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.

The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.

开始日期2026-03-26

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

NCT06858319

/ Recruiting临床3期

A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.

The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.

开始日期2025-07-28

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

ChiCTR2500096892

/ Recruiting临床3期IIT

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults with IgA Nephropathy(The BEYOND Study)

开始日期2024-09-25

申办/合作机构-

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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项与泽戈奇拜单抗相关的文献（医药）

2026-06-01·Kidney 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).

2025-09-01·KIDNEY 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).

2023-12-01·Clinical rheumatology

A narrative review of potential drug treatments for nephritis in children with IgA vasculitis (HSP)

Review

作者: Lamond, Megan ; Chetwynd, Andrew J ; Marro, Julien ; Oni, Louise ; Williams, Chloe E C

Abstract:

Immunoglobulin A (IgA) vasculitis (IgAV, also known as Henoch-Schoenlein purpura, HSP) is the most common vasculitis of childhood. It usually presents with a simple, self-limiting disease course; however, a small subset of patients may develop kidney involvement (IgAV-N) which occurs 4–12 weeks after disease onset and is the biggest contributor to long-term morbidity. Treatment currently targets patients with established kidney involvement; however; there is a desire to work towards early prevention of inflammation during the window of opportunity between disease presentation and onset of significant nephritis. There are no clinical trials evaluating drugs which may prevent or halt the progression of nephritis in children with IgAV apart from the early use of corticosteroids which have no benefit. This article summarises the latest scientific evidence and clinical trials that support potential therapeutic targets for IgAV-N that are currently being developed based on the evolving understanding of the pathophysiology of IgAV-N. These span the mucosal immunity, B-cell and T-cell modulation, RAAS inhibition, and regulation of complement pathways, amongst others. Novel drugs that may be considered for use in early nephritis include TRF-budesonide; B-cell inhibiting agents including belimumab, telitacicept, blisibimod, VIS649, and BION-1301; B-cell depleting agents such as rituximab, ofatumumab, and bortezomib; sparsentan; angiotensin converting enzyme inhibitors (ACE-Is); and complement pathway inhibitors including avacopan, iptacopan, and narsoplimab. Further clinical trials, as well as pre-clinical scientific studies, are needed to identify mechanistic pathways as there may be an opportunity to prevent nephritis in this condition.Key Points• Kidney involvement is the main cause of long-term morbidity and mortality in IgA vasculitis despite the current treatment recommendations.• The evolving understanding of the pathophysiology of IgA vasculitis is allowing exploration of novel treatment options which target underlying immune pathways.• Novel treatments currently being trialled in IgA nephropathy may have benefit in IgA vasculitis due to the similarities in the underlying pathophysiology, such as TRF-budesonide, B-cell modulators, and complement inhibitors.• Further studies, including clinical trials of novel drugs, are urgently needed to improve the long-term outcomes for children with IgA vasculitis nephritis.

