DelveInsight’s “IgG4-Related Disease – Pipeline Insight, 2025” report sheds light on a dynamic and rapidly evolving pipeline, featuring over 10 key investigational therapies that target the underlying B-cell-driven pathogenesis and fibrotic mechanisms of the disease. The field is shifting toward precision immunotherapy, focusing on therapies that offer durable remission while minimizing immunosuppressive toxicity.
Leading the innovation are companies such as Zenas BioPharma, Horizon Therapeutics (Amgen), Kyverna Therapeutics, and Sanofi, developing therapies that include anti-CD19/CD20 monoclonal antibodies, BTK inhibitors, and novel T-cell directed therapies. Zenas BioPharma’s obexelimab (XmAb5871), a bispecific antibody targeting CD19 and FcγRIIb, has emerged as a promising candidate in mid- to late-stage trials, demonstrating potential to control disease activity without the broad immunosuppression of corticosteroids.
Other investigational approaches are exploring the modulation of fibrosis-related pathways and long-lived plasma cells, which play a central role in IgG4-RD pathology. These strategies highlight a transition from symptomatic relief to disease modification, with the goal of halting progression and preserving organ function.
DelveInsight’s comprehensive report provides detailed insights into the mechanisms of action, clinical trial landscapes, development timelines, regulatory milestones, and the competitive environment shaping the future of IgG4-RD treatment. With increasing disease awareness and the growing availability of biologics and targeted therapies, the IgG4-RD market is poised for significant advancement, offering renewed hope for long-term disease control and improved quality of life.
Interested in learning more about the current treatment landscape and the key drivers shaping the IgG4-Related Disease pipeline? Dive in now!
Key Takeaways from the IgG4-Related Disease Pipeline Report
• DelveInsight’s IgG4-Related Disease pipeline analysis depicts a strong space with 10+ active players working to develop 10+ pipeline drugs for IgG4-Related Disease treatment.
• The leading IgG4-Related Disease companies include Amgen, Sanofi, Zenas Biopharma, Bristol-Myers Squibb, and others, which are evaluating their lead assets to improve the IgG4-Related Disease treatment landscape.
• Key IgG4-Related Disease pipeline therapies in various stages of development include Inebilizumab, Rilzabrutinib, Obexelimab, Abatacept, and others.
• In April 2025, IgG4-related disease (IgG4-RD), a systemic fibroinflammatory condition, was highlighted for its impact on various organs, including the pancreas, kidneys, lungs, and more. The disease is characterized by the accumulation of IgG4-positive plasma cells in tissues and elevated blood IgG4 levels.
• In April 2025, Amgen announced FDA approval of UPLIZNA, the first treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition affecting multiple organs. The drug received Breakthrough Therapy Designation for addressing this serious unmet need.
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IgG4-Related Disease Overview
IgG4-Related Disease (IgG4-RD) is a chronic, immune-mediated fibroinflammatory condition characterized by the infiltration of IgG4-positive plasma cells into various tissues and organs. It can affect virtually any organ system, commonly involving the pancreas (autoimmune pancreatitis), salivary glands, lymph nodes, kidneys, and lungs. The disease often presents with tumor-like swelling, organ dysfunction, and fibrosis.
The exact cause of IgG4-RD remains unclear, but it is believed to result from an abnormal immune response. Patients typically exhibit elevated serum IgG4 levels, although diagnosis relies on a combination of clinical presentation, imaging, histopathology, and laboratory findings.
Treatment usually involves corticosteroids as first-line therapy, often leading to rapid improvement. However, relapse is common, and immunosuppressive agents or B-cell depleting therapies such as rituximab are increasingly used to maintain remission and manage refractory cases.
IgG4-Related Disease Treatment Analysis: Drug Profile
Inebilizumab: Amgen
Inebilizumab is a humanized monoclonal antibody that selectively targets and depletes CD19-expressing B cells through antibody-dependent cell-mediated cytotoxicity. It was first approved in the United States in June 2020 for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are seropositive for aquaporin-4 immunoglobulin G autoantibodies (AQP4-IgG). Currently, inebilizumab is being investigated in Phase III clinical trials for its potential use in treating IgG4-Related Disease.
Rilzabrutinib: Sanofi
Rilzabrutinib is an oral, reversible, covalent inhibitor of Bruton’s tyrosine kinase (BTK) with the potential to become a first- or best-in-class therapy for various immune-mediated conditions. It is presently under evaluation in Phase II clinical trials for the treatment of patients with IgG4-Related Disease.
Discover the emerging therapies transforming IgG4-Related Disease treatment here: https://www.delveinsight.com/sample-request/igg4-related-disease-pipeline-insight
IgG4-Related 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
• Intravenous
• Subcutaneous
• Oral
• Intramuscular
By Molecule Type
• Monoclonal antibody
• Small molecule
• Peptide
Scope of the IgG4-Related Disease Pipeline Report
• Coverage: Global
• Key IgG4-Related Disease Companies: Amgen, Sanofi, Zenas Biopharma, Bristol-Myers Squibb, and others.
• Key IgG4-Related Disease Pipeline Therapies: Inebilizumab, Rilzabrutinib, Obexelimab, Abatacept, and others.
Take a deep dive into key insights on leading and emerging therapies for IgG4-Related Disease!
Table of Contents
1. Introduction
2. Executive Summary
3. IgG4-Related Disease Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. IgG4-Related Disease Pipeline Therapeutics
6. IgG4-Related Disease Pipeline: Late-Stage Products (Phase III)
7. IgG4-Related Disease Pipeline: Mid-Stage Products (Phase II)
8. IgG4-Related 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
About DelveInsight
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