Nexletol: which tox species, and why?

“In conclusion, safety margins established from the 26-week rat and 52-week monkey studies support the proposed 180 mg/day dose of bempedoic acid”

“From the pharmacokinetic point of view, the rats and monkeys were the most relevant species for non-clinical efficacy and safety studies.”

“Bempedoic acid produced mild increases (up to 62%) in creatinine in both sexes treated at ≥20 mg/kg/day without any correlating histological kidney changes.”

“In conclusion, safety margins established from the 26-week rat and 52-week monkey studies support the proposed 180 mg/day dose of bempedoic acid”

“Bempedoic acid was not teratogenic when given orally at doses of 60 and 80 mg/kg/day, resulting in 11 and 12 times the systemic exposure in humans at the maximum recommended human dose (MRHD) of 180 mg to pregnant rats and rabbits, respectively.”

“The carcinogenic potential of bempedoic acid was evaluated in a 2-year study in mice and rats.”