J&J’s test drug for manic episodes in bipolar disorder meets main goal

HQ Team

September 22, 2026: American pharmaceutical company Johnson & Johnson’s investigational drug met its main goal during end-stage trials for the treatment of manic episodes in adults with bipolar I disorder, according to the company.

The drug Caplyta (lumateperone) showed “a statistically significant and rapid reduction in manic symptoms versus placebo (dummy drug) at week 3, with significant improvement seen as early as day 3,” according to a statement.

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

Bipolar disorder is a mental health condition that affects a person’s mood, energy, activity and thought; it is characterised by manic (or hypomanic) and depressive episodes.

36 million people

An estimated 1 in 226 (or 36 million) people live with bipolar disorder worldwide. There are effective care options, which combine medicines and psychosocial interventions to help people with bipolar disorder stay well, according to the World Health Organization.

During a manic episode, a person experiences an extremely high mood with lots of energy (feeling very happy, excited, overactive). They may experience euphoria, sudden mood changes, or excessive emotion (uncontrollable laughing or feeling much more irritable, agitated, or restless than usual).

These may be accompanied by other characteristic symptoms, including a highly inflated sense of self-worth or self-esteem, talking quickly and shifting rapidly from one idea to the next, and having trouble concentrating and being easily distracted.

Other symptoms are decreased need for sleep, reckless or risk-taking behaviour, for example, overspending, risky sexual activity, drinking, or harming oneself or others, and fixed and mistaken grandiose or persecutory beliefs in something untrue (e.g. “I am a very famous person,” “My neighbour is spying on me.”)

‘Dangerous, worrisome’

“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 E. Thase, MD, Professor of Psychiatry and Chief, Division of Mood and Anxiety Disorders Treatment & Research Program, University of Pennsylvania.

The study met the primary endpoint, with Caplyta showing a statistically significant 4.8-point greater reduction in Young Mania Rating Scale (YMRS) total score when compared to the placebo in the third week. “Significant improvement was observed as early as day 3 and sustained through week 3.”

Patients treated with the experimental drug also showed significantly greater improvement in overall illness severity versus placebo at Week 3, as measured by the Clinical Global Impression–Severity (CGI-S) score, a key secondary endpoint.

“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,” said Jane Tiller, Vice President, Global Head of Development, Neuroscience, Johnson & Johnson.

“These Phase 3 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.”

A second pivotal late-stage study evaluating Caplyta for the treatment of manic episodes in adults with bipolar I disorder has been completed, and data analysis is underway, according to the company statement.