Ensacove: how long were the pivotal tox studies?

“To assess the safety of ensartinib, the Applicant conducted repeat-dose toxicology studies up to 13 weeks in duration in rats and dogs.”

“In the 13-week GLP-compliant toxicology studies, ensartinib was administered QD via oral gavage to rats (12.5, 25, or 50 mg/kg) and dogs (5, 10, or 20/15 mg/kg).”

“In the 13-week GLP-compliant toxicology studies, ensartinib was administered QD via oral gavage to rats (12.5, 25, or 50 mg/kg) and dogs (5, 10, or 20/15 mg/kg).”