斯贝利单抗(Sibeprenlimab) - 药物靶点：APRIL_在研适应症：免疫球蛋白a肾病，自身免疫性疾病，局灶性节段性肾小球硬化症_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Sebeprenlimab、Sibeprenlimab-szs、sibeprenlimab-szsi

+ [6]

靶点

APRIL

作用方式

抑制剂

作用机制

APRIL抑制剂(肿瘤坏死因子配体超家族成员13抑制剂)

治疗领域

免疫系统疾病泌尿生殖系统疾病眼部疾病+ [3]

在研适应症

免疫球蛋白a肾病自身免疫性疾病局灶性节段性肾小球硬化症+ [3]

非在研适应症-

原研机构

Otsuka Pharmaceutical Co., Ltd.

在研机构

Otsuka Pharmaceutical Development & Commercialization, Inc.

Otsuka Pharmaceutical Co., Ltd.

大冢制药研发（北京）有限公司

非在研机构-

权益机构

Visterra, Inc.

Otsuka Pharmaceutical Co., Ltd.

Pantherx Rare Pharmacy

最高研发阶段批准上市

首次获批日期

美国 (2025-11-25),

免疫球蛋白a肾病

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、孤儿药 (日本)、孤儿药 (澳大利亚)、突破性疗法 (中国)、优先审评 (美国)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国)

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结构/序列

Sequence Code 616722899H

来源: *****

Sequence Code 616722900L

来源: *****

关联

15

项与斯贝利单抗相关的临床试验

NCT07861113

/ Not yet recruiting临床2期

A Phase 2, Multicenter, Open-label Trial to Evaluate the Efficacy and Safety of Sibeprenlimab in Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease

This study will assess whether sibeprenlimab can help improve kidney disease in adults with primary membranous nephropathy (pMN) by reducing harmful antibodies linked to the disease. The study will also assess whether sibeprenlimab can help adults with immune-mediated focal segmental glomerulosclerosis (IM-FSGS) or minimal change disease (MCD) stay in remission and prevent their kidney disease from returning.

开始日期2026-12-15

申办/合作机构

Otsuka Pharmaceutical Development & Commercialization, Inc.

NCT07770815

/ Not yet recruiting临床3期

A Phase 3, Open-label, Single-arm, Repeat-dose Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Sibeprenlimab Administered Subcutaneously in Children and Adolescents With Immunoglobulin A Nephropathy

This Phase 3, open-label study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of sibeprenlimab administered subcutaneously every 4 weeks in pediatric participants aged 2 to 17 years with IgA nephropathy (IgAN). Sibeprenlimab will be administered as an add-on to standard of care therapy consisting of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs).

开始日期2026-10-30

申办/合作机构

Otsuka Pharmaceutical Development & Commercialization, Inc.

NCT06928142

/ Active, not recruiting临床2期

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's

This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.

开始日期2025-04-23

申办/合作机构

Otsuka Pharmaceutical Development & Commercialization, Inc.

100 项与斯贝利单抗相关的临床结果

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100 项与斯贝利单抗相关的转化医学

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100 项与斯贝利单抗相关的专利（医药）

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23

项与斯贝利单抗相关的文献（医药）

2026-11-01·Kidney 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.

2026-08-01·Kidney International Supplements

Approved therapies in the IgA nephropathy armamentarium: a summary of the evidence

Review

作者: Lafayette, Richard A ; Norouzi, Sayna

Historically, IgA nephropathy (IgAN) was managed using supportive care, with a suggested 6 months of immunosuppressive therapy considered for patients at high risk of progressive kidney function decline (proteinuria, >0.75-1 g/d) despite ≥90 days of optimized supportive care. The evolving treatment landscape includes agents that target immunologic aspects of IgAN or better preserve kidney function, or both. Recent approvals include Nefecon, sparsentan, iptacopan, atrasentan, and sibeprenlimab. Nefecon, a targeted-release formulation of budesonide, is the only US Food and Drug Administration and European Medicines Agency fully approved agent that is designed to target the primary source of IgAN: galactose-deficient IgA1 production in the gut mucosa. Phase 3 data showed that Nefecon slowed estimated glomerular filtration rate decline and decreased proteinuria versus placebo, with an acceptable safety profile. Sparsentan, a fully US Food and Drug Administration- and European Medicines Agency-approved dual endothelin A/angiotensin II receptor antagonist, affects the generic responses to IgAN-induced nephron loss, potentially including glomerular inflammation and fibrosis. Sparsentan demonstrated a significant reduction in proteinuria and estimated glomerular filtration rate decline compared with irbesartan. Iptacopan inhibits complement factor B and has received accelerated US Food and Drug Administration approval. Interim phase 3 study data have shown that iptacopan significantly reduces proteinuria when compared with placebo. The endothelin A receptor antagonist atrasentan and A proliferation binding ligand inhibitor sibeprenlimab have also received accelerated US Food and Drug Administration approval, based on interim phase 3 results showing significant proteinuria reduction versus placebo in patients with IgAN. This expanded clinical armamentarium offers clinicians and patients greater choice and improved disease control in IgAN management.

