BMS-986519 (KarXT/Cobenfy): A Novel Muscarinic Agonist Combination for Neuropsychiatric Disorders

1. Introduction to BMS-986519 (KarXT/Cobenfy)

1.1. Identification and Nomenclature

BMS-986519 is an investigational agent identified in the Bristol Myers Squibb (BMS) pipeline, undergoing Phase 1 development for psychiatric disorders.[1] This development code is intrinsically linked to KarXT, a fixed-dose combination of xanomeline, a muscarinic acetylcholine receptor agonist, and trospium chloride, a peripherally acting muscarinic antagonist.[1] Upon its approval by the U.S. Food and Drug Administration (FDA), KarXT has been marketed under the brand name COBENFY™.[2] Other development codes associated with this therapeutic program include BMS-986510 and KarX-EC, the latter referring to an enteric-coated formulation of xanomeline.[1] Given that BMS-986519 is an early development identifier for the KarXT/Cobenfy program, this report will focus on the comprehensive pharmacological and clinical profile of the xanomeline and trospium chloride combination as the clinically realized entity.

The development of multiple internal codes such as BMS-986519, BMS-986510, and KarX-EC [1] for what is essentially the same core combination of xanomeline and trospium chloride suggests a multifaceted early development strategy by Bristol Myers Squibb. Pharmaceutical companies often assign distinct internal codes to different formulations, dosage strengths, or specific research initiatives related to a lead compound. The explicit mention of "Xanomeline Enteric-coated" for KarX-EC [1] clearly indicates exploration of formulation modifications, potentially aimed at optimizing pharmacokinetic profiles, enhancing tolerability by altering drug release characteristics, or tailoring the product for specific patient populations or indications before consolidating under the unified KarXT/Cobenfy branding for broader clinical development and commercialization.