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KarX-EC is a proprietary enteric-coated (EC) capsule formulation of xanomeline, a small molecule muscarinic acetylcholine receptor agonist selective for the M1 and M4 subtypes. Developed by Karuna Therapeutics (now Bristol Myers Squibb), KarX-EC is designed to be administered in combination with KarXT (a fixed-dose combination of immediate-release xanomeline and the peripheral muscarinic antagonist trospium chloride) to achieve a "dual-burst" release profile of xanomeline. This dosing strategy aims to optimize the pharmacokinetic profile of xanomeline, providing sustained therapeutic exposure while utilizing the peripheral blockade of trospium to mitigate gastrointestinal side effects. KarX-EC is currently in Phase 3 development for the treatment of cognitive impairment, psychosis, and agitation associated with Alzheimer's disease, as well as irritability in pediatric patients with autism spectrum disorder.
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