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Last update 13 Mar 2026

Tegoprubart

Last update 13 Mar 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

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]

Target

CD40L

Action

inhibitors

Mechanism

CD40L inhibitors(CD40 ligand inhibitors)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesEndocrinology and Metabolic Disease+ [2]

Active Indication

Glomerulonephritis, IGARenal transplant rejectionAmyotrophic Lateral Sclerosis+ [1]

Inactive Indication

Diabetes Mellitus, Type 1

Originator Organization

ALS Therapy Development Foundation, Inc.

Active Organization

ALS Therapy Development Foundation, Inc.

Eledon Pharmaceuticals, Inc.

Inactive Organization

Anelixis Therapeutics, LLC.

License Organization

CareDx, Inc.

eGenesis, Inc.

Eledon Pharmaceuticals, Inc.

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (United States)

Structure/Sequence

Sequence Code 9720936L

Source: *****

Sequence Code 10205963H

Source: *****

Clinical Trials associated with Tegoprubart

NCT06305286

/ RecruitingPhase 1/2IIT

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.

Start Date04 Mar 2024

Sponsor / Collaborator

The University of Chicago

[+2]

NCT06126380

/ Enrolling by invitationPhase 2

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.

Start Date25 Oct 2023

Sponsor / Collaborator

Eledon Pharmaceuticals, Inc.

NCT05983770

/ CompletedPhase 2

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.

Start Date30 Aug 2023

Sponsor / Collaborator

Eledon Pharmaceuticals, Inc.

100 Clinical Results associated with Tegoprubart

100 Translational Medicine associated with Tegoprubart

100 Patents (Medical) associated with Tegoprubart

Literatures (Medical) associated with Tegoprubart

01 Apr 2025·Current Opinion in Organ Transplantation

Costimulation blockade: the next generation

Review

Author: Yakubu, Idris ; Sterling, Sara ; Moinuddin, Irfan ; Brown, Andrew ; Kumar, Dhiren ; Sinhmar, Pawan

Purpose of review:

Calcineurin inhibitors (CNIs) are central to immunosuppression in kidney transplantation (KT), improving short-term outcomes but falling short in enhancing long-term outcomes due to cardiovascular, metabolic, and renal complications. Belatacept, an FDA-approved costimulation blocker, offers a less toxic alternative to CNIs but is limited by its intravenous administration and reduced efficacy in high-immunological-risk patients.

Recent findings:

Emerging therapies target more specific pathways to improve efficacy and accessibility. Abatacept, a first-generation cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) immunoglobulin, has shown favorable outcomes in small studies. VEL-101 and Lulizumab selectively block CD28 while preserving CTLA-4 signaling, showing promise in early trials. In the CD40/CD40L pathway, results have been mixed. Iscalimab (CD40 antibody) was inferior to tacrolimus in Phase 2 trials, and Bleselumab (CD40 antibody) showed variable rejection rates despite being noninferior to tacrolimus. CD40L-targeting agents such as TNX-1500, Tegoprubart, and Dazodalibep have demonstrated promising efficacy and safety in rejection prophylaxis.

Summary:

The focus in transplantation is shifting toward safer, long-term therapies with greater accessibility. Investigational agents with subcutaneous delivery methods could overcome logistical challenges, improve adherence, and redefine posttransplant care. These advancements in costimulation blockade may enhance long-term graft survival and transform the management of KT recipients.

01 Feb 2025·NATURE MEDICINE

Transplantation of a genetically modified porcine heart into a live human

Article

Author: Zhang, Tianshu ; Lewis, Billeta ; Lau, Christine L ; Shah, Aakash ; Ananthram, Manjula ; Perrin, Steve ; Kuravi, Kasinath ; Grazioli, Alison ; Griffith, Bartley P ; Rothblatt, Martine ; Hershfeld, Alena ; Drachenberg, Cinthia B ; Dickfeld, Timm ; Galindo, Javier ; Ayares, David ; Mezine, Fariza ; Tamburro, Lo ; Odonkor, Patrick N ; Goutaudier, Valentin ; Taylor, Bradley ; 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 ; Saharia, Kapil K ; Silverman, Henry J

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.

17 Mar 2022·BloodQ1 · MEDICINE

A CD45-targeted antibody-drug conjugate successfully conditions for allogeneic hematopoietic stem cell transplantation in mice

Q1 · MEDICINE

Article

Author: Clark, Nicholas ; Bhattarai, Prashant ; Kiem, Hans-Peter ; Palchaudhuri, Rahul ; Wagner, John E. ; MacMillan, Margaret L. ; Hammond, Katelyn ; Proctor, Jennifer ; Olson, Lisa M. ; Saha, Asim ; Lamothe, Tahirih ; Panoskaltsis-Mortari, Angela ; Riddle, Megan J. ; Lanieri, Leanne ; Gillard, Geoffrey O. ; Blazar, Bruce R. ; Hyzy, Sharon

Abstract:

