As Acute Graft-versus-Host Disease (aGvHD) becomes increasingly prevalent worldwide and contributes to comorbidities such as diabetes, cardiovascular disease, and certain cancers, there is a growing need for safer and more effective therapies. DelveInsight reports that over 4 pharmaceutical and biotech companies are actively developing more than 6 therapeutic candidates targeting aGvHD. These therapies are in various stages of clinical and preclinical development, highlighting significant innovation and commitment to tackling this critical health challenge.
The “Acute Graft-versus-Host Disease Pipeline Insight 2025” report from DelveInsight provides a comprehensive strategic analysis of the R&D landscape, including clinical trial progress, emerging therapies, mechanisms of action, competitive positioning, and key company initiatives. It serves as a vital resource for researchers, healthcare investors, and decision-makers seeking insights into the evolving aGvHD therapeutics market and the innovations shaping its future.
Explore the Cutting-Edge Landscape of Acute Graft-versus-Host Disease Drug Development
Key Takeaways from the Acute Graft-versus-Host Disease Pipeline Report
DelveInsight’s Acute Graft-versus-Host Disease (aGvHD) pipeline report highlights a dynamic landscape with over 4 active companies developing more than 6 therapeutic candidates for aGvHD treatment.
Key updates in 2025 include:
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April 2025: The FDA declined Breakthrough Therapy designation for Itolizumab, pausing its development pathway in acute GVHD.
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January 2025: The FDA approved Ryoncil for the treatment of steroid-refractory acute GVHD following allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Leading companies such as Equillium, Regimmune Corporation, MaaT Pharma, ReAlta Life Sciences, and others are actively developing new therapies to enhance the aGvHD treatment landscape.
Promising pipeline candidates in various stages of development include Itolizumab, RGI-2001, and others.
Acute Graft-versus-Host Disease Overview:
Acute Graft-versus-Host Disease (aGVHD) is a serious post-transplant complication that occurs after allogeneic hematopoietic stem cell transplantation (HSCT), in which the donor’s immune cells attack the recipient’s tissues. It affects 35–50% of transplant patients, often targeting multiple organs.
Diagnosis is primarily clinical, though biopsies may be required to differentiate aGVHD from infections or drug-related reactions. The standard treatment involves immunosuppressive therapy, typically starting with methylprednisolone, while second-line treatments are used for steroid-refractory cases. Patients with severe (grade III/IV) aGVHD generally have poor outcomes, and approximately half may later develop chronic GVHD.
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Acute Graft-versus-Host Disease Pipeline Analysis
The Acute Graft-versus-Host Disease pipeline insights report 2025, provides insights into:
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Provides comprehensive insights into key companies developing therapies in the Acute Graft-versus-Host Disease Market.
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Categorizes Acute Graft-versus-Host Disease therapeutic companies by development stage: early, mid, and late-stage.
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Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.
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Reviews emerging Acute Graft-versus-Host Disease drugs under development based on:
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Stage of development
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Acute Graft-versus-Host Disease Route of administration
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Target receptor
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Monotherapy vs. combination therapy
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Acute Graft-versus-Host Disease Mechanism of action
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Molecular type
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Offers detailed analysis of:
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Company-to-company and company-academia collaborations
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Acute Graft-versus-Host Disease Licensing agreements
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Funding and investment activities supporting future Acute Graft-versus-Host Disease market advancement.
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Unlock key insights into emerging Acute Graft-versus-Host Disease therapies and market strategies here: https://www.delveinsight.com/report-store/acute-graft-versus-host-disease-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Acute Graft-versus-Host Disease Emerging Drugs
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Itolizumab: Equillium
Itolizumab is an experimental monoclonal antibody in Phase III clinical trials for treating acute graft-versus-host disease (aGVHD). As a first-in-class therapy, it selectively targets the CD6-ALCAM signaling pathway, which plays a crucial role in controlling T-cell activation and migration, central to many immune-mediated inflammatory conditions.
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RGI-2001: Regimmune Corporation
RGI-2001, developed by Regimmune Corporation, is an investigational therapy designed as a liposomal form of alpha-galactosylceramide (α-GalCer). The compound interacts with CD1d, a molecule present on antigen-presenting cells and invariant natural killer T (iNKT) cells.
Acute Graft-versus-Host Disease Pipeline Therapeutic Assessment
Acute Graft-versus-Host Disease Assessment by Product Type
• Mono
• Combination
• Mono/Combination
Acute Graft-versus-Host Disease By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
Acute Graft-versus-Host Disease Assessment by Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
Acute Graft-versus-Host Disease Assessment by Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
Download sample pages to get an in-depth assessment of the emerging Acute Graft-versus-Host Disease therapies and key Acute Graft-versus-Host Disease companies
Table of Contents
1. Report Introduction
2. Executive Summary
3. Acute Graft-versus-Host Disease Current Treatment Patterns
4. Acute Graft-versus-Host Disease – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
6. Acute Graft-versus-Host Disease Late-Stage Products (Phase-III)
7. Acute Graft-versus-Host Disease Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Acute Graft-versus-Host Disease Discontinued Products
13. Acute Graft-versus-Host Disease Product Profiles
14. Acute Graft-versus-Host Disease Key Companies
15. Acute Graft-versus-Host Disease Key Products
16. Dormant and Discontinued Products
17. Acute Graft-versus-Host Disease Unmet Needs
18. Acute Graft-versus-Host Disease Future Perspectives
19. Acute Graft-versus-Host Disease Analyst Review
20. Appendix
21. Report Methodology
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