Ojjaara: which tox species, and why?

“The toxicity of momelotinib was assessed in rats for up to 26 weeks and in dogs for up to 39 weeks.”

“Rats and dogs were considered pharmacologically relevant nonclinical species based on similar sensitivity to momelotinib compared to humans.”

“The toxicity of momelotinib was assessed in rats for up to 26 weeks and in dogs for up to 39 weeks.”

“The toxicity of momelotinib was assessed in rats for up to 26 weeks and in dogs for up to 39 weeks.”

“Reproductive assessments included fertility and early embryofetal development studies in male and female rats, embryofetal development studies in rats and rabbits, and a pre- and postnatal development study in rats.”

“The potential carcinogenicity of momelotinib was assessed in 6-month rasH2 transgenic mouse and 2-year Sprague-Dawley rat studies.”

“Since rats do not generate an adequate quantity of human metabolite M21, additional mid dose groups (5 mg/kg/day of momelotinib) were spiked with 25 mg/kg/day of M21.”