WS Investor
10 Nov 2026, 16:18
Johnson & Johnson Reports Second Positive Phase 3 Study for CAPLYTA in Bipolar Mania
Johnson & Johnson (NYSE: JNJ) reported positive results from a second pivotal Phase 3 study of CAPLYTA in adults with bipolar I disorder experiencing manic episodes, strengthening the case for a planned U.S. FDA submission in the indication.
In Study 452, once-daily CAPLYTA 42 mg produced a statistically significant improvement in manic symptoms versus placebo after three weeks. The drug achieved a 3.7-point greater reduction on the Young Mania Rating Scale, with benefits appearing as early as Day 3 and continuing through Week 3.
Clinical response rates were also materially higher. At Week 3, 43.9% of CAPLYTA-treated patients achieved at least a 50% improvement in YMRS scores compared with 23.7% of patients receiving placebo. CAPLYTA also significantly improved overall illness severity on the CGI-S scale.
Safety was consistent with CAPLYTA’s established profile, with dizziness, dry mouth and somnolence or sedation among the most common treatment-related adverse events.
Together with the previously positive Study 451, the results provide two successful pivotal Phase 3 trials supporting Johnson & Johnson’s planned regulatory submission for bipolar mania. CAPLYTA is already approved for bipolar depression, schizophrenia and as adjunctive therapy for major depressive disorder, but is not currently approved for manic episodes associated with bipolar I disorder.
Johnson & Johnson (NYSE: JNJ) reported positive results from a second pivotal Phase 3 study of CAPLYTA in adults with bipolar I disorder experiencing manic episodes, strengthening the case for a planned U.S. FDA submission in the indication.
In Study 452, once-daily CAPLYTA 42 mg produced a statistically significant improvement in manic symptoms versus placebo after three weeks. The drug achieved a 3.7-point greater reduction on the Young Mania Rating Scale, with benefits appearing as early as Day 3 and continuing through Week 3.
Clinical response rates were also materially higher. At Week 3, 43.9% of CAPLYTA-treated patients achieved at least a 50% improvement in YMRS scores compared with 23.7% of patients receiving placebo. CAPLYTA also significantly improved overall illness severity on the CGI-S scale.
Safety was consistent with CAPLYTA’s established profile, with dizziness, dry mouth and somnolence or sedation among the most common treatment-related adverse events.
Together with the previously positive Study 451, the results provide two successful pivotal Phase 3 trials supporting Johnson & Johnson’s planned regulatory submission for bipolar mania. CAPLYTA is already approved for bipolar depression, schizophrenia and as adjunctive therapy for major depressive disorder, but is not currently approved for manic episodes associated with bipolar I disorder.
