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.”