“In a 9-month toxicology study in dogs, tenapanor was administered orally to beagle dogs at doses of 50, 300 and 1000 mg/kg/day.”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗
Pivotal GLP studies
6-month rat and 9-month dog oral studies
“In support of the safety of tenapanor, the Applicant submitted the following nonclinical studies: pharmacology, PK, single dose and repeat dose oral toxicity studies in rats (up to 6 months) and dogs (up to 9 months)”
✓ VerifiedFDA multi-discipline review, p. 32Source ↗
Route in tox
Oral
“single dose and repeat dose oral toxicity studies in rats (up to 6 months) and dogs (up to 9 months)”
✓ VerifiedFDA multi-discipline review, p. 32Source ↗