Vasculitis Clinical Trials Analysis 2025: Targeted Immunotherapies, Complement Inhibitors, and Novel Pathways Reshape the Landscape | DelveInsight

DelveInsight's "Vasculitis - Clinical Trials Analysis, 2025" highlights a dynamic pipeline aimed at improving remission durability and minimizing steroid dependence in this group of rare, organ-threatening autoimmune diseases. Despite existing options like rituximab and tocilizumab, relapse rates and treatment-related toxicity remain high, underscoring the need for safer, more effective therapies.

Ongoing trials are advancing next-generation B-cell-directed agents, complement pathway inhibitors, JAK/BTK inhibitors, and selective cytokine modulators. These therapies are being explored across ANCA-associated vasculitis, giant cell arteritis, Takayasu arteritis, and other subtypes, with strategies focusing on biomarker-guided patient selection, steroid-sparing regimens, and optimized maintenance therapy.

The field is shifting toward precision immunomodulation, with studies incorporating molecular profiling, imaging biomarkers, and patient-reported outcomes to demonstrate both clinical efficacy and quality-of-life benefits. With several late-stage candidates progressing, the vasculitis treatment paradigm is poised to move from broad immunosuppression toward tailored, mechanism-based approaches that prioritize organ protection and long-term remission.

Curious about the latest breakthroughs in vasculitis treatment? Discover cutting-edge drugs and the evolving pipeline-click here to explore: https://www.delveinsight.com/report-store/vasculitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Vasculitis Pipeline Report
• DelveInsight's Vasculitis Pipeline analysis depicts a robust space with 25+ active players working to develop 30+ pipeline drugs for Vasculitis treatment.
• The leading Vasculitis companies include Mitsubishi Tanabe Pharma Corporation, Yake Biotechnology Ltd., Kyverna Therapeutics, Guangdong Hengrui Pharmaceutical Co., Ltd, InflaRx GmbH, Ganzhou Hemay Pharmaceutical Co., Ltd., and others are evaluating their lead assets to improve the Vasculitis treatment landscape.
• Key Vasculitis pipeline therapies in various stages of development include MT-2990, CD19/BCMA CAR T-cells, KYV-101, SHR-1703, IFX-1, Hemay005, and others.
• In April 2025, RINVOQ (upadacitinib) was approved by the FDA for giant cell arteritis (GCA) in adults. This is the first oral JAK inhibitor for GCA, based on the Phase 3 SELECT-GCA trial, which showed sustained remission in 46.4% of patients compared to 29.0% on placebo, with a longer steroid taper.
• In September 2024, AstraZeneca's Fasenra (benralizumab) was approved in the U.S. for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare and potentially fatal vasculitis affecting multiple organs.
• In June 2024, NovelMed announced FDA clearance for its investigational drug, Ruxoprubart, to begin an efficacy trial for ANCA-associated vasculitis (AAV), a chronic autoimmune vasculitis causing inflammation in small blood vessels.
• Also in June 2024, Nkarta, Inc. initiated the Ntrust-1 clinical trial of NKX019 for lupus nephritis and received FDA clearance for a second IND for NKX019, targeting autoimmune diseases including systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), and AAV.

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Vasculitis Overview
Vasculitis is a group of rare diseases involving inflammation of blood vessels-arteries and veins-varying widely in symptoms and severity. Causes are often unknown, and it can affect all ages, though some types target specific groups, such as Kawasaki disease in children and giant cell arteritis in adults over 50. Vasculitis is classified by vessel size: large vessel (e.g., giant cell arteritis, Takayasu's arteritis), medium vessel (e.g., Kawasaki disease, polyarteritis nodosa), and diseases like Behçet's that affect vessels of various sizes. Inflammation reduces blood flow, risking damage to organs like lungs, nerves, and skin, and can lead to serious, potentially life-threatening complications.

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Vasculitis Treatment Analysis: Drug Profile
Hemay-005: Ganzhou Hemay Pharmaceutical
Hemay-005 is an investigational therapy being developed for the treatment of moderate to severe ulcerative colitis, plaque psoriasis, atopic dermatitis, Behçet's disease, and ankylosing spondylitis. The drug is administered orally in both tablet and suspension forms. It functions by targeting phosphodiesterase 4 (PDE4) and is classified as a novel small-molecule chemical entity. Currently, Hemay-005 is in Phase III clinical development for the treatment of vasculitis.

SHR-1703: Guangdong Hengrui Pharmaceutical
SHR-1703 is an injectable humanized anti-IL-5 monoclonal antibody (IgG1 subtype) designed to bind to IL-5, thereby inhibiting the IL-5/IL-5R signaling pathway. This mechanism helps suppress the proliferation, activation, and migration of eosinophils, ultimately reducing asthma exacerbations, improving lung function, and enhancing patients' quality of life. Three IL-5/IL-5R-targeting monoclonal antibodies have already received global approval: Mepolizumab (GlaxoSmithKline), Reslizumab (Teva), and Benralizumab (AstraZeneca), all indicated as additional maintenance treatments for eosinophilic granulocytic asthma. Currently, SHR-1703 is in Phase II/III clinical development for the treatment of vasculitis.

Learn more about the novel and emerging Vasculitis pipeline therapies @ https://www.delveinsight.com/report-store/vasculitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Vasculitis 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
• Parenteral
• Topical

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

Scope of the Vasculitis Pipeline Report
• Coverage: Global
• Key Vasculitis Companies: itsubishi Tanabe Pharma Corporation, Yake Biotechnology Ltd., Kyverna Therapeutics, Guangdong Hengrui Pharmaceutical Co., Ltd, InflaRx GmbH, Ganzhou Hemay Pharmaceutical Co., Ltd., and others.
• Key Vasculitis Pipeline Therapies: MT-2990, CD19/BCMA CAR T-cells, KYV-101, SHR-1703, IFX-1, Hemay005, and others.

Dive deep into rich insights for drugs used for Vasculitis treatment; visit @ https://www.delveinsight.com/report-store/vasculitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

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

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
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This release was published on openPR.