“Intranasal toxicity studies of zavegepant were conducted in Sprague Dawley rat (4-, 13-, and 26-week) and cynomolgus monkey (4-, 13-, and 39-week).”
✓ VerifiedFDA pharmacology/toxicology review, p. 3Source ↗
Why that species
Monkey CGRP receptor binding affinity similar to human; far lower affinity in rodent, rabbit and dog
“similar binding affinity was observed to the CGRP receptors in cynomolgus (IC50 = 0.06 nM) and marmoset (IC50 = 0.13 nM) monkeys. In vitro binding affinity was substantially lower to the CGRP receptors in the other animal species tested (IC50 values of 500, 600, 8,700, 25,000, and 140,000 nM for beagle dog, guinea pig, rabbit, rat, and mouse, respectively).”
✓ VerifiedFDA pharmacology/toxicology review, p. 15Source ↗
Surrogate molecule
No surrogate; the clinical compound was tested
“Monkey: zavegepant was administered at doses of 0, 7.5, 17, and 25 mg/day in the 4-week intranasal study, at doses of 0, 18, 27, and 36 mg/day in the 13-week study, and at doses of 0, 18, 36, and 45 mg/day in the 39-week study.”
✓ VerifiedFDA pharmacology/toxicology review, p. 4Source ↗