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment of patients with nonmalignant or malignant blood disorders. Its success has been limited by graft-versus-host disease (GVHD). Current systemic nontargeted conditioning regimens mediate tissue injury and potentially incite and amplify GVHD, limiting the use of this potentially curative treatment beyond malignant disorders. Minimizing systemic nontargeted conditioning while achieving alloengraftment without global immune suppression is highly desirable. Antibody-drug-conjugates (ADCs) targeting hematopoietic cells can specifically deplete host stem and immune cells and enable alloengraftment. We report an anti-mouse CD45-targeted-ADC (CD45-ADC) that facilitates stable murine multilineage donor cell engraftment. Conditioning with CD45-ADC (3 mg/kg) was effective as a single agent in both congenic and minor-mismatch transplant models resulting in full donor chimerism comparable to lethal total body irradiation (TBI). In an MHC-disparate allo-HSCT model, pretransplant CD45-ADC (3 mg/kg) combined with low-dose TBI (150 cGy) and a short course of costimulatory blockade with anti-CD40 ligand antibody enabled 89% of recipients to achieve stable alloengraftment (mean value: 72%). When CD45-ADC was combined with pretransplant TBI (50 cGy) and posttransplant rapamycin, cyclophosphamide (Cytoxan), or a JAK inhibitor, 90% to 100% of recipients achieved stable chimerism (mean: 77%, 59%, 78%, respectively). At a higher dose (5 mg/kg), CD45-ADC as a single agent was sufficient for rapid, high-level multilineage chimerism sustained through the 22 weeks observation period. Therefore, CD45-ADC has the potential utility to confer the benefit of fully myeloablative conditioning but with substantially reduced toxicity when given as a single agent or at lower doses in conjunction with reduced-intensity conditioning.

103

News (Medical) associated with Tegoprubart

13 Mar 2026

·www.biospace.com

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.

Orphan DrugImmunotherapy

10 Mar 2026

·www.prnewswire.com

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.

ImmunotherapyClinical StudyCell Therapy

10 Mar 2026

·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

Cell TherapyAcquisitionLicense out/inImmunotherapyDrug Approval

100 Deals associated with Tegoprubart

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Renal transplant rejection	Phase 2	United States	Eledon Pharmaceuticals, Inc.	01 Aug 2022
Glomerulonephritis, IGA	Phase 2	Australia	Eledon Pharmaceuticals, Inc.	21 Mar 2022
Glomerulonephritis, IGA	Phase 2	Croatia	Eledon Pharmaceuticals, Inc.	21 Mar 2022
Glomerulonephritis, IGA	Phase 2	Malaysia	Eledon Pharmaceuticals, Inc.	21 Mar 2022
Glomerulonephritis, IGA	Phase 2	New Zealand	Eledon Pharmaceuticals, Inc.	21 Mar 2022
Glomerulonephritis, IGA	Phase 2	Philippines	Eledon Pharmaceuticals, Inc.	21 Mar 2022
Glomerulonephritis, IGA	Phase 2	Poland	Eledon Pharmaceuticals, Inc.	21 Mar 2022
Glomerulonephritis, IGA	Phase 2	Spain	Eledon Pharmaceuticals, Inc.	21 Mar 2022
Glomerulonephritis, IGA	Phase 2	Sri Lanka	Eledon Pharmaceuticals, Inc.	21 Mar 2022
Glomerulonephritis, IGA	Phase 2	Thailand	Eledon Pharmaceuticals, Inc.	21 Mar 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04322149 (Phase 2A, Pubmed \| PLoS Med)	Phase 2	Amyotrophic Lateral Sclerosis pro-inflammatory biomarkers	54	Tegoprubart	diqzznvxlx(ityviwoydg) = ADA titers were low and circulating levels of tegoprubart were as predicted for all cohorts dvxbskanza (puwllxsrwo ) View more	Positive	31 Oct 2024
NCT06305286 (Company_Website) Manual	Phase 1/2	Diabetes Mellitus, Type 1	3	Tegoprubart + mycophenolate mofetil + islet transplants	jginlyrcnx(ohqucludwp) = czegjxmwuv ynxesbrlyp (qlfxwvesvw ) View more	Positive	29 Oct 2024
NCT05027906 (GlobeNewswire) Manual	Phase 1	Renal transplant rejection	13	Tegoprubart	weyinsxxdy(lcypfsuyvz) = 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. osdbgljeik (prlkbbaxdo ) View more	Positive	03 Jun 2024
ASN2023 Manual	Phase 1	Renal transplant rejection	11	Tegoprubart	ewwxcsqxcg(awmlkzjyvs) = 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. cdytlfnscp (pdrstfevya ) View more	Positive	02 Nov 2023
NCT04322149 (Corporate Publications) Manual	Phase 2	Amyotrophic Lateral Sclerosis	54	tegoprubart	jwgrxkglrd(izfrgcfzkv) = oxnsfmdwbe lwdaiyupsw (cfgaujzlik ) View more	Positive	31 May 2022

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