Graft versus Host Disease Clinical Trial Pipeline Accelerates as 45+ Pharma Companies Rigorously Develop Drugs for Market Entry | DelveInsight

DelveInsight's, "Graft versus host disease Pipeline Insight 2025" report provides comprehensive insights about 45+ Graft Versus Host Disease Companies and 50+ pipeline drugs in Graft versus host disease pipeline landscape. It covers the Graft Versus Host Disease pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Graft Versus Host Disease Pipeline Report
• On 07 November 2025, Incyte Corporation conducted a study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
• On 05 November 2025, Fred Hutchinson Cancer Center announced a phase II trial studies how well acalabrutinib works in treating patients with chronic graft versus host disease. Acalabrutinib may be an effective treatment for graft-versus-host disease caused by a stem cell transplant.
• On 04 November 2025, CSL Behring conducted a study is a phase 2 / 3 prospective, double-blind, randomized, multicenter, placebo-controlled study for prevention of acute GVHD (aGVHD) in participants undergoing an unrelated (matched or single allele mismatched) or matched related allogeneic hematopoietic cell transplantation (HCT).
• DelveInsight's Graft Versus Host Disease pipeline report depicts a robust space with 45+ active players working to develop 50+ pipeline therapies for Graft Versus Host Disease treatment.
• The leading Graft Versus Host Disease Companies such as Abbisko Therapeutics, Equillium, Theriva Biologics, Seres Therapeutics, CytoMed Therapeutics, Beijing Tide Pharmaceutical Co., Ltd, CTI BioPharma, ViGenCell Inc., Lipella Pharmaceuticals, Cellestia Biotech, Jiangsu HengRui Medicine Therapeutics, Genentech, AltruBio, Orca Bio, GSK, Amgen and others.
• Promising Graft Versus Host Disease Therapies such as Ibrutinib, Prednisone, ruxolitinib, Axatilimab, GDC-8264, Ruxolitinib, Defibrotide, and others.

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Graft versus Host Disease Overview
Graft versus host disease (GVHD) is a serious complication that occurs when donor immune cells attack the recipient's body following an allogeneic stem cell or bone marrow transplant. This condition arises because the donor's immune cells, recognizing the recipient's cells as foreign, initiate an immune response against them. GVHD primarily involves T-cells from the donor graft and can be classified into two main types: acute and chronic. Acute GVHD typically develops within the first 100 days post-transplant, manifesting through symptoms like skin rashes, jaundice, liver enzyme abnormalities, and diarrhea. Chronic GVHD, on the other hand, occurs after 100 days and can affect multiple organs, leading to symptoms such as skin thickening, joint contractures, dry eyes, and lung dysfunction.

Graft versus host disease Emerging Drugs Profile

• Itolizumab: Equillium
Itolizumab is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab was launched in India in 2013 under the brand name ALZUMAB. Itolizumab received emergency use approval in India to treat cytokine release syndrome in COVID-19 patients with moderate to severe acute respiratory distress syndrome. The drug is currently in Phase III clinical development for the treatment of acute graft-versus-host disease (aGVHD).

• ABSK021: Abbisko Therapeutics
Pimicotinib (ABSK021), which was independently developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Abbisko is actively exploring the potential of pimicotinib in treating other indications including many types of solid tumors in clinic, and has obtained approval from NMPA to conduct a Phase II clinical study in chronic graft-versus-host disease. Currently, the drug is in the Phase II stage of its development for the treatment of Chronic Graft Versus Host Disease.

• SYN-004: Theriva Biologics
SYN-004 (ribaxamase) is an oral prophylactic therapy designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. Allogeneic HCT recipients routinely receive long courses of IV beta-lactam antibiotics to treat infection. Antibiotic-mediated damage of the gut microbiome in allogeneic HCT recipients has been strongly associated with adverse outcomes including CDI, vancomycin-resistant enterococci (VRE) colonization and potentially fatal bacteremia and aGVHD. Currently, the drug is in the Phase I/II stage of its development for the treatment of Graft versus host disease.

• SER-155: Seres Therapeutics
SER-155 is an oral, investigational therapeutic comprising a fermented consortium of commensal bacteria, specifically designed to support immunocompromised patients. Its primary mechanism of action involves augmenting crucial microbiome functions that contribute to improved survival and reduced risks of infections and graft versus host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). By leveraging insights from human clinical data, SER-155 aims to fortify the gut microbiome, enhance immune function, and protect against gastrointestinal infections and bacteremia. This multifaceted approach may offer a promising solution for patients facing the challenges of stem cell transplantation. Currently, the drug is in Phase I stage of its clinical trial for the treatment of GvHD.

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Graft Versus Host Disease Companies
Abbisko Therapeutics, Equillium, Theriva Biologics, Seres Therapeutics, CytoMed Therapeutics, Beijing Tide Pharmaceutical Co., Ltd, CTI BioPharma, ViGenCell Inc., Lipella Pharmaceuticals, Cellestia Biotech, Jiangsu HengRui Medicine Therapeutics, Genentech, AltruBio, Orca Bio, GSK, Amgen and others.

GVHD pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Graft versus host disease products have been categorized under various ROAs such as
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Graft versus host disease Products have been categorized under various Molecule types such as
• Monoclonal antibody
• Small molecule
• Peptide

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Scope of the Graft Versus Host Disease Pipeline Report
• Coverage- Global
• Graft Versus Host Disease Companies- Abbisko Therapeutics, Equillium, Theriva Biologics, Seres Therapeutics, CytoMed Therapeutics, Beijing Tide Pharmaceutical Co., Ltd, CTI BioPharma, ViGenCell Inc., Lipella Pharmaceuticals, Cellestia Biotech, Jiangsu HengRui Medicine Therapeutics, Genentech, AltruBio, Orca Bio, GSK, Amgen and others.
• Graft Versus Host Disease Therapies- Ibrutinib, Prednisone, ruxolitinib, Axatilimab, GDC-8264, Ruxolitinib, Defibrotide, and others.
• Graft Versus Host Disease Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Graft Versus Host Disease Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content
1. Introduction
2. Executive Summary
3. Graft versus host disease: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Graft versus host disease- DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. Itolizumab: Equillium
9. Drug profiles in the detailed report.....
10. Mid Stage Products (Phase II)
11. ABSK021: Abbisko Therapeutics
12. Drug profiles in the detailed report.....
13. Early Stage Products (Phase I)
14. SER-155: Seres Therapeutics
15. Drug profiles in the detailed report.....
16. Preclinical and Discovery Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report.....
19. Inactive Products
20. Graft versus host disease Key Companies
21. Graft versus host disease Key Products
22. Graft versus host disease- Unmet Needs
23. Graft versus host disease- Market Drivers and Barriers
24. Graft versus host disease- Future Perspectives and Conclusion
25. Graft versus host disease Analyst Views
26. Graft versus host disease Key Companies
27. Appendix

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