Ongentys: how long were the pivotal tox studies?

“Study title: 52-week oral (gavage) toxicity study in the Cynomolgus monkey with an 8-week recovery period.”

“In the subchronic and chronic toxicity studies in rat (up to 6 months) and monkey (up to 52 weeks) and in the carcinogenicity studies in mouse and rat, opicapone was tested at doses up to 1000 mg/kg/day, which was identified as the NOAEL in all three species.”

“The oral route of administration (gavage) with a once daily regimen was used in the toxicology studies as this is the intended human therapeutic route.”