PR Newswire·Sep 21, 2026, 8:00 AM ET

CAPLYTA® (lumateperone) shows significant and rapid improvement in bipolar mania in pivotal Phase 3 study

JNJ

Johnson & Johnson announced positive topline results from the pivotal Phase 3 Study 451 evaluating CAPLYTA® for acute manic episodes in adults with bipolar I disorder.
The study met its primary endpoint, showing CAPLYTA® significantly reduced manic symptoms versus placebo as early as Day 3 with benefits sustained through Week 3.
Patients treated with CAPLYTA® demonstrated a 4.8-point greater reduction in Young Mania Rating Scale (YMRS) total scores compared to placebo at Week 3.
Twice as many patients on CAPLYTA® achieved clinical response (≥50% reduction in YMRS) compared to placebo, with rates of 45.8% vs. 20.9%.
CAPLYTA® showed significantly greater improvement in overall illness severity versus placebo at Week 3 based on Clinical Global Impression–Severity scores.
The drug was well-tolerated with a safety profile consistent with its established profile, though dry mouth (7.9% vs. 3.4%) and nausea (7.9% vs. 2.3%) were the most common treatment-related adverse events.
CAPLYTA® is currently not approved for the treatment of manic episodes associated with bipolar I disorder, though it is approved for bipolar depression, schizophrenia, and major depressive disorder.
A second pivotal Phase 3 study (Study 452) evaluating CAPLYTA® for manic episodes has been completed with data analysis underway.
Findings were presented as a late-breaking report at the 2026 Psych Congress Annual Meeting in New Orleans, LA.
CAPLYTA® carries important safety warnings including increased mortality in elderly patients with dementia-related psychosis, suicidal thoughts in young patients, stroke risk, metabolic changes, tardive dyskinesia, neuroleptic malignant syndrome, seizures, \& falls.