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

“Remdesivir was not genotoxic in a battery of assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes, and in vivo rat micronucleus assays.”

“Given the short-term administration of VEKLURY for the treatment of COVID-19, long-term animal studies to evaluate the carcinogenic potential of remdesivir were not conducted.”

“In the reproductive and development toxicity studies, there was a decrease in corpora lutea, a consequent decrease in implantation sites and viable embryos, and lower ovary and uterus/cervix/oviduct weights in the rats at 10 mg/kg; these changes were observed at a systemically toxic dose. There were no remarkable findings in male rats in the fertility study, no adverse findings in embryo-fetal studies in rats and rabbits, and no adverse changes in the pre- and postnatal study in rats.”

“RDV did show only a weak inhibition in vitro of the hERG channel, IC20 and IC50 values for the inhibitory effect were 7.5 μM and 28.9 μM, respectively”