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

“Suzetrigine was not mutagenic in the bacterial reverse mutation assay (Ames test), or clastogenic in the in vitro micronucleus assay with a human TK6 lymphoblastoid cell line, or in the in vivo rat bone marrow micronucleus assay.”

“Long-term animal studies have not been completed to evaluate the carcinogenic potential of suzetrigine.”

“SUZ doses up to 1000 mg/kg did not affect male reproductive performance when administered at least 28 days before mating and throughout mating. In a female fertility study in rats, increased preimplantation loss was observed at oral SUZ doses of 15 mg/kg when administered prior to mating and through gestation day (GD) 7.”

“SUZ and M6-SUZ were evaluated in good laboratory practice (GLP) in vitro human ether-à-go-go-related gene (hERG) assays, and they had no effect on hERG channel activity (IC50 greater than 10µM).”