Crenessity: which tox species, and why?

“TK results from pivotal 6-month rat and 12-month dog studies are presented in Table 97 and Table 98 below.”

“The metabolism of crinecerfont was similar among species, with no unique or disproportionate human metabolites (Figure 29).”

“Subsequently, the tosylate salt formulation was replaced with a free base form of crinecerfont for evaluation in the pivotal chronic toxicology, carcinogenicity, prenatal and postnatal and juvenile nonclinical studies, and for the clinical studies.”

“TK results from pivotal 6-month rat and 12-month dog studies are presented in Table 97 and Table 98 below.”

“The effects of crinecerfont on fertility, reproduction, early embryonic and embryo-fetal development, and juvenile development were evaluated in rat and rabbit toxicology studies.”

“The Applicant evaluated the oncogenic potential of crinecerfont by conducting 2-year rat and 6-month transgenic mouse carcinogenicity studies.”

“Subsequently, the tosylate salt formulation was replaced with a free base form of crinecerfont for evaluation in the pivotal chronic toxicology, carcinogenicity, prenatal and postnatal and juvenile nonclinical studies, and for the clinical studies.”