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

“Oveporexton was found to be negative in an Ames assay and in an in vivo micronucleus assay; however, it was found to be positive for induction of micronuclei in an in vitro micronucleus assay following 24-hours of continuous treatment. Overall oveporexton was determined to be non-genotoxic.”

“Oveporexton was also found to be non-carcinogenic in a GLP 2-year rat and a GLP 6-month transgenic mouse carcinogenicity study.”

“There were no drug-related effects on the incidence of congenital malformations or embryo-fetal lethality in either rats or rabbits.”

“Results from GLP-compliant safety pharmacology studies indicated that oveporexton can affect the CNS (increased body temperature at 20 and 100 mg/kg, decreased body temperature at 1000 mg/kg, and hyperactivity at ≥20 mg/kg in rats), the cardiovascular system (increased blood pressure and left ventricular pressure at ≥3 mg/kg in monkeys), and the respiratory system”