MDD approval for Caplyta as adjunctive therapy with antidepressants

7 November 2025

Healthcare giant Johnson & Johnson (NYSE: JNJ) has announced that the US Food and Drug Administration (FDA) has approved Caplyta (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.

The approval is the first under J&J leadership following its $14.6 billion acquisition of Intra-Cellular Therapies in January of this year, with Caplyta being the company’s lead asset.

According to J&J, Caplyta makes it easy to start and stay on treatment without the need for titration. Weight gain and other metabolic side effects that typically lead to discontinuation of care were similar to placebo in research.

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