Johnson & Johnson reported that its antipsychotic drug Caplyta met the primary endpoint in a Phase 3 trial for manic episodes of bipolar I disorder. The double‑blind, randomized study compared once‑daily 42 mg Caplyta with placebo over three weeks in adult patients.
Caplyta produced a statistically significant 4.8‑point greater reduction in the Young Mania Rating Scale total score versus placebo at week 3, with improvement observable as early as day 3 and sustained through the study period. Clinical response, defined as a 50% or greater symptom reduction, was achieved by 45.8% of patients on Caplyta compared with 20.9% on placebo.
Safety findings indicated that the drug was well tolerated. Treatment‑related adverse events occurring in at least 5% of patients and at least twice the rate of placebo were dry mouth (7.9% vs 3.4%) and nausea (7.9% vs 2.3%). Discontinuation rates were low and the overall safety profile matched existing data.
The results were presented at the 2026 Psych Congress Annual Meeting in New Orleans (September 15‑19) and published on September 21, 2026. Caplyta is already FDA‑approved for depressive episodes of bipolar I or II disorder, schizophrenia, and as an adjunct for major depressive disorder, but it is not yet approved for treating manic episodes associated with bipolar I disorder.
