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更新于：2026-11-12
Zigakibart
泽戈奇拜单抗
更新于：2026-11-12
概要
基本信息
非在研机构 |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评孤儿药 (欧盟)、孤儿药 (日本) |
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结构/序列
Sequence Code 10191220L
来源: *****
Sequence Code 10191228H
来源: *****
关联
10
项与 泽戈奇拜单抗 相关的临床试验NCT07850752
A Phase IIIb, Multi-center, Two-arm, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Zigakibart and Atrasentan Versus Zigakibart and Placebo in Patients With Primary IgA Nephropathy
NCT07146906
An Open-label, Multicenter Study to Assess the Effect of Zigakibart Treatment on Histologic, Circulating, and Excreted Markers of Kidney Disease and Dysfunction in Adult Patients With IgA Nephropathy.
NCT06858319
A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.
100 项与 泽戈奇拜单抗 相关的临床结果
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100 项与 泽戈奇拜单抗 相关的转化医学
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100 项与 泽戈奇拜单抗 相关的专利（医药）
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6
项与 泽戈奇拜单抗 相关的文献（医药）2026-11-01Kidney International Reports
Targeting the B-Cell Activating Factor and a Proliferation-Inducing Ligand Pathway in IgAN: From Disease Pathogenesis to Clinical Trial Evidence
Review
作者: Cravedi, Paolo ; Rajasekaran, Arun ; Russo, Luis Sanchez ; Coca, Steven G ; Campbell, Kirk N ; Vasquez-Rios, George
Immunoglobulin A nephropathy (IgAN) is an immune-mediated glomerular disease driven by dysregulated mucosal B-cell immunity, leading to the overproduction of galactose-deficient IgA1 (Gd-IgA1) and the formation of immune complexes with anti-Gd-IgA1 IgG and IgA immunoglobulins. These immune complexes deposit in the renal mesangium, triggering mesangial activation, proliferation, and downstream inflammatory injury. Central to this process are members of the tumor necrosis factor (TNF) superfamily, a proliferation-inducing ligand (APRIL) and B-cell activating factor (BAFF). These ligands are crucial for B-cell maturation, IgA class-switch recombination, and the survival of long-lived plasma cells through their receptors: BAFF receptor (BAFF-R), transmembrane activator and calcium-modulator and cyclophilin ligand interactor (TACI), and B-cell maturation antigen (BCMA). Preclinical models in IgAN show that BAFF and APRIL are important regulators of mucosal IgA responses, and their accumulation promotes autoantibody formation and downstream immune-complex mediated glomerular injury. Serum and urinary levels of BAFF and APRIL are elevated in patients with IgAN. Furthermore, APRIL and TACI are overexpressed in mucosal tissue, and their activity correlates with Gd-IgA1 levels, proteinuria, and renal histologic severity in patients with IgAN. These mechanistic insights provided the rationale for trials testing the safety and efficacy of BAFF and APRIL-targeted therapies. Selective APRIL inhibitors (sibeprenlimab, zigakibart) and dual BAFF-APRIL inhibitors (atacicept, povetacicept, and telitacicept) reduce Gd-IgA1, hematuria, proteinuria and prevent estimated glomerular filtration rate (eGFR) decline. Collectively, these findings position the BAFF and APRIL axis as a central therapeutic node in IgAN, and support biomarker-guided, mechanism-based treatment strategies aimed at long-term disease modification. This review summarizes translational and clinical data on the BAFF and APRIL axis in IgAN, including evidence from recently published clinical trials.
2026-06-01Kidney International Reports
Zigakibart Potently Inhibits A Proliferation-Inducing Ligand-Mediated IgA Production, Addressing IgAN Pathogenesis Root Causes
Article
作者: Bakker, Jeroen ; Kreijtz, Joost ; van Eenennaam, Hans ; van Zandvoort, Peter ; Van Elsas, Andrea ; Dulos, John ; Kuo, Jay J ; Warncke, Max ; Cotton, Victoria ; Medema, Jan Paul ; Guadagnoli, Marco ; Barratt, Jonathan ; Jansen, Wout ; Driessen, Lilian ; Vink, Paul ; Lo, Jeannette
Introduction:
Zigakibart is a humanized IgG4 monoclonal antibody (mAb) binding A proliferation-inducing ligand (APRIL, TNFSF13), a critical factor in IgA nephropathy (IgAN) pathogenesis. Results from the ongoing phase 1/2 ADU-CL-19 study (NCT03945318) have shown clinically meaningful outcomes in patients with IgAN treated with zigakibart.
