“In repeated-dose toxicity studies osilodrostat was tested in mice for up to 13 weeks at 10 to 200 mg/kg/day, in rats for up to 26 weeks at 0.2 to 50 mg/kg/day and in dogs for up to 39 weeks at 0.1 to 10 mg/kg/day.”
Pharmacokinetic and metabolic profiles qualitatively similar to humans
“Pharmacokinetic and metabolic profiles were qualitatively similar between humans and nonclinical species used for evaluating the potential toxicity or osilodrostat thereby supporting the translatability of the findings from these studies.”
✓ VerifiedFDA pharmacology/toxicology review, p. 11Source ↗
Surrogate molecule
No surrogate; the clinical compound was tested
“39-Week Oral Gavage Chronic Toxicity and Toxicokinetic Study with LCI699 in Dogs with a 4-Week Recovery Period”
✓ VerifiedFDA pharmacology/toxicology review, p. 49Source ↗