PR Newswire·Nov 10, 2026, 8:00 AM ET

Johnson & Johnson Announces CAPLYTA (lumateperone) Shows Significant and Rapid Improvement in Bipolar Mania in Second Pivotal Phase 3 Study

Study 452, a Phase 3 trial, met its primary & key secondary endpoints for CAPLYTA in treating manic episodes in adults with bipolar I disorder.
CAPLYTA demonstrated statistically significant improvement in manic symptoms versus placebo at Week 3, with effects observed as early as Day 3.
Patients receiving CAPLYTA showed a 3.7-point greater reduction in Young Mania Rating Scale (YMRS) total scores compared to placebo (P<.0001).
43.9% of patients on CAPLYTA achieved a clinical response (≥50% improvement on YMRS) versus 23.7% on placebo at Week 3.
Significant improvements were also recorded in overall illness severity (CGI-S scores) with benefits starting on Day 3.
Two positive Phase 3 studies (Study 451 & Study 452) will support a planned U.S. FDA submission for bipolar mania.
CAPLYTA safety & tolerability were consistent with prior studies, with common adverse events including dizziness, dry mouth, & somnolence/sedation.
CAPLYTA is currently approved for bipolar depression, schizophrenia, & major depressive disorder but is not yet approved for manic episodes.
The results were presented as a late-breaking session at the 2026 Neuroscience Education Institute Fall Congress.
Johnson & Johnson plans to submit data to the FDA to expand CAPLYTA indications to address rapid symptom stabilization in bipolar mania.