Itovebi: how long were the pivotal tox studies?

“Preliminary and definitive GLP repeat-dose toxicity studies were conducted with inavolisib in rats and dogs up to 13 weeks of duration.”

“In the 4-week and 13-week repeat-dose toxicology studies with inavolisib in rats and dogs, histopathology changes observed in reproductive organs suggest that inavolisib has the potential to impair male and female fertility.”

“Inavolisib was evaluated in GLP-compliant, repeat-dose toxicology studies in Sprague-Dawley rats and Beagle dogs following once daily oral administration, consistent with the clinical route of administration and intended dosing schedule, for up to 3 months in duration.”