预约演示

更新于：2026-03-13

Tegoprubart

更新于：2026-03-13

概要

概要

基本信息

药物类型

单克隆抗体

别名

Anti-CD40 ligand monoclonal antibody (Eledon Pharmaceuticals)、Anti-CD40 ligand monoclonal antibody(ALS Therapy Development Institute/Eledon Pharmaceuticals)、Anti-CD40L ( ALS Therapy Development Institute)

+ [2]

靶点

CD40L

作用方式

抑制剂

作用机制

CD40L抑制剂(CD40配体抑制剂)

治疗领域

免疫系统疾病神经系统疾病内分泌与代谢疾病+ [2]

在研适应症

免疫球蛋白a肾病肾移植排斥反应肌萎缩侧索硬化+ [1]

非在研适应症

1型糖尿病

原研机构

ALS Therapy Development Foundation, Inc.

在研机构

ALS Therapy Development Foundation, Inc.

Eledon Pharmaceuticals, Inc.

非在研机构

Anelixis Therapeutics, LLC.

权益机构

CareDx, Inc.

eGenesis, Inc.

Eledon Pharmaceuticals, Inc.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床申请批准

特殊审评孤儿药 (美国)

登录后查看时间轴

结构/序列

Sequence Code 9720936L

来源: *****

Sequence Code 10205963H

来源: *****

关联

项与 Tegoprubart 相关的临床试验

NCT06305286

/ Recruiting临床1/2期IIT

A Pilot Study Assessing the Safety of Using a Monoclonal Antibody Against Cluster of Differentiation 40 (CD40) Ligand to Achieve a Calcineurin Inhibitor-free Immunosuppression Regimen in Patients With Type 1 Diabetes Mellitus (T1D) and Problematic Hypoglycemia Undergoing Islet Cell Transplantation

Tegoprubart (AT-1501) is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by the subject's immune system to attack and fight foreign substances that cause illness. Monoclonal antibodies are man-made proteins manufactured to serve as substitute antibodies to fight diseases. Monoclonal antibodies can restore, enhance, or mimic (copy) the immune system's attack process; they can also tone down the immune system. Tegoprubart (AT-1501) is thought to work by dampening down the immune system so that it will be less likely to attack the transplanted cells. For other types of transplants, like kidney, a drug called a calcineurin inhibitor is usually used to prevent rejection. That class of drugs can be toxic to islet cells. Tegoprubart (AT-1501) is an experimental agent that is anticipated to prevent rejection without harming the islet cells.

开始日期2024-03-04

申办/合作机构

The University of Chicago

[+2]

NCT06126380

/ Enrolling by invitation临床2期

AT-1501-K209: BESTOW-EXTENSION: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.

开始日期2023-10-25

申办/合作机构

Eledon Pharmaceuticals, Inc.

NCT05983770

/ Completed临床2期

AT-1501-K207: BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.

开始日期2023-08-30

申办/合作机构

Eledon Pharmaceuticals, Inc.

100 项与 Tegoprubart 相关的临床结果

登录后查看更多信息

100 项与 Tegoprubart 相关的转化医学

登录后查看更多信息

100 项与 Tegoprubart 相关的专利（医药）

登录后查看更多信息

项与 Tegoprubart 相关的文献（医药）

2025-02-01·NATURE MEDICINE

Transplantation of a genetically modified porcine heart into a live human

Article

作者: Zhang, Tianshu ; Lewis, Billeta ; Lau, Christine L ; Shah, Aakash ; Ananthram, Manjula ; Kuravi, Kasinath ; Perrin, Steve ; Grazioli, Alison ; Griffith, Bartley P ; Hershfeld, Alena ; Rothblatt, Martine ; Drachenberg, Cinthia B ; Dickfeld, Timm ; Galindo, Javier ; Ayares, David ; Mezine, Fariza ; Tamburro, Lo ; Odonkor, Patrick N ; Taylor, Bradley ; Goutaudier, Valentin ; Tully, Andy ; Wells, Chris L ; Singh, Avneesh K ; Sorrells, Lori ; Loupy, Alexandre ; Williams, Brittney ; Mohiuddin, Muhammad M ; Hicks, Albert J ; Morgand, Erwan ; Christenson, Robert H ; Feller, Erika D ; Gupta, Anuj ; Burke, Allen ; Hong, Susie N ; Strauss, Erik R ; Silverman, Henry J ; Saharia, Kapil K

