Vasculitis Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Clinical Trials, Therapies, Medication, NDA Approval, IND, Mechanism of Action, Route of Administration by DelveInsight

Vasculitis Clinical Trials

(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 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

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.

Download Sample PDF Report to know more about Vasculitis drugs and therapies

Vasculitis Pipeline Market Drivers

• Rising incidence of Vasculitis, the surge in R&D on the treatment of Vasculitis, technological advancement in the diagnostic kits are some of the important factors that are fueling the Vasculitis Market.

Vasculitis Pipeline Market Barriers

• However, side effects caused by the current treatment methods, lack of trained professionals and stringent governmental regulations for Vasculitis drugs and other factors are creating obstacles in the Vasculitis Market growth.

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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Table of Contents

1. Vasculitis Report Introduction

2. Vasculitis Executive Summary

3. Vasculitis Overview

4. Vasculitis- Analytical Perspective In-depth Commercial Assessment

5. Vasculitis Pipeline Therapeutics

6. Vasculitis Late Stage Products (Phase II/III)

7. Vasculitis Mid Stage Products (Phase II)

8. Vasculitis Early Stage Products (Phase I)

9. Vasculitis Preclinical Stage Products

10. Vasculitis Therapeutics Assessment

11. Vasculitis Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Vasculitis Key Companies

14. Vasculitis Key Products

15. Vasculitis Unmet Needs

16 . Vasculitis Market Drivers and Barriers

17. Vasculitis Future Perspectives and Conclusion

18. Vasculitis Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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