Johnson & Johnson says Phase 3 trial shows Caplyta cuts bipolar I mania symptoms by Week 3
JNJ•Phase 3 Caplyta results in bipolar I mania
Johnson & Johnson reported positive topline Phase 3 results for Caplyta in acute manic episodes tied to bipolar I disorder.
Findings were already presented in a late-breaking session at the 2026 Psych Congress Annual Meeting.
The trial showed rapid, sustained symptom improvement versus placebo, supporting a potential expansion beyond bipolar depression and schizophrenia.
Caplyta is not approved for bipolar I mania; a second pivotal Phase 3 study has finished with analysis underway.