Following our previous experience with cardiac xenotransplantation of a genetically modified porcine heart into a live human, we sought to achieve improved results by selecting a healthier recipient and through more sensitive donor screening for potential zoonotic pathogens. Here we transplanted a 10-gene-edited pig heart into a 58-year-old man with progressive, debilitating inotrope-dependent heart failure due to ischemic cardiomyopathy who was not a candidate for standard advanced heart failure therapies. He was maintained on a costimulation (anti-CD40L, Tegoprubart) blockade-based immunomodulatory regimen. The xenograft initially functioned well, with excellent systolic and diastolic function during the first several weeks posttransplantation. Subsequently, the xenograft developed rapidly progressing diastolic heart failure, biventricular wall thickening and, ultimately, near-complete loss of systolic function necessitating initiation of extracorporeal membranous oxygenation on day 31. Given these setbacks, the patient chose to transition to comfort care after 40 days. As with our first patient, histology did not reveal substantial immune cell infiltration but suggested capillary endothelial injury with interstitial edema and early fibrosis. No evidence of porcine cytomegalovirus replication in the xenograft was observed. Strategies to overcome the obstacle of antibody-mediated rejection are needed to advance the field of xenotransplantation.

2013-10-24·Clinical and experimental immunology3区 · 医学

Anti-CD40 ligand monoclonal antibody delays the progression of murine autoimmune cholangitis

3区 · 医学

Article

作者: Bowlus, C ; Joh, T ; Kawata, K ; Tanaka, H ; Leung, P ; Gershwin, M E ; Yang, G-X ; Knechtle, S J ; Ansari, A A ; Tsuneyama, K ; Iwakoshi, N ; Coppel, R L

Summary:

While there have been significant advances in our understanding of the autoimmune responses and the molecular nature of the target autoantigens in primary biliary cirrhosis (PBC), unfortunately these data have yet to be translated into new therapeutic agents. We have taken advantage of a unique murine model of autoimmune cholangitis in which mice expressing a dominant negative form of transforming growth factor β receptor II (dnTGFβRII), under the control of the CD4 promoter, develop an intense autoimmune cholangitis associated with serological features similar to human PBC. CD40-CD40 ligand (CD40L) is a major receptor–ligand pair that provides key signals between cells of the adaptive immune system, prompting us to determine the therapeutic potential of treating autoimmune cholangitis with anti-CD40L antibody (anti-CD40L; MR-1). Four-week-old dnTGFβRII mice were injected intraperitoneally with either anti-CD40L or control immunoglobulin (Ig)G at days 0, 2, 4 and 7 and then weekly until 12 or 24 weeks of age and monitored for the progress of serological and histological features of PBC, including rigorous definition of liver cellular infiltrates and cytokine production. Administration of anti-CD40L reduced liver inflammation significantly to 12 weeks of age. In addition, anti-CD40L initially lowered the levels of anti-mitochondrial autoantibodies (AMA), but these reductions were not sustained. These data indicate that anti-CD40L delays autoimmune cholangitis, but the effect wanes over time. Further dissection of the mechanisms involved, and defining the events that lead to the reduction in therapeutic effectiveness will be critical to determining whether such efforts can be applied to PBC.

2013-01-01·Chimerism

Toward minimal conditioning protocols for allogeneic chimerism in tolerance resistant recipients

Article

作者: David P. Al-Adra ; Colin C. Anderson

Mixed chimerism is a promising approach toward generating donor-specific immunological tolerance. However, chimerism induction can be toxic; therefore, there is an effort to develop non-myeloablative, minimal intensity protocols that can generate chimerism without the toxic side effects. Recently, with the goal of creating a minimalistic chimerism induction protocol in the tolerance resistant non-obese diabetic (NOD) mouse model, we identified pre-existing T cells as cells that resist fully allogeneic chimerism. With monoclonals targeting NOD T cells, we showed that long-term chimerism and tolerance toward donor islets could be established. However, this promising new protocol relied on the administration of a single dose of anti-CD40 ligand, which is not clinically applicable. In refining protocols to move even closer to clinical utility, we report here initial success at generating fully allogeneic mixed chimerism in NOD mice by adding cyclophosphamide to the conditioning regimen in place of anti-CD40 ligand antibodies.