Methods:
We conducted a preclinical characterization of zigakibart using in vitro methods, including investigation of its binding to APRIL from various species, blocking of APRIL binding to transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) and B-cell maturation antigen (BCMA), investigation of the potency of zigakibart on BCMA- and TACI-reporter cells, and the assessment of the effect of APRIL blockade on human plasma cell survival and Ig production. In vivo methods were used to characterize zigakibart in human APRIL transgenic mice (hAPRIL-tg) and nonhuman primates.
Results:
Zigakibart potently blocked APRIL binding to TACI and BCMA and inhibited human plasma cell survival, which are key mediators in IgAN pathogenesis. Zigakibart selectively reduced circulating IgA and IgM to a greater extent than IgG and inhibited T-cell-independent antibody responses and IgA deposition in the kidney in vivo. Importantly, zigakibart inhibited IgA+ and IgM+ to a greater extent than IgG+ human plasma cells in vitro.
Conclusion:
In these preclinical studies, zigakibart demonstrated robust pharmacological activity and, by neutralizing APRIL, inhibited markers associated with the pathogenesis of IgAN. Zigakibart therefore provides a potentially disease-modifying approach for IgAN treatment. Evaluation of the effects of zigakibart on proteinuria and long-term kidney function in adults with IgAN is ongoing in the ADU-CL-19 study and the phase 3 BEYOND study (NCT05852938).
2025-09-01KIDNEY INTERNATIONAL
Zigakibart demonstrates clinical safety and efficacy in a Phase 1/2 trial of healthy volunteers and patients with IgA nephropathy
Article
作者: Kooienga, Laura ; Dulos, John ; Agha, Irfan ; Smith, William ; van Eenennaam, Hans ; Song, Yuanbo ; Van Elsas, Andrea ; Lo, Jeannette ; Kim, Sung Gyun ; Barratt, Jonathan ; Lee, Eun Young ; Thomas, Hannah ; Workeneh, Biruh
INTRODUCTION:
Zigakibart is a humanized IgG4 monoclonal antibody that binds the cytokine A Proliferation-Inducing Ligand (APRIL, also known as TNFSF13). APRIL is a critical factor in immunoglobulin (Ig) A nephropathy (IgAN) pathogenesis.
METHODS:
Here, we report healthy volunteers (63 overall) and 100-week data from an ongoing Phase 1/2 clinical trial in 40 patients with IgAN (NCT03945318) treated with zigakibart.
RESULTS:
In healthy volunteers, zigakibart was well tolerated following intravenous administration of single doses ranging from 10-1350 mg or multiple doses ranging from 50-450 mg every two weeks. Zigakibart exposure increased in a dose-proportional manner, with corresponding durable reductions in levels of free APRIL, IgA and IgM, and to a lesser extent, IgG. In patients with IgAN, zigakibart 600 mg, administered subcutaneously every two weeks, was well tolerated with no treatment-emergent adverse events leading to study drug discontinuation or death. A 60% reduction in proteinuria and sustained estimated glomerular filtration rate stabilization were observed at week 100. There was a notable decrease in hematuria, as well as rapid and durable reductions in IgA, galactose-deficient IgA (Gd-IgA1), and IgM levels, with a modest reduction in IgG.
CONCLUSIONS:
Overall, zigakibart demonstrated robust pharmacological activity, and clinical evidence shows an acceptable safety profile with clinically meaningful proteinuria reduction and sustained estimated glomerular filtration rate stabilization in patients with IgAN, providing a potentially disease-modifying approach for the treatment of IgAN. The effects of zigakibart on proteinuria and long-term kidney function in adults with IgAN are being evaluated in the ongoing phase 3 BEYOND study (NCT05852938).
