CAPLYTA (lumateperone), from Intra-Cellular Therapies
Acquisition of Intra-Cellular Therapies closed April 2, 2025; CAPLYTA is now part of J&J's neuroscience business.
What it is
Antipsychotic for schizophrenia and bipolar disorder, with an FDA-approved adjunctive use for bipolar depression. It came with the Intra-Cellular Therapies acquisition, which also brought the Phase 2 compound ITI-1284.
Why it matters to the stock. The main neuroscience growth bet after SPRAVATO. Its sales show whether J&J can grow a psychiatry franchise after buying Intra-Cellular.
News
FDA approves CAPLYTA for relapse prevention in schizophrenia, with 63% lower relapse risk versus placebo
The FDA approved an expanded use of CAPLYTA (lumateperone) for the prevention of relapse in schizophrenia.
Regulation
CAPLYTA adjunctive depression data: 25.5% reach remission at six weeks versus 13.6% on placebo
Johnson & Johnson presented pooled Phase 3 analyses of CAPLYTA taken with an antidepressant for major depressive disorder at the ACNP 2026 meeting.
Product