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

“Finerenone was also negative in the in vitro chromosomal aberration assay in mammalian cells and in the in vivo mouse micronucleus test.”

“Two-year carcinogenicity studies conducted in mice and rats showed no significant increase in neoplasms in males or females in either study; the CDER Exec CAC concurred with this conclusion.”

“In the embryo-fetal toxicity study in rats, finerenone resulted in reduced placental weights and signs of fetal toxicity, including reduced fetal weights and retarded ossification at the maternal toxic dose of 10 mg/kg/day, corresponding to an AUC unbound of 19 times that in humans.”

“Finerenone showed no adverse effects on CNS parameters and respiratory functions (rat), on hemodynamic/ECG parameters (dog), and on cardiac repolarization in vitro (hERG K+ current).”