J&J’s Caplyta succeeds in phase 3 trial for manic episodes in bipolar disorder, supporting potential label expansion

Johnson & Johnson’s (J&J) schizophrenia and depression treatment Caplyta (ingredient: lumateperone) demonstrated efficacy in treating manic episodes associated with bipolar disorder.

According to Fierce Pharma on the 21st local time, J&J announced that Caplyta rapidly improved manic symptoms compared with placebo in a phase 3 clinical trial of adults with manic episodes associated with bipolar I disorder.

The study, named “451,” was one of two phase 3 trials involving patients with manic episodes of bipolar I disorder. The results were presented at the 2026 annual meeting of the psychiatric association recently held in New Orleans.

In the trial, the group receiving Caplyta 42 mg had a 4.8-point greater reduction in manic symptom scores than the placebo group at week 3, meeting the primary endpoint. J&J said significant improvement emerged as early as day 3 of treatment and was maintained throughout the 21-day study period.

The clinical response rate was also 45.8% in the Caplyta group, more than twice the rate in the placebo group (20.9%). Caplyta also showed a significant benefit over placebo in improving overall disease severity, achieving a key secondary endpoint.

J&J said Caplyta did not cause any new safety issues beyond its established safety profile and was well tolerated.

Michael Thase, a professor of psychiatry at the University of Pennsylvania, said, “Mania is the most dangerous and concerning phase of bipolar disorder,” adding that “it is important to control symptoms as quickly as possible.”

Jane Tiller, J&J’s head of neuroscience development, said, “These phase 3 results represent an important advance in evaluating Caplyta’s potential to address both depressive and acute manic episodes associated with bipolar I disorder, building on its demonstrated efficacy in bipolar depression.”

Caplyta was first approved by Intra-Cellular Therapies in 2019 as a treatment for schizophrenia, then expanded its indications to bipolar depression in 2021 and as an adjunctive treatment for major depressive disorder (MDD) in November last year.

J&J acquired Intra-Cellular Therapies early last year for $14.6 billion (approximately 19.6 trillion won), securing Caplyta. The company expects Caplyta’s peak sales to reach several billion dollars.

J&J added that the second phase 3 trial in patients with manic episodes of bipolar I disorder has already been completed and that data analysis is underway.