J&J's Caplyta meets main goal in bipolar mania phase 3 trial
J&J’s Caplyta cut manic symptoms 4.8 YMRS points more than placebo at Week 3 in Phase 3 Study 451; not yet approved for bipolar mania.
Health · 7 sources · Sep 22, 2026Read itThe journal
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About lumateperone
Lumateperone, sold under the brand name Caplyta, is an atypical antipsychotic medication of the pyridopyrroloquinoxaline and butyrophenone families. It is approved for the treatment of schizophrenia as well as bipolar depression, as either monotherapy or adjunctive therapy, and for major depressive disorder as an adjunctive therapy only. It is developed by Intra-Cellular Therapies, licensed from Bristol-Myers Squibb. Lumateperone was approved for medical use in the US in December 2019 with an initial indication for schizophrenia. It became available in February 2020.
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