IgG4-Related Disease - Pipeline Insight, 2025

This “IgG4-Related Disease - Pipeline Insight, 2025” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in IgG4-Related 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

IgG4-Related Disease: Understanding

IgG4-Related Disease: Overview

IgG4 Related Disease (IgG4-RD) is a systemic fibroinflammatory disease characterized by dense infiltration of IgG4-positive plasma cells in the affected tissue(s) with or without elevated plasma levels of IgG4. It is a chronic-fibroinflammatory disorder affecting a wide range of organs. Elevation of serum IgG4 concentrations and abundant infiltration of IgG4-expressing plasma cells are key diagnostic features of this autoimmune disease. IgG4RD may be present in a certain proportion of patients with a wide variety of diseases, including Mikulicz’s disease, autoimmune pancreatitis, hypophysitis, Riedel thyroiditis, interstitial pneumonitis, interstitial nephritis, prostatitis, lymphadenopathy, retroperitoneal fibrosis, inflammatory aortic aneurysm, and inflammatory pseudotumor.

The signs and symptoms of the IgG4-related disease vary based on the organ that gets affected, such as pancreas, bile ducts, gallbladder, liver, thyroid gland, salivary and lacrimal glands, orbits, retroperitoneal fibrosis and large vessel involvement, intrapulmonary, mediastinal and pleural involvement, lymph nodes and kidney. While the most characteristic clinical sign of IgG4-related disease includes obstructive jaundice in the patients. There are also several clinical manifestations involved with the IgG4-RD, which include Lymphadenopathy, Autoimmune pancreatitis, IgG4-related sclerosing cholangitis, etc.

The diagnosis of IgG4-RD generally requires piecing together clues from several areas:

• Clinical findings
• Serological data
• Radiology studies
• Pathology results

Clinical findings, such as the presence of simultaneous enlargement in the lacrimal, parotid, and submandibular glands, can be a major tip-off to the presence of IgG4-RD. Another major clue to IgG4-RD is the finding of an elevated serum IgG4 concentration. Some patients have levels of IgG4 in their blood that are twenty or thirty times higher than the upper limit of normal. In a significant minority of patients, however, the serum IgG4 concentration is normal. Certain radiology features, such as the finding of a “sausage-shaped pancreas”, also strongly suggest this condition.

There are no specific drugs available that cure the disease completely as the pathophysiology of the IgG4 related disease is not clear and still under research and development. Currently, the market holds no approved therapies for patients with IgG4-related diseases. According to the recent guidelines published by “International Consensus Guidance Statement on the Management and Treatment of IgG4‐Related Disease,” which explained the criteria for determining the type of disease caused due to IgG4 levels and the treatment guidelines for the patients. The commonly used treatment options include Glucocorticoids, Immunomodulators, and Rituximab. Conventional “Disease-Modifying Anti-Rheumatic Drugs” (DMARDs) in IgG4-RD is also used for the treatment in specific cases.

"IgG4-Related Disease - Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the IgG4-Related Disease pipeline landscape is provided which includes the disease overview and IgG4-Related Disease treatment guidelines. The assessment part of the report embraces, in depth IgG4-Related 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, IgG4-Related 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 IgG4-Related Disease R&D. The therapies under development are focused on novel approaches to treat/improve IgG4-Related Disease.

IgG4-Related Disease Emerging Drugs Chapters

This segment of the IgG4-Related Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II/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.

IgG4-Related Disease Emerging Drugs

Inebilizumab: Amgen

Inebilizumab is a humanized monoclonal antibody designed to target and deplete CD19-expressing B cells. Inebilizumab targets and depletes CD19-expressing B cells through antibody-dependent cell-mediated cytotoxicity. In June 2020, inebilizumab received its first global approval in the USA for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are seropositive for immunoglobulin G autoantibodies against aquaporin-4 (AQP4-IgG). The drug is currently being evaluated under Phase III clinical trial for the treatment of patients with IgG4-Related Disease.

• Rilzabrutinib: Sanofi

Rilzabrutinib is an oral, reversible, covalent BTK inhibitor that has the potential to be a first- or best-in-class treatment of a number of immune-mediated diseases. The drug is currently being evaluated under Phase II clinical trial for the treatment of patients with IgG4-Related Disease.

IgG4-Related Disease: Therapeutic Assessment

This segment of the report provides insights about the different IgG4-Related Disease drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in IgG4-Related Disease

There are approx. 10+ key companies which are developing the therapies for IgG4-Related Disease. The companies which have their IgG4-Related Disease drug candidates in the most advanced stage, i.e. Phase III include, Amgen.

Phases

The report covers around 10+ 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

IgG4-Related 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

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

Product Type

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

IgG4-Related Disease: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses IgG4-Related 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 IgG4-Related Disease drugs.

IgG4-Related Disease Report Insights

• IgG4-Related Disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

IgG4-Related 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 IgG4-Related Disease drugs?
• How many IgG4-Related Disease drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of IgG4-Related Disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the IgG4-Related 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 IgG4-Related Disease and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Amgen
• Sanofi
• Zenas Biopharma
• Bristol-Myers Squibb

Key Products

• Inebilizumab
• Rilzabrutinib
• Obexelimab
• Abatacept

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