Gemtesa: which tox species, and why?

“General toxicity of chronic oral administration of vibegron was adequately evaluated in rats (3 & 6 months) and monkeys (3 & 9 months).”

“The choice of toxicology species rats and monkeys was based on that the metabolic profile of these species is similar to that of human.”

“Vibegron was tested up to 9 months in monkeys and 6 months in rats.”

“General toxicity of chronic oral administration of vibegron was adequately evaluated in rats (3 & 6 months) and monkeys (3 & 9 months).”

“Reproductive studies to examine fertility, embryofetal development, and pre- and postnatal development were also conducted in rats and rabbits.”

“Two year carcinogenicity studies were also conducted in mice and rats, with no treatment-related malignancies observed in either species at adequate exposure margins”

“Vibegron was tested up to 9 months in monkeys and 6 months in rats.”