Vasculitis Clinical Trials Analysis 2026: Competitive Landscape, Regulatory Updates, Emerging Therapies, Mechanisms Of Action, And Routes Of Administration Delveinsight

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.