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项与泽戈奇拜单抗相关的新闻（医药）

2026-07-17

·FiercePharma

Novartis gains full FDA nod for Fabhalta in kidney disorder IgAN

With two approved medicines to treat primary immunoglobulin A nephropathy (IgAN) and a third therapy in phase 3 testing, Novartis is on its way to cornering the market for the indication. On Friday its first drug to hit the market for IgAN, Fabhalta, gained a full blessing from the FDA, with the U.S. regulator converting the drug's accelerated approval into a traditional nod. Fabhalta is now endorsed to slow kidney function decline in adult IgAN patients who are at risk for disease progression. The original, speedy IgAN approval for the first-in-class factor B complement inhibitor came two years ago to reduce proteinuria. “Today’s approval reinforces Fabhalta’s role in preserving kidney function by significantly slowing disease progression, an outcome that matters deeply to patients at risk of long-term kidney damage,” Victor Bultó, Novartis’ US president, said in a release. Backing the approval was data from a phase 3 placebo-controlled trial that showed statistically significant and clinically meaningful improvement in estimated glomerular filtration rate (eGFR) over two years on Novartis' drug. When done over time, an eGFR blood test can assess kidney functioning and the progress of an IgAN patient. Fabhalta’s first approval in the indication was based on surrogate endpoint data from the same trial, which measured the reduction in patients’ proteinuria (protein in the urine) at nine months versus placebo. That endpoint is an “increasingly recognized surrogate marker correlating with progression to kidney failure,” Novartis said at the time of that readout. Autoimmune kidney disease IgAN is diagnosed in roughly 25 per million people worldwide. Up to 50% of IgAN patients with proteinuria progress to kidney failure within 10 to 20 years of diagnosis, often requiring dialysis and/or kidney transplantation, Novartis said. “The ability to significantly slow kidney function decline is a critical treatment goal,” Dana Rizk, M.D., of the Division of Nephrology at the University of Alabama at Birmingham, said in a release. “This approval of Fabhalta reinforces the importance of targeting underlying disease mechanisms, including complement activation, in treating IgAN to help preserve kidney health.” In addition to Fabhalta, Novartis gained an FDA accelerated approval last year for another of its oral medicines Vanrafia, which it picked up in a $3.2 billion buyout of Chinook Therapeutics in 2023. Early this year, the Swiss company said it would seek full approval for the endothelin A (ETA) receptor antagonist, even though it came up short in a phase 3 study assessing kidney function improvement. Novartis is testing its anti-APRIL antibody zigakibart in a phase 3 IgAN study, too. The company amended the trial’s protocol to focus on eGFR and potentially gain a full approval. An interim eGFR readout is expected in the first half of next year. Also on the IgAN treatment landscape are Travere Therapeutics with Filspari, which gained a full approval in the indication in 2024, and Calliditas Therapeutics’ Tarpeyo, which was cleared a year earlier, becoming the first drug to treat the disorder in the U.S. In 2024, Japanese chemical giant Asahi Kasei acquired Sweden-based Calliditas for $1.1 billion. Last year, sales of Fabhalta reached $505 million, which were up 291%. In the first quarter of this year, Novartis reported sales of Fabhalta at $169 million, while Vanrafia chipped in an additional $16 million. Fabhalta originally reached the market in 2023 for paroxysmal nocturnal hemoglobinuria (PNH). Last year, Novartis tacked on an FDA nod for Fabhalta to treat C3 glomerulopathy, as well.

