Lynkuet: which tox species, and why?

“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.”

“SD rats and Cynomolgus monkeys were selected as species for the investigation of systemic toxicological effects based on pharmacological responsiveness (potency, sequence homology, and pharmacologic effects on the NK receptors) as well as based on the pharmacokinetic and metabolic profile.”

“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.”