Zanvastro: how long were the pivotal tox studies?

“The nonclinical package submitted to the NDA included general toxicology studies of up to 26 and 39 weeks' duration in mouse (subcutaneous [SC]) and monkey (intrathecal lumbar [ITL]), respectively”

“In nonclinical toxicology studies, zilganersen was administered via ICV injection in juvenile C57BL/B6Ncrl mouse (13 weeks; 0, 0.05, 0.1, or 0.2 mg every 6 weeks) and via ITL injection in juvenile monkey (9 months; 0, 3, 8, or 25 mg Q4W).”

“In nonclinical toxicology studies, zilganersen was administered via ICV injection in juvenile C57BL/B6Ncrl mouse”