临床3期上市批准临床结果并购加速审批

2026-07-17

·新浪医药

重磅IgA肾病新适应症获批，可延缓肾功能下降

当地时间 7 月 17 日，诺华宣布，美国 FDA 已正式批准伊普可泮（Iptacopan）用于延缓原发性免疫球蛋白 A 肾病（IgAN）成人患者的肾功能下降，这些患者存在疾病进展风险。新闻稿指出，此次批准使得 Fabhalta 成为首个也是目前唯一一个能显著延缓原发性 IgA 肾病肾功能下降的补体抑制剂。 Fabhalta 是诺华首创的 CFB 补体抑制剂，该药于 2023 年 12 月首次获 FDA 批准上市，用于阵发性睡眠性血红蛋白尿症。2024 年 8 月获得 FDA 加速批准，用于降低原发性 IgAN 患者的蛋白尿；2025 年 3 月又获批拓展适应症，用于 C3 肾小球病。 IgAN是一种慢性免疫介导性疾病，会导致肾衰竭，严重影响患者的生活，显著延缓肾功能衰退是治疗的关键目标。诺华美国区总裁 Victor Bultó 表示，此次 FDA 的批准巩固了 Fabhalta 在保护肾功能方面的作用，它能显著延缓疾病进展，这对面临长期肾损伤风险的患者至关重要，这一里程碑凸显了持续创新对 IgA 肾病患者的重要性。此次 Fabhalta 新适应症的获批基于 III 期 APPLAUSE-IgAN 研究的数据。结果显示，Fabhalta 在两年内使估算肾小球滤过率 (eGFR)下降速度减缓了 48%，表明其具有肾功能保护作用。Fabhalta 组的 eGFR 年均变化为 -3.0 mL/min/1.73 m² /年，而安慰剂组为 -5.7 mL/min/1.73 m² /年。Fabhalta 在关键肾脏结局指标方面始终优于安慰剂。 APPLAUSE-IgAN 研究表明，Fabhalta 具有良好的安全性，与先前报道的数据一致。IgAN 患者使用 Fabhalta 最常见的不良事件为腹痛、头晕和恶心。Fabhalta 可能会增加由荚膜细菌引起的严重感染风险，目前仅可通过风险评估和缓解策略 (REMS) 项目获得，该项目要求患者在治疗前接种适当的疫苗。值得一提的是，诺华致力于通过各种支持项目帮助 IgAN 患者获得 Fabhalta，在美国，几乎 100% 的患者每月只需支付 10 美元或更少的费用。 Insight 数据库显示，诺华在 IgA 肾病领域深耕已久，除了 Fabhalta 以外，还有 3 款产品，旨在针对不同的 IgA 肾病驱动因素，为患者群体提供多样化的治疗选择：阿曲生坦是一种强效选择性口服 ETA 受体拮抗剂，2025 年 4 月，该药首次获 FDA 加速批准用于 IgA 肾病，成为首个也是唯一一个用于该适应症的强效选择性口服 ETA 受体拮抗剂。诺华还有一款靶向增殖诱导配体（APRIL）的 IgA 肾病新药泽戈奇拜单抗（Zigakibart），目前正处于 III 期临床阶段。菲泽妥单抗是诺华以 29 亿美元收购 Morphosys 而获得的一款 CD38 单抗，目前 IgA 肾病适应症也处于 III 期临床阶段。来源：Insight数据库加入读者交流群： —精彩回顾— 乙肝临床治愈王座之争进入决胜时刻 “全球首个”难治性肾病新药获批上市国产银屑病1类新药获批上市默沙东长效 RSV 单抗在中国获批上市干燥综合征，全球首个生物药在我国获批联系我们： wbfsh@staff.weibo.com

