Mayzent: which tox species, and why?

“Pivotal oral (gavage) toxicity studies were conducted in Wistar rat (up to 26 weeks) and cynomolgus monkey (up to 52 weeks).”

“These species are pharmacologically relevant for the assessment of the safety of siponimod.”

“Pivotal oral (gavage) toxicity studies were conducted in Wistar rat (up to 26 weeks) and cynomolgus monkey (up to 52 weeks).”

“Pivotal oral (gavage) toxicity studies were conducted in Wistar rat (up to 26 weeks) and cynomolgus monkey (up to 52 weeks).”

“A battery of oral (gavage) reproductive and development toxicology studies was conducted; separate male and female fertility and early embryonic development studies in Wistar rat, embryofetal development studies in Wistar rat and New Zealand White rabbit, and a pre- and postnatal development study in Wistar rat.”

“Oral carcinogenicity studies of siponimod were conducted in mice and rats. In mice administered siponimod (0, 2, 8, or 25 mg/kg/day) for up to 104 weeks”

“Pivotal oral (gavage) toxicity studies were conducted in Wistar rat (up to 26 weeks) and cynomolgus monkey (up to 52 weeks).”