Psychiatry research · 2026
Post-marketing safety surveillance of the novel muscarinic antipsychotic Xanomeline-Trospium for schizophrenia: A comparative disproportionality analysis against olanzapine based on FAERS data.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Zeng Yining, Wang Xueting, Wu Hao, Tan Xiyue, Wang Ruixia, Liu Yuxia, Duan Junguo
Аннотация
OBJECTIVE: To characterize the real-world post-marketing safety reporting profile and adverse event (AE) signals of Xanomeline-Trospium, a novel dual M1/M4 muscarinic antipsychotic for schizophrenia.
METHODS: FAERS data from 2024Q4 to 2025Q4 were retrospectively analyzed. Reports listing Xanomeline-Trospium as the primary suspected drug were extracted. Signals were detected using four algorithms: ROR, PRR, BCPNN, and MGPS. Additional analyses included Weibull time-to-onset modeling, exploratory comparison with olanzapine, sex- and age-stratified subgroup analyses, and sensitivity analysis excluding concomitant medications.
RESULTS: A total of 1410 valid reports were identified. After excluding underlying disease-related confounders, 42 clinically meaningful Preferred Terms showed positive signals. The reporting profile was dominated by gastrointestinal events, including nausea and projectile vomiting; renal and urinary events, especially urinary retention; and acute psychiatric activation, including intrusive thoughts and anger. Compared with olanzapine, Xanomeline-Trospium showed lower reporting odds for metabolic and extrapyramidal events but higher reporting odds for autonomic, gastrointestinal, and acute neurobehavioral signals. Sex subgroup analysis suggested potential divergent autonomic reporting patterns, with females showing more cholinergic signals and males showing more anticholinergic signals. Weibull analysis indicated an "early failure" pattern, with 86.8% of AEs occurring within 30 days of treatment initiation and a median onset of 6.4 days.
CONCLUSION: Xanomeline-Trospium showed a distinct FAERS reporting profile characterized by gastrointestinal, urological, and acute psychiatric signals. These findings are hypothesis-generating associations rather than causal risks and support intensive monitoring during treatment initiation.
METHODS: FAERS data from 2024Q4 to 2025Q4 were retrospectively analyzed. Reports listing Xanomeline-Trospium as the primary suspected drug were extracted. Signals were detected using four algorithms: ROR, PRR, BCPNN, and MGPS. Additional analyses included Weibull time-to-onset modeling, exploratory comparison with olanzapine, sex- and age-stratified subgroup analyses, and sensitivity analysis excluding concomitant medications.
RESULTS: A total of 1410 valid reports were identified. After excluding underlying disease-related confounders, 42 clinically meaningful Preferred Terms showed positive signals. The reporting profile was dominated by gastrointestinal events, including nausea and projectile vomiting; renal and urinary events, especially urinary retention; and acute psychiatric activation, including intrusive thoughts and anger. Compared with olanzapine, Xanomeline-Trospium showed lower reporting odds for metabolic and extrapyramidal events but higher reporting odds for autonomic, gastrointestinal, and acute neurobehavioral signals. Sex subgroup analysis suggested potential divergent autonomic reporting patterns, with females showing more cholinergic signals and males showing more anticholinergic signals. Weibull analysis indicated an "early failure" pattern, with 86.8% of AEs occurring within 30 days of treatment initiation and a median onset of 6.4 days.
CONCLUSION: Xanomeline-Trospium showed a distinct FAERS reporting profile characterized by gastrointestinal, urological, and acute psychiatric signals. These findings are hypothesis-generating associations rather than causal risks and support intensive monitoring during treatment initiation.