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Vonapanitase is an investigational recombinant human elastase enzyme developed to improve vascular access outcomes in patients with chronic kidney disease (CKD) undergoing hemodialysis. It is a 25–26 kDa serine protease that cleaves peptide bonds in the protein elastin, which is a principal component of elastic fibers in blood vessels. By partially fragmenting elastin fibers when applied locally to the external surface of newly created arteriovenous fistulas or grafts, vonapanitase aims to inhibit neointimal hyperplasia and promote outward vascular remodeling, thereby increasing vessel dilation and reducing the risk of access failure. The drug was primarily developed for use during surgical creation of radiocephalic arteriovenous fistulas for hemodialysis but has also been studied for peripheral artery disease (PAD). Vonapanitase received Breakthrough Therapy, Fast Track, and Orphan Drug designations from regulatory agencies but failed to meet primary endpoints in Phase 3 clinical trials for its main indication[1][3][4][5][6][8].
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