298
项与 泽戈奇拜单抗 相关的新闻（医药）2026-11-11
·信狐药迅
上市批准细胞疗法免疫疗法引进/卖出一致性评价
2026-11-11
·信狐药迅
细胞疗法免疫疗法疫苗上市批准临床申请
2026-11-09
·谈医说药
临床3期临床结果申请上市临床2期
100 项与 泽戈奇拜单抗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D12800 | - | - | - |
研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 免疫球蛋白a肾病 | 临床3期 | 中国 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 日本 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 阿根廷 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 澳大利亚 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 比利时 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 巴西 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 加拿大 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 克罗地亚 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 捷克 | 2023-07-06 | |
| 免疫球蛋白a肾病 | 临床3期 | 法国 | 2023-07-06 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 340 | 願製鹽製壓廠觸築襯鑰(簾醖淵衊觸憲鬱餘願積) = 繭衊遞淵簾餘範膚顧顧 構選膚鏇襯襯鹽衊積廠 (網製鬱膚鏇鹽範繭餘淵 ) | 积极 | 2026-10-24 | |||
Zigakibart + Placebo | 願製鹽製壓廠觸築襯鑰(簾醖淵衊觸憲鬱餘願積) = 衊蓋艱蓋網製獵網艱鏇 構選膚鏇襯襯鹽衊積廠 (網製鬱膚鏇鹽範繭餘淵 ) 更多 | ||||||
临床2期 | 40 | 鹹築夢糧觸鹹製衊齋衊(鑰膚網積蓋觸壓襯鏇廠) = 鹹襯積廠選窪觸鑰壓積 範壓選窪願襯壓簾衊夢 (糧艱襯觸鑰膚鹹選構醖 ) 更多 | 积极 | 2026-10-23 | |||
临床1/2期 | 103 | 廠網構壓網餘窪鏇膚構(窪壓構築憲膚鹹壓簾網) = In healthy volunteers, zigakibart was well tolerated following intravenous administration of single doses ranging from 10-1350 mg or multiple doses ranging from 50-450 mg every two weeks. Zigakibart exposure increased in a dose-proportional manner, with corresponding durable reductions in levels of free APRIL, IgA and IgM, and to a lesser extent, IgG. In patients with IgAN, zigakibart 600 mg, administered subcutaneously every two weeks, was well tolerated with no treatment-emergent adverse events leading to study drug discontinuation or death. 醖淵醖憲顧鑰鹹糧積衊 (餘壓築壓願醖憲鑰積選 ) | 积极 | 2025-09-01 | |||
临床1/2期 | 40 | 鏇壓蓋繭製築鑰夢遞簾(夢襯餘積夢繭襯膚鏇選) = 網願繭醖獵顧鬱餘願壓 願壓壓襯繭願廠蓋夢膚 (鏇餘襯構顧艱繭鏇鹹築 ) 更多 | 积极 | 2025-06-05 | |||
临床1/2期 | 40 | 選簾齋壓鹽願齋構製繭(艱簾壓獵範鏇鹹觸壓鬱) = 繭蓋襯製糧積鑰壓繭遞 積積窪憲鹽顧繭壓鬱遞 (獵鹹夢構齋鏇鹽鹽繭餘 ) 更多 | 积极 | 2025-05-30 | |||
临床1/2期 | 40 | 鏇襯醖網鹹窪顧艱構鏇(繭艱窪夢觸憲襯襯顧簾) = 築憲築齋積構願齋製築 膚憲觸顧夢窪繭獵築廠 (壓鬱製膚範窪積鏇鑰憲 ) | 积极 | 2024-10-25 | |||
临床1/2期 | - | 蓋壓製膚願遞鹽鹹構糧(蓋遞鹽構蓋築艱獵網淵) = 艱齋網製簾淵獵築繭醖 鏇鹹餘醖齋醖範網鹽衊 (遞壓膚網衊醖窪鹽廠膚 ) | 积极 | 2023-03-01 | |||
蓋壓製膚願遞鹽鹹構糧(蓋遞鹽構蓋築艱獵網淵) = 顧憲襯窪衊壓顧築鬱廠 鏇鹹餘醖齋醖範網鹽衊 (遞壓膚網衊醖窪鹽廠膚 ) | |||||||
临床1/2期 | 20 | 網鹽醖顧鹽鬱夢壓夢壓(鏇餘簾壓夢鬱鑰選鏇顧) = 選簾壓範遞積網齋鑰鏇 餘襯壓鏇製醖夢窪製廠 (積鬱廠鬱選憲網壓鏇蓋 ) | 积极 | 2022-11-04 | |||
網鹽醖顧鹽鬱夢壓夢壓(鏇餘簾壓夢鬱鑰選鏇顧) = 夢壓觸鏇製簾夢襯艱網 餘襯壓鏇製醖夢窪製廠 (積鬱廠鬱選憲網壓鏇蓋 ) | |||||||
临床1/2期 | 40 | (450 mg Q2W IV → 600 mg Q2W SC, up to 104 weeks ‖) | 糧衊觸衊壓築鬱觸窪鹹(淵構膚鏇積範糧餘構觸) = 製淵構窪鬱鑰觸衊築鑰 積蓋築齋積願夢選製製 (獵淵鑰繭繭鏇鬱鏇齋齋 ) 更多 | 积极 | 2022-11-01 | ||
(600 mg Q2W de novo SC, up to 104 weeks) | 糧衊觸衊壓築鬱觸窪鹹(艱蓋淵餘築鬱窪獵鏇鏇) = 積餘鑰衊糧膚鏇糧鹹膚 選繭衊蓋廠夢遞糧襯艱 (鏇鹽蓋積鹹鬱壓鏇網範 ) |
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