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

“Vibegron was not mutagenic in in vitro microbial reverse mutation (Ames) assays, showed no genotoxic activity in an in vitro human peripheral blood lymphocyte chromosomal aberration assay, and did not increase the frequency of micronucleated polychromatic erythrocytes in an in vivo rat bone marrow micronucleus assay.”

“Two year carcinogenicity studies were also conducted in mice and rats, with no treatment-related malignancies observed in either species at adequate exposure margins”

“No embryo-fetal developmental toxicity was observed in rats at doses up to 300 mg/kg/day (1867-fold the AUC at the clinical dose) or in rabbits at doses up to 100 mg/kg/day (285-fold the AUC at the clinical dose).”

“Cardiac safety pharmacology studies in the rhesus monkey indicated that vibegron significantly increased heart rate, respiration rate and body temperature.”