2026-08-01·Clinical Journal of the American Society of Nephrology

Humoral Response to COVID-19 Vaccines and Infection during Sibeprenlimab Treatment of IgA Nephropathy

Article

作者: Moc Willeford, Courtney ; Andrews, Lee ; Chacko, Bobby ; Honig, Gerard ; Pasetti, Marcela F. ; Wong, Muh Geot ; Kooienga, Laura ; Lafayette, Richard ; Liew, Adrian ; Sahay, Manisha ; Suzuki, Yusuke ; Rizk, Dana V. ; Mathur, Mohit ; Olinski, Lauren E. ; Follman, Kristin ; Barratt, Jonathan ; Oldach, David ; Shriver, Mallory C. ; McCafferty, Kieran

Key Points:

The phase 2 ENVISION trial evaluated efficacy and safety of intravenous sibeprenlimab, a selective A PRoliferation-Inducing Ligand inhibitor.Because the trial was conducted during the coronavirus disease 2019 pandemic, we assessed if sibeprenlimab affected humoral responses to coronavirus disease 2019 infection or vaccine.Sibeprenlimab treatment resulted in reduced pathogenic IgA and preserved protective humoral response to coronavirus disease 2019 vaccine and infection.

Background:

In phase 2 ENVISION trial, sibeprenlimab, a selective A PRoliferation-Inducing Ligand inhibitor, significantly decreased proteinuria and stabilized eGFR in adults with IgA nephropathy. This exploratory substudy evaluated coronavirus disease 2019 (COVID-19) severity, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)–specific antibody responses to vaccine and infection, and circulating B-cell populations in patients with IgA nephropathy treated with sibeprenlimab or placebo.

Methods:

Participants enrolled in ENVISION (NCT04287985) received 12 monthly intravenous infusions of sibeprenlimab (2, 4, or 8 mg/kg) or placebo. COVID-19 infection and vaccination data were recorded for all participants. In a substudy, serum IgG responses to SARS-CoV-2 spike protein, its receptor binding domain (RBD), and nucleocapsid antigen were assessed, with further analysis of serum IgM and IgA and salivary IgA against RBD in a subset of participants. Circulating T cells and B-cell subsets were analyzed by flow cytometry.

Results:

Overall, symptomatic COVID-19 incidence was comparable between groups (33.3% sibeprenlimab versus 44.7% placebo), indicating no observable excess risk of COVID-19 infection with sibeprenlimab. Of 155 participants, 72 (sibeprenlimab n =52; placebo n =20) consented to the substudy. Within the substudy, COVID-19 seroconversion rates were 100% for IgG against SARS-CoV-2 RBD (IgG-RBD) after vaccination or infection. Peak IgG-RBD titers after mRNA vaccination exceeded protective thresholds in all COVID-19–naive sibeprenlimab recipients, and IgG-RBD durability was comparable between sibeprenlimab and placebo. COVID-19–specific IgG, IgA, and IgM antibody responses to infection were preserved, and IgA-RBD responses detected in saliva suggested preservation of mucosal immunity with sibeprenlimab. No meaningful perturbations in B or T cells were observed.

Conclusions:

A PRoliferation-Inducing Ligand inhibition with sibeprenlimab reduced pathogenic IgA while preserving mucosal immunity and systemic antibody responses to COVID-19 vaccination and infection. The absence of B-cell perturbations and the apparent absence of an increased risk of impaired vaccine response suggest that sibeprenlimab may not confer clinically significant immunosuppressive risks; the substudy's size and exploratory design preclude definitive conclusions, warranting further evaluation.

