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

“In studies conducted by the Applicant, artesunate was negative in the Ames test, mammalian chromosome aberration assay (CHO), and in vivo micronucleus assay (up to 500 mg/kg, highest concentration tested).”

“No carcinogenicity studies have been conducted with artesunate. Given the short duration of treatment (up to 7 days) carcinogenicity studies are not indicated.”

“Oral administration of artesunate during organogenesis caused a significant increase in post-implantation loss in pregnant rats, rabbits and cynomolgus monkeys at significantly less than clinically relevant doses based on body surface area comparisons.”

“No adverse effects on cardiovascular function were observed in conscious beagle dogs following single or repeated (up to 27 days) IV dosing up to 40 mg/kg, approximately nine times the clinical dose based on body surface area comparison.”