Xanomeline/trospium chloride in schizophrenia: a profile of its use

<p dir="ltr"><b>Funding</b> The preparation of this review was not supported by any external funding.</p><p dir="ltr"><b>Declarations</b></p><p dir="ltr"><b>Authorship and conflict of interest</b> A. McGuigan and H. A. Blair are salaried employees of Adis International Ltd/Springer Nature and declare no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.</p><p><br></p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability</b> Not applicable.</p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank">here</a>.</p><p dir="ltr"><b>Abstract</b></p><p dir="ltr">Xanomeline/trospium chloride (COBENFY^™) is a promising new treatment option for schizophrenia in the USA. The orally-administered, first-in-class drug is composed of xanomeline, an M₁ and M₄receptor selective muscarinic agonist, and trospium chloride, a peripherally-restricted, non-selective muscarinic antagonist. Across one phase 2 and two phase 3 inpatient studies in adult patients with schizophrenia experiencing acutely exacerbated psychosis, twice-daily treatment with xanomeline/trospium chloride for 5 weeks significantly improved schizophrenia symptoms compared with placebo. Additionally, two long-term, open-label, phase 3 studies demonstrated the efficacy of xanomeline/trospium chloride for up to 52 weeks. Xanomeline/trospium chloride therapy is generally well tolerated. Across the short- and long-term trials, most adverse events were gastrointestinal, of mild or moderate severity, and transient in nature. Xanomeline/trospium chloride treatment was associated with a low risk of extrapyramidal symptoms or metabolic disturbances.</p><p><br></p><p dir="ltr"><b>©</b> The Author(s), under exclusive licence to Springer Nature Switzerland AG 2025</p>