Johnson & Johnson Announces CAPLYTA (lumateperone) Shows Significant and Rapid Improvement in Bipolar Mania in Second Pivotal Phase 3 Study
Key Highlights
- ➤CAPLYTA met primary and key secondary endpoints in second pivotal Phase 3 study
- ➤YMRS scores improved 3.7 points versus placebo at Week 3 (P<.0001)
- ➤CAPLYTA improved manic symptoms significantly as early as Day 3
- ➤43.9% achieved clinical response versus 23.7% with placebo at Week 3
- ➤Two positive Phase 3 studies support planned U.S. FDA submission for bipolar mania
Expert Statements
Jane Tiller, Vice President, Global Head of Development, Neuroscience, Johnson & Johnson
“Manic episodes can disrupt a person's safety, relationships, and daily life within days, underscoring the need for treatments that act rapidly.”
Jane Tiller, Vice President, Global Head of Development, Neuroscience, Johnson & Johnson
“Building on the established safety and efficacy profile of CAPLYTA in bipolar I and II depression, consistent, positive results across two pivotal Phase 3 studies in acute mania associated with bipolar I disorder support its potential to help stabilize symptoms for patients during some of the most difficult moments of their illness.”
Johnson & Johnson Announces CAPLYTA (lumateperone) Shows Significant and Rapid Improvement in Bipolar Mania in Second Pivotal Phase 3 Study PR Newswire
* CAPLYTA improved manic symptoms versus placebo as early as Day 3, with improvement sustained through Week 3 and a safety and tolerability profile consistent with prior studies * Two positive Phase 3 studies will support a planned U.S. FDA submission of CAPLYTA for bipolar mania, reinforcing its potential to address both depressive and manic episodes of bipolar disorder NEW BRUNSWICK, N.J., Nov. 10, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that Study 452, the second pivotal Phase 3 study evaluating CAPLYTA (lumateperone) for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder, met its primary and key secondary endpoints. CAPLYTA significantly improved manic symptoms and overall illness severity versus placebo at Week 3, with significant improvements observed as early as Day 3.(1) The results were featured as a late-breaking presentation at the 2026 Neuroscience Education Institute (NEI) Fall Congress (November 5-8, Colorado Springs, CO).
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