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

“Oteseconazole was negative in the bacterial reverse mutation assay, in vitro chromosomal aberration assay, and in vivo micronucleus assay in rats.”

“In a 2-year oral carcinogenicity study of oteseconazole, male Sprague Dawley rats showed increased incidence of Leydig cell adenomas of the testes and thyroid follicular cell adenomas/carcinomas combined at ≥1.5 mg/kg/day.”

“In pre- and postnatal studies, oteseconazole administration to pregnant and lactating rats at 7.5 mg/kg/day resulted in lens opacities, swollen eyes, hemorrhage, hyphema, buphthalmos, corneal ulceration, retinal and optic nerve atrophy, as well as lens degeneration.”

“Oteseconazole administered as a single oral dose (up to 1000 mg/kg) had no significant effect on neurobehavioral or respiratory function in rats. Similarly, a single oral dose (up to 300 mg/kg) had no significant effect on cardiovascular function in dogs.”