Lynkuet: how long were the pivotal tox studies?

“Pivotal GLP-compliant repeated dose studies were conducted in Sprague Dawley (SD) rats and Cynomolgus monkeys and comprised studies of 4, 13 (two studies), and 26 weeks duration in rats and 4, 13 (two studies) and 39 weeks duration in monkeys.”

“In the pivotal chronic toxicity studies conducted by the Applicant, including a 26-week study in SD rats (Study R-13894) and a 39-week study in monkeys (Study R-13895), elinzanetant increased levels of the liver-associated enzymes ALT, AST, and ALP.”

“The in vivo PK/TK studies with elinzanetant (BAY 3427080) were conducted via oral administration, which is the intended route of administration in humans, in rats and Cynomolgus monkeys which were used for toxicology studies.”