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

“Levacetylleucine was non-mutagenic in vitro (in bacterial cells) and non-clastogenic in vitro (in cultured human peripheral lymphocytes) and in vivo (in bone marrow cells of the CD rats).”

“We are requiring juvenile toxicity, fertility, and early embryonic development, pre- and postnatal development, and carcinogenicity studies to be conducted postapproval.”

“In pregnant rats, increases in resorptions, post-implantation loss, and skeletal malformation were seen due to exposure to levacetylleucine at doses of 600 mg/kg/day and at the human-equivalent dose of 97 mg/kg/day.”

“At the highest feasible concentration of 525μM, levacetylleucine inhibited hERG tail currents by less than 30%, therefore, half-maximal inhibitory concentration (IC50) could not be determined, as the concentration response curve was limited by solubility.”