“Repeated dose toxicology studies of up to 6 months and 9 months were conducted in rats and dogs, respectively.”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗
Why that species
Target (NHE3) expressed at similar intestinal levels in rat, dog and human
“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.”
✓ VerifiedFDA multi-discipline review, p. 146Source ↗
Surrogate molecule
No surrogate; the clinical compound was tested
“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.”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