ORIGINAL RESEARCH article
Front. Psychiatry
Sec. Psychopharmacology
This article is part of the Research TopicHealth Outcomes of Using AntipsychoticsView all articles
Real-World Effectiveness and Safety of Xanomeline and Trospium for Treatment-Resistant Schizophrenia in a State Hospital System
Provisionally accepted
- 1College of Pharmacy, The University of Texas at Austin, Austin, United States
- 2The University of Texas at Austin College of Pharmacy, Austin, United States
- 3The University of Texas at Austin Dell Medical School, Austin, United States
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Objective: Xanomeline and trospium (XT) is a novel medication for schizophrenia that was approved by the United States (U.S.) Food and Drug Administration (FDA) in September 2024. The purpose of this study is to evaluate the effectiveness and safety of using XT in the Texas state hospital setting. Methods: Data were analyzed retrospectively from five hospitals within the Texas Health and Human Services Commission state hospital system. Adults aged ≥ 18 years administered XT between October 2024 and October 2025 were included. A chart extracted Clinical Global Impression (CGI) of Severity of Illness/Improvement was used to determine XT effectiveness. Patient demographics, clinical characteristics and documented adverse effects are reported. Results: All patients (N=20) had treatment-resistant schizophrenia and were classified as markedly or severely ill prior to XT initiation. All patients except one were prescribed ≥ 1 dopamine receptor blocking agents (DRBA)s while taking XT, with olanzapine (n=9; 45%) and clozapine (n=6; 30%) being most common. Fourteen patients (70%) discontinued XT during the study time frame due to intolerability (n=9; 45%) and/or lack of effectiveness (n=12; 60%). The average global improvement CGI score was 4 (no change). Gastrointestinal side-effects were most common, specifically, vomiting (n=9; 45%), dyspepsia (n=5; 25%), and sialorrhea (n=5; 25%). Conclusion: In inpatients with TRS taking adjunct DRBAs (including anticholinergic DRBAs) XT use was commonly discontinued due to intolerability/ineffectiveness. Larger controlled trials are needed to further investigate XT's effectiveness for treating TRS and determine how adjunct anticholinergic use impacts its safety/efficacy.
Keywords: xanomeline and trospium, Schizophrenia, Treatment-resistant, effective, Safety
Received: 31 Oct 2025; Accepted: 01 Dec 2025.
Copyright: © 2025 Vadiei and Crismon. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Nina Vadiei
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