Johnson & Johnson has announced positive topline results from a Phase III study evaluating Caplyta (lumateperone) for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder.  

The study met its primary endpoint, with Caplyta demonstrating a statistically significant and rapid reduction in manic symptoms versus placebo at Week 3, with significant improvement seen as early as Day 3.  

The findings were presented at the 2026 Psych Congress Annual Meeting (September 15-19, New Orleans, LA). 

Study 451 is the first of two pivotal Phase III studies evaluating Caplyta in adults with manic episodes associated with bipolar I disorder. These findings support its potential to address both depressive and acute manic episodes. 

“Mania is among the most dangerous and worrisome phases of bipolar disorder, and treating it effectively takes more than partial or temporary relief of symptoms; it means bringing the episode itself under control as quickly as possible,” said Michael Thase, Professor of Psychiatry and Chief, Division of Mood and Anxiety Disorders Treatment & Research Program, University of Pennsylvania. “These results are encouraging because Caplyta not only significantly improved the symptoms of mania, but did so as early as Day 3, with benefits sustained through Week 3, supporting its potential to meaningfully advance how we treat acute mania in bipolar I disorder.” 

“Bipolar I disorder is a lifelong, cycling illness, and managing it means navigating both manic and depressive episodes over time, each with distinct treatment needs,” added Jane Tiller, Vice President, Global Head of Development, Neuroscience, Johnson & Johnson. “These Phase III results build on the established efficacy of Caplyta in bipolar depression and represent an important step in evaluating its potential to address both depressive and acute manic episodes associated with bipolar I disorder.”