Veklury: which tox species, and why?

“Repeat-dose toxicity in rats and cynomolgus monkeys have been conducted, 2-week studies with a 4-week recovery period, and 4-week studies in both species.”

“Pharmacokinetic studies supported the selection of the rat and monkey for the assessment of RDV toxicology. Both rat and monkey formed the intermediate metabolite GS-704277 and the nucleoside metabolite GS-441524.”

“Intravenous administration (slow bolus) of remdesivir to rats at dosage levels of ≥3 mg/kg/day for up to 4 weeks resulted in findings indicative of kidney injury and/or dysfunction.”