Proposed Schizophrenia Treatment Now Before the FDA

October 4, 2018

Intra-Cellular Therapies, Inc. has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lumateperone, a investigational medicine with a novel mechanism of action for the treatment of schizophrenia.

The submission is supported by data from 20 clinical trials and more than 1900 subjects, the company said in a statement.

Lumateperone, which is taken orally once-daily, received the FDA’s Fast Track designation in November 2017 for the treatment of schizophrenia.

“Our first NDA submission represents a significant milestone for the company and the development of lumateperone, which we believe has the potential to be an important advance in the treatment of schizophrenia,” said Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies. “We look forward to the prospect of working with the FDA to bring lumateperone to patients living with this debilitating disease as quickly as possible.”

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Lumateperone, also known as ITI-007,  provides selective and simultaneous modulation of serotonin, dopamine, and glutamate. As a dopamine receptor phosphoprotein modulator (DPPM), it acts as a presynaptic partial agonist and postsynaptic antagonist at D2 receptors.

“We believe 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,” the company statement read. “This compound has the potential to benefit patients suffering from a range of neuropsychiatric and neurodegenerative diseases.”

Intra-Cellular Therapies is also developing lumateperone as a treatment for bipolar disorder, behavioral disturbances in people with Alzheimer's disease, depression, and other neuropsychiatric and neurological disorders.

—Terri Airov


Intra-Cellular Therapies completes submission of New Drug Application for lumateperone for treatment of schizophrenia [press release]. New York, NY: Intra-Cellular Therapies; September 28, 2018.