Inpefa: which tox species, and why?

“This includes a single-dose rat study, a battery of definitive repeat-dose general toxicity studies in rats (up to 26 weeks) and dogs (up to 39 weeks), a full battery of genetic toxicity studies, mouse and rat carcinogenicity studies”

“Repeat-dose toxicity studies were performed in rats and dogs. Carcinogenicity evaluation was performed in mice and rats. Embryofetal development studies were performed in rats and rabbits. All species are pharmacologically relevant.”

“the NOAEL in 39-week oral sotagliflozin for male and female beagle dogs was 20 mg/kg/day”

“a battery of definitive repeat-dose general toxicity studies in rats (up to 26 weeks) and dogs (up to 39 weeks)”

“Sotagliflozin did not impair fertility or alter early embryonic development in the rat at doses up to 300 mg/kg/day, the highest dose evaluated. Embryo-fetal development was evaluated in rats and rabbits.”

“The carcinogenic potential of sotagliflozin was evaluated in a 26-week transgenic RasH2 mouse carcinogenicity study and a 2-year rat carcinogenicity study.”

“Repeat-dose toxicity studies were performed in rats and dogs. Carcinogenicity evaluation was performed in mice and rats. Embryofetal development studies were performed in rats and rabbits. All species are pharmacologically relevant.”