Cobenfy: which tox species, and why?

“The binding affinity and functional activity of xanomeline at the mAChR receptors were generally similar between human and animal species (rat and monkey), therefore, supporting the use of the rat and monkey as the nonclinical species for pharmacology and toxicology evaluation.”

“The binding affinity and functional activity of xanomeline at the mAChR receptors were generally similar between human and animal species (rat and monkey), therefore, supporting the use of the rat and monkey as the nonclinical species for pharmacology and toxicology evaluation.”

“In addition, the Applicant conducted toxicity studies with the combination via oral gavage, including repeat-dose toxicity studies in the rat for up to 90 days; embryofetal development toxicity studies in the rat and rabbit; and pre- and postnatal toxicity study with an additional follow-up pre- and postnatal study with xanomeline alone in the rat.”