Fixed-dose combination
Trospium and Xanomeline is a fixed-dose combination of a cholinergic muscarinic agonist and a cholinergic muscarinic antagonist indicated for the treatment of schizophrenia in adults. It is available as capsules and kits for oral use. MedsAcross supplies Trospium and Xanomeline for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
COBENFY 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.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
• 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. • Geriatric patients: Recommended starting dosage of COBENFY is 50 mg/20 mg orally twice daily. Consider a slower titration. The maximum recommended dosage is 100 mg/20 mg twice daily.
Source: US FDA prescribing information
COBENFY 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. COBENFY is contraindicated in: • urinary retention. • moderate or severe hepatic impairment. • gastric retention. • history of hypersensitivity to COBENFY or trospium chloride. • untreated narrow-angle glaucoma
Source: US FDA prescribing information
• 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. Discontinue COBENFY in the presence of signs or symptoms of substantial liver injury. • Decreased Gastrointestinal Motility: COBENFY may decrease gastrointestinal motility. Use with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Risk of Urinary Retention • Risk of Use in Patients with Hepatic Impairment • Risk of Use in Patients with Biliary Disease • Decreased Gastrointestinal Motility • Risk of Angioedema • Risk of Use in Patients with Narrow-angle Glaucoma • Increases in Heart Rate • Anticholinergic Adverse Reactions in Patients with Renal Impairment • Central Nervous System Effects Most common adverse reactions (incidence ≥ 5% and at least twice placebo) were nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastrointestinal reflux disease.
Source: US FDA prescribing information
• Drugs Eliminated by Active Tubular Secretion: Monitor for increased frequency and/or severity of adverse reactions related to COBENFY and to drugs eliminated by active tubular secretion. • Strong CYP2D6 Inhibitors: Monitor for increased frequency and/or severity of COBENFY-related adverse reactions. • Sensitive Substrates of CYP3A4 or P-glycoprotein: Monitor for increased frequency and/or severity of adverse reactions from these substrates. • Antimuscarinic Drugs: Monitor for increased frequency or severity of anticholinergic adverse reactions.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Trospium and Xanomeline, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Cobenfy 20 mg/100 mg capsuleOral | Trospium and Xanomeline | ER Squibb & Sons | US FDA | Available on request |
| Cobenfy 20 mg/50 mg capsuleOral | Trospium and Xanomeline | ER Squibb & Sons | US FDA | Available on request |
| Cobenfy 30 mg/125 mg capsuleOral | Trospium and Xanomeline | ER Squibb & Sons | US FDA | Available on request |
| Cobenfy kit | Trospium and Xanomeline | ER Squibb & Sons | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 26 September 2024 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 4 presentations of Trospium and Xanomeline and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Trospium and Xanomeline, including Cobenfy.
Yes. The US FDA first approved Trospium and Xanomeline on 26 September 2024, according to Drugs@FDA.
No listed presentation of Trospium and Xanomeline is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.