Vasculitis Clinical Trials Outlook 2025: Competitive Landscape, Regulatory Milestones, Therapies in Development, Mechanisms of Action, and Routes of Administration - By DelveInsight

(Albany, United States) "Vasculitis Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Vasculitis Market.

As per DelveInsight's assessment, globally, Vasculitis pipeline constitutes 25+ key companies continuously working towards developing 30+ Vasculitis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Vasculitis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

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Some of the key takeaways from the Vasculitis Pipeline Report:
• Vasculitis Companies across the globe are diligently working toward developing novel Vasculitis treatment therapies with a considerable amount of success over the years.
• Vasculitis companies working in the treatment market are 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 are developing therapies for the Vasculitis treatment
• Emerging Vasculitis therapies in the different phases of clinical trials are- AMB 301, BDB 1, Guselkumab, Secukinumab, Upadacitinib, and others are expected to have a significant impact on the Vasculitis market in the coming years.
• In September 2025, Amgen announced results of a Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children From 6 Years to < 18 Years of Age With Active ANCA-associated Vasculitis (AAV)
• In August 2025, Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to dusquetide, the active ingredient in SGX945, for "treatment of Behçet's Disease" following review of recent Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet's Disease.
• In December 2024, Q32 Bio delays the Phase 2 trial of ADX-097 in patients with AAV.
• In December 2024, Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company focused on developing engineered natural killer (NK) cell therapies, has announced the launch of the Ntrust-2 trial and the IND clearance for an investigator-sponsored trial (IST) to assess NKX019, Nkarta's allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy in patients with myasthenia gravis (MG). The multi-center Ntrust-2 trial will evaluate NKX019 across three cohorts, which include patients with systemic sclerosis (SSc, scleroderma), idiopathic inflammatory myopathy (IIM, myositis), and ANCA-associated vasculitis (AAV).
• In June 2024, The U.S. Food and Drug Administration (FDA) approved NovelMed to begin a Phase 2 clinical trial of its investigational antibody-based therapy, ruxoprubart, in adults with ANCA-associated vasculitis (AAV). This Phase 2 trial (NCT06226662) will assess the safety and efficacy of the therapy in up to 12 adults with microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA) - the two most common forms of AAV - or kidney-limited AAV. Enrollment is expected to begin soon.
• In May 2024, Amgen announced results from the Phase 1 study of AMG104/AZD8630, an investigational inhaled anti-TSLP therapy under evaluation for patients with poorly controlled asthma. Additionally, they shared a post-hoc analysis from the Phase 3 ADVOCATE trial, which examined the efficacy and safety of TAVNEOS® (avacopan) in patients with severe active ANCA-associated vasculitis (GPA or MPA) with lung involvement.

Vasculitis Overview
Vasculitis refers to a group of rare disorders characterized by inflammation of the blood vessels, which can affect arteries, veins, and capillaries. This inflammation can lead to thickening, weakening, narrowing, or scarring of blood vessels, potentially disrupting blood flow to vital organs and tissues. Vasculitis can be acute or chronic and may occur as a primary condition or secondary to other diseases, such as autoimmune disorders, infections, or reactions to certain medications.
There are several types of Vasculitis, including Giant Cell Arteritis, Granulomatosis with Polyangiitis, Takayasu Arteritis, Polyarteritis Nodosa, and Henoch-Schönlein Purpura, among others. Symptoms vary depending on the organs involved but commonly include fatigue, fever, weight loss, muscle and joint pain, and specific signs related to organ damage, such as rashes, numbness, or breathing issues.
Diagnosis of Vasculitis typically involves blood tests, imaging studies, biopsy of affected tissue, and other specialized tests. Treatment depends on the type and severity of the condition but generally includes corticosteroids and immunosuppressive medications to reduce inflammation and prevent further damage. Early detection and prompt management are crucial in improving outcomes and preventing serious complications related to Vasculitis.

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Emerging Vasculitis Drugs Under Different Phases of Clinical Development Include:
• AMB 301: Ambulero
• BDB 1:Beijing Defengrei Biotechnology
• Guselkumab: Janssen Biotech
• Secukinumab: Novartis
• Upadacitinib: AbbVie

Vasculitis Route of Administration
Vasculitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
• Oral
• Subcutaneous
• Intravenous
• Intramuscular

Vasculitis Molecule Type
Vasculitis Products have been categorized under various Molecule types, such as
• Bispecific Antibody
• Peptides
• Small molecule
• Gene therapy

Vasculitis Pipeline Therapeutics Assessment
• Vasculitis Assessment by Product Type
• Vasculitis By Stage and Product Type
• Vasculitis Assessment by Route of Administration
• Vasculitis By Stage and Route of Administration
• Vasculitis Assessment by Molecule Type
• Vasculitis by Stage and Molecule Type

DelveInsight's Vasculitis Report covers around 30+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Vasculitis product details are provided in the report. Download the Vasculitis pipeline report to learn more about the emerging Vasculitis therapies - https://www.delveinsight.com/sample-request/vasculitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Some of the key companies in the Vasculitis Therapeutics Market include:
Key companies developing therapies for Vasculitis are - 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.

Vasculitis Pipeline Analysis:
The Vasculitis pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Vasculitis with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Vasculitis Treatment.
• Vasculitis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Vasculitis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Vasculitis market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

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Vasculitis Pipeline Market Drivers
• Growing Prevalence & Improved Diagnosis Rates
Increased awareness and better diagnostic tools (e.g., ANCA testing, imaging) are leading to higher identification of vasculitis cases, expanding the treatable patient pool.
• Rising Focus on Rare and Orphan Diseases
Vasculitis falls under rare disease categories such as GPA, MPA, and GCA, attracting incentives like orphan drug designation, regulatory fast-tracks, and premium pricing opportunities.
• Advancements in Immunology & Targeted Therapies
Shift from broad immunosuppressants to biologics and precision-based treatments like anti-IL6 (Tocilizumab) and anti-CD20 (Rituximab) is driving innovation and pipeline expansion.
• Strong Clinical Research Activity
Over 25+ active companies developing 30+ therapeutic candidates, reflecting heightened industry engagement and investment interest.
• Supportive Regulatory and Reimbursement Landscape
Approved therapies such as Actemra and Avacopan have set precedents for accelerated approvals and reimbursement acceptance, encouraging further R&D.

Vasculitis Pipeline Market Barriers
• Complex and Heterogeneous Disease Landscape
Multiple subtypes (e.g., ANCA-associated vasculitis, Takayasu arteritis, Behçet's disease) require indication-specific drug development, limiting broad applicability.
• Limited Patient Populations for Clinical Trials
As an ultra-rare disease group, recruitment challenges can delay studies and increase trial costs.
• High Dependency on Off-Label Standard Therapies
Many physicians still rely on glucocorticoids and conventional immunosuppressants (cyclophosphamide, methotrexate) due to long-standing clinical familiarity and lower cost.
• Safety Risks Associated with Long-term Immunosuppression
Biologics and targeted agents often come with risks of infection, malignancy, or relapse, necessitating strong safety monitoring and risk mitigation strategies.
• Cost Burden and Access Challenges
Novel biologics and complement inhibitors can be highly expensive, leading to payer reluctance and slower market penetration in low-to-middle-income regions.

Scope of Vasculitis Pipeline Drug 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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About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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