“Repeated dose toxicity studies were conducted in rats up to 26 weeks and in monkeys up to 39 weeks.”
✓ VerifiedFDA pharmacology/toxicology review, p. 19Source ↗
Pivotal GLP studies
4-, 13- and 26-week rat and 5-, 13- and 39-week monkey GLP studies
“Pivotal GLP-compliant repeated dose studies were conducted in rats and monkeys and comprised the studies of 4, 13 and 26 weeks duration in rats and 5, 13 and 39 weeks duration in monkeys.”
“In the 39-week monkey study (Study No 8331280), fezolinetant was administered orally by daily gavage to sexually mature female monkeys at a dose of 0, 10, 25, or 40 mg/kg.”
✓ VerifiedFDA pharmacology/toxicology review, p. 19Source ↗