J&J to unveil first Phase 3 data for Caplyta in bipolar mania at psychiatry meeting

Johnson & Johnson (J&J) will unveil pivotal Phase 3 clinical data for Caplyta (lumateperone), a treatment for mania associated with bipolar disorder, for the first time.

On the 8th (local time), J&J said it will present 24 abstracts covering clinical data and real-world evidence across its neuropsychiatry portfolio at the 2026 Psych Congress Annual Meeting, to be held Aug. 15-19 in New Orleans, Louisiana.

The data being presented for the first time are results from a pivotal Phase 3 study evaluating the efficacy and safety of Caplyta for acute treatment of patients with manic episodes or manic episodes with mixed features associated with bipolar I disorder.

The company said the presentation demonstrates Caplyta’s potential across mood disorders.

Also to be presented are data analyzing depressive symptoms, remission, patient subgroups and metabolic outcomes when Caplyta was used as an adjunctive treatment in patients with major depressive disorder (MDD), as well as a study examining real-world prescribing patterns in patients with bipolar depression.

Other presentations will include real-world evidence analyzing the effect of Spravato (esketamine) nasal spray on anhedonia, a core symptom of depression, and Phase 3 data for seltorexant, an investigational treatment for MDD with insomnia symptoms.

In schizophrenia, real-world studies will examine schizophrenia-related hospitalization and relapse risk in young patients before long-acting injectable (LAI) treatment, as well as satisfaction with LAI treatment.

Jane Tiller, J&J’s vice president and global head of neuroscience development, said, “People living with neuropsychiatric conditions often experience complex, overlapping symptoms that make identification, treatment selection and long-term management challenging. We will advance clinical and real-world evidence to help clinicians make better decisions.”

Meanwhile, according to J&J, bipolar disorder affects about 37 million people worldwide, and MDD is a leading cause of disability, affecting about 332 million people worldwide.