Zurzuvae: which tox species, and why?

“The toxicologic and toxicokinetic (TK) profile of orally administered zuranolone was assessed in a series of single and repeat dose studies in rats and dogs for up to 6 and 9 months, respectively.”

“All human metabolites detected at greater than 1% of drug, were also detected in rat or dog plasma.”

“In the pivotal 9-month study in dogs (0, 0.6, 1.2 and 2.5 mg/kg), sedation, sedation-related clinical signs (impaired equilibrium, hypoactivity, ataxia, tremors, and being prostrate) and increased heart rate and mortality were observed.”