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# FDA Seeks More Data on Intra-Cellular Schizophrenia Drug
- URL: https://www.fdaweb.com/fda-seeks-more-data-on-intra-cellular-schizophrenia-drug/
- Published: 2017-05-03T12:00:00.000Z
- Updated: 2026-09-14T22:21:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138603

FDA has told Intra-Cellular Therapies that it has concerns with certain findings observed in nonclinical animal toxicology studies involving ITI-007 (lumateperone), an investigational therapy for schizophrenia. During a company-requested feedback meeting, the agency requested additional information to confirm that the nonclinical findings are not indicative of a safety risk associated with long term exposure in humans. “These findings only occurred in one of the nonclinical toxicology species and only after high exposure to drug related material,” the company says.

“We and our expert consultants,” continues the company, “believe these findings are not indicative of a safety risk for humans due to species differences in the metabolism of lumateperone. In humans, lumateperone and its metabolites are rapidly eliminated from the body and there is no retention of drug or drug related material. In the animal species in question, a substantial amount of drug related metabolites are retained for an extended period of time and metabolites are formed in this species that are not detected in humans.”

  
Intra-Cellular says it is preparing responses to FDA’s request for additional information and it intends to proceed with its long-term safety study of lumateperone in patients with schizophrenia. “If the FDA deems our responses regarding the nonclinical findings to be sufficient, we intend to submit an NDA for lumateperone for the treatment of schizophrenia by mid-year 2018 supported by the efficacy studies we have conducted to date,” it adds.