The U.S. Food and Drug Administration approved an expanded use of Johnson & Johnson’s drug Caplyta as an add‑on therapy for adults with major depressive disorder, announced on Thursday, November 6, 2025.
This approval broadens Caplyta’s therapeutic profile, allowing it to be prescribed alongside existing antidepressants. By entering the major depressive disorder market, the drug can tap into a large patient population that often requires adjunctive treatment, potentially increasing sales and strengthening J&J’s position in the psychiatric therapeutics space.
Caplyta, originally developed by Intra‑Cellular Therapies and acquired by J&J, had already been approved for bipolar I and II depression and schizophrenia. The new indication expands the drug’s utility, enhances its competitive moat, and aligns with J&J’s strategy of leveraging its diversified portfolio to capture unmet needs in high‑growth therapeutic areas.
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