Zegfrovy: how long were the pivotal tox studies?

“The Applicant conducted 13-week repeat-dose toxicology studies in rats and dogs with a recovery period of 4 weeks.”

“A series of general toxicology studies in compliance with GLP have been completed, including single-dose oral toxicity studies in Wistar Han rats and Beagle dogs, 4-week and 13-week repeated dose toxicity and toxicokinetics studies in Wistar Han rats and Beagle dogs with 4-week recovery.”

“DZD9008 - 13 Week Oral (Gavage) Toxicity Study in the Rat with a 4 Week Treatment-Free Period (JXB0023)”