2026-07-17

·好肾医

一文看懂IgA肾病新药格局：14款药，4条赛道，都在解决什么问题

过去两年，IgA肾病领域的新药消息一篇接一篇。泰它西普刚获批，阿塞西普在排队，Povetacicept在冲刺，耐赋康、阿曲生坦、伊普可泮、斯贝利单抗都已经先后上市……药越来越多，名字越来越绕口，很多肾友看得眼花，却不太清楚这些药到底有什么不一样。今天我们把目前最受关注的创新药梳理一遍，按照它们各自解决的问题分类，帮大家建立一个清晰的框架。先回顾一下：IgA肾病是怎么发生的？理解这些新药，要先回到IgA肾病的发病机制——就是我们之前常提到的“四重打击”：体内B细胞异常活化，产生致病性IgA（Gd-IgA1）→ 机体针对它产生自身抗体 → 两者结合形成免疫复合物 → 免疫复合物沉积在肾脏、激活补体，引发炎症损伤 → 肾单位不断丢失，功能持续下降。目前几乎所有的创新药，都是冲着这条链条上的某一个环节去的。我们把它们分成四条赛道，外加一条还在探索中的前沿方向。一管住B细胞，从源头少产生致病性IgA 这是目前竞争最热闹的一条赛道，参与的药企也最多。这类药的共同思路很直接：体内有两个信号，叫BAFF和APRIL，专门负责“催熟”B细胞、让它疯狂干活。把这两个信号压下去，B细胞就没那么活跃了，致病性IgA自然就少了。 1 泰它西普今年6月在国内正式获批，是国内第一款用于IgA肾病的原创生物药，同时压住BAFF和APRIL两个信号。三期临床A阶段纳入318人，治疗39周后，蛋白尿比治疗前降了58.9%，比安慰剂组多了55个百分点，效果非常显著。肾功能方面，泰它西普组eGFR基本没怎么往下掉（-1.0%），安慰剂组则明显下降了7.7%。用药特点：泰它西普只需每周打一次皮下注射，常见的副作用是注射部位反应，还有免疫球蛋白水平会下降一些，用药期间需要定期查血。 2 阿塞西普思路跟泰它西普差不多，也是同时压住BAFF和APRIL两个信号，但走的是另外一条研发路线。它的三期临床纳入203人做中期分析，治疗36周后，蛋白尿降了45.7%，安慰剂组只降了6.8%，两组相差41.8个百分点。这次试验里还测了致病性IgA的变化，下降了近七成（68.3%）；原本有血尿的患者里，超过八成（81.0%）血尿消失。用药特点：每周皮下注射一次，整体不良反应发生率比安慰剂组高一些，但大多是轻中度，不用停药。 3 Povetacicept 该药的研发代号ALPN-303，可以理解成这条赛道的升级款——通过改造分子结构，让它抓得更紧、在肾脏里待得更久，所以打针的间隔能拉长到一个月一次。三期数据显示，治疗36周后蛋白尿降幅近一半（49.8%），致病性IgA下降了近八成（79.3%）；原本有血尿的患者里，85.1%实现了缓解。常见副作用是注射部位反应（14.5%）和上呼吸道感染（18.3%），值得注意的是，少数患者出现了比较严重的免疫球蛋白偏低，所以用药期间监测免疫球蛋白水平很重要。目前国内已经有企业拿到了这款药的开发权益。 4 斯贝利单抗国内已经获批，跟前面几款不太一样——它不是同时压两个信号，只专门盯着APRIL这一个靶点。三期研究显示，治疗9个月后蛋白尿降幅过半（51.2%）。早期数据里还发现，斯贝利单抗能让IgA肾病的eGFR基本保持稳定，甚至略有改善。每四周皮下注射一次，不良事件发生率比安慰剂组反而更低一些，严重不良事件发生率不到6%，整体安全性表现不错。 5 Zigakibart 同样靶向APRIL这一个靶点，目前在全球范围内处于三期临床阶段，给药频率是每两周一次。早期I/II期数据显示，致病性IgA降幅超过七成（74.4%），部分患者亚组的肾功能甚至出现了正向改善，最高能涨7.59%。三期完整数据还没有公布，但因为机制和斯贝利单抗高度接近，会是它最直接的竞争对手。这条赛道目前是“群雄逐鹿”的局面，几款药机制接近、数据也都不错，未来比的更多是打针频率、长期安全性和价格。二拦住补体，掐断炎症被放大的那一步免疫复合物沉积到肾脏之后，会触发体内的补体系统，这是炎症被进一步放大、肾脏受到实质性损伤的关键一步。这条赛道的药，瞄准的正是补体系统里不同的节点。 6 伊普可泮国内已经获批，盯着补体替代途径里的一个关键蛋白——B因子。三期研究中期数据显示，治疗9个月后蛋白尿降幅38.3%。后来公布的两年最终数据更值得关注：肾功能下降的速度，治疗组每年只下降3.10，安慰剂组每年下降6.12，差了将近一倍，这说明它不只是能让蛋白尿降下来，对长期保护肾功能也确实有用。需要注意的是，这款药感染风险会高一些，用药期间要留意有没有发热、咳嗽等感染信号。 7 HSK39297 同样靶向补体B因子，是国产药里目前进展较快、数据也比较亮眼的一个。二期临床纳入87人，分成50mg每日两次、100mg每日两次、200mg每日一次三个剂量组和安慰剂组，治疗12周后，各剂量组蛋白尿分别降低52.3%、52.5%、48.2%，安慰剂组只降了5.3%，相比安慰剂多降了45到50个百分点不等，三个剂量组的效果都非常显著。不良反应大多是轻中度，没有因为不良反应而停药的严重事件。2025年9月，这款药被国家药监局拟纳入突破性治疗，2026年1月正式启动三期临床，是这条赛道里值得重点关注的国产选手。 8 HRS-5965 靶向的同样是补体B因子，跟伊普可泮、HSK39297是一个靶点，原发性IgA肾病这个适应症已被拟纳入突破性治疗品种，目前国内处于二期临床阶段，完整数据尚未公布。 9 CM338 走的是补体系统里另外一条更上游的路——凝集素途径，靶向的是这条途径里的一个关键酶（MASP-2）。相当于在补体被激活之前，更早一步就把闸门关上。