Intra-Cellular Therapies completes rolling submission of lumateperone to treat schizophrenia.

Intra-Cellular Therapies, Inc. announced that the Company has completed the rolling submission of its New Drug Application (NDA) to the FDA for lumateperone, a once-daily, oral investigational medicine with a novel mechanism of action for the treatment of schizophrenia. The NDA submission is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone. Lumateperone received Fast Track designation from the FDA in November 2017 for the treatment of schizophrenia.

Lumateperone is a first-in-class molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate - three neurotransmitter pathways implicated in severe mental illness. Unlike existing schizophrenia treatments, lumateperone is a dopamine receptor phosphoprotein modulator (DPPM) acting as a pre-synaptic partial agonist and post-synaptic antagonist at D2 receptors. Intra-Cellular Therapies believes this mechanism, along with potent interactions at 5-HT2A receptors, serotonin transporters, and D1 receptors with indirect glutamatergic modulation, may contribute to the efficacy of lumateperone across a broad array of symptoms, with improved psychosocial function and favorable tolerability. This compound has the potential to benefit patients suffering from a range of neuropsychiatric and neurodegenerative diseases.