Ponvory: how long were the pivotal tox studies?

“Study title: ACT-128800: 52-Week Follow-up Oral (Gavage) Toxicity Study in the Beagle Dog”

“After chronic treatment for 26 weeks, NOAELs for systemic toxicity were established at 30 mg/kg/day in rats and at 2 mg/kg/day in dogs. In the 52-week toxicity study in dogs, the applicant derived a NOAEL at 3 mg/kg/day.”

“Route of administration: Oral by gavage”