Johnson & Johnson has released results from its pivotal phase 3 study, in which Caplyta (lumateperone) demonstrated a rapid improvement in acute manic episodes associated with bipolar I disorder, with or without mixed features.
The drug significantly reduced signs and symptoms of mania compared to a placebo, with effects occurring as early as day 3 and remaining through week 3. The study met its primary endpoint, reducing Young Mania Rating Scale (YMRS) by 4.8 points more than the placebo, as well as a key secondary endpoint of improvement in Clinical Global Impression-Severity (CGI-S) score. The drug was well tolerated and demonstrated a safety profile consistent with its existing profile. The data analysis for a second pivotal phase 3 study is currently in progress.
Caplyta was approved for schizophrenia in 2019 and as an adjunctive and monotherapy for bipolar I and II depression in 2021. In November 2025, the FDA approved Caplyta for major depressive disorder (MDD), based on a six-month open-label extension safety study that showed a consistent safety profile with pivotal studies and a phase 3 trial that demonstrated superior efficacy.