Johnson & Johnson Highlights New Neuropsychiatry Data

Titusville, New Jersey, U.S., September 8, 2026

CAPLYTA Data Expand Bipolar and Depression Evidence

A major focus of Johnson & Johnson’s Psych Congress program will be new data from a pivotal Phase 3 study of CAPLYTA evaluating its efficacy and safety in the acute treatment of adults with manic episodes or manic episodes with mixed features associated with bipolar I disorder. The presentation represents an important development for CAPLYTA, which already has established indications in schizophrenia, bipolar depression and as an adjunctive treatment with antidepressants for MDD. Additional CAPLYTA analyses will examine its use in major depressive disorder, including depressive symptoms, remission, patient subgroups and metabolic outcomes. Johnson & Johnson will also present real-world evidence examining treatment patterns among patients with bipolar depression, including dosing and treatment duration in routine clinical practice. Together, the data are intended to broaden understanding of how the therapy performs across different mood-disorder populations and treatment settings. CAPLYTA is an oral, once-daily atypical antipsychotic containing lumateperone. Its mechanism involves activity at central serotonin 5-HT2A receptors and dopamine D2 receptors, although the precise mechanism responsible for its clinical effects remains unknown. The company is also evaluating the medicine in additional neuropsychiatric settings, while a recently approved supplemental application added long-term evidence concerning delayed time to relapse in schizophrenia.

SPRAVATO and Seltorexant Target Unmet Needs

The Psych Congress program will also include new analyses of SPRAVATO (esketamine) CIII nasal spray, focusing on its effects on anhedonia, a core symptom of depression characterized by reduced interest or pleasure in previously rewarding activities. Johnson & Johnson said the analyses use real-world evidence to examine treatment effects on this clinically important symptom, which has been associated with poorer treatment outcomes and greater functional impairment. SPRAVATO is FDA-approved for adults with treatment-resistant depression as monotherapy or with an oral antidepressant, as well as for depressive symptoms in adults with MDD accompanied by acute suicidal ideation or behavior when used with an oral antidepressant. The therapy acts as a non-selective, non-competitive NMDA receptor antagonist, representing a pharmacological approach distinct from conventional antidepressant mechanisms. Johnson & Johnson will additionally present Phase 3 clinical-trial data for seltorexant, an investigational selective orexin-2 receptor antagonist being developed as an adjunctive treatment for adults with MDD and insomnia symptoms. The development program is focused on the relationship between mood disorders and sleep disturbances, with the therapy designed to investigate whether targeting orexin-2 signaling can address both depressive symptoms and associated insomnia. Seltorexant remains investigational and is not approved for marketing.

Schizophrenia Research Supports Broader Portfolio

Beyond mood disorders, Johnson & Johnson will present real-world studies involving schizophrenia and long-acting injectable (LAI) treatments. The research includes analyses of schizophrenia-related hospitalizations among young dual-eligible patients before LAI initiation and subsequent relapse risk, as well as studies examining treatment satisfaction with long-acting injectable therapies. The company’s schizophrenia portfolio includes INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA, providing one-, three- and six-month dosing options respectively for appropriate adult patients. The presentations at Psych Congress highlight the importance of treatment persistence, relapse prevention and real-world outcomes in the long-term management of chronic schizophrenia. Overall, the 24 presentations at Psych Congress 2026 demonstrate Johnson & Johnson’s continued investment in generating clinical and real-world evidence across complex neuropsychiatric conditions. The combination of pivotal Phase 3 research, real-world evidence and pipeline development provides additional data for understanding treatment response, disease burden and long-term management across bipolar disorder, depression and schizophrenia.

Source: Johnson & Johnson press release