Veozah: which tox species, and why?

“Repeat dose toxicity studies were conducted in intact female rats and cynomolgus monkeys.”

“Cynomolgus monkey was selected as the relevant nonrodent species as nonhuman primates are anatomically and functionally similar to humans in the reproductive system, which is known to be affected by LH change. In addition, according to the in vitro radioligand assay, fezolinetant has a similar affinity for the human and cynomolgus monkey NK3 receptor orthologs.”

“In the 26-week rat study (Study No 8331724), fezolinetant was administered orally by daily gavage to sexually mature female rats at a dose of 0 (vehicle), 30, 100, or 200 mg/kg.”