Intra-Cellular Therapies (NASDAQ:ITCI) (NASDAQ:ITCI) is a clinical-stage biopharmaceutical company headquartered in New York City that focuses on the development of novel small-molecule therapies for central nervous system (CNS) disorders. Since its founding in 2002, the company has pursued an intracellular signaling approach to address conditions such as schizophrenia, bipolar depression and neuropsychiatric manifestations of Parkinson’s disease. Its research platform is built on the modulation of key neurotransmitter receptors and intracellular pathways, distinguishing its pipeline from traditional receptor-targeted drug candidates.
The company’s flagship product, lumateperone (marketed as CAPLYTA®), is approved in the United States for the treatment of schizophrenia in adults and for bipolar depression in adults. Lumateperone’s mechanism of action involves simultaneous modulation of serotonin, dopamine and glutamate signaling, offering a differentiated side-effect profile compared to existing antipsychotics. In addition to its approved indications, Intra-Cellular Therapies is pursuing regulatory filings in multiple territories and is exploring additional psychiatric and neurological indications for lumateperone.
Beyond CAPLYTA®, ITCI’s pipeline includes early-stage programs such as ITI-333, which targets non-motor symptoms of Parkinson’s disease and REM sleep behavior disorder, and ITI-214, a phosphodiesterase-1 inhibitor in development for cognitive impairment associated with schizophrenia. The company conducts its clinical trials primarily in North America and Europe, leveraging strategic partnerships and academic collaborations to support patient enrollment and translational research efforts.
Under the guidance of a leadership team with deep expertise in neuropsychopharmacology, Intra-Cellular Therapies has built its organizational capabilities around clinical development, regulatory strategy and commercialization readiness. The company’s co-founders and executive management maintain active engagement with scientific advisory boards and professional societies, ensuring that its research advances reflect evolving standards in CNS drug development.
