“In a 39-week oral gavage toxicity study in cynomolgus monkeys with a 4-week recovery phase, baxdrostat was administered at doses of 0, 1, 3, or 6 mg/kg/day.”
✓ VerifiedFDA pharmacology/toxicology review, p. 19Source ↗
Pivotal GLP studies
26-week rat and 39-week cynomolgus monkey oral studies
“Baxdrostat was evaluated in repeat-dose oral toxicology studies of up to 6 months in rats and 9 months in monkeys.”
✓ VerifiedFDA pharmacology/toxicology review, p. 19Source ↗
Route in tox
Oral gavage
“In 13-week and 26-week oral gavage toxicity study in Wistar Han rats with a 4-week recovery phase, baxdrostat was administered at doses of 0, 1, 3, or 10 mg/kg/day.”
✓ VerifiedFDA pharmacology/toxicology review, p. 19Source ↗