“Toxicological characterization of danicopan was evaluated in beagle dogs (5 days, 2-weeks, 13- weeks, 13-weeks, and 9 months), wistar han (WH) rats (14 days, 28-days, 13-weeks, and 6- months)”
Dog selected as non-rodent safety species; rat (pharmacologically inactive) used to assess off-target toxicity
“The dog was selected as the nonrodent nonclinical safety species (repeat-dose toxicology), and the off-target activity/toxicity of danicopan was assessed in rats.”
“In the 6-month toxicity study in rats (species not pharmacologically sensitive to danicopan), hypertrophy in liver, thyroid and adrenal gland was observed at doses of 1000 mg/kg/day (~26-fold above human exposure at 200 mg three times a day based on AUC).”