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News|Articles|November 13, 2025
Everything You Need to Know About the Approval of Lumateperone for Major Depressive Disorder
Author(s)Leah Kuntz
EXCLUSIVE: Check out this recap on the approval of lumateperone (Caplyta) for major depressive disorder.
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On November 6, 2025, the US Food and Drug Administration (FDA) approved Johnson & Johnson’s lumateperone (Caplyta) as an adjunctive therapy for the treatment of adults with major depressive disorder (MDD).1 Here's what you need to know:
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In the second positive phase 3 trial of lumateperone (Caplyta) for bipolar mania, participants saw improved manic symptoms vs placebo as early as day 3.
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