“Repeat-dose toxicity studies were conducted with imlunestrant in rats (≤ 150 mg/kg/day) up to 6- months duration and monkeys (≤ 600 mg/kg/day) up to 3-months duration.”
✓ VerifiedFDA multi-discipline review, p. 41Source ↗
Pivotal GLP studies
6-month rat and 3-month cynomolgus monkey oral gavage studies
“Imlunestrant has been administered by QD oral gavage to rats for up to 6 months and to monkeys for up to 3 months.”
✓ VerifiedFDA multi-discipline review, p. 50Source ↗
Route in tox
Oral gavage
“Imlunestrant has been administered by QD oral gavage to rats for up to 6 months and to monkeys for up to 3 months.”
✓ VerifiedFDA multi-discipline review, p. 50Source ↗