Xanomeline

Drug

Drug Profile

Xanomeline is a muscarinic receptor agonist active ingredient used in the fixed-dose product Cobenfy (xanomeline and trospium chloride), which is FDA-approved for schizophrenia in adults. In this combination, xanomeline provides central M1/M4-preferring agonist activity while trospium limits peripheral muscarinic effects. The approved clinical indication is tied to the combination product.

Drug Class
Muscarinic receptor agonist (M1/M4-preferring) active pharmaceutical ingredient
Approval Status
Component of FDA-approved combination product Cobenfy (approved September 2024)
Mechanism of Action
Provides central muscarinic M1/M4 agonism in combination with peripheral muscarinic antagonism from trospium
Indications
  • \Schizophrenia in adults (as part of the fixed-dose combination xanomeline and trospium chloride)\

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NCT ID Title Status Phase
NCT07063342

A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, Explore the Effect of Food After Multiple Doses of Selected Prototypes, and Evaluate Alternative Formulations of KarX and KarXT Following Single and Multiple Ascending Doses

RECRUITING PHASE1