113

项与 Tegoprubart 相关的新闻（医药）

2026-03-13

·BioSpace

Eledon Pharmaceuticals Announces Orphan Drug Designation Granted to Tegoprubart for the Prevention of Allograft Rejection in Liver Transplantation

March 10, 2026 -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to tegoprubart for the prevention of allograft rejection in liver transplantation. Tegoprubart has previously received orphan drug designation from the FDA for the prevention of allograft rejection in pancreatic islet cell transplantation and for the treatment of amyotrophic lateral sclerosis (ALS). “Clinical studies in kidney transplantation have demonstrated that tegoprubart has the potential to improve graft survival and function while reducing the side effects associated with calcineurin inhibitors, supporting its promise as a novel immunosuppressive therapy across multiple organ transplant settings,” said David-Alexandre C. Gros, MD, Chief Executive Officer of Eledon. “Based on the encouraging preclinical evidence we have generated to date, we believe liver transplantation represents a significant incremental opportunity for tegoprubart, and we look forward to evaluating its potential in the clinical setting through an anticipated investigator sponsored trial initiating later this year.” Orphan Drug Designation is intended to support the development of therapies for rare diseases, defined as conditions affecting fewer than 200,000 people in the United States or fewer than 5 in 10,000 individuals in the European Union. These designations provide sponsors with a range of incentives intended to encourage the development of medicines for diseases with high unmet medical needs. Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. The content above comes from the network. if any infringement, please contact us to modify.

孤儿药免疫疗法

2026-03-10

·PRNewswire

NewcelX Announces Strategic Collaboration with Eledon Pharmaceuticals to Advance NCEL-101 Program for Type 1 Diabetes

March 9, 2026 -- NewcelX Ltd. ("NewcelX") (Nasdaq: NCEL), a clinical-stage company advancing stem-cell-derived therapies for Type 1 Diabetes, today announced a collaborative research agreement with Eledon Pharmaceuticals, Inc. ("Eledon") (Nasdaq: ELDN), a clinical-stage immunology company with a focus on transplant medicine. The collaboration is designed to advance combination strategies integrating NewcelX's lead program, NCEL-101, with Eledon's investigational anti-CD40L monoclonal antibody, tegoprubart (AT-1501), with the goal of supporting durable, immune-protected islet replacement and advancing a potential functional cure for Type 1 Diabetes. Eledon's tegoprubart is a next-generation anti-CD40L monoclonal antibody designed to modulate immune activation pathways central to T-cell–mediated transplant rejection. The collaboration leverages clinical experience from over 100 transplant patients treated with tegoprubart, including patients in kidney, heart and diabetes-related transplant settings, developed under multiple U.S. Food and Drug Administration–cleared Investigational New Drug (IND) applications. This extensive transplant experience provides clinically informed insights and data relevant to cell replacement therapies, and could potentially lead to a clearer regulatory pathway for NCEL-101 while streamlining the development program. Integrating targeted immune modulation with NCEL-101 is intended to support durable graft survival comparable to outcomes observed with donor human islets (see press release link). Importantly, NCEL-101 remains NewcelX's core therapeutic product, designed to address the shortage of functional insulin-producing cells through scalable, off-the-shelf manufacturing. The immune modulation component is intended to enhance durability and graft survival of the cells. Professor Michel Revel, MD, PhD, CSO of NewcelX: "The collaboration marks an important strategic milestone for NewcelX, enhancing its execution-focused clinical programs and broadening collaboration with established leaders in immune biology and transplant medicine". The collaboration is anticipated to accelerate timelines, establish a well-defined regulatory pathway, and enhance development visibility, supporting NewcelX's strategy to advance its clinical programs efficiently toward pivotal milestones. Ronen Twito, Executive Chairman & CEO of NewcelX, added: "Collaborating with Eledon Pharmaceuticals represents a meaningful milestone of our product and a strategic step forward for NewcelX. Leveraging Eledon's extensive transplant experience across more than 100 procedures provides us with clinically grounded insight that potentially supports a clearer regulatory pathway and a more efficient development plan for NCEL-101. Our focus is to translate this advantage into disciplined execution and long-term shareholder value." NewcelX is an innovative biopharmaceutical company focused on developing transformative stem-cell-derived therapies for Type 1 Diabetes. Built on a validated human pluripotent stem cell (hPSC) platform, the company's lead program, NCEL-101, is designed to restore functional insulin production through scalable, off-the-shelf cell replacement. NewcelX is advancing a comprehensive therapeutic approach for Type 1 Diabetes integrating cell therapy, immune protection, and translational science to address critical unmet medical needs. The content above comes from the network. if any infringement, please contact us to modify.

