Jaypirca: how long were the pivotal tox studies?

“Repeat-dose toxicology studies of up to 3 months were conducted in rats and dogs, using an oral route of administration, consistent with the proposed clinical route.”

“See additional information provided below for the 3-month repeat-dose toxicity studies in rats and dogs.”

“In this GLP study, pirtobrutinib was administered to Sprague Dawley rats at 0, 50, or 500 mg/kg in males or 0, 60, 300 mg/kg in females BID via oral gavage for 15 weeks.”