Clinical Trial registry name and registration number::

ClinicalTrials.gov, NCT04287985.

485

项与斯贝利单抗相关的新闻（医药）

2026-10-26

·网易号

大冢制药IgA肾病新药两年结果登NEJM，风险降97.1%！

10月23日，大冢制药（Otsuka）及其子公司OPDC公布，斯贝利单抗（sibeprenlimab，VOYXACT®）治疗原发性免疫球蛋白A肾病（IgAN）的Ⅲ期VISIONARY研究两年最终结果，相关成果同步发表于《新英格兰医学杂志》。研究显示，与安慰剂相比，斯贝利单抗使患者发生肾功能下降或肾衰竭复合终点事件的风险降低97.1%。此外，该药在维持肾功能、改善蛋白尿和血尿方面也展现出积极结果，两年总体安全性与耐受性良好。一、肾功能不良事件风险降低97.1%VISIONARY是一项在全球范围内开展的双盲对照试验，共纳入510例原发性IgAN患者，旨在评估斯贝利单抗的疗效与安全性。两年最终结果显示，斯贝利单抗组259例患者中，仅1例发生肾功能下降或肾衰竭复合终点事件，发生率为0.4%；安慰剂组251例患者中，有28例发生此类事件，发生率为11.2%，对应风险降低97.1%。具体来看，斯贝利单抗组持续估算肾小球滤过率（eGFR）下降≥40%的患者为1例，安慰剂组为28例；血清肌酐持续翻倍的患者分别为0例和13例；持续eGFR低于15 mL/min/1.73 m²的患者分别为1例和10例。此外，斯贝利单抗组无患者需要接受肾脏替代治疗，安慰剂组则有5例。在关键次要终点方面，治疗24个月时，斯贝利单抗组年化eGFR斜率为+0.3 mL/min/1.73 m²/年，安慰剂组为−4.2 mL/min/1.73 m²/年，组间差异达+4.5 mL/min/1.73 m²/年（p＜0.0001），且治疗效应在预设的所有亚组中均保持一致。除肾功能指标外，斯贝利单抗还改善了患者的蛋白尿和血尿。在基线存在血尿的患者中，血尿消除率达到78.6%。值得关注的是，VISIONARY研究的两年结果不仅显示了斯贝利单抗对肾功能相关终点的影响，也进一步提供了其持续治疗效果的临床数据。二、靶向APRIL，国内外获批进展持续推进斯贝利单抗由Visterra开发，是一款靶向增殖诱导配体（APRIL）的单克隆抗体。APRIL参与IgA肾病的发病过程，斯贝利单抗通过选择性结合并抑制APRIL活性，有助于降低免疫球蛋白A（IgA）及病理性半乳糖缺陷型IgA1（Gd-IgA1）的水平，从疾病发生机制的上游进行干预，进而减缓肾脏损伤、延缓疾病进展。IgA肾病是一种慢性、进行性免疫介导的肾脏疾病，常见于20至40岁的成年人，部分患者可能随着病程进展出现肾功能持续下降，甚至发展为终末期肾病。因此，延缓肾功能恶化是该病治疗的重要目标。斯贝利单抗每四周给药一次，为患者提供了一种新的治疗选择。安全性方面，VISIONARY研究两年结果显示，斯贝利单抗总体安全性与耐受性良好，与安慰剂组相近。两组总不良事件发生率分别为90.7%和90.0%，感染发生率分别为51.4%和51.0%，注射部位反应发生率分别为35.1%和32.3%。斯贝利单抗组严重感染发生率为1.9%，低于安慰剂组的4.0%，研究期间未发现新的安全信号。在临床研究推进的同时，斯贝利单抗也已取得国内外监管进展。2025年11月，斯贝利单抗获得美国FDA加速批准，用于治疗成人IgA肾病，成为全球首款获批上市的APRIL单抗。此次加速批准基于Ⅲ期VISIONARY研究的中期分析结果。随着两年最终结果公布，大冢制药进一步获得了该药长期疗效与安全性方面的数据，并已完成向FDA滚动提交补充生物制品许可申请（sBLA），以寻求传统批准。国内方面，2026年6月，摩熵医药全球药物研发数据库显示，大冢制药申报的斯贝利单抗注射液获批上市，用于维持成人原发性IgA肾病患者的肾脏功能。此前，该申请已被纳入优先审评。此外，2018年7月，大冢制药以4.3亿美元收购Visterra，获得斯贝利单抗等相关资产。从美国FDA加速批准到中国获批上市，再到Ⅲ期研究两年最终结果公布，斯贝利单抗的临床证据与商业化进程均取得了新的进展。

