Tryvio: which tox species, and why?

“Repeat dose toxicology studies were conducted in rats (up to 26 weeks) and dogs (up to 39 weeks). These animal species were considered relevant for human risk assessment because pharmacodynamic (PD) and PK/ADME profiles are similar to those in humans.”

“Repeat dose toxicology studies were conducted in rats (up to 26 weeks) and dogs (up to 39 weeks). These animal species were considered relevant for human risk assessment because pharmacodynamic (PD) and PK/ADME profiles are similar to those in humans.”

“In the repeat-dose toxicology studies in male rats and dogs given aprocitentan for 26 weeks or 39 weeks, respectively, at doses up to 250 mg/kg/day, an increased incidence of tubular degeneration/atrophy was observed at 250 mg/kg/day in rats and at ≥25 mg/kg/day in dogs, representing approximately 41-fold and 53-fold, respectively, the exposure at the MRHD, based on AUC.”