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<p>Schizophrenia treatments targeting dopamine D2 receptors often fail due to resistance and side effects, highlighting the need for alternatives like KarXT (xanomeline-trospium; Cobenfy™), FDA-approved in September 2024. A systematic review of KarXT would evaluate its efficacy, safety, and potential, guiding future treatment strategies and research.&#xa0;This study systematically evaluated the efficacy and safety of KarXT (xanomeline–trospium; Cobenfy™) in schizophrenia, focusing on its impact on positive and negative symptoms, cognitive function, and adverse effects.&#xa0;Randomized controlled trials on KarXT’s efficacy and safety in schizophrenia were selected based on predefined criteria. English-language studies published by August 25, 2025, were identified via major databases. Eligible post hoc analyses from single trials were included. PANSS total scores from five trials were pooled to estimate overall treatment effect. The review followed PRISMA and Cochrane Risk of Bias standards.&#xa0;Seven trials including 1,316 participants (645 KarXT, 671 placebo) consistently showed that KarXT significantly reduced both positive and negative symptoms of schizophrenia in individual trials, reflected in lower PANSS subscale and CGI-S scores. It also improved cognitive function, particularly in patients with severe impairments, and was generally well tolerated, with mild to moderate gastrointestinal adverse events being the most common. Meta-analysis revealed no heterogeneity among studies (Q = 0.26, df = 4, I² = 0.0%), supporting the reliability of the pooled results. Nonetheless, despite study limitations, the pooled meta-analysis showed no significant effect on PANSS total scores, notwithstanding that KarXT clearly benefits specific symptoms and cognition.&#xa0;The results, albeit with some limitations, provided plausible evidence for the efficacy and safety of KarXT in treating schizophrenia.</p>

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Efficacy and Safety of KarXT (Xanomeline-Trospium; Cobenfy™) in Schizophrenia: A Systematic and Meta-Analysis Review of Randomized Controlled Trials

  • 期刊论文

  • 发表日期：

    2025年10月4日

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  • Ali Azargoonjahromi,
  • Hamide Nasiri

摘要

Schizophrenia treatments targeting dopamine D2 receptors often fail due to resistance and side effects, highlighting the need for alternatives like KarXT (xanomeline-trospium; Cobenfy™), FDA-approved in September 2024. A systematic review of KarXT would evaluate its efficacy, safety, and potential, guiding future treatment strategies and research. This study systematically evaluated the efficacy and safety of KarXT (xanomeline–trospium; Cobenfy™) in schizophrenia, focusing on its impact on positive and negative symptoms, cognitive function, and adverse effects. Randomized controlled trials on KarXT’s efficacy and safety in schizophrenia were selected based on predefined criteria. English-language studies published by August 25, 2025, were identified via major databases. Eligible post hoc analyses from single trials were included. PANSS total scores from five trials were pooled to estimate overall treatment effect. The review followed PRISMA and Cochrane Risk of Bias standards. Seven trials including 1,316 participants (645 KarXT, 671 placebo) consistently showed that KarXT significantly reduced both positive and negative symptoms of schizophrenia in individual trials, reflected in lower PANSS subscale and CGI-S scores. It also improved cognitive function, particularly in patients with severe impairments, and was generally well tolerated, with mild to moderate gastrointestinal adverse events being the most common. Meta-analysis revealed no heterogeneity among studies (Q = 0.26, df = 4, I² = 0.0%), supporting the reliability of the pooled results. Nonetheless, despite study limitations, the pooled meta-analysis showed no significant effect on PANSS total scores, notwithstanding that KarXT clearly benefits specific symptoms and cognition. The results, albeit with some limitations, provided plausible evidence for the efficacy and safety of KarXT in treating schizophrenia.