Abdelmoteleb Salma, Totlani Jayant, Ramadan Salma, Salem Mohamed, Meyer Ashley, Chang Tiffany, Ewing Madeline, Freire Luiza, Murphy Nathalie, Renteria Sabrina, Dymkoski Romana, Liran Omer, Hedrick Rebecca, Danovitch Itai, Pechnick Robert N, IsHak Waguih William
Cedars-Sinai Health System, Los Angeles, CA, USA.
Virginia Commonwealth University Health System, Richmond, VA, USA.
Neurosci Appl. 2025 Feb 6;4:105507. doi: 10.1016/j.nsa.2025.105507. eCollection 2025.
This systematic review evaluates psychiatric medications for schizophrenia approved between 2008 and 2024, considering regulatory practices and approvals across multiple regions, including the United States, Europe, and Asian countries. It details the mechanism of action, indications, efficacy, dosing, and adverse effects of each medication. The methodology involved a literature search of the PubMed database for studies published from 2008 to December 31, 2024 on FDA-approved psychiatric medications and Phase 3 pipeline medications, along with additional medications approved in Europe using the keywords "schizophrenia" OR "psychosis" AND "psychopharm∗" OR "medic∗" OR "pharm∗." An independent assessment was conducted, followed by a consensus on eligible studies for inclusion in the systematic review. From 2008 to December 31, 2024, the FDA approved 29 medications for schizophrenia including 13 long-acting injectables (LAI), in addition to that there are additional three other medications that are available in Europe but not in the United States. Additionally, 8 pipeline medications are currently in Phase-3 clinical trials including one LAI. Each medication is analyzed, and its mechanisms of action, indications, dosing, efficacy, and adverse effects are described. The 13 approved LAIs and the one LAI in the pipeline are detailed in a separate manuscript. This review highlights a significant increase in approved medications for the treatment of schizophrenia, including long-acting injectable formulations that enhance the range of existing oral therapies. Furthermore, new treatments for medication-related movement disorders have been introduced. Innovative developments in Phase-3 trials for schizophrenia medications, including new mechanisms of action and administration routes, promise to transform treatment strategies and enhance patient outcomes.
本系统评价评估了2008年至2024年期间获批用于治疗精神分裂症的精神科药物,考虑了包括美国、欧洲和亚洲国家在内的多个地区的监管实践和批准情况。它详细介绍了每种药物的作用机制、适应症、疗效、剂量和不良反应。该方法包括在PubMed数据库中进行文献检索,以查找2008年至2024年12月31日发表的关于FDA批准的精神科药物和3期在研药物的研究,以及在欧洲获批的其他药物,关键词为“精神分裂症”或“精神病”以及“精神药物*”或“药物*”或“药剂*”。进行了独立评估,随后就纳入系统评价的合格研究达成了共识。从2008年到2024年12月31日,FDA批准了29种用于精神分裂症的药物,包括13种长效注射剂(LAI),此外,欧洲还有另外三种药物在美国未获批。此外,目前有8种在研药物处于3期临床试验阶段,其中包括一种长效注射剂。对每种药物进行了分析,并描述了其作用机制、适应症、剂量、疗效和不良反应。13种获批的长效注射剂和一种在研长效注射剂在另一篇稿件中详细介绍。本综述强调了获批用于治疗精神分裂症的药物显著增加,包括长效注射剂剂型,这扩大了现有口服疗法的范围。此外,还引入了针对药物相关运动障碍的新治疗方法。精神分裂症药物3期试验的创新进展,包括新的作用机制和给药途径,有望改变治疗策略并改善患者预后。