Johnson & Johnson Reports Second Positive Phase 3 Study Of CAPLYTA In Bipolar Mania
(RTTNews) - Johnson & Johnson (JNJ) reported positive results from a second pivotal Phase 3 study of CAPLYTA (lumateperone) in adults experiencing manic episodes associated with bipolar I disorder, supporting plans for a future U.S. regulatory submission.
Bipolar I disorder is characterized by episodes of depression and mania. Manic episodes can involve unusually elevated mood, increased energy, reduced need for sleep, racing thoughts and impulsive behavior, often disrupting daily life and sometimes requiring hospitalization.
Phase 3 Study Meets Key Goals
The study met its primary endpoint, with CAPLYTA showed a 3.7-point greater reduction in Young Mania Rating Scale (YMRS), a commonly used measure of mania severity. Improvements were observed as early as Day 3 and were maintained through Week 3.
Nearly 44% of patients treated with CAPLYTA achieved at least a 50% improvement in YMRS scores, compared with 24% of patients receiving placebo.
The trial also met a key secondary endpoint measuring overall illness severity, with CAPLYTA showing significantly greater improvement than placebo. Benefits were again seen as early as Day 3.
Safety Profile
Johnson & Johnson said CAPLYTA was generally well tolerated, with a safety profile consistent with previous studies. The most common treatment-related side effects reported more frequently than placebo were dizziness, dry mouth, and sleepiness or sedation.
Regulatory Plans
The positive findings follow an earlier successful Phase 3 study, giving the company two positive pivotal trials in bipolar mania.
Johnson & Johnson said the results from both studies are expected to support a planned FDA submission seeking approval of CAPLYTA for bipolar mania.
CAPLYTA is currently approved in the United States for schizophrenia, bipolar depression, and as an add-on treatment for major depressive disorder, but it is not currently approved for bipolar mania.
The latest findings were presented at the 2026 Neuroscience Education Institute (NEI) Fall Congress.
JNJ has traded between $189.05 and $282.73 over the past year. The stock closed Monday's trading at $282.11, up 2.13%. In pre-market trading the stock is at $284.00, up 0.67%.
