Inluriyo: which tox species, and why?

“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.”

“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.”

“Imlunestrant has been administered by QD oral gavage to rats for up to 6 months and to monkeys for up to 3 months.”

“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.”

“A dedicated fertility study was not conducted with imlunestrant in accordance with ICH S9 guidance and the intended advanced cancer indication.”

“Nevertheless, a 6-month carcinogenicity study in transgenic rasH2 mouse was conducted to support possible extensions to other indications.”

“Imlunestrant has been administered by QD oral gavage to rats for up to 6 months and to monkeys for up to 3 months.”