Tryvio: how long were the pivotal tox studies?

“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.”

“General toxicity studies were conducted for durations up to 26 weeks in rats and 39 weeks in dogs.”

“Repeat dose toxicity studies were conducted in dogs for up to 39 weeks with oral dose levels from 5 to 1000 mg/kg/day.”