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

“Ensitrelvir was not genotoxic in the reverse mutation bacterial (Ames) test, in vitro micronucleus assay using human lymphoblastoid TK6 cells, or the in vivo rat micronucleus assays.”

“Carcinogenesis studies were not conducted due to the short duration of drug administration.”

“In rabbits, malformations and variations of the axial skeleton, embryofetal lethality, abortion, and post-implantation loss, accompanied by maternal toxicity were observed, with a NOAEL of 30 mg/kg/day and a safety margin of 3X.”

“There were no adverse effects in any of the cardiovascular, respiratory, and central nervous system assessments in dogs and rats. In the hERG assay, the maximum tested concentration of 100 µmol/L inhibited the hERG current by 39%, which was not considered significant and suggested a low risk for QT prolongation.”

“Ensitrelvir was not genotoxic in the reverse mutation bacterial (Ames) test, in vitro micronucleus assay using human lymphoblastoid TK6 cells, or the in vivo rat micronucleus assays.”

“Ensitrelvir was not genotoxic in the reverse mutation bacterial (Ames) test, in vitro micronucleus assay using human lymphoblastoid TK6 cells, or the in vivo rat micronucleus assays.”

“Ensitrelvir was not genotoxic in the reverse mutation bacterial (Ames) test, in vitro micronucleus assay using human lymphoblastoid TK6 cells, or the in vivo rat micronucleus assays.”

“conducted due to the short duration (five days) of drug administration in humans.”

“Carcinogenesis studies were not conducted due to the short duration of drug administration.”

“In the hERG assay, the maximum tested concentration of 100 µmol/L inhibited the hERG current by 39%, which was not considered significant and suggested a low risk for QT prolongation.”