Xanomeline / Trospium Chloride

What it is and how it works

Mechanism of Action The mechanism of action of xanomeline in the treatment of schizophrenia is unclear; however, its efficacy is thought to be due to its agonist activity at M1 and M4 muscarinic acetylcholine receptors in the central nervous system. Trospium chloride is a muscarinic antagonist. Trospium chloride antagonizes the muscarinic receptors primarily in the peripheral tissues.

Mechanism class: Cholinergic Muscarinic Agonists · Cytochrome P450 3A4 Inhibitors · P-Glycoprotein Inhibitors

Indications

is indicated for the treatment of schizophrenia in adults. COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist, indicated for the treatment of schizophrenia in adults.

Dosage and administration (summary)

• Assess liver enzymes and bilirubin prior to initiating treatment with COBENFY and as clinically indicated during treatment. • Assess heart rate at baseline and as clinically indicated during treatment with COBENFY. • Recommended starting dosage of COBENFY is 50 mg/20 mg orally twice daily for at least two days, then increase the dosage to 100 mg/20 mg twice daily for at least five days. • Dosage may be increased to 125 mg/30 mg orally twice daily based on patient tolerability and response. • See the full prescribing information for the recommended titration and maximum recommended dosage. • Take at least 1 hour before a meal or at least 2 hours after a meal. Do not open capsules.

Contraindications

is contraindicated in patients with: • urinary retention . • moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment . • gastric retention . • history of hypersensitivity to COBENFY or trospium chloride. Angioedema has been reported with COBENFY and trospium chloride . • untreated narrow-angle glaucoma .

Warnings and precautions

• Risk of Urinary Retention: COBENFY can cause urinary retention. Geriatric patients and patients with bladder outlet obstruction and incomplete bladder emptying are at increased risk. Monitor patients for symptoms of acute urinary retention. • Risk of Use in Patients with Hepatic Impairment: COBENFY is contraindicated in patients with moderate to severe hepatic impairment and is not recommended in patients with mild hepatic impairment. • Risk of Use in Patients with Biliary Disease: Assess liver enzymes and bilirubin prior to initiating COBENFY and as clinically indicated.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women exposed to psychiatric medications, including COBENFY, during pregnancy.

Storage and supply

How Supplied COBENFY is available as: • 50 mg/20 mg (xanomeline/trospium chloride): Buff capsules imprinted with Karuna 50/20 mg • 100 mg/20 mg (xanomeline/trospium chloride): Brown capsules imprinted with Karuna 100/20 mg • 125 mg/30 mg (xanomeline/trospium chloride): Swedish Orange capsules imprinted with Karuna 125/30 mg COBENFY capsules are pac…

Source: Xanomeline And Trospium Chloride (Cobenfy) — US FDA prescribing information, 2026-01-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.