Oxbryta: which tox species, and why?

“Major findings associated with repeat-dose administration of voxelotor in mice, rats and Cynomolgus monkeys were changes in hematopoietic parameters and gastrointestinal (GI) intolerance that was attributed to local irritation.”

“The exposure in dogs in the 4-week study at the highest tolerated dose was not sufficiently high to cause decreased tissue O2 extraction and dogs did not have erythroid or bone marrow changes, therefore dogs were not further considered as test species.”

“In a fertility and early embryonic development study, voxelotor was administered orally to rats at 15, 50, and 250 mg/kg/day.”