免疫疗法临床研究细胞疗法

2026-03-10

·allsci.com

NewcelX, Eledon to pair stem cell therapy with CD40 mAb against type 1 diabetes

Zurich-based NewcelX Ltd. (Nasdaq: NCEL) and Irvine, California-based Eledon Pharmaceuticals, Inc. (Nasdaq: ELDN) have entered a collaborative research agreement to evaluate a combination strategy pairing NewcelX’s NCEL-101, a stem cell derived islet therapy, with Eledon’s tegoprubart (AT-1501), an anti-CD40L monoclonal antibody designed to modulate T-cell-mediated immune activation. The aim is to evaluate the pairing as a durable, immune-protected islet replacement and potential functional cure for type 1 diabetes. No financial terms linked to the deal were disclosed. The agreement is structured as a research collaboration rather than a traditional licensing arrangement. Eledon contributes clinical transplant data generated from over 100 patients treated with tegoprubart across kidney, heart, and diabetes-related transplant settings under multiple US FDA-cleared Investigational New Drug applications. NewcelX contributes NCEL-101, its lead program built on a human pluripotent stem cell platform and designed as a scalable, off-the-shelf cell replacement therapy intended to restore endogenous insulin production. Deal context NCEL-101 is a stem cell-derived islet cell therapy that aims to replace pancreatic β-cells destroyed by the autoimmune process underlying type 1 diabetes. Rather than targeting a single molecular pathway, the therapy delivers functional insulin-producing cells to restore glycemic control. Tegoprubart is a next-generation monoclonal antibody that binds CD40 ligand (CD40L/CD154), blocking its interaction with CD40 on antigen-presenting cells and thereby inhibiting downstream T-cell activation. Earlier-generation anti-CD40L antibodies were associated with thromboembolic complications; tegoprubart was designed to mitigate that risk. The rationale for the NewcelX collaboration is that pairing cell replacement with targeted immune modulation could promote durable islet graft survival without the broad immunosuppression typically required in transplant settings. NewcelX was formed through the October 2025 merger of NLS Pharmaceutics Ltd. (Switzerland) and Kadimastem Ltd. (Israel). The company’s pipeline is centered on cell therapy type 1 diabetes applications, with NCEL-101 as its lead asset. The cell therapy type 1 diabetes space has attracted substantial deal activity. Vertex Pharmaceuticals acquired Semma Therapeutics in September 2019 for approximately USD 950 million to obtain stem cell-derived islet cell therapy technology that later advanced as VX-880. Vertex subsequently acquired ViaCyte in July 2022 for approximately USD 320 million, consolidating additional islet cell programs. In 2023, Novo Nordisk entered a partnership with Aspect Biosystems valued at up to approximately USD 725 million per bioprinted stem cell-derived islet cell therapy emerging from the partnership. Of note, Lantidra (from CellTrans) is an allogeneic pancreatic islet cell therapy that received US FDA approval in 2023, becoming the first donor-derived islet cell transplant product approved for certain adults with type 1 diabetes. Also under development in the space is Vertex Pharmaceuticals’ zimislecel (formerly VX-880) — a stem cell-derived islet cell therapy in Phase I/II clinical development for type 1 diabetes Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

