“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 ↗
Why that species
Pharmacokinetics and toxicokinetics in rat and monkey similar enough to human to be representative
“Overall, it can be concluded that rats and monkeys are suitable non-clinical species for the safety assessment of imlunestrant. The pharmaco-and toxicokinetics are similar enough to human pharmacokinetics to be representative.”