20 November 2017 - Intra-Cellular Therapies today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for lumateperone for the treatment of schizophrenia. 

The company requested fast track designation for lumateperone based on clinical evidence that lumateperone has the potential to address the unmet medical need for the treatment of schizophrenia with significant improvements on several clinically significant safety parameters, including with respect to metabolic, motor and cardiovascular issues associated with many currently available antipsychotic agents.

Lumateperone, our lead product candidate, 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.

Read Intra-Cellular Therapies press release