The Food and Drug Administration (FDA) has granted Fast Track designation to lumateperone (Intra-Cellular Therapies) for the treatment of schizophrenia. 

Lumateperone, a first-in-class molecule, works via potent interactions at 5-HT2A receptors, serotonin transporters, and D1 receptors with indirect glutamatergic modulation. It also acts as a pre-synaptic partial agonist and post-synaptic antagonist at D2 receptors. 

The safety and efficacy of lumateperone is being investigated in three large randomized, double-blind, placebo-controlled trials (Studies 005, 301, and 302). In two of these studies, lumateperone 60mg showed statistically significant separation from placebo on the Positive and Negative Syndrome Scale (PANSS) total score, the primary endpoint of the studies. 

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In addition to schizophrenia, the Company is also developing lumateperone for the treatment of bipolar disorder, agitation associated with dementia, including Alzheimer’s disease, and other neuropsychiatric and neurological disorders.

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