Rhapsido: how long were the pivotal tox studies?

“In a 39-week GLP oral repeat-dose toxicity study in beagle dogs, animals (4/sex/group) were administered doses of 0 (vehicle), 10, 50, and 300 mg/kg/day remibrutinib.”

“GLP repeat-dose toxicity studies were conducted in rats (up to 26-week daily dosing; dose levels in 26-week rat study were 30, 300, and 1000 mg/kg/day) and dogs (up to 39-week daily dosing; dose levels in 39-week dog study were 10, 50, and 300 mg/kg/day).”

“In a 26-week GLP toxicity study, Wistar rats (20/sex/group) were dosed by oral gavage with 0, 30, 300, and 1000 mg/kg/day remibrutinib.”