Intra-Cellular Therapies announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lumateperone (ITI-007) for the treatment of schizophrenia

Lumateperone, a first-in-class molecule, is a potent serotonin 5-HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM) acting as a presynaptic partial agonist and postsynaptic antagonist at dopamine D2 receptors, a dopamine D1 receptor-dependent indirect modulator of glutamate (both NDMA and AMPA), and a serotonin reuptake inhibitor. The NDA submission includes data from 20 trials involving >1900 patients.

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Lumateperone and follow-on compounds are also being evaluated for bipolar depression, behavioral disturbances associated with dementia, sleep disturbances associated with neuropsychiatric disorders, and other neuropsychiatric conditions including major depressive disorder and autism. 

The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of September 27, 2019. 

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