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Vasculitis Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight

09-17-2025 08:18 PM CET | Health & Medicine

Press release from: DelveInsight Business Research

Vasculitis Pipeline 2025: FDA Approvals and Clinical Trials

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Vasculitis pipeline constitutes 20+ 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.

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

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.

Some of the key takeaways from the Vasculitis Pipeline Report: https://www.delveinsight.com/sample-request/vasculitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• 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 Ambulero, Beijing Defengrei Biotechnology, Janssen Biotech, Novartis, AbbVie, 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 April 2025, The U.S. Patent and Trademark Office (USPTO) has awarded Conduit Pharmaceuticals a patent for AZD1656, their investigational treatment for ANCA-associated vasculitis (AAV) and other autoimmune disorders. The patent granted is a composition of matter patent, covering new compounds created from two or more different substances. Recognized by the U.S. Food and Drug Administration (FDA) as a drug substance patent, it provides Conduit with up to 20 years of intellectual property protection for AZD1656.
• In March 2025, A Phase 1 clinical trial evaluating SC291, an experimental CAR T-cell therapy developed by Sana Biotechnology for ANCA-associated vasculitis (AAV) and other autoimmune diseases, is currently enrolling patients at multiple locations across the U.S. Named GLEAM (NCT06294236), the study began recruiting up to 36 adults aged 18-75 last year at two sites-one in Aurora, Colorado, and another in Seattle. It has since expanded to three more locations in Atlanta, Baltimore, and Boston. The trial targets AAV patients diagnosed with granulomatosis with polyangiitis or microscopic polyangiitis-the two most common AAV forms-who have not responded to or have relapsed following prior treatments. Additionally, the study will include adults with specific types of lupus, another autoimmune condition that, like AAV, can impact the kidneys.
• In January 2025, Alentis Therapeutics announced that Lixudebart (ALE.F02), an investigational treatment aimed at preserving kidney function in ANCA-associated vasculitis (AAV), demonstrated a favorable safety profile in a Phase 2 clinical trial. Additionally, a separate study evaluating lixudebart in patients with liver disease also reported a positive safety outcome. Results from both trials indicate that lixudebart is performing as expected.
• In October 2024, Adicet Bio, a US-based biopharmaceutical company, has started enrolling patients in a Phase I clinical trial of ADI-001 for the treatment of autoimmune diseases. Enrollment began after the U.S. Food and Drug Administration (FDA) granted fast-track designation to ADI-001 for the treatment of relapsed/refractory class III or class IV lupus nephritis (LN). The FDA has also recently approved the drug's development for LN, systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV).

Vasculitis Overview
Vasculitis is a group of disorders characterized by inflammation of the blood vessels. This inflammation can cause changes in the walls of the blood vessels, including thickening, weakening, narrowing, or scarring. These changes can restrict blood flow, leading to organ and tissue damage. Vasculitis can affect any of the body's blood vessels, including arteries, veins, and capillaries.

Get a Free Sample PDF Report to know more about Vasculitis Pipeline Therapeutic Assessment-
https://www.delveinsight.com/report-store/vasculitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

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 at:
https://www.delveinsight.com/sample-request/vasculitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

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-
https://www.delveinsight.com/sample-request/vasculitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

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: Ambulero, Beijing Defengrei Biotechnology, Janssen Biotech, Novartis, AbbVie, 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

Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

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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