Jascayd: which tox species, and why?

“As listed in Table 46, the Applicant characterized the toxicity profile of nerandomilast with general toxicity studies in rats (13 weeks and 26 weeks), minipigs (13 weeks and 39 weeks), and monkeys (39 weeks).”

“The nonclinical species used in toxicology assessment of nerandomilast are considered pharmacologically relevant for various reasons including data demonstrating similar IC50 values for human and minipig for nerandomilast.”

“Repeat-dose toxicity studies with nerandomilast were performed by the oral route of administration in rats, minipigs, and cynomolgus monkeys in studies of up to 26, 39, and 39 weeks, respectively.”