Xcopri: which tox species, and why?

“The toxicology package included repeat-dose toxicity (up to 13 weeks in mice, 26 weeks in rats, and 52 weeks in monkeys, in vitro and in vivo genotoxicity,”

“Monkey had a similar metabolic profile as the human profile.”

“In the chronic (26-week) oral rat study, mortality was seen at the HD of 48 mg/kg/day and CNS clinical signs (decreased activity, uncoordinated gait) at doses ≥ 24 mg/kg/day.”

“The toxicology package included repeat-dose toxicity (up to 13 weeks in mice, 26 weeks in rats, and 52 weeks in monkeys,”

“A potential for adverse effects on development was identified in rat and rabbit studies.”

“carcinogenicity (26-week in transgenic rasH2 mice, 104-week in rats)”

“The toxicology package included repeat-dose toxicity (up to 13 weeks in mice, 26 weeks in rats, and 52 weeks in monkeys,”