Iqirvo: which tox species, and why?

“repeat-dose oral toxicology studies (mouse studies of up to 3 months, rat studies of up to 6 months, and monkey studies of up to 12 months)”

“The reports indeed state that dogs are more sensitive to PPAR toxic effects than other species, and that it is recommended to conduct the general toxicity testing for this type of substances in rats and monkeys.”

“In the 52-week oral toxicity study in monkeys, elafibranor at 50 mg/kg/day caused body weight reduction by 22% in males”