Acute Graft-versus-Host Disease Pipeline Analysis

DelveInsight’s, “Acute Graft-versus-Host Disease - Pipeline Insight, 2025” report provides comprehensive insights about 4+ companies and 6+ pipeline drugs in Acute Graft-versus-Host Disease pipeline landscape. It covers the 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.

 

Geography Covered

• Global coverage

 

Acute Graft-versus-Host Disease: Understanding

Acute Graft-versus-Host Disease: Overview

Acute graft-versus-host disease (aGVHD) is a complication that occurs after allogeneic hematopoietic stem cell transplantation (HSCT), where donor immune cells attack the recipient's tissues. It affects approximately 35%–50% of HSCT recipients, with symptoms involving the skin, liver, and gastrointestinal tract. The condition is diagnosed clinically and may require biopsies to differentiate it from other conditions like viral infections or drug reactions. Treatment typically involves immunosuppressive therapy, such as methylprednisolone, with second-line treatments available for cases that do not respond. Patients with severe aGVHD (grade III/IV) tend to have a poor prognosis, and about half of them will eventually develop chronic GVHD.

 

Graft-versus-host disease (GVHD) occurs when donor immune cells attack the recipient's tissues after stem cell or bone marrow transplantation. The immune system's ability to distinguish self from nonself cells, primarily through histocompatibility genes, plays a central role in this process. Donor T-cells recognize the recipient's MHC proteins as foreign, triggering an immune response that damages tissues. The pathogenesis of GVHD is divided into three phases: the afferent phase (where preparative chemotherapy or radiation damages host tissue and activates antigen-presenting cells), the efferent phase (where donor T-cells proliferate and release inflammatory cytokines), and the effector phase (where cytotoxic T lymphocytes and natural killer cells cause tissue damage and multiorgan failure). Key cytokines like IL-2, TNF-α, IL-6, and IFN-γ contribute to the inflammation and tissue destruction characteristic of GVHD, making them targets for potential therapeutic interventions.

 

Acute graft-versus-host disease (aGVHD) typically presents with symptoms like skin rash, often starting as red, itchy patches that may progress to blisters or peeling. Gastrointestinal issues such as diarrhea, abdominal pain, and nausea are common, and liver involvement can lead to jaundice and elevated liver enzymes. In severe cases, systemic symptoms like fever, fatigue, and weight loss can occur. Prompt recognition and treatment are crucial to managing the disease. The severity of aGVHD is often classified into stages, with higher stages indicating more intense organ damage. Early intervention can significantly improve patient outcomes, preventing long-term complications. Close monitoring of transplant recipients is essential for detecting the onset of aGVHD. Immunosuppressive therapies, including corticosteroids, are commonly used to manage the condition. The disease can vary in severity, making individualized treatment strategies important. Without proper management, aGVHD can lead to life-threatening organ damage. 

 

All patients undergoing hematopoietic cell transplantation should receive prophylactic treatment for graft-versus-host disease (GVHD), typically involving a combination of cyclosporine and methotrexate (MTX) for several months post-transplant. Additional antibacterial, antiviral, and antifungal prophylaxis are often used to reduce infection risk. Treatment for GVHD depends on symptom severity and the organs involved, with corticosteroids being the most common first-line therapy. Grade 1 GVHD is usually managed with topical steroids, while grade 2 or higher requires systemic steroids, often methylprednisolone. For gastrointestinal involvement, nonabsorbable corticosteroids like budesonide are more effective. Steroids should be tapered gradually over time to prevent flares, and chronic GVHD may require prolonged steroid use or additional agents like mycophenolate, etanercept, and monoclonal antibodies. Cyclosporine may be added to help reduce steroid dosage and duration.

 

"Acute Graft-versus-Host Disease- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Acute Graft-versus-Host Disease pipeline landscape is provided which includes the disease overview and Acute Graft-versus-Host Disease treatment guidelines. The assessment part of the report embraces, in depth Acute Graft-versus-Host Disease commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Acute Graft-versus-Host Disease collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

 

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Acute Graft-versus-Host Disease R&D. The therapies under development are focused on novel approaches to treat/improve Acute Graft-versus-Host Disease.

 

Acute Graft-versus-Host Disease Emerging Drugs Chapters

This segment of the Acute Graft-versus-Host Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

 

Acute Graft-versus-Host Disease Emerging Drugs

• 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 binds to CD6 which modulates T-lymphocyte activation and proliferation. Itolizumab has also been granted Fast Track designation and Orphan Drug designation by the the US Food and Drug Administration (FDA) for the treatment of acute graft-versus-host disease (aGVHD). The drug is currently in Phase III clinical development for the treatment of acute graft-versus-host disease (aGVHD).

 

• RGI-2001: Regimmune Corporation

RGI-2001, is a liposomal formulation of an alpha-galactosylceramide (alpha-GalCer) analog. Alpha-GalCer is a ligand for CD1d expressed on antigen presenting cells and invariant NKT cells. It was discovered that a liposomal alpha-GalCer promotes tolerogenic immune cascade, resulting in the activation and expansion of Tregs. In animal studies, RGI-2001 demonstrated to prolong the survival of mice with MHC-fully mismatched bone marrow transplantation without compromising graft-versus-leukemia (GvL) effect or immune responses to third-party antigens. RGI-2001 has also been granted an Orphan Drug Designation by the USFDA to prevent aGvHD.  Currently, the drug is in Phase II stage of its development for the treatment of Acute Graft-versus-Host Disease.

Further product details are provided in the report……..

 

Acute Graft-versus-Host Disease: Therapeutic Assessment

This segment of the report provides insights about the different Acute Graft-versus-Host Disease drugs segregated based on following parameters that define the scope of the report, such as:

 

 Major  Players in Acute Graft-versus-Host Disease

There are approx. 4+ key companies which are developing the therapies for Acute Graft-versus-Host Disease. The companies which have their Acute Graft-versus-Host Disease drug candidates in the most advanced stage, i.e. Phase III include, Equillium.

 

Phases

DelveInsight’s report covers around 6+ products under different phases of clinical development like

• 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

 

Route of Administration

Acute Graft-versus-Host Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as 

• Oral
• Intravenous
• Subcutaneous
• Parenteral 
• Topical

 

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer 
• Gene therapy

 

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

 

Acute Graft-versus-Host Disease: Pipeline Development Activities 

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Acute Graft-versus-Host Disease therapeutic drugs key players involved in developing key drugs. 

 

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Acute Graft-versus-Host Disease drugs.

 

Acute Graft-versus-Host Disease Report Insights

• Acute Graft-versus-Host Disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

 

Acute Graft-versus-Host Disease Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

 

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Acute Graft-versus-Host Disease drugs?
• How many Acute Graft-versus-Host Disease drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Acute Graft-versus-Host Disease?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Acute Graft-versus-Host Disease therapeutics? 
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? 
• What are the clinical studies going on for Acute Graft-versus-Host Disease and their status?
• What are the key designations that have been granted to the emerging drugs?