临床结果临床3期临床成功临床2期

2026-10-26

·有驾

大冢制药公布斯贝利单抗VISIONARY两年最终数据：IgA肾病风险降低97.1%，结果登NEJM！

10月23日，大冢制药（Otsuka）及其子公司OPDC公布，斯贝利单抗（sibeprenlimab，VOYXACT®）治疗原发性免疫球蛋白A肾病（IgAN）的Ⅲ期VISIONARY研究两年最终结果，相关成果同步发表于《新英格兰医学杂志》。研究显示，与安慰剂相比，斯贝利单抗使患者发生肾功能下降或肾衰竭复合终点事件的风险降低97.1%。此外，该药在维持肾功能、改善蛋白尿和血尿方面也展现出积极结果，两年总体安全性与耐受性良好。一、肾功能不良事件风险降低97.1% VISIONARY是一项在全球范围内开展的双盲对照试验，共纳入510例原发性IgAN患者，旨在评估斯贝利单抗的疗效与安全性。两年最终结果显示，斯贝利单抗组259例患者中，仅1例发生肾功能下降或肾衰竭复合终点事件，发生率为0.4%；安慰剂组251例患者中，有28例发生此类事件，发生率为11.2%，对应风险降低97.1%。具体来看，斯贝利单抗组持续估算肾小球滤过率（eGFR）下降≥40%的患者为1例，安慰剂组为28例；血清肌酐持续翻倍的患者分别为0例和13例；持续eGFR低于15 mL/min/1.73 m²的患者分别为1例和10例。此外，斯贝利单抗组无患者需要接受肾脏替代治疗，安慰剂组则有5例。在关键次要终点方面，治疗24个月时，斯贝利单抗组年化eGFR斜率为+0.3 mL/min/1.73 m²/年，安慰剂组为−4.2 mL/min/1.73 m²/年，组间差异达+4.5 mL/min/1.73 m²/年（p＜0.0001），且治疗效应在预设的所有亚组中均保持一致。除肾功能指标外，斯贝利单抗还改善了患者的蛋白尿和血尿。在基线存在血尿的患者中，血尿消除率达到78.6%。值得关注的是，VISIONARY研究的两年结果不仅显示了斯贝利单抗对肾功能相关终点的影响，也进一步提供了其持续治疗效果的临床数据。二、靶向APRIL，国内外获批进展持续推进斯贝利单抗由Visterra开发，是一款靶向增殖诱导配体（APRIL）的单克隆抗体。APRIL参与IgA肾病的发病过程，斯贝利单抗通过选择性结合并抑制APRIL活性，有助于降低免疫球蛋白A（IgA）及病理性半乳糖缺陷型IgA1（Gd-IgA1）的水平，从疾病发生机制的上游进行干预，进而减缓肾脏损伤、延缓疾病进展。 IgA肾病是一种慢性、进行性免疫介导的肾脏疾病，常见于20至40岁的成年人，部分患者可能随着病程进展出现肾功能持续下降，甚至发展为终末期肾病。因此，延缓肾功能恶化是该病治疗的重要目标。斯贝利单抗每四周给药一次，为患者提供了一种新的治疗选择。安全性方面，VISIONARY研究两年结果显示，斯贝利单抗总体安全性与耐受性良好，与安慰剂组相近。两组总不良事件发生率分别为90.7%和90.0%，感染发生率分别为51.4%和51.0%，注射部位反应发生率分别为35.1%和32.3%。斯贝利单抗组严重感染发生率为1.9%，低于安慰剂组的4.0%，研究期间未发现新的安全信号。在临床研究推进的同时，斯贝利单抗也已取得国内外监管进展。 2025年11月，斯贝利单抗获得美国FDA加速批准，用于治疗成人IgA肾病，成为全球首款获批上市的APRIL单抗。此次加速批准基于Ⅲ期VISIONARY研究的中期分析结果。随着两年最终结果公布，大冢制药进一步获得了该药长期疗效与安全性方面的数据，并已完成向FDA滚动提交补充生物制品许可申请（sBLA），以寻求传统批准。国内方面，2026年6月，摩熵医药全球药物研发数据库显示，大冢制药申报的斯贝利单抗注射液获批上市，用于维持成人原发性IgA肾病患者的肾脏功能。此前，该申请已被纳入优先审评。此外，2018年7月，大冢制药以4.3亿美元收购Visterra，获得斯贝利单抗等相关资产。从美国FDA加速批准到中国获批上市，再到Ⅲ期研究两年最终结果公布，斯贝利单抗的临床证据与商业化进程均取得了新的进展。

