Foundayo: genotox, carcinogenicity and repro: done or skipped?

“Orforglipron was not mutagenic or clastogenic in a bacterial reverse mutation test, an in vitro micronucleus test in human lymphoblastoid cells, or in an in vivo bone marrow micronucleus study in rats.”

“FDA concurs with the Applicant that orforglipron was not carcinogenic in a lifetime study in rats and a 6-month study in rasH2 transgenic mice.”

“In a rabbit embryofetal development study, orforglipron caused off-target embryofetal effects which included decreased fetal and placental weights and malformations at exposures 14x the MRHD.”

“Orforglipron did not affect respiratory or CNS functions in monkeys. In cardiovascular studies in monkeys, orforglipron produces effects consistent with GLP-1 pharmacology including increases in heart rate and PR interval prolongation.”