Sotyktu: which tox species, and why?

“Deucravacitinib was evaluated in two pivotal repeat-dose general toxicity studies, one in rats and the other in monkeys.”

“All metabolites present in humans were present in at least 1 of the nonclinical safety species, with every human metabolite being detected in rats, and there were no unique human metabolites.”

“In the 6-month rat toxicity study, deucravacitinib was orally administered at the doses of 0, 5, 15, and 50 mg/kg, once daily.”

“Pivotal repeat-dose GLP studies were conducted in CByB6F1 mice (≤28 days), Sprague-Dawley rats (≤6 months) and cynomolgus monkeys (≤9 months).”

“fertility and pre- and postnatal development (PPND) (rat) and embryo-fetal development (EFD) (rat and rabbit) studies”

“Deucravacitinib did not cause increases of tumor incidences in a 6-month oral carcinogenicity study in transgenic rasH2 mice and a 2-year oral carcinogenicity study in rats.”

“In the 6-month rat toxicity study, deucravacitinib was orally administered at the doses of 0, 5, 15, and 50 mg/kg, once daily.”