{"title":"Sibeprenlimab: First Approval.","authors":"Arnold Lee","doi":"10.1007/s40265-026-02298-x","DOIUrl":null,"url":null,"abstract":"<p><p>Sibeprenlimab (VOYXACT<sup>®</sup>; sibeprenlimab-szsi) is a fully humanized monoclonal antibody that binds to A PRoliferation Inducing Ligand (APRIL) being developed by Otsuka Pharmaceutical for the treatment of immunoglobulin A (IgA) nephropathy and Sjögren's disease. Signalling via APRIL is implicated in the inflammatory processes that ultimately result in damage to the glomeruli in patients with IgA nephropathy. Treatment with sibeprenlimab suppressed APRIL levels and reduced proteinuria in patients with IgA nephropathy, according to interim analyses from the ongoing VISIONARY phase III clinical trial. This article summarizes the milestones in the development of sibeprenlimab leading to this first approval to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"765-768"},"PeriodicalIF":14.7000,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40265-026-02298-x","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/3/21 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Sibeprenlimab (VOYXACT®; sibeprenlimab-szsi) is a fully humanized monoclonal antibody that binds to A PRoliferation Inducing Ligand (APRIL) being developed by Otsuka Pharmaceutical for the treatment of immunoglobulin A (IgA) nephropathy and Sjögren's disease. Signalling via APRIL is implicated in the inflammatory processes that ultimately result in damage to the glomeruli in patients with IgA nephropathy. Treatment with sibeprenlimab suppressed APRIL levels and reduced proteinuria in patients with IgA nephropathy, according to interim analyses from the ongoing VISIONARY phase III clinical trial. This article summarizes the milestones in the development of sibeprenlimab leading to this first approval to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression.
期刊介绍：
Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes:
Leading/current opinion articles providing an overview of contentious or emerging issues.
Definitive reviews of drugs and drug classes, and their place in disease management.
Therapy in Practice articles including recommendations for specific clinical situations.
High-quality, well designed, original clinical research.
Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs.
AdisInsight Reports summarising development at first global approval.
Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.
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