这是国内第一个进入临床阶段的同类药物，目前在二期阶段，离上市还有比较长的距离，但靶点方向比较新，值得留意。补体系统本身有好几条不同的激活路径，这几款药分别卡在不同的节点上，未来说不定会出现联合使用的方案。三不碰免疫系统，专门给肾脏内部减压这条赛道思路完全不一样——它不针对免疫系统，而是着眼于肾脏内部的血流压力。IgA肾病发展过程中，肾小球内部会出现压力过高、过滤负担加重的情况，长期下来会加速肾单位的损耗。这类药通过阻断一种叫内皮素的信号，让肾小球内部的压力降下来，从而减轻负担、减少蛋白尿。 10 阿曲生坦国内已经获批，是高选择性的内皮素A受体阻断剂。三期临床36周的数据显示，蛋白尿比安慰剂组多降了36.1个百分点。更长期的2.5年数据也出来了：eGFR每年下降速度比安慰剂组慢了2.4，每天口服一次，整体耐受性不错，没有出现明显的心衰或严重水肿。 11 斯帕生坦思路更进一步——同时阻断内皮素A受体和血管紧张素受体两条通路。三期研究里它的对照组不是安慰剂，而是另一款常用降压药厄贝沙坦，治疗36周后，蛋白尿相对厄贝沙坦组多降了41个百分点，治疗110周时仍然多降40%。这款药在美国已经完全获批上市，国内目前还没有明确的上市进展。需要特别提醒的是，这类药有引起肝功能异常和体液潴留（也就是水肿）的风险，使用前需要查肝功能，治疗期间也要密切关注体重变化。 12 SC0062 走的也是阻断内皮素A受体这条路，二期数据显示，不到半年（24周时）就能让蛋白尿降幅过半（51.6%）。它还解决了同类药物一个老问题——容易引起水肿，这款药在试验中的水肿发生率比安慰剂组还低。目前国内外都在同步推进三期临床。这条赛道不涉及免疫抑制，相对来说安全性顾虑小一些，但水肿和肝功能是需要留意的两个点。四在肠道局部出手，不走全身循环这条赛道目前只有一款代表性药物，但思路很独特。 13 布地奈德肠溶胶囊（耐赋康）国内已经获批，也是全球第一款针对IgA肾病发病机制本身的药物。它的设计目标，是让药物精准地在肠道末端（回肠末端）释放，直接作用于那里聚集的免疫细胞，从源头上减少致病性IgA的产生，而不需要依赖全身血液循环。三期临床显示，9个月治疗后，尿蛋白下降明显，肾功能保护效果能维持到2年。这款药本质上是一种糖皮质激素的局部释放剂型，全身性的激素副作用相对少一些，但仍需要关注血糖、血脂、血压等指标的变化。前沿方向：能不能直接把已经沉积的IgA清掉？前面四条赛道，思路基本都是“减少新增”——从源头减少致病性IgA的产生，或者拦住它沉积之后引发的炎症反应。但还有一种更直接的想法：已经沉积在肾脏里的IgA，能不能直接把它清掉？ 14 PEG-AK183 也写作Fc-AK183，它正是这个方向的早期探索。它是把一种细菌来源的、专门切割IgA的酶，和人体自身抗体的一部分融合在一起做成重组蛋白。这种酶能精确地把IgA切断，切断后的碎片就会被肾脏过滤排出体外。在动物实验里，这种药物的效果能持续一周以上，不仅能清除血液里的IgA，连已经沉积在肾小球里的IgA和补体C3也能一并清除掉。需要说清楚的是，这款药目前还停留在动物实验阶段，距离真正用到人身上、用到患者身上，还有很长的路要走。我们把它放在这里说一说，是想让大家知道，IgA肾病新药的研发思路还在不断拓展，“直接清掉沉积物”这条路径，是个值得长期关注的新方向。一张表.把这些药放在一起对比看看短短几年，IgA肾病可用的药从几乎为零，发展到今天四条赛道、十多款药同时推进的局面。这背后是无数研究者，还有参与临床试验的患者，多年攒下来的成果。不过药越多，选择反而越要谨慎。这些药瞄准的环节不一样，适合的人群也不完全一样——有的对蛋白尿控制立竿见影，有的更看重长期肾功能保护，有的会明显影响免疫功能、需要密切盯着，有的安全性顾虑小一些，但要留意水肿和肝功能。具体到每个人该不该用、用哪一款、什么时候用，得结合自己的病情基线、蛋白尿水平、肾功能状况，跟主治医生一起商量着来。点击下方卡片，关注好肾医，可看更多历史文章👇 好肾医审稿专家好肾医专职医生周爽主任医师参考文献 [1] Lv J, Liu L, Wang W, et al. Telitacicept for IgA Nephropathy - Interim Analysis of a Phase 3 Trial. N Engl J Med. 2026;394(19):1916-1924. doi:10.1056/NEJMoa2514415 [2]Lafayette R, Barbour SJ, Brenner RM, et al. A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy. N Engl J Med. 2026;394(7):647-657. doi:10.1056/NEJMoa2510198 [3] Atacicept significantly reduced proteinuria in patients with IgA nephropathy, phase 3 data show. Presented at ASN Kidney Week 2025, November 6, 2025. [4] Madan A, Yalavarthy R, Kim DK, et al. Povetacicept for IgA Nephropathy and Primary Membranous Nephropathy. Kidney Int Rep. 2025;11(1):106-116. Published 2025 Nov 3. doi:10.1016/j.ekir.2025.10.029 [5] Perkovic V, Trimarchi H, Tesar V, et al. Sibeprenlimab in IgA Nephropathy - Interim Analysis of a Phase 3 Trial. N Engl J Med. 2026;394(7):635-646. doi:10.1056/NEJMoa2512133 [6] Mathur M, Barratt J, Chacko B, et al. A Phase 2 Trial of Sibeprenlimab in Patients with IgA Nephropathy. N Engl J Med. 2024;390(1):20-31. doi:10.1056/NEJMoa2305635 [7] Kooienga L, Lo J, Lee EY, et al. Zigakibart demonstrates clinical safety and efficacy in a Phase 1/2 trial of healthy volunteers and patients with IgA nephropathy. Kidney Int. 2025;108(3):445-454. doi:10.1016/j.kint.2025.05.006 [8]Perkovic V, Barratt J, Rovin B, et al. Alternative Complement Pathway Inhibition with Iptacopan in IgA Nephropathy. N Engl J Med. 2025;392(6):531-543. doi:10.1056/NEJMoa2410316 [9] Iptacopan in IgA Nephropathy — Final 24-Month Data. N Engl J Med. Published online March 29, 2026. [10] Lv J, et al. WCN 2026. Abstract: WCN26-AB-5558。 [11] 国家药品监督管理局药品审评中心. HRS-5965 IgA肾病适应症获突破性治疗品种认定公示. 北京: 国家药品监督管理局; 2025. [12] Keymed Biosciences. A phase II clinical study evaluating the efficacy and safety of CM338 injection in subjects with immunoglobulin A nephropathy. ClinicalTrials.gov identifier: NCT05775042. [13] Heerspink HJL, Jardine M, Kohan DE, et al. Atrasentan in Patients with IgA Nephropathy. N Engl J Med. 2025;392(6):544-554. doi:10.1056/NEJMoa2409415 [14]Heerspink HJL, Jardine MJ, Kohan DE, et al. Atrasentan in patients with IgA nephropathy (ALIGN): final 2·5-year results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2026;407(10546):2387-2401. doi:10.1016/S0140-6736(26)00960-8 [15] Rovin BH, Barratt J, Heerspink HJL, et al. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial. Lancet. 2023;402(10417):2077-2090. doi:10.1016/S0140-6736(23)02302-4 [16] Heerspink HJL, Du X, Xu Y, et al. The Selective Endothelin Receptor Antagonist SC0062 in IgA Nephropathy: A Randomized Double-Blind Placebo-Controlled Clinical Trial. J Am Soc Nephrol. 2025;36(4):657-667. doi:10.1681/ASN.0000000538 [17] Lafayette R, Kristensen J, Stone A, et al. Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomised phase 3 trial. Lancet. 2023;402(10405):859-870. doi:10.1016/S0140-6736(23)01554-4 [18]Shen X, Shu C, Dong Y, et al. Therapeutic Efficacy and Antigenicity of a Novel PEGylated IgA Protease in Preclinical Models of IgA Nephropathy. Kidney International. 2026. doi:10.1016/j.kint.2026.04.020

