In July 2025, Johnson & Johnson submitted a supplemental New Drug Application (sNDA) for Caplyta (lumateperone) to the U.S. Food and Drug Administration (FDA), seeking an expanded indication for the prevention of relapse in adults with schizophrenia. The filing is supported by data from a Phase III randomized withdrawal study that demonstrated a 63% reduction in risk of relapse compared to placebo. The study enrolled patients who had achieved clinical stability during an open-label run-in phase and were then randomized to either continue Caplyta or switch to placebo. The primary endpoint—time to relapse—was met with statistical significance, and secondary endpoints, including changes in PANSS total score and CGI-Severity, also favored Caplyta. Notably, the safety and tolerability profile observed in the trial remained consistent with Caplyta’s known profile, reinforcing its suitability for long-term use. If approved, this would represent Caplyta’s first labeling for relapse prevention, augmenting its existing approvals for bipolar depression and schizophrenia. The submission reflects strategic efforts by J&J to position Caplyta as a broad-spectrum antipsychotic agent with utility across acute and maintenance treatment paradigms.

Citation: https://www.investor.jnj.com/news/news-details/2025/Supplemental-new-drug-application-submitted-to-U-S--FDA-for-CAPLYTA-lumateperone-with-data-demonstrating-significant-schizophrenia-relapse-prevention-compared-to-placebo/default.aspx

Implication: Approval would support Caplyta’s use in chronic schizophrenia management, enhancing its market competitiveness versus long-established maintenance agents.