American Society of Hirudotherapy

Current status of the anticoagulant hirudin: its biotechnological production and clinical practice

Review published in Applied microbiology and biotechnology (2001)

Last Updated: November 1, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Narrative reviewDrug DevelopmentClinical LiteratureSohn J et al. · Applied microbiology and biotechnology, 2001

Abstract

Hirudin is a potent thrombin inhibitor originally derived from the medicinal leech, Hirudo medicinalis. Owing to its high affinity and specificity for thrombin, hirudin has been intensively investigated for research and therapeutic purposes. The investigation of hirudin has contributed greatly to the understanding of the mode of action of thrombin and the clotting system. Hirudin and several hirudin analogues have also been demonstrated to have several advantages as a highly specific anticoagulant over the most widely used drug, heparin. Due to the great demand for hirudin in physicochemical and clinical studies, various recombinant systems have been developed, using bacteria, yeasts, and higher eukaryotes, to obtain the biologically active hirudin in significant quantities. After 10 years of clinical applications, two recombinant hirudins and a hirudin analogue have gained marketing approval from the United States Food and Drug Administration, for several applications. Clinical trials are currently ongoing for other treatments for thrombotic disease. As a consequence, it is conceivable that hirudin may expand its therapeutic utility over heparin in the near future.

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

Publication typeJournal ArticleReview
Indexed MeSH termsAmino Acid SequenceAnimalsBiotechnologyFibrinolytic AgentsHirudin TherapyHirudinsHumansLeechesMolecular Sequence DataRecombinant ProteinsSequence Homology, Amino Acid

Summary

This review surveys hirudin, the leech-derived thrombin inhibitor: recombinant production in bacteria, yeasts and higher eukaryotes supplies research and clinical demand, two recombinant hirudins and one analogue have US FDA marketing approval, and trials for other thrombotic diseases continue.

Why This Matters for Hirudotherapy

This article examines hirudin, a potent thrombin inhibitor originally derived from the medicinal leech Hirudo medicinalis, discussing its biotechnological production via recombinant systems in bacteria, yeasts, and higher eukaryotes and its clinical applications, including FDA marketing approval for two recombinant hirudins and a hirudin analogue. The paper addresses the therapeutic potential of a leech-derived anticoagulant protein, noting demonstrated advantages over heparin and contributions to understanding thrombin's mode of action and the clotting system. The abstract does not provide specific quantitative data, trial results, or methodological details, and its claims are general and wide-ranging rather than tied to particular experiments, datasets, or patient outcomes.

Citation

Reference (Vancouver style)

Sohn JH, Kang HA, Rao KJ, Kim CH, Choi ES, Chung BH, et al. Current status of the anticoagulant hirudin: its biotechnological production and clinical practice. Appl Microbiol Biotechnol. 2001;57(5-6):606-613. doi:10.1007/s00253-001-0856-9. PMID: 11778867

Bibliographic details (authors, volume, pages, DOI) are taken from the PubMed record.

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