Ensacove: which tox species, and why?

“To assess the safety of ensartinib, the Applicant conducted repeat-dose toxicology studies up to 13 weeks in duration in rats and dogs.”

“Because dog microsomes shared greater metabolic similarities with human microsomes (major metabolites, rate of metabolism, and relative abundance), they were selected by the Applicant as the non-rodent toxicologic species.”

“In the 13-week GLP-compliant toxicology studies, ensartinib was administered QD via oral gavage to rats (12.5, 25, or 50 mg/kg) and dogs (5, 10, or 20/15 mg/kg).”