100 项与泽戈奇拜单抗相关的药物交易

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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	Novartis Pharmaceuticals Canada, Inc.	2023-07-06
免疫球蛋白a肾病	临床3期	日本	Novartis Pharmaceuticals Canada, Inc.	2023-07-06
免疫球蛋白a肾病	临床3期	阿根廷	Novartis Pharmaceuticals Canada, Inc.	2023-07-06
免疫球蛋白a肾病	临床3期	澳大利亚	Novartis Pharmaceuticals Canada, Inc.	2023-07-06
免疫球蛋白a肾病	临床3期	比利时	Novartis Pharmaceuticals Canada, Inc.	2023-07-06
免疫球蛋白a肾病	临床3期	巴西	Novartis Pharmaceuticals Canada, Inc.	2023-07-06
免疫球蛋白a肾病	临床3期	加拿大	Novartis Pharmaceuticals Canada, Inc.	2023-07-06
免疫球蛋白a肾病	临床3期	克罗地亚	Novartis Pharmaceuticals Canada, Inc.	2023-07-06
免疫球蛋白a肾病	临床3期	捷克	Novartis Pharmaceuticals Canada, Inc.	2023-07-06
免疫球蛋白a肾病	临床3期	法国	Novartis Pharmaceuticals Canada, Inc.	2023-07-06

