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# J&J Plans FDA Filing for Caplyta in Bipolar Mania After New Data
- URL: https://www.fdaweb.com/j-j-plans-fda-filing-for-caplyta-in-bipolar-mania-after-new-data/
- Published: 2026-11-11T19:30:03.000Z
- Updated: 2026-11-11T19:30:03.000Z
- Author: David McFarland
- Tags: Drugs

Johnson & Johnson plans to seek FDA approval of Caplyta (lumateperone) for manic episodes associated with Bipolar I disorder following positive results from a second pivotal Phase 3 trial, which demonstrated statistically significant improvements in manic symptoms as early as Day 3.

The company said its Study 452 met its primary endpoint, showing a 3.7-point greater reduction than placebo on the Young Mania Rating Scale (YMRS) at Week 3\. The benefit emerged by Day 3 and was sustained through the three-week treatment period. Clinical response, defined as at least a 50% reduction in YMRS scores, was achieved by 43.9% of Caplyta-treated patients compared with 23.7% receiving placebo.

The trial also met its key secondary endpoint measuring overall illness severity, with a least-squares mean difference of −0.41 on the Clinical Global Impression–Severity scale at Week 3.

Study 452 (NCT06462612) was a global, randomized, double-blind, placebo-controlled trial evaluating once-daily Caplyta 42 mg in adults experiencing manic episodes, with or without mixed features, associated with bipolar I disorder, according to the company. The results follow positive findings from Study 451 (NCT06462586), reported in September, in which Caplyta produced a 4.8-point greater reduction in YMRS scores than placebo at Week 3\. Clinical response rates in that study were 45.8% and 20.9%, respectively.

J&J said the drug was generally well tolerated in Study 452, with low discontinuation rates and a safety profile consistent with previous trials. The most common treatment-related adverse events occurring in at least 5% of treated patients and at least twice the placebo rate were dizziness, dry mouth and somnolence or sedation.

The company said the two positive studies will support a planned U.S. regulatory submission but did not specify a filing date.

Caplyta is currently FDA-approved for schizophrenia, depressive episodes associated with Bipolar I and II disorders, and adjunctive treatment of major depressive disorder.