2026-10-26

·搜狐新闻

大冢制药斯贝利单抗VISIONARY两年结果登NEJM，IgA肾病风险降低97.1%！

10月23日，大冢制药（Otsuka）及其子公司OPDC公布，斯贝利单抗（sibeprenlimab，VOYXACT®）治疗原发性免疫球蛋白A肾病（IgAN）的Ⅲ期VISIONARY研究两年最终结果，相关成果同步发表于《新英格兰医学杂志》。图源：大冢制药官网研究显示，与安慰剂相比，斯贝利单抗使患者发生肾功能下降或肾衰竭复合终点事件的风险降低97.1%。此外，该药在维持肾功能、改善蛋白尿和血尿方面也展现出积极结果，两年总体安全性与耐受性良好。一、肾功能不良事件风险降低97.1% VISIONARY是一项在全球范围内开展的双盲对照试验，共纳入510例原发性IgAN患者，旨在评估斯贝利单抗的疗效与安全性。两年最终结果显示，斯贝利单抗组259例患者中，仅1例发生肾功能下降或肾衰竭复合终点事件，发生率为0.4%；安慰剂组251例患者中，有28例发生此类事件，发生率为11.2%，对应风险降低97.1%。图源：摩熵医药-全球药物研发数据库具体来看，斯贝利单抗组持续估算肾小球滤过率（eGFR）下降≥40%的患者为1例，安慰剂组为28例；血清肌酐持续翻倍的患者分别为0例和13例；持续eGFR低于15 mL/min/1.73 m²的患者分别为1例和10例。此外，斯贝利单抗组无患者需要接受肾脏替代治疗，安慰剂组则有5例。在关键次要终点方面，治疗24个月时，斯贝利单抗组年化eGFR斜率为+0.3 mL/min/1.73 m²/年，安慰剂组为−4.2 mL/min/1.73 m²/年，组间差异达+4.5 mL/min/1.73 m²/年（p＜0.0001），且治疗效应在预设的所有亚组中均保持一致。除肾功能指标外，斯贝利单抗还改善了患者的蛋白尿和血尿。在基线存在血尿的患者中，血尿消除率达到78.6%。值得关注的是，VISIONARY研究的两年结果不仅显示了斯贝利单抗对肾功能相关终点的影响，也进一步提供了其持续治疗效果的临床数据。二、靶向APRIL，国内外获批进展持续推进斯贝利单抗由Visterra开发，是一款靶向增殖诱导配体（APRIL）的单克隆抗体。APRIL参与IgA肾病的发病过程，斯贝利单抗通过选择性结合并抑制APRIL活性，有助于降低免疫球蛋白A（IgA）及病理性半乳糖缺陷型IgA1（Gd-IgA1）的水平，从疾病发生机制的上游进行干预，进而减缓肾脏损伤、延缓疾病进展。图源：摩熵医药-全球药物研发数据库 IgA肾病是一种慢性、进行性免疫介导的肾脏疾病，常见于20至40岁的成年人，部分患者可能随着病程进展出现肾功能持续下降，甚至发展为终末期肾病。因此，延缓肾功能恶化是该病治疗的重要目标。斯贝利单抗每四周给药一次，为患者提供了一种新的治疗选择。安全性方面，VISIONARY研究两年结果显示，斯贝利单抗总体安全性与耐受性良好，与安慰剂组相近。两组总不良事件发生率分别为90.7%和90.0%，感染发生率分别为51.4%和51.0%，注射部位反应发生率分别为35.1%和32.3%。斯贝利单抗组严重感染发生率为1.9%，低于安慰剂组的4.0%，研究期间未发现新的安全信号。在临床研究推进的同时，斯贝利单抗也已取得国内外监管进展。 2025年11月，斯贝利单抗获得美国FDA加速批准，用于治疗成人IgA肾病，成为全球首款获批上市的APRIL单抗。此次加速批准基于Ⅲ期VISIONARY研究的中期分析结果。随着两年最终结果公布，大冢制药进一步获得了该药长期疗效与安全性方面的数据，并已完成向FDA滚动提交补充生物制品许可申请（sBLA），以寻求传统批准。国内方面，2026年6月，摩熵医药全球药物研发数据库显示，大冢制药申报的斯贝利单抗注射液获批上市，用于维持成人原发性IgA肾病患者的肾脏功能。此前，该申请已被纳入优先审评。图源：摩熵医药-全球药物研发数据库此外，2018年7月，大冢制药以4.3亿美元收购Visterra，获得斯贝利单抗等相关资产。从美国FDA加速批准到中国获批上市，再到Ⅲ期研究两年最终结果公布，斯贝利单抗的临床证据与商业化进程均取得了新的进展。返回搜狐，查看更多

