Johnson & Johnson (J&J) announced on 8 July its supplemental New Drug Application (sNDA) submission to US regulator the Food and Drug Administration (FDA) for Caplyta (lumateperone) to prevent schizophrenia relapse. The filing follows positive results from Phase III Study 304 (n=228), where the 42 mg once-daily oral antipsychotic reduced relapse risk by 63% versus placebo (HR=0.37, p=0.0002) and delayed time to discontinuation (p=0.0007). Acquired through J&J's USD 14.6 billion buyout of Intra-Cellular Therapies in January 2025, lumateperone modulates dopamine D2 and serotonin 5-HT2A receptors.

Originally approved in 2019 for schizophrenia and later for bipolar depression, lumateperone’s safety profile remained consistent with prior data. Schizophrenia affects approximately 2.8 million US adults, with 40% undertreated. Without intervention, patients average nine relapses within six years, underscoring the need for maintenance therapies.