Posted by Michael Wonder on 06 Nov 2025
FDA approval of Caplyta (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder
6 November 2025 - Johnson & Johnson announced today that the US FDA approved Caplyta (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder in adults.
The approval – the first under J&J leadership following its acquisition of Intra-Cellular Therapies – provides patients with a safe and effective new treatment option that can enable a path to remission.
