Lynavoy: which tox species, and why?

“Linerixibat has been evaluated in oral repeat-dose general toxicity studies of up to 4, 26, and 39 weeks in mice, rats, and dogs, respectively.”

“The consistent absorption, distribution, metabolism, and excretion profile across rats, dogs, and humans supports the use of these nonclinical species for toxicological evaluation and provides confidence in the safety assessment for human use.”

“Linerixibat has been evaluated in oral repeat-dose general toxicity studies of up to 4, 26, and 39 weeks in mice, rats, and dogs, respectively.”

“Linerixibat has been evaluated in oral repeat-dose general toxicity studies of up to 4, 26, and 39 weeks in mice, rats, and dogs, respectively.”

“Reproductive and developmental toxicology studies using oral administration of linerixibat 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.”

“Linerixibat was not tumorigenic in a 2-year oral carcinogenicity study in rats with oral administration of up to 1,000 mg/kg/day (approximately 3,900 times the recommended dose based on AUC). In a 26-week oral carcinogenicity study in TgRasH2 mice, no drug-related tumors were observed following administration of linerixibat up to 160 mg/kg/day.”

“Linerixibat has been evaluated in oral repeat-dose general toxicity studies of up to 4, 26, and 39 weeks in mice, rats, and dogs, respectively.”