临床结果临床3期临床成功

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KEGG	Wiki	ATC	Drug Bank
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研发状态

批准上市

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适应症	国家/地区	公司	日期
免疫球蛋白a肾病	美国	Otsuka Pharmaceutical Co., Ltd.	2025-11-25

未上市

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适应症	最高研发状态	国家/地区	公司	日期
自身免疫性疾病	申请上市	加拿大	Otsuka Pharmaceutical Co., Ltd.	2026-04-01
局灶性节段性肾小球硬化症	临床2期	-	Otsuka Pharmaceutical Development & Commercialization, Inc.	2026-12-15
特发性膜性肾病	临床2期	-	Otsuka Pharmaceutical Development & Commercialization, Inc.	2026-12-15
微小病变性肾病	临床2期	-	Otsuka Pharmaceutical Development & Commercialization, Inc.	2026-12-15
干燥综合征	临床2期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2025-04-23
干燥综合征	临床2期	阿根廷	Otsuka Pharmaceutical Development & Commercialization, Inc.	2025-04-23
干燥综合征	临床2期	保加利亚	Otsuka Pharmaceutical Development & Commercialization, Inc.	2025-04-23
干燥综合征	临床2期	德国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2025-04-23
干燥综合征	临床2期	希腊	Otsuka Pharmaceutical Development & Commercialization, Inc.	2025-04-23
干燥综合征	临床2期	波兰	Otsuka Pharmaceutical Development & Commercialization, Inc.	2025-04-23

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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


