Steroid-Refractory Acute Graft-Versus-Host Disease Pipeline: Innovation Surge as New Agents Address High Mortality in Post-Transplant Complications | DelveInsight

Steroid-refractory acute graft-versus-host disease (SR-aGVHD) represents a severe and life-threatening complication of allogeneic stem cell transplantation, with limited treatment options and poor prognosis. Key companies, including MaaT Pharma, ReAlta Life Sciences, Inc., and Ironwood Pharmaceuticals, are leading the charge in developing novel therapies such as JAK inhibitors, MSC-based treatments, and cytokine-targeting agents.

DelveInsight's "Steroid-Refractory Acute Graft-Versus-Host Disease - Pipeline Insight, 2025" provides a thorough analysis of the evolving clinical pipeline and regulatory landscape. It details the mechanisms of action, clinical trials, and the progress of promising candidates poised to redefine treatment standards. The report delivers comprehensive insights into the SR-aGVHD drug pipeline across all stages of development, assessing strategic alliances, breakthrough designations, and clinical success rates. It is an essential resource for understanding future opportunities and challenges in the SR-aGVHD therapeutic landscape.

For emerging steroid-refractory acute graft-versus-host disease drugs, the steroid-refractory acute graft-versus-host disease pipeline analysis report provides a 360° view of the therapeutic landscape by development stage, product type, route of administration, molecule type, and mechanism of action (MOA). The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Steroid-Refractory Acute Graft-Versus-Host Disease Pipeline Report
• DelveInsight's steroid-refractory acute graft-versus-host disease pipeline analysis depicts a strong space with 3+ active players working to develop 4+ pipeline drugs for steroid-refractory acute graft-versus-host disease treatment.
• The leading steroid-refractory acute graft-versus-host disease companies include MaaT Pharma, ReAlta Life Sciences, Inc., Ironwood Pharmaceuticals, Wuhan Optics Valley Vcanbiopharma Co., Ltd., and others are evaluating their lead assets to improve the steroid-refractory acute graft-versus-host disease treatment landscape.
• Key steroid-refractory acute graft-versus-host disease pipeline therapies in various stages of development include MaaT013, RLS-0071, Apraglutide, VUM02, and others.
• In April 2025, Mesoblast Limited (ASX:MSB; Nasdaq:MESO) highlighted its recent activities for Q3 ending March 31, 2025. Dr. Silviu Itescu, CEO, announced the commercial availability of RYONCIL® (remestemcel-L) for pediatric acute GVHD, following FDA approval as the first MSC therapy for any indication. With a strong cash position, the company plans to expand RYONCIL®'s use to other severe pediatric inflammatory diseases and adults with acute GVHD.
• In December 2024, the FDA approved RYONCIL® (remestemcel-L-rknd), a bone marrow-derived MSC therapy for treating steroid-refractory acute GVHD in pediatric patients aged 2 months and older.
• In August 2024, ReAlta Life Sciences received Orphan Drug and Fast Track Designations from the FDA for RLS-0071, its lead candidate, to treat steroid-refractory acute GVHD in hospitalized patients.

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Steroid-Refractory Acute Graft-Versus-Host Disease Overview
Steroid-refractory acute graft-versus-host disease (SR-aGVHD) is a severe complication following allogeneic stem cell transplantation, occurring in 35-50% of patients and associated with poor prognosis, including a 6-month survival rate of about 49%. Despite some partial responses to alternative immunosuppressive treatments, long-term survival remains rare, making SR-aGVHD a major cause of post-transplant morbidity and mortality. Research continues to focus on developing targeted therapies to improve outcomes.

SR-aGVHD progresses through three phases: initial tissue damage from conditioning treatments triggers inflammation; donor-derived T cells are activated and migrate to target organs; immune cells cause tissue damage through apoptosis. The pathophysiology of SR-aGVHD is less understood, with refractory cases continuing to experience organ damage despite T-cell targeting, indicated by elevated cytokeratin-18 fragments.

Diagnosis involves clinical evaluation, grading using the modified Glucksberg staging system, and biopsy of affected tissues (e.g., skin, liver). SR-aGVHD is defined by disease progression or lack of response to steroids within a few days.

Treatment options for SR-aGVHD are limited. Ruxolitinib, a Janus kinase inhibitor, has shown promise in clinical trials and has seen growing adoption, contributing to rising ruxolitinib sales. Emerging therapies such as mesenchymal stromal cell (MSC) therapy are also being explored. However, the survival rate remains low, underscoring the urgent need for more effective treatments. Management is typically individualized, considering disease progression, patient characteristics, and potential side effects.

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Steroid Refractory Acute Graft-Versus-Host Disease Treatment Analysis: Drug Profile
MaaT013: MaaT Pharma
MaaT013 is a pioneering, first-in-class, pooled allogeneic microbiome therapy developed by MaaT Pharma to treat steroid-refractory acute graft-versus-host disease (SR-aGVHD). This therapy involves a standardized, carefully screened fecal microbiota preparation from multiple donors, aimed at restoring gut microbiome diversity and modulating immune responses in patients unresponsive to standard steroid treatments. MaaT013 is a donor-derived, high-richness, high-diversity microbiome ecosystem therapy containing Butycore, a group of bacterial species that produce anti-inflammatory short-chain fatty acids. The therapy has received Orphan Drug Designation from both the FDA and EMA and is currently in Phase III clinical trials for SR-aGVHD treatment.

RLS-0071: ReAlta Life Sciences, Inc.
RLS-0071 (pegtarazimod) is an investigational therapeutic developed by ReAlta Life Sciences for treating steroid-refractory acute graft-versus-host disease (SR-aGVHD). Using the company's EPICC peptide platform, RLS-0071 targets both complement and innate inflammatory pathways, offering a novel approach to this serious post-transplant complication. The drug has received Orphan Drug and Fast Track Designations from the FDA and is currently in Phase II clinical trials for SR-aGVHD.

Learn more about the novel and emerging steroid-refractory acute graft-versus-host disease pipeline therapies @ https://www.delveinsight.com/report-store/steroid-refractory-acute-graft-versus-host-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Steroid Refractory Acute Graft-Versus-Host Disease Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

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

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Intramuscular

By Molecule Type
• Monoclonal Antibody
• Peptides
• Small molecule

Scope of the Steroid-Refractory Acute Graft-Versus-Host Disease Pipeline Report
• Coverage: Global
• Key Steroid Refractory Acute Graft-Versus-Host Disease Companies: MaaT Pharma, ReAlta Life Sciences, Inc., Ironwood Pharmaceuticals, Wuhan Optics Valley Vcanbiopharma Co., Ltd., and others.
• Key Steroid Refractory Acute Graft-Versus-Host Disease Pipeline Therapies: MaaT013, RLS-0071, Apraglutide, VUM02, and others.

Dive deep into rich insights for drugs used for steroid-refractory acute graft-versus-host disease treatment; visit @ https://www.delveinsight.com/report-store/steroid-refractory-acute-graft-versus-host-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Steroid-Refractory Acute Graft-Versus-Host Disease Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Steroid-Refractory Acute Graft-Versus-Host Disease Pipeline Therapeutics
6. Steroid Refractory Acute Graft-Versus-Host Disease Pipeline: Late-Stage Products (Phase III)
7. Steroid Refractory Acute Graft-Versus-Host Disease Pipeline: Mid-Stage Products (Phase II)
8. Steroid Refractory Acute Graft-Versus-Host Disease Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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Jatin Vimal
jvimal@delveinsight.com
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Healthcare Consulting
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About DelveInsight
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This release was published on openPR.