JNJ · News · 20260921N

Caplyta Bipolar Mania Trial

JOHNSON & JOHNSON · 2026-09-21 · Importance 34 · Surprise 42

Johnson & Johnson reported that Caplyta (lumateperone) met the primary endpoint in a Phase 3 study of adults with bipolar I disorder experiencing manic episodes. The trial showed significantly reduced manic symptoms versus placebo, with improvement beginning by day three and sustained for three weeks. The result could expand Caplyta beyond its current approvals for schizophrenia, bipolar depression, and adjunctive treatment of major depressive disorder following J&J’s acquisition of Intra-Cellular Therapies.

Key facts

• Caplyta (lumateperone) successfully met the primary endpoint in a late-stage study evaluating its use for bipolar mania according to Johnson & Johnson. source
• The Caplyta bipolar mania study demonstrated that Caplyta significantly reduced symptoms of bipolar mania, with improvements observed as early as three days into treatment and sustained over three weeks. source