United Statesintracellulartherapies.com
Intra-Cellular Therapies, Inc. is a U.S.-based biopharmaceutical company focused on discovering, developing, and commercializing small-molecule drugs for neuropsychiatric and neurological disorders. The company applies insights into intracellular signaling within the central nervous system to design compounds with differentiated receptor and pathway profiles.
Its lead product, lumateperone (CAPLYTA), is approved in the United States for the treatment of schizophrenia and for depressive episodes associated with bipolar I or II disorder in adults. The pipeline includes additional CNS candidates, including selective phosphodiesterase type 1 (PDE1) inhibitors and other next‑generation agents aimed at mood, psychotic, and neurodegenerative conditions. Intra-Cellular Therapies is headquartered in New York and is listed on Nasdaq under the ticker ITCI.
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Network meta-analysis of 10 trials found an adjunctive atypical antipsychotic superior on MADRS change, response, remission and CGI‑S, with no significant weight gain and favorable tolerability.
FDA approved sNDA for CAPLYTA (lumateperone) to prevent relapse in schizophrenia. Phase 3 randomized‑withdrawal: 63% lower relapse risk (HR 0.37); 84% relapse‑free at 6 months; safety consistent.
FDA approves CAPLYTA® as adjunctive therapy for major depressive disorder, showing significant symptom improvement and safety in trials, with potential for remission.