JNJ · News · 20260921N

Neuropsychiatry Pipeline Progress

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

Johnson & Johnson reported that Caplyta met the primary endpoint in a late-stage study for adults with manic episodes associated with bipolar I disorder. The study showed significant symptom reduction versus placebo, with improvement reported as early as day three and sustained over three weeks. The result could support expansion of Caplyta beyond its existing approvals for schizophrenia, bipolar depression, and adjunctive treatment of major depressive disorder, following J&J’s acquisition of Intra-Cellular Therapies.

Key facts

• Johnson & Johnson reported topline Phase 3 results from a study evaluating Caplyta (lumateperone) for adults experiencing manic episodes linked to bipolar I disorder. source
• Johnson & Johnson's Caplyta has successfully completed its first Phase 3 trial for treating manic episodes associated with bipolar I disorder, demonstrating rapid improvement in manic symptoms and overall illness severity compared to placebo with benefits observed as early as day 3. source