Johnson & Johnson Announces CAPLYTA Demonstrates Reduction In Signs, Symptoms Of Acute Manic Episodes Associated With Bipolar I Disorder In Phase 3 Trial

Johnson & Johnson (NYSE: JNJ) announced positive topline results from a pivotal Phase 3 study of CAPLYTA (lumateperone) for treating manic episodes associated with bipolar I disorder. The study met its primary endpoint, showing a statistically significant reduction in manic symptoms compared to placebo by Week 3, with improvements noted as early as Day 3. These findings were presented at the 2026 Psych Congress Annual Meeting, highlighting the potential of CAPLYTA to address both manic and depressive episodes in bipolar disorder, although it is not yet approved for this indication.