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

“Tradipitant was negative in a complete battery of genetic toxicity studies, including the Ames assay, an in vitro chromosomal aberration assay in human lymphocytes, and an in vivo micronucleus assay in mice.”

“In transgenic rasH2 mice orally administered tradipitant (15, 50, or 1500 mg/kg/day) for 26 weeks, there was no increase in tumors. In rats orally administered tradipitant (10, 30, or 150 mg/kg/day) for at least 104 weeks, a dose- related increase in the incidence of thyroid follicular cell tumors (adenomas or adenomas combined with carcinomas), correlating with the findings of thyroid masses and cysts, was observed at all tested doses”

“No effects on fertility, maternal health, or embryo-fetal development were observed in rats treated with tradipitant during the periods of mating and organogenesis at doses up to 1000 mg/kg/day (57-fold the maximum clinical dose, based on HED; 2.2-fold based on AUC).”

“In a cardiovascular safety pharmacology study in conscious male and female Beagle dogs, single oral doses of tradipitant up to 800 mg/kg had no significant effects on qualitative or quantitative ECG parameters (157-fold the maximum clinical dose of 170 mg, based on HED).”