Johnson & Johnson’s (J&J’s) $14.6bn acquisition of Intra-Cellular Therapies is continuing to reap rewards after a Phase III trial of Caplyta (lumateperone) met its endpoints in bipolar disorder patients.
In study 451 (NCT06462586), Caplyta was investigated for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder.
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The study met its primary endpoint, with patients treated with the study drug achieving a statistically significant and rapid reduction in manic symptoms versus placebo after three weeks, with improvement seen as early as day three.
Patients saw a 4.8-point greater reduction in Young Mania Rating Scale (YMRS) total score versus placebo, with twice as many patients treated with Caplyta achieving clinical response, defined as a ≥50% reduction in YMRS total score.
Patients also benefitted from a significantly greater improvement in overall illness severity at the same time point, as measured by the Clinical Global Impression–Severity (CGI-S) score, a key secondary endpoint.
Caplyta was well-tolerated, with low rates of discontinuation and a safety profile consistent with its established profile, with the most common adverse events (AEs) being dry mouth and nausea.
“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 Dr Michael Thase, professor of psychiatry and chief, Division of Mood and Anxiety Disorders Treatment & Research Program at the University of Pennsylvania. Thase has previously disclosed he has been involved in advisory or consulting work for J&J.
Caplyta is being investigated in a second pivotal study in bipolar disorder (NCT06462612), which has also concluded, but data are yet to be announced.
The findings from 451 were presented in a late-breaking presentation at the 2026 Psych Congress Annual Meeting, which took place in New Orleans on 15-19 September.
J&J acquired the drug’s original developer, Intra-Cellular Therapies, in a $14.6bn deal announced at the JP Morgan Healthcare Conference 2025, with the deal centred around Caplyta. The deal was the largest M&A pharma transaction of the year.
The drug was first approved by the US Food and Drug Administration (FDA) in December 2019 for treating schizophrenia in adults, with the label expanded since to include bipolar depression, major depressive disorder (MDD) and schizophrenia relapse prevention.
Bipolar disorder is a complex, lifelong condition which affects an estimated 37 million patients worldwide. Manic episodes, a defining feature of bipolar I disorder, can escalate quickly and often require hospitalisation, with treatment options remaining limited.
In March 2025, Biohaven announced that its pipeline candidate did not show benefit in a Phase II/III bipolar disorder trial. The Nasdaq-listed company’s stock fell by 13.77% on the news.
According to a GlobalData report, the bipolar disorder market across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) was valued at $5.6bn in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 5.3%, reaching $9.4bn by 2034.
GlobalData is the parent company of Clinical Trials Arena.
