DelveInsight’s “Arteriovenous (AV) Fistula – Pipeline Insight, 2025” outlines a diverse array of development programs targeting the fistula lifecycle from creation to long-term maintenance. Endovascular AV fistula creation systems, such as radiofrequency- and thermal-based devices, are advancing in clinical adoption, offering reduced surgical trauma and faster recovery. Bioengineered vascular grafts seeded with human cells or synthetic scaffolds are being evaluated to promote natural tissue integration and resist neointimal hyperplasia. Adjunctive pharmacological strategies—including antiproliferative drug coatings, local nitric oxide delivery, and targeted anti-inflammatory agents—are also under investigation to prolong patency and reduce intervention frequency.
Among the most notable candidates are endovascular systems like Ellipsys and WavelinQ, which are being studied for expanded patient eligibility and improved maturation outcomes, and next-generation bioengineered conduits designed for use when autologous vessels are unsuitable. As regulatory bodies increasingly recognize the unmet need in vascular access care, breakthrough device designations and streamlined approval pathways are supporting rapid innovation. The 2025 pipeline signals a paradigm shift toward less invasive, more durable, and biologically compatible solutions, with the potential to transform AV fistula management for dialysis patients worldwide.
Interested in learning more about the current treatment landscape and the key drivers shaping the arteriovenous fistula pipeline? Click here
Key Takeaways from the Arteriovenous Fistula Pipeline Report
• DelveInsight’s arteriovenous fistula pipeline analysis depicts a strong space with 3+ active players working to develop 3+ pipeline drugs for arteriovenous fistula treatment.
• The leading arteriovenous fistula companies include Enceladus Pharmaceuticals, Kintara Therapeutics, Symic Bio, and others are evaluating their lead assets to improve the arteriovenous fistula treatment landscape.
• Key arteriovenous fistula pipeline therapies in various stages of development include Sirolimus, Liposome encapsulated prednisolone, Rostaporfin, and others.
• In March 2025, A pilot study called ED‑VeRT, conducted in an Emergency Department setting, found that vestibular rehabilitation therapy (VRT) significantly eased dizziness and improved discharge outcomes compared to usual care, marking a promising nonpharmacological intervention.
• In December 2024, Sound Pharmaceuticals announced that its Phase III trial (STOPMD-3) of SPI-1005 (ebselen) met its co-primary efficacy endpoints for improving hearing loss and speech discrimination in patients with Meniere’s Disease. MD is a chronic inner ear disorder causing hearing loss, tinnitus, and episodes of Arteriovenous Fistula, with no current FDA-approved treatments.
• In September 2024, Spiral Therapeutics announced the successful completion of a Phase 1b/2a trial for SPT‑2101—a long‑acting dexamethasone gel delivered via their MICS™ platform. The results demonstrated significant reductions in Arteriovenous Fistula days for Menière’s disease, using a minimally invasive delivery directly to the inner ear.
Arteriovenous Fistula Overview
Arteriovenous Fistula (AVF) is an abnormal connection between an artery and a vein that bypasses the capillary system. This direct link causes blood to flow rapidly from the high-pressure arterial system into the low-pressure venous system, which can lead to various complications depending on the location and size of the fistula. AVFs can be congenital or acquired, with acquired types often resulting from trauma, surgical procedures, or medical interventions such as hemodialysis access creation.
Clinically, AVFs may present with symptoms like swelling, pain, skin changes, or a palpable thrill and bruit over the affected area. In some cases, large or high-flow AVFs can cause complications such as heart failure due to increased cardiac workload or ischemia downstream of the fistula. Treatment depends on the fistula’s cause and severity and may involve surgical repair, endovascular interventions, or careful monitoring if asymptomatic and stable. In chronic kidney disease patients, AVFs are commonly created surgically to provide durable vascular access for hemodialysis.
Find out more about arteriovenous fistula medication at https://www.delveinsight.com/report-store/arteriovenous-fistula-av-pipeline-insight
Arteriovenous Fistula Treatment Analysis: Drug Profile
Liposome Encapsulated Prednisolone: Enceladus Pharmaceuticals
Liposome-encapsulated prednisolone is an arachidonic acid inhibitor currently under investigation in a Phase II clinical trial for the treatment of Arteriovenous (AV) Fistula. In preclinical studies using a murine AV fistula model, this liposomal formulation demonstrated the ability to reduce vascular inflammation and promote venous outward remodeling.
Learn more about the novel and emerging arteriovenous fistula pipeline therapies.
Arteriovenous Fistula Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.
By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
By Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
By Molecule Type
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy
Scope of the Arteriovenous Fistula Pipeline Report
• Coverage: Global
• Key Arteriovenous Fistula Companies: Enceladus Pharmaceuticals, Kintara Therapeutics, Symic Bio, and others.
• Key Arteriovenous Fistula Pipeline Therapies: Sirolimus, Liposome encapsulated prednisolone, Rostaporfin, and others.
Explore detailed insights on drugs used in the treatment of arteriovenous fistula here.
Table of Contents
1. Introduction
2. Executive Summary
3. Arteriovenous Fistula Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Arteriovenous Fistula Pipeline Therapeutics
6. Arteriovenous Fistula Pipeline: Late-Stage Products (Phase III)
7. Arteriovenous Fistula Pipeline: Mid-Stage Products (Phase II)
8. Arteriovenous Fistula Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix
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