Johnson & Johnson (NYSE: JNJ) today announced positive topline results from the pivotal Phase 3 study evaluating CAPLYTA® (lumateperone) for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder. The study met its primary endpoint, with CAPLYTA® demonstrating a statistically significant and rapid reduction in manic symptoms versus placebo at Week 3, with significant improvement seen as early as Day 3. The findings were presented in a late-breaking presentation at the 2026 Psych Congress Annual Meeting (September 15-19, New Orleans, LA), among 24 Johnson & Johnson neuropsychiatry presentations featured at this year's meeting.

Bipolar disorder is a complex, lifelong condition affecting an estimated 37 million people worldwide and marked by recurring depressive and manic episodes that can profoundly affect a person's health and daily life.1 Manic episodes, a defining feature of bipolar I disorder, can escalate quickly and often require hospitalization.2,3 Treatment options remain limited by variability in response and tolerability concerns, underscoring the need for therapies that can provide rapid and robust symptom control.

Study 451 is the first of two pivotal Phase 3 studies evaluating CAPLYTA® in adults with manic episodes associated with bipolar I disorder.4 These findings build on the established efficacy of CAPLYTA® in bipolar depression and support its potential to address both depressive and acute manic episodes associated with bipolar I disorder. CAPLYTA® is not approved for the treatment of manic episodes associated with bipolar I disorder.