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

“Delgocitinib was not mutagenic in the Ames assay. Delgocitinib had the potential to induce polyploidy in human peripheral blood lymphocytes, but not chromosomal structural aberrations in vitro. Delgocitinib did not induce chromosomal aberrations (structural or numerical aberrations) in rat bone marrow cells in vivo.”

“No drug-related neoplastic findings were noted at topical doses up to 5% delgocitinib ointment. In the 2-year oral carcinogenicity study in rats, increased incidence of benign thymoma was noted in females at 30 mg/kg/day”

“Adverse effects were seen at higher doses in each of the reproductive and developmental toxicology studies, but a NOAEL was established in each study with acceptable margins of exposures.”

“Delgocitinib had no effects on cardiovascular, respiratory, or neurological parameters at clinically relevant doses. Delgocitinib had no remarkable inhibitory effect on the human ether-à-go-go-related gene (hERG) current at clinically relevant concentrations.”

“Delgocitinib was not mutagenic in the Ames assay. Delgocitinib had the potential to induce polyploidy in human peripheral blood lymphocytes, but not chromosomal structural aberrations in vitro.”

“Delgocitinib was not mutagenic in the Ames assay. Delgocitinib had the potential to induce polyploidy in human peripheral blood lymphocytes, but not chromosomal structural aberrations in vitro.”

“Delgocitinib did not induce chromosomal aberrations (structural or numerical aberrations) in rat bone marrow cells in vivo. Delgocitinib ointment (5%) did not induce micronuclei in the epidermal cells of hairless mice.”

“In the dermal carcinogenicity study in mice, delgocitinib ointment (1%, 3% and 5%) was administered once daily for 104 weeks. No drug-related neoplastic findings were noted at topical doses up to 5% delgocitinib ointment. In the 2-year oral carcinogenicity study in rats, increased incidence of benign thymoma was noted in females at 30 mg/kg/day”

“In the dermal carcinogenicity study in mice, delgocitinib ointment (1%, 3% and 5%) was administered once daily for 104 weeks. No drug-related neoplastic findings were noted at topical doses up to 5% delgocitinib ointment. In the 2-year oral carcinogenicity study in rats, increased incidence of benign thymoma was noted in females at 30 mg/kg/day”

“Delgocitinib had no effects on cardiovascular, respiratory, or neurological parameters at clinically relevant doses. Delgocitinib had no remarkable inhibitory effect on the human ether-à-go-go-related gene (hERG) current at clinically relevant concentrations.”