Brexafemme: which tox species, and why?

“Oral-dose toxicology studies with ibrexafungerp included 1-month and 13-week studies in rats and dogs.”

“The 13-week studies were conducted with the citrate salt form which is the ibrexafungerp form in the current clinical formulation and these studies included 14-day recovery periods.”

“Oral-dose toxicology studies with ibrexafungerp included 1-month and 13-week studies in rats and dogs.”

“In contrast to the results of the embryo-fetal study in rabbits, ibrexafungerp was not associated with fetal malformations in a rat embryo-fetal study. Also, ibrexafungerp did not inhibit male or female fertility in a fertility study in rats or produce adverse effects on the survival, growth, behavior, or reproductive ability of first-generation offspring in a pre-postnatal study in rats.”

“Carcinogenicity studies were not performed for ibrexafungerp due to the limited duration of its intended use for the treatment of VVC.”