European Investor
21 Sep 2026, 19:38
Johnson & Johnson’s CAPLYTA Shows Rapid Improvement in Bipolar Mania in Phase 3 Study
Johnson & Johnson reported positive Phase 3 results for CAPLYTA in adults with manic episodes associated with bipolar I disorder, with the drug significantly reducing manic symptoms versus placebo and showing improvement as early as Day 3.
The pivotal Study 451 met its primary endpoint. CAPLYTA 42 mg produced a 4.8-point greater reduction in the Young Mania Rating Scale score versus placebo at Week 3, with an effect size of -0.69 and p<0.0001. Benefits were sustained through Week 3.
Clinical response was also stronger with CAPLYTA, with 45.8% of treated patients achieving at least a 50% reduction in mania symptoms versus 20.9% for placebo. Patients also showed significantly greater improvement in overall illness severity.
The safety profile was consistent with CAPLYTA’s established profile, with dry mouth and nausea the most common treatment-related adverse events reported at higher rates than placebo.
CAPLYTA is already approved for bipolar depression, schizophrenia and as adjunctive treatment for major depressive disorder, but it is not currently approved for manic episodes in bipolar I disorder. A second pivotal Phase 3 mania study has been completed and is under analysis.
Johnson & Johnson reported positive Phase 3 results for CAPLYTA in adults with manic episodes associated with bipolar I disorder, with the drug significantly reducing manic symptoms versus placebo and showing improvement as early as Day 3.
The pivotal Study 451 met its primary endpoint. CAPLYTA 42 mg produced a 4.8-point greater reduction in the Young Mania Rating Scale score versus placebo at Week 3, with an effect size of -0.69 and p<0.0001. Benefits were sustained through Week 3.
Clinical response was also stronger with CAPLYTA, with 45.8% of treated patients achieving at least a 50% reduction in mania symptoms versus 20.9% for placebo. Patients also showed significantly greater improvement in overall illness severity.
The safety profile was consistent with CAPLYTA’s established profile, with dry mouth and nausea the most common treatment-related adverse events reported at higher rates than placebo.
CAPLYTA is already approved for bipolar depression, schizophrenia and as adjunctive treatment for major depressive disorder, but it is not currently approved for manic episodes in bipolar I disorder. A second pivotal Phase 3 mania study has been completed and is under analysis.
