Caplyta: which tox species, and why?

“The toxicological profile of lumateperone was studied in mice, rats, and dogs following oral administration for up to 3, 6, and 9 months, respectively.”

“The Applicant was unable to identify an alternative nonclinical species with a similar metabolic profile to humans and, therefore, the rat and dog were used.”

“In the rat 6-month chronic toxicology study, adverse effects occurred at doses of lumateperone that are ~ 5 times the MRHD of 42 mg on a mg/m2 basis.”

“The toxicological profile of lumateperone was studied in mice, rats, and dogs following oral administration for up to 3, 6, and 9 months, respectively.”

“In animal reproduction studies, no malformations were observed with oral administration of lumateperone to pregnant rats and rabbits during organogenesis at doses up to 2.4 and 9.7 times, respectively, the maximum recommended human dose (MRHD) of 42 mg/day on a mg/m 2 basis.”

“Its carcinogenic potential was studied following oral administration for up to 21 months in rats and mice, providing additional information on its toxicology.”

“The Applicant was unable to identify an alternative nonclinical species with a similar metabolic profile to humans and, therefore, the rat and dog were used.”