse

The U.S. Food and Drug Administration has approved a supplemental New Drug Application for Johnson & Johnson's CAPLYTA (lumateperone) for preventing relapse in schizophrenia patients, the company announced.

The approval is based on a Phase 3 double-blind, randomized withdrawal trial where CAPLYTA significantly extended time to relapse versus placebo during a 26-week treatment period. Patients receiving CAPLYTA had a 63 percent lower risk of relapse compared with placebo, with 84 percent of patients remaining relapse-free over six months.

Schizophrenia affects approximately 2.8 million adults in the United States, with roughly 40 percent not receiving adequate care. Adults with schizophrenia experience an average of nine relapse episodes within six years, according to the company's data. The societal cost of schizophrenia was estimated at $366.8 billion in the U.S. in 2024.

In the clinical trial, CAPLYTA also significantly delayed time to all-cause treatment discontinuation. The safety profile remained consistent with existing clinical data, with headache being the most common treatment-related adverse event, occurring in at least 5 percent of patients.

"These Phase 3 results—showing significantly longer time to relapse with 84% remaining relapse free over 6-months—provide clinicians with another tool that can offer long-term stability for people living with schizophrenia," said Christoph U. Correll, M.D., Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell.

CAPLYTA is currently FDA approved for adults as an adjunctive therapy with antidepressants for major depressive disorder, schizophrenia, and depressive episodes associated with bipolar I or II disorder.

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