“General toxicology studies were conducted in mice (3-month), rats (4-week, 3-month, 6-month), and dogs (4-week, 3-month, 9-month) using the oral route of administration”
Dose-related erythropoietic (pharmacological) response shown in mice, rats and dogs
“A dose-related erythropoietic response was observed in mice, rats, and dogs, showing that the appropriate pharmacological response occurs in the toxicological species used.”
“The toxicology profile of vadadustat has been evaluated in single- and repeat-dose studies following oral administration across multiple species (mice, rats, and dogs) for up to 6 and 9 months in rats and dogs, respectively, and in reproductive and developmental toxicity studies in rats and rabbits.”