American Society of Hirudotherapy

Novel drug delivery systems for hirudin-based product development and clinical applications

Systematic review published in International journal of biological macromolecules (2025)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Systematic reviewDrug DevelopmentSalivary PharmacologyClinical TrialsGenomics & ProteomicsMo L et al. · International journal of biological macromolecules, 2025

Abstract

Hirudin, a natural biological polypeptide macromolecule secreted by the salivary glands of medicinal leech, is a specific thrombin inhibitor with multiple favourable bioactivities, including anti-coagulation, anti-fibrotic, and anti-tumour. Despite several anticoagulants have been widely applied in clinic, hirudin shows advantages in reducing the incidence of bleeding side effects by virtue of its high specificity in binding to thrombin. As a result, hirudin has been tested in clinical practice to prevent and treat several complex diseases. However, the application of this polypeptide macromolecule is compromised by its low bioavailability and bioactivity due to poor serum stability and susceptibility to protease degradation in vivo. To overcome these drawbacks, several studies have proposed novel drug delivery systems (NDDSs) to prevent the degradation and increase the targeting efficiency of hirudin. This systematic review summarises the clinical research on hirudin, including its classification and bioactivities, and highlights the opportunities and challenges in the clinical use of hirudin. The NDDSs designed to enhance the bioavailability and bioactivity of hirudin are discussed to explore its application in the treatment of related diseases. This review may considerably contribute to the advancement of delivery science and technology, particularly in the context of polypeptide-based therapeutics.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

Publication typeJournal ArticleSystematic Review
Indexed MeSH termsHirudinsDrug Delivery SystemsHumansAnimalsBiological Availability

Summary

Hirudin, a natural biological polypeptide macromolecule secreted by the salivary glands of medicinal leech, is a specific thrombin inhibitor with multiple favourable bioactivities, including anti-coagulation, anti-fibrotic, and anti-tumour.

Why This Matters for Hirudotherapy

This systematic review summarizes clinical research on hirudin — a polypeptide secreted by medicinal leech salivary glands that functions as a specific thrombin inhibitor with anti-coagulation, anti-fibrotic, and anti-tumour bioactivities — and surveys novel drug delivery systems (NDDSs) proposed to overcome its poor serum stability and susceptibility to protease degradation in vivo. The topic is centrally relevant to hirudotherapy and ASH's domain because hirudin is a key bioactive constituent of the leech salivary secretome, and the review directly addresses pharmaceutical challenges in translating this leech-derived peptide into effective therapeutics by improving bioavailability and targeting efficiency. As a systematic review, it synthesizes existing literature rather than generating new experimental or clinical data; the abstract does not provide specific quantitative outcomes, comparative efficacy results, or performance metrics for individual NDDSs.

Citation

Novel drug delivery systems for hirudin-based product development and clinical applications.

Mo L et al. · International journal of biological macromolecules, 2025

Added to ASH library: March 18, 2026 · Site last updated: June 18, 2026

This website provides educational information and does not constitute medical advice, diagnosis, or treatment recommendations. Medicinal leech therapy carries clinically meaningful risks and should be performed only by qualified clinicians under institutionally approved protocols. FDA 510(k) clearance for medicinal leeches is limited to specific indications; investigational and off-label discussions are labeled accordingly. For patient-specific guidance, consult a qualified healthcare provider.