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03945318 \| NCT05852938 (Pubmed \| Kidney Int)	临床1/2期	免疫球蛋白a肾病 APRIL \| IgA \| IgM ... 更多	103	Zigakibart 600 mg	壓鹽衊簾艱膚廠積構築(憲願淵遞餘夢艱簾膚觸) = 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. 鑰壓艱獵壓醖糧鑰鑰範 (襯願網窪鹹範構繭齋壓 )	积极	2025-09-01
NCT03945318 (Phase 1/2 Study of BION-1301 \| ADU-CL-19, PRNewswire) 人工标引	临床1/2期	免疫球蛋白a肾病	40	Zigakibart	艱膚憲憲壓範鑰糧顧築(觸鹽範築繭構壓蓋顧簾) = 獵憲醖鹹鑰遞範遞觸衊製壓鏇鹽製選築醖襯廠 (夢選鬱餘鬱齋醖糧鹽衊 ) 更多	积极	2025-06-05
NCT03945318 (ADU-CL-19, ASN2025 \| PRNewswire \| Pubmed)	临床1/2期	免疫球蛋白a肾病	40	zigakibart	衊膚餘齋製構壓鏇夢醖(構鏇製蓋範獵顧鬱衊壓) = 衊艱鏇餘網膚製鹽鏇築淵艱廠鹹衊積遞願鏇衊 (鏇觸遞壓築鑰蓋襯淵鏇 ) 更多	积极	2025-05-30
NCT03945318 (ADU-CL-19, ASN2024)	临床1/2期	免疫球蛋白a肾病	40	Zigakibart 450 mg Q2W IV→600 mg Q2W SC	齋廠獵選蓋鏇餘網廠廠(範築獵餘鏇淵獵鹽範遞) = 襯廠糧窪壓繭蓋鏇餘鹹淵鏇夢鬱淵艱醖鏇鏇製 (繭願構餘夢範憲網願選 )	积极	2024-10-25
NCT03945318 (ADU-CL-19, ISN WCN2023)	临床1/2期	免疫球蛋白a肾病 APRIL \| IgA \| Gd-IgA1 ... 更多	-	BION-1301 450 mg IV	糧鑰餘簾製蓋膚鹽積憲(餘顧範醖襯窪壓餘廠觸) = 顧憲壓簾製淵構夢鬱製蓋遞構顧遞淵繭淵觸觸 (製獵築選廠顧繭獵糧淵 )	积极	2023-03-01
NCT03945318 (ADU-CL-19, ISN WCN2023)	临床1/2期	免疫球蛋白a肾病 APRIL \| IgA \| Gd-IgA1 ... 更多	-	BION-1301 600 mg SC	糧鑰餘簾製蓋膚鹽積憲(餘顧範醖襯窪壓餘廠觸) = 築糧淵糧鹹齋憲鏇構鬱蓋遞構顧遞淵繭淵觸觸 (製獵築選廠顧繭獵糧淵 )	积极	2023-03-01
NCT03945318 (Phase 1/2 Study of BION-1301, ASN2022)	临床1/2期	免疫球蛋白a肾病 APRIL \| IgA \| Gd-IgA1 ... 更多	20	BION-1301 450 mg IV	膚衊憲鏇淵醖糧醖窪網(獵夢選廠鹽夢鹽鏇範範) = 廠醖夢壓鹽選鏇網繭獵壓顧網襯廠衊鏇鏇廠膚 (繭淵選願願蓋淵構餘鹽 )	积极	2022-11-04
NCT03945318 (Phase 1/2 Study of BION-1301, ASN2022)	临床1/2期	免疫球蛋白a肾病 APRIL \| IgA \| Gd-IgA1 ... 更多	20	BION-1301 600 mg SC	膚衊憲鏇淵醖糧醖窪網(獵夢選廠鹽夢鹽鏇範範) = 夢淵願築淵鑰鏇簾鏇淵壓顧網襯廠衊鏇鏇廠膚 (繭淵選願願蓋淵構餘鹽 )	积极	2022-11-04
NCT03945318 (Corporate Publications) 人工标引	临床1/2期	免疫球蛋白a肾病	40	BION-1301 (450 mg Q2W IV → 600 mg Q2W SC, up to 104 weeks ‖)	遞鏇淵獵鏇膚築廠鏇鏇(鬱衊壓襯窪範廠蓋襯衊) = 範構構餘鹹膚膚淵艱齋顧網製壓蓋鏇繭糧壓願 (廠築餘鬱顧醖鏇繭膚蓋 ) 更多	积极	2022-11-01
NCT03945318 (Corporate Publications) 人工标引	临床1/2期	免疫球蛋白a肾病	40	BION-1301 (600 mg Q2W de novo SC, up to 104 weeks)	遞鏇淵獵鏇膚築廠鏇鏇(觸廠獵窪遞網襯顧醖廠) = 簾餘鬱鬱網糧艱壓繭窪製鑰膚糧願廠選鏇壓構 (窪鑰壓齋遞構廠壓網願 )	积极	2022-11-01
NCT03945318 (Corporate Publications) 人工标引	临床1/2期	免疫球蛋白a肾病	10	BION-1301	築鏇鬱鹽鹽艱築夢餘餘(餘繭蓋積網艱網選鏇繭) = 衊齋選憲醖膚鬱壓鹽築簾鏇夢觸願觸繭齋襯鏇 (繭鑰艱夢獵壓觸簾構築 ) 更多	积极	2021-11-04
NCT03340883 (CTgov)	临床1/2期	复发性多发性骨髓瘤 \| 难治性多发性骨髓瘤	21	BION-1301 (BION-1301 50 mg Q2W)	願範鏇鏇遞淵鏇夢鹹製 = 壓鏇鹽醖衊醖鹽製獵構夢壓觸襯顧鑰夢衊夢積 (廠壓齋餘鹽夢願網餘醖, 鏇膚壓膚艱獵膚構範構 ~ 廠獵願選鏇鹽膚窪夢鑰) 更多	-	2020-09-07
NCT03340883 (CTgov)	临床1/2期	复发性多发性骨髓瘤 \| 难治性多发性骨髓瘤	21	BION-1301 (BION-1301 150 mg Q2W)	願範鏇鏇遞淵鏇夢鹹製 = 壓憲簾鏇鑰醖選遞壓顧夢壓觸襯顧鑰夢衊夢積 (廠壓齋餘鹽夢願網餘醖, 鬱壓鏇廠淵願餘觸製醖 ~ 選觸鏇鏇鹽壓網鬱製網) 更多	-	2020-09-07