Ibsrela: which tox species, and why?

“Repeated dose toxicology studies of up to 6 months and 9 months were conducted in rats and dogs, respectively.”

“SLC9A3 (NHE3) expression was observed along the entire intestinal tract in the rat, dog, and human. NHE3 expression levels were similar across all three species throughout the intestine with a few segment specific differences noted.”

“In a 6-month toxicology study in rats, tenapanor was administered orally to SD rats at doses of 1, 3, and 10 mg/kg/day.”

“Repeated dose toxicology studies of up to 6 months and 9 months were conducted in rats and dogs, respectively.”

“In reproduction studies with tenapanor in pregnant rats and rabbits, no adverse fetal effects were observed in rats at 0.1 times the maximum recommended human dose and in rabbits at doses up to 8.8 times the maximum recommended human dose (based on body surface area).”

“Tenapanor was not tumorigenic in 2-year rat and 6- month Tg rasH2 mouse carcinogenicity bioassays.”

“Repeated dose toxicology studies of up to 6 months and 9 months were conducted in rats and dogs, respectively.”