J&J: Caplyta Hits Goals in 2nd Phase 3 Bipolar Mania Study
By Colin Kellaher
Johnson & Johnson said its Caplyta antipsychotic medication met the key goals in a second late-stage study in bipolar mania.
J&J on Tuesday said the Phase 3 study of Caplyta for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder met its primary and key secondary endpoints.
The New Brunswick, N.J., drugmaker said Caplyta significantly improved manic symptoms and overall illness severity versus placebo at week 3, with significant improvements observed as early as day 3.
J&J, which in September reported positive results from a separate Phase 3 study of Caplyta, said the findings will support a planned submission seeking expanded U.S. Food and Drug Administration approval of Caplyta for bipolar mania, a bipolar disorder that affects around 36 million people worldwide.
Caplyta, which is already approved for uses in depressive episodes associated with bipolar I or II disorder, schizophrenia and major depressive disorder, was the key assets in J&J's $14.6 billion acquisition of Intra-Cellular Therapies last year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 10, 2026 09:19 ET (14:19 GMT)
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