Palsonify: which tox species, and why?

“These studies included repeat-dose toxicology studies in rats (up to 26 weeks) and dogs (up to 39 weeks), and reproductive and developmental toxicology studies in rats and rabbits.”

“The rat and dog were selected as the species for non-clinical toxicity studies based on similarity in the metabolic profiles compared to humans. Both species are also pharmacologically relevant.”

“In the pivotal 26-week chronic study, rats were administered paltusotine at doses of 25, 75, or 500 mg/kg/day.”

“These studies included repeat-dose toxicology studies in rats (up to 26 weeks) and dogs (up to 39 weeks), and reproductive and developmental toxicology studies in rats and rabbits.”

“DART program is composed with a GLP fertility and early embryonic development study in rats, embryo-foetal development studies in rats and rabbits and a pre- and postnatal study in rats.”

“Paltusotine did not elicit any treatment-related increase in the incidence of tumors in a 2-year study in rats or a 26-week study in Tg.rasH2 transgenic mice.”

“The rat and dog were selected as the species for non-clinical toxicity studies based on similarity in the metabolic profiles compared to humans. Both species are also pharmacologically relevant.”