Jascayd: how long were the pivotal tox studies?

“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.”

“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).”

“In a GLP-compliant 39-week oral repeat-dose toxicology and toxicokinetic study in Gottingen minipigs, BI 1015550 was administered by oral gavage once daily at 0, 3, 10, and 25/20 mg/kg/day.”