FDA Approval

Lumateperone (Caplyta) Gains FDA Approval for Relapse Prevention in Schizophrenia

Edited by:
Anthony Calabro, MA

Key Highlights

  • The FDA approved lumateperone (Caplyta) for the prevention of relapse in adults with schizophrenia.
  • The approval was supported by a phase 3, double-blind, randomized withdrawal trial (Study 304).
  • Lumateperone reduced the risk of relapse by 63% compared with placebo, with 84% of patients remaining relapse-free at 6 months.
  • The safety profile was consistent with prior studies, with headaches reported as the most common adverse event.

On April 27, 2026, the FDA approved a supplemental new drug application for Caplyta (lumateperone) for the prevention of relapse in adults with schizophrenia. The approval expands the indication of lumateperone, an oral atypical antipsychotic, to include relapse prevention based on long-term clinical data. The therapy is administered once daily at a dose of 42 mg and does not require titration.

The approval was supported by Study 304, a phase 3, multicenter, double-blind, placebo-controlled, randomized withdrawal trial evaluating lumateperone in adults with schizophrenia. Following an 18-week open-label stabilization phase with lumateperone 42 mg daily, eligible patients were randomized to continue lumateperone (n = 110) or switch to placebo (n=114) for up to 26 weeks. The primary endpoint was time to first symptomatic relapse. Lumateperone significantly prolonged time to relapse compared with placebo (P = .0002), with a 63% reduction in relapse risk (hazard ratio, 0.37). At 6 months, 84% of patients receiving lumateperone remained relapse-free. The study also demonstrated a significant delay in time to all-cause treatment discontinuation.

“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, Christoph U. Correll, MD, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York, said in a press release.

The safety profile observed in the phase 3 trial was consistent with prior lumateperone studies, and no new safety signals were identified. The most common treatment-related adverse event was headache, occurring in at least 5% of patients and at least twice the rate observed with placebo. No clinically relevant increases in prolactin or cardiometabolic parameters were reported at the end of the double-blind treatment period.

Lumateperone is administered orally at a recommended dose of 42 mg once daily. In the clinical trial, patients were initiated and maintained on this dose without titration.

Reference
Johnson & Johnson. FDA approves CAPLYTA (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia. News release. April 27, 2026. Accessed April 29, 2026. FDA approves CAPLYTA (lumateperone) sND