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- Sep 21, 202690% CONFIDENCEfrom the source
Caplyta Hits Its Goal in a Phase 3 Bipolar Mania Trial
- Johnson & Johnson announced positive topline results from Study 451, the first of two pivotal Phase 3 trials of Caplyta (lumateperone) for manic episodes, with or without mixed features, in adults with bipolar I disorder[1].
- Once-daily Caplyta 42 mg cut the Young Mania Rating Scale score by 4.8 points more than placebo at week 3 (effect size -0.69, p<0.0001), with significant improvement from day 3[1][3].
- Twice as many patients responded on Caplyta as on placebo (45.8% vs 20.9%), overall illness severity also improved, and dry mouth and nausea were the most common side effects[1][3].
- The randomized, double-blind trial enrolled 354 patients, began in June 2024 and reached primary completion in February 2026[2].
- The results were a late-breaker at the 2026 Psych Congress in New Orleans (15-19 September); the second pivotal study, 452, is complete and being analysed[1].
- Caplyta came to J&J with its acquisition of Intra-Cellular Therapies, completed on 2 April 2025, and is already approved for bipolar I and II depression, schizophrenia and, as an add-on, major depressive disorder; it is not approved for mania[1][4].
References 485% CONFIDENCE
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- [1]90%jnj.com/media-center/press-releases/caplyta-lumateperone-shows-significant-and-rapid-improvement-in-bipolar-mania-in-pivotal-phase-3-studyjnj.com· Posted Sep 23, 2026· Starts Sep 21, 2026 ✓· 32% of score
The release is datelined "TITUSVILLE, N.J. (September 21, 2026) - Johnson & Johnson (NYSE: JNJ[4]) today announced positive topline results from the pivotal Phase 3 study", and its PR Newswire copy is timestamped "Sep 21, 2026, 08:00 ET" (12:00 UTC).
- [2]80%NCT06462586: Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania (ClinicalTrials.gov)clinicaltrials.gov· Added Sep 23, 2026· 32% of score
The trial registry record for Study 451: sponsored by Intra-Cellular Therapies, 354 patients enrolled, started 19 June 2024, primary completion 24 February 2026, status completed.[1]
- [3]85%Positive Topline Phase 3 Study Results: Lumateperone for Manic Episodes in Bipolar I Disorder (Psychiatric Times)psychiatrictimes.com· Published Sep 21, 2026· 32% of score
Independent psychiatry trade coverage of Study 451 the same day: the -4.8 YMRS difference at week 3 (effect size -0.69), day-3 onset, 45.8% vs 20.9% response and the completed second study, 452.[1]
- [4]78%Johnson & Johnson Closes Landmark Intra-Cellular Therapies, Inc. Acquisition to Solidify Neuroscience Leadershipjnj.com· Published Apr 2, 2025· 4% of score
J&J's own release of 2 April 2025 completing the Intra-Cellular Therapies acquisition, which brought Caplyta into J&J Innovative Medicine; background for how J&J came to own the drug.[1]
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