细胞疗法并购引进/卖出免疫疗法上市批准

100 项与 Tegoprubart 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
肾移植排斥反应	临床2期	美国	Eledon Pharmaceuticals, Inc.	2022-08-01
免疫球蛋白a肾病	临床2期	澳大利亚	Eledon Pharmaceuticals, Inc.	2022-03-21
免疫球蛋白a肾病	临床2期	克罗地亚	Eledon Pharmaceuticals, Inc.	2022-03-21
免疫球蛋白a肾病	临床2期	马来西亚	Eledon Pharmaceuticals, Inc.	2022-03-21
免疫球蛋白a肾病	临床2期	新西兰	Eledon Pharmaceuticals, Inc.	2022-03-21
免疫球蛋白a肾病	临床2期	菲律宾	Eledon Pharmaceuticals, Inc.	2022-03-21
免疫球蛋白a肾病	临床2期	波兰	Eledon Pharmaceuticals, Inc.	2022-03-21
免疫球蛋白a肾病	临床2期	西班牙	Eledon Pharmaceuticals, Inc.	2022-03-21
免疫球蛋白a肾病	临床2期	斯里兰卡	Eledon Pharmaceuticals, Inc.	2022-03-21
免疫球蛋白a肾病	临床2期	泰国	Eledon Pharmaceuticals, Inc.	2022-03-21

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04322149 (Phase 2A, Pubmed \| PLoS Med)	临床2期	肌萎缩侧索硬化 pro-inflammatory biomarkers	54	Tegoprubart	獵築積範簾鏇觸衊獵繭(鏇遞廠鑰獵廠窪鏇獵觸) = ADA titers were low and circulating levels of tegoprubart were as predicted for all cohorts 夢憲鑰憲範艱獵遞衊憲 (壓艱築網積廠選積鬱醖 ) 更多	积极	2024-10-31
NCT06305286 (Company_Website) 人工标引	临床1/2期	1型糖尿病	3	Tegoprubart + mycophenolate mofetil + islet transplants	鹹觸遞淵膚築顧淵願夢(淵築願範襯鹹艱積範繭) = 網糧艱鑰選衊鬱襯築餘鏇遞齋網蓋糧觸襯膚顧 (膚簾餘願繭糧憲壓積鏇 ) 更多	积极	2024-10-29
NCT05027906 (GlobeNewswire) 人工标引	临床1期	肾移植排斥反应	13	Tegoprubart	齋願窪壓顧鹹鬱繭餘繭(築衊繭繭鑰窪觸鑰壓製) = mean eGFR was above 60 mL/min/1.73m² at each reported time points after day 30, with an overall mean eGFR of 70.5 mL/min/1.73m² for all the reported time points after day 30 post-transplant. 繭遞顧夢鏇淵範獵蓋憲 (積選憲顧蓋襯糧遞遞糧 ) 更多	积极	2024-06-03
ASN2023 人工标引	临床1期	肾移植排斥反应	11	Tegoprubart	壓願壓糧襯衊鹹餘簾窪(遞廠構壓衊夢範糧觸膚) = One discontinued due to an SAE of BK viremia and another for mild alopecia and fatigue. BK viremia was the only SAE reported to date, and the drug appears safe and well tolerated. 蓋遞願鏇繭簾觸簾築夢 (襯餘鏇艱鏇蓋繭淵範壓 ) 更多	积极	2023-11-02
NCT04322149 (Corporate Publications) 人工标引	临床2期	肌萎缩侧索硬化	54	tegoprubart	鑰憲鏇窪顧窪鹹鹹築築(遞顧製顧齋襯鏇鹽鬱構) = 鹹膚壓窪鑰築衊鏇鑰鑰築淵積願鬱鬱夢鹹襯構 (壓築窪範簾憲範鹹願廠 ) 更多	积极	2022-05-31