Ubrelvy: genotox, carcinogenicity and repro: done or skipped?

“In genetic toxicology assessments, ubrogepant was negative in OECD-compliant Ames, in vitro chromosomal aberration, and in vivo rat bone marrow micronucleus assays.”

“In adequately designed and conducted 104-week oral carcinogenicity studies in CD-1 mouse (0, 5, 15, and 50 mg/kg/day) and Wistar rat (males: 0, 10, 30, and 100 mg/kg/day; females: 0, 10, 30, and 150 mg/kg/day), ubrogepant was negative for drug-related neoplasms.”

“In animal studies, adverse effects on embryofetal development were observed following administration of ubrogepant during pregnancy (increased embryofetal mortality in rabbits) or during pregnancy and lactation (decreased body weight in offspring in rats) at doses greater than those used clinically and which were associated with maternal toxicity”

“Ubrogepant was negative in an in vitro hERG assay. There were no effects on respiratory or cardiovascular parameters at oral doses up to 75 mg/kg or 300 mg/kg, respectively, in telemetered Rhesus monkeys.”