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”

“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)”

“Reproductive and developmental toxicology studies of elafibranor included a fertility study in male and female rats, embryo-fetal development studies in rats and rabbits, and a pre- and postnatal development study in rats.”

“Carcinogenicity of elafibranor was tested in rats and mice. In the GLP-compliant 104-week study with Sprague-Dawley rats, elafibranor induced increased incidence of hepatocellular carcinomas/adenomas and pancreatic acinar cell adenomas in both sexes”

“The nonclinical safety profile of elafibranor was evaluated in safety pharmacology studies, 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)”