DelveInsight’s latest publication, “Vasculitis Pipeline Insight, 2026” provides a detailed evaluation of the current clinical development landscape along with future growth opportunities within the Vasculitis market.
According to DelveInsight’s analysis, the global Vasculitis pipeline comprises more than 25 key companies developing over 30 therapeutic candidates. The report evaluates ongoing clinical trials, investigational therapies, mechanisms of action, routes of administration, and recent strategic developments shaping the treatment ecosystem.
The Vasculitis pipeline report delivers an extensive commercial and clinical assessment of investigational products spanning from preclinical research to marketed therapies. It offers comprehensive drug profiles covering mechanisms of action, clinical trial data, regulatory milestones including NDA approvals (where applicable), and development activities such as technology advancements, collaborations, mergers and acquisitions, funding initiatives, regulatory designations, and other product-specific insights.
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Key Insights from the Vasculitis Pipeline Report
- Companies worldwide are actively advancing innovative Vasculitis therapies, demonstrating steady clinical progress over recent years.
- Major players such as R-Pharm Overseas, AbbVie, Toleranzia, Ambulero, Visterra, CytoDyn, ChemoCentryx, Hoffmann-La Roche, GlaxoSmithKline, Vifor Pharma, Beijing Defengrei Biotechnology, InflaRx, Janssen Biotech, Novartis, Oxitope Pharma, Eli Lilly and Company, Travere Therapeutics, Caladrius Biosciences, and Yake Biotechnology are spearheading therapeutic development.
- Emerging candidates including AMB 301, BDB 1, Guselkumab, Secukinumab, and Upadacitinib are progressing through various clinical phases and are anticipated to significantly influence the Vasculitis market landscape.
- In September 2025, Amgen reported findings from a Phase III open-label, single-arm study evaluating Avacopan in combination with rituximab or cyclophosphamide-based regimens in pediatric patients aged 6 to under 18 years with active ANCA-associated vasculitis (AAV).
- In August 2025, Soligenix announced that the U.S. FDA’s Office of Orphan Products Development granted orphan drug designation to dusquetide (SGX945) for the treatment of Behçet’s Disease, following positive Phase IIa results demonstrating biological activity and safety.
- In December 2024, Q32 Bio announced a delay in the Phase II study of ADX-097 in patients with ANCA-associated vasculitis.
- Also in December 2024, Nkarta launched the Ntrust-2 clinical trial and received IND clearance for an investigator-sponsored trial assessing NKX019, its allogeneic CD19-targeted CAR-NK cell therapy, in autoimmune conditions including systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis.
- In June 2024, the U.S. FDA authorized NovelMed to initiate a Phase II trial of ruxoprubart in adults with ANCA-associated vasculitis, evaluating safety and efficacy in patients with microscopic polyangiitis, granulomatosis with polyangiitis, or kidney-limited AAV.
- In May 2024, Amgen shared Phase I data for AMG104/AZD8630, an inhaled anti-TSLP therapy for poorly controlled asthma, along with post-hoc analyses from the Phase III ADVOCATE study evaluating the safety and efficacy of TAVNEOS® (avacopan) in severe active ANCA-associated vasculitis with pulmonary involvement.
Vasculitis Overview
Vasculitis represents a group of rare inflammatory disorders characterized by inflammation of blood vessels, including arteries, veins, and capillaries. This inflammation may result in vessel wall thickening, narrowing, weakening, or scarring, potentially impairing blood flow to vital organs. Vasculitis may present as either acute or chronic and can arise as a primary autoimmune condition or secondary to infections, medications, or systemic diseases.
Common forms include Giant Cell Arteritis, Granulomatosis with Polyangiitis, Takayasu Arteritis, Polyarteritis Nodosa, and Henoch–Schönlein Purpura. Clinical manifestations vary by organ involvement but frequently include fatigue, fever, weight loss, musculoskeletal pain, dermatological symptoms, neurological complications, and respiratory issues.
Diagnosis typically involves laboratory testing (including ANCA assays), imaging modalities, tissue biopsy, and specialized assessments. Standard treatment strategies focus on corticosteroids and immunosuppressive agents to control inflammation and prevent organ damage. Early diagnosis and prompt intervention remain critical to improving patient outcomes and reducing complications.
