Xocova: how long were the pivotal tox studies?

“In a 4-week oral repeat-dose toxicology study in cynomolgus monkeys, ensitrelvir was administered at 0, 3, 10 or 30 mg/kg/day.”

“Evaluation of the safety of S-217622 (ensitrelvir) fumaric acid, included safety pharmacology in rats and dogs, repeat-dose oral toxicity studies in rats and monkeys (2- and 4-week), genotoxicity studies, reproductive and developmental toxicity studies in rats and rabbits, and other mechanistic studies.”

“In a 4-week oral repeat-dose toxicology study in cynomolgus monkeys, ensitrelvir was administered at 0, 3, 10 or 30 mg/kg/day.”