J&J's Caplyta meets main goal in bipolar mania phase 3 trial

Johnson & Johnson on September 21, 2026 announced positive topline results from pivotal Phase 3 Study 451 of once-daily Caplyta (lumateperone) 42 mg versus placebo over three weeks in adults with manic episodes, with or without mixed features, associated with bipolar I disorder. The trial met its primary endpoint with a 4.8-point greater reduction in Young Mania Rating Scale total score at Week 3 (effect size -0.69), with significant improvement seen as early as Day 3. Key secondary CGI-S improved by a least-squares mean difference of -0.5, and 45.8% of Caplyta patients achieved clinical response versus 20.9% on placebo. Dry mouth and nausea each occurred in 7.9% on Caplyta versus 3.4% and 2.3% on placebo. Findings were presented as late-breaking data at the 2026 Psych Congress in New Orleans among 24 J&J neuropsychiatry presentations. Caplyta is already FDA-approved for bipolar depression, schizophrenia, and adjunctive major depressive disorder but is not approved for bipolar mania. J&J obtained the drug through its $14.6 billion acquisition. A second pivotal Phase 3 study (Study 452) has been completed and data analysis is underway,