SPL Set ID: 8f0e73bf-6025-44f6-ab64-0983322de0df

COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C 14 H 23 N 3 OS.C 4 H 6 O 6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is: Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C 25 H 30 NO 3 .Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is: COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: • 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium). • 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium). • 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium). COBENFY capsules contain a combination of pellets of xanomeline and pellets of trospium chloride. Inactive ingredients: The xanomeline tartrate pellets contain ascorbic acid, microcrystalline cellulose, and talc. The trospium chloride pellets contain lactose monohydrate, microcrystalline cellulose, and talc. The capsules, printed with black ink, contain black iron oxide (only 100 mg/20 mg), hypromellose, red iron oxide, titanium dioxide, and yellow iron oxide (only 50 mg/20 mg and 100 mg/20 mg). Chemical Structure Chemical Structure