Duvyzat: how long were the pivotal tox studies?

“At the same high dose in a 39-week monkey study, findings consisted of transient gait abnormalities and decreased grip strength, increases in ALT and bilirubin, bile duct hyperplasia, and reduced bone marrow cellularity; reduced thymus weight was seen at all doses (0, 5, 12, and 30 mg/kg).”

“The toxicity of orally administered givinostat was investigated in single and repeat-dose studies for up to 13 weeks in mice, 26 weeks in rats 4 weeks in dogs and 39 weeks in monkeys.”

“All general toxicity and reproductive and development toxicology studies were GLP-compliant and conducted using daily oral administration.”