Caplyta is prescribed for adults to treat schizophrenia, depression related to bipolar I or II disorder, and as an add-on treatment with antidepressants for major depressive disorder (MDD) Caplyta ...

Pooled analysis of 3 randomized, double-blind, pacebo-cotrolled trials supports the safety and the distinct and favorable tolerability profile of lumateperone 42 mg Mean change from baseline in ...

TITUSVILLE, N.J., April 27, 2026 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on ...

Intra-Cellular Therapies develops small-molecule drugs targeting the central nervous system for neuropsychiatric and neurological disorders. Caplyta is their lead drug, approved by the FDA for ...

CAPLYTA® ranked highest among FDA-approved adjunctive therapies across four measures of efficacy, based on indirect comparisons from placebo plus antidepressant therapy-controlled trials Among the ...

Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA ® is FDA approved to treat schizophrenia ...

Intra-Cellular Therapies Inc.’s phase III data with Caplyta (lumateperone) 42 mg in major depressive disorder (MDD) with mixed features (MF) and in patients with bipolar depression with MF may augur ...

The efficacy and safety of CAPLYTA (lumateperone) as a maintenance treatment in adults with schizophrenia was demonstrated in a randomized withdrawal trial The study demonstrated a statistically ...

Caplyta (lumateperone) is a brand-name capsule prescribed for schizophrenia, bipolar depression, and major depressive disorder (MDD) in adults. Caplyta interacts with certain other drugs, including ...