NCT05248646 (VISIONARY, Pubmed \| Clin Kidney J)	临床3期	免疫球蛋白a肾病	42	Sibeprenlimab 400 mg	鏇糧衊蓋餘觸鏇繭願觸(觸夢窪鏇觸壓鹹窪製簾) = similar between treatment groups 構鹹糧膚遞襯壓齋範簾 (蓋願積膚簾顧壓憲構蓋 ) 更多	积极	2026-07-31
				Placebo
NCT05248646 (VISIONARY, ISN WCN2026)	临床3期	免疫球蛋白a肾病	320	Sibeprenlimab	築膚積範觸繭膚鏇膚鹹(簾鹽簾憲願選築鹽餘鏇) = 鬱築網選簾蓋範觸襯獵遞蓋艱簾壓糧構膚淵網 (膚醖夢鹽衊夢製繭淵糧 ) 更多	积极	2026-04-01
				Placebo	築膚積範觸繭膚鏇膚鹹(簾鹽簾憲願選築鹽餘鏇) = 獵製鹹選製醖鹽鹹糧艱遞蓋艱簾壓糧構膚淵網 (膚醖夢鹽衊夢製繭淵糧 ) 更多
NCT05248646 (VISIONARY, ISN WCN2026)	临床3期	免疫球蛋白a肾病	42	Sibeprenlimab 400 mg SC	齋鹹廠廠齋簾糧遞廠遞(製廠蓋簾壓蓋蓋夢膚齋) = 觸窪鹹糧繭衊壓鏇範觸積範淵醖築鏇簾餘憲鬱 (網餘膚鑰願憲餘襯顧餘 ) 更多	积极	2026-04-01
NCT05248646 (VISIONARY, Company_Website 1 \| Company_Website 2 \| NEWS) 人工标引	临床3期	免疫球蛋白a肾病	320	Sibeprenlimab 400 mg	鑰糧鑰淵膚鏇願鏇簾鹹(壓餘繭積願觸遞繭製範) = 餘餘淵製衊淵夢構襯艱膚憲範齋顧淵廠鑰艱淵 (繭窪簾餘簾糧築醖構鹹 ) 更多	积极	2025-06-11
				Placebo	鑰糧鑰淵膚鏇願鏇簾鹹(壓餘繭積願觸遞繭製範) = 繭淵繭製觸築獵觸簾膚膚憲範齋顧淵廠鑰艱淵 (繭窪簾餘簾糧築醖構鹹 ) 更多
NCT03719443 (VIS649, CTgov)	临床1期	免疫球蛋白a肾病	51	placebo (Pooled Placebo)	遞鹽願範鹽獵製蓋鹹觸 = 願鑰鹽齋製壓壓簾築觸壓糧築壓鹹憲願膚鬱糧 (獵選廠鹹製憲製鹽蓋積, 遞壓窪醖淵獵觸鏇簾鹹 ~ 願鹽夢蓋鏇顧廠鹹繭餘) 更多	-	2025-03-20
				VIS649 (VIS649 Cohort 1)	遞鹽願範鹽獵製蓋鹹觸 = 構顧獵網淵觸衊夢鏇廠壓糧築壓鹹憲願膚鬱糧 (獵選廠鹹製憲製鹽蓋積, 網遞窪膚憲範範鏇壓衊 ~ 遞繭積鬱積構齋鹽廠遞) 更多
NCT05248646 (VISIONARY, ISN WCN2025)	临床3期	免疫球蛋白a肾病	510	SIBEPRENLIMAB 400 mg	選夢鹹糧鹹淵構觸鬱願(蓋願構憲艱窪蓋夢蓋製) = 壓繭鬱簾糧網鑰製顧遞鹹夢憲淵願築觸淵鹹選 (餘鬱築築鬱鏇鑰膚鏇鹹, 0.9) 更多	积极	2025-02-01
NCT04287985 (VIS649-201, CTgov)	临床2期	免疫球蛋白a肾病	155	Dose-Placebo	壓鏇鹹選艱壓製鏇觸廠 = 鏇積鑰襯鹹範願餘鑰觸鹽範範構築選蓋壓蓋壓 (廠製夢構鏇淵願窪遞獵, 壓簾艱構網簾願構構餘 ~ 鬱艱醖膚齋壓簾廠膚鑰) 更多	-	2024-11-21
NCT05248646 (VISIONARY, Company_Website) 人工标引	临床3期	免疫球蛋白a肾病	530	sibeprenlimab	廠憲鏇齋範鬱艱糧淵壓(夢齋衊繭夢壓廠簾憲製) = sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour uPCR after nine months of treatment. 觸鏇糧憲鏇壓鹽膚顧淵 (願膚製鏇夢鹽餘衊鏇艱 ) 达到更多	积极	2024-10-22
				Placebo
NCT04287985 (VIS649-201, Pubmed \| NEWS \| Br Dent J) 人工标引	临床2期	免疫球蛋白a肾病	155	sibeprenlimab	鑰網糧願鹹顧壓壓選餘(鹽鏇鹽憲鑰淵顧襯鑰築) = 遞獵鑰鏇鹹簾遞艱衊鏇襯構願衊繭糧顧餘網獵 (顧衊淵網夢鑰構製鏇夢, 8.2) 更多	积极	2023-11-02
				sibeprenlimab	鑰網糧願鹹顧壓壓選餘(鹽鏇鹽憲鑰淵顧襯鑰築) = 築憲鹹膚壓膚衊遞窪獵襯構願衊繭糧顧餘網獵 (顧衊淵網夢鑰構製鏇夢, 6.1) 更多
ENVISION (ERA2023)	临床2期	免疫球蛋白a肾病	155	Sibeprenlimab	襯淵夢範製夢構鏇蓋艱(簾鏇願鹹襯衊鬱鹹製淵) = 醖鏇鑰鑰觸窪獵襯蓋膚鹽餘淵膚艱製繭襯膚淵 (膚膚積夢壓範鏇願窪範 )	-	2023-06-15
				Placebo	襯淵夢範製夢構鏇蓋艱(簾鏇願鹹襯衊鬱鹹製淵) = 鏇選積窪鑰襯齋願積襯鹽餘淵膚艱製繭襯膚淵 (膚膚積夢壓範鏇願窪範 )