“Repeat-dose toxicity studies of up to six months duration in rats and nine months duration in dogs were conducted to support the chronic use of etrasimod in humans.”
✓ VerifiedFDA multi-discipline review, p. 49Source ↗
Why that species
Rats sufficiently exposed to metabolites M3 and M6
“The overview shows that rats were exposed sufficiently to the metabolites M3 and M6 during toxicity testing.”
“No adverse effects were observed in rats or dogs at exposures up to 738- and 446-fold, respectively, the exposure at the MRHD (based on AUC comparison).”
✓ VerifiedFDA multi-discipline review, p. 42Source ↗