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Emerging Vasculitis Therapies in Clinical Development
- AMB 301 – Ambulero
- BDB 1 – Beijing Defengrei Biotechnology
- Guselkumab – Janssen Biotech
- Secukinumab – Novartis
- Upadacitinib – AbbVie
Route of Administration Analysis
The pipeline report categorizes investigational therapies based on their route of administration, including:
- Oral
- Subcutaneous
- Intravenous
- Intramuscular
Molecule Type Segmentation
Vasculitis pipeline candidates are classified by molecular type, such as:
- Bispecific antibodies
- Peptides
- Small molecules
- Gene therapies
Comprehensive Vasculitis Therapeutics Assessment
The report includes:
- Evaluation by product type
- Analysis by stage of development and product category
- Assessment by route of administration
- Stage-wise segmentation by administration route
- Classification by molecule type
- Stage-wise molecule type analysis
DelveInsight’s report encompasses more than 30 therapeutic candidates across multiple development stages, including Phase III, Phase II, Phase I, preclinical, discovery-stage, inactive, and discontinued programs.
Further Vasculitis product details are provided in the report. Download the Vasculitis pipeline report to learn more about the emerging Vasculitis therapies
Vasculitis Pipeline Analysis
The report provides:
- Detailed company-wise pipeline evaluation
- Stage-based segmentation of therapeutic candidates
- Insights into active and dormant programs
- Drug analysis based on development phase, target receptor, mechanism of action, route of administration, monotherapy versus combination therapy, and molecular class
- Comprehensive review of strategic collaborations, licensing agreements, partnerships, and funding activities
The research methodology integrates proprietary databases, company disclosures, clinical trial registries, investor presentations, conference proceedings, SEC filings, and credible third-party industry sources.
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Vasculitis Pipeline Market Drivers
- Increasing disease awareness and improved diagnostic capabilities
- Growing focus on rare and orphan indications
- Advances in immunology and targeted biologic therapies
- Strong clinical research engagement from over 25 companies
- Supportive regulatory and reimbursement precedents
Vasculitis Pipeline Market Challenges
- Heterogeneous disease subtypes requiring targeted drug development
- Recruitment difficulties due to rare patient populations
- Continued reliance on off-label immunosuppressants
- Long-term safety considerations with biologics
- High therapy costs limiting accessibility in certain regions
Scope of the Vasculitis Pipeline Insight
- Coverage: Global
- Key Vasculitis Companies: R-Pharm Overseas, Abbvie, Toleranzia, Ambulero, Visterra, CytoDyn, ChemoCentryx, Hoffman-la-Roche, GlaxoSmithKline, Vifor Pharma, Beijing Defengrei Biotechnology, InflaRx, Janssen Biotech, Novartis, AbbVie, Oxitope Pharma, InflaRx, Eli Lilly and company, Toleranzia, Travere Therapeutics, Caladrius Biosciences, Caladrius Biosciences, Yake Biotechnology, and others.
- Key Vasculitis Therapies: AMB 301, BDB 1, Guselkumab, Secukinumab, Upadacitinib, and others
- Vasculitis Therapeutic Assessment: Vasculitis current marketed and Vasculitis emerging therapies
- Vasculitis Market Dynamics: Vasculitis market drivers and Vasculitis market barriers
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Table of Contents
- Introduction
- Executive Summary
- Disease Overview
- Commercial Assessment
- Pipeline Therapeutics
- Late-Stage Products
- Mid-Stage Products
- Early-Stage Products
- Preclinical Candidates
- Therapeutic Assessment
- Inactive Programs
- Collaboration Analysis
- Key Companies
- Key Products
- Unmet Needs
- Market Drivers and Barriers
- Future Outlook
- Analyst Perspectives
- Appendix
- About DelveInsight
About DelveInsight
DelveInsight is a leading life sciences-focused business consulting and market research firm. The company provides comprehensive strategic solutions to pharmaceutical and biotechnology organizations, supporting performance enhancement through data-driven insights, healthcare consulting services, and practical market intelligence to accelerate growth and address industry challenges effectively.
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