Lumateperone Hits Goals in Bipolar Mania Trial
Johnson & Johnson reports its second pivotal phase 3 study of lumateperone met primary and key secondary endpoints in adults with bipolar I mania.
Updated on Nov. 10, 2026 in Mental Health
Johnson & Johnson announced that Study 452 met its primary and key secondary endpoints for lumateperone, marketed as Caplyta, in adults with manic episodes associated with bipolar I disorder. The company plans a US regulatory submission based on this study and an earlier positive phase 3 study.
Why it matters
The results add a second pivotal phase 3 trial supporting lumateperone as a treatment for manic episodes in bipolar I disorder. The findings will support the planned US regulatory submission and could inform how the drug is considered for patients with bipolar mania.
The phase 3 trial compared once-daily Caplyta 42 mg with placebo over 3 weeks, with 43.9% of Caplyta patients reaching at least a 50% improvement on the Young Mania Rating Scale versus 23.7% on placebo. Results beyond the 3-week window were not reported in the source material.
The players
Johnson & Johnson
A multinational pharmaceutical and medical device company headquartered in New Brunswick, New Jersey, and the sponsor of the lumateperone studies.
The details
Study 452 was a global, randomized, double-blind phase 3 study in adults with manic episodes, with or without mixed features, associated with bipolar I disorder. Caplyta significantly improved YMRS and Clinical Global Impression-Severity scores versus placebo, with improvement visible as early as day 3, and was well-tolerated with dizziness, dry mouth and somnolence/sedation the most common treatment-related adverse events.
Timeline
September 21, 2026: Earlier positive results from Study 451 were announced in a news release.
November 10, 2026: Johnson & Johnson announced Study 452 results.
Results from Study 452 were presented as a late-breaking presentation at the 2026 NEI Fall Congress in Colorado Springs, Colorado.
Health Landscape
The Study 452 results extend the phase 3 evidence base for lumateperone, following the earlier positive Study 451, as the company moves toward a US regulatory submission. Together, the two pivotal trials form the core clinical dataset the FDA would review for the drug's use in bipolar I mania.
If approved, lumateperone would add a treatment option for manic episodes in bipolar I disorder, a condition typically managed with long-term care. Patients and clinicians will be watching the regulatory submission for details on dosing and side effects.
The takeaway
Two positive phase 3 trials are the foundation of the regulatory case for lumateperone in bipolar mania. Readers tracking bipolar treatment options should watch for the outcome of the planned US submission.
Further reading
Explore more research and treatment news in our Mental Health section.
Source note: This article includes information reported by Psychiatrictimes.
