Lepirudin
First-generation recombinant hirudin — FDA-approved 1998 for heparin-induced thrombocytopenia (HIT). Withdrawn 2012 by Bayer for commercial reasons.
Mechanistic Evidence Box
Studied off-label- Page type
- Compound profile
- Evidence type
- First-generation recombinant hirudin — FDA-approved 1998 for heparin-induced thrombocytopenia (HIT). Withdrawn 2012 by Bayer for commercial reasons.
- Evidence level
- FDA-cleared regulatory context
- Drug vs leech
- Recombinant (genetically expressed)
- Safety domains
- Bleeding · Allergy / anaphylaxis
Clinical translation limit
Lepirudin is a yeast-expressed recombinant hirudin drug, FDA-approved for HIT until commercial withdrawal in 2012. Its clinical evidence base applies only to the recombinant drug; it does NOT extend to whole medicinal-leech therapy. Lepirudin and whole-leech therapy are separate regulatory products.
Molecular Profile
- Category
- Anticoagulant
- Evidence tier
- Tier A — FDA-approved derivative
- Molecular weight
- 6,979 Da
- Source species
- Recombinant (Saccharomyces cerevisiae expression of hirudin)
- Discovered
- 1986 · Hoechst Marion Roussel / Behringwerke
- PDB structures
- 1HRT
- Derived FDA-approved drug
- Refludan (FDA approved 1998, withdrawn 2012)
Biological Targets
- → thrombin (Factor IIa)
Key Citations
- Greinacher A et al. (1999), Circulation · PMID 10441094
- Lubenow N, Greinacher A (2002), Semin Thromb Hemost · PMID 12420238
External Resources
Related Anticoagulant Compounds
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The most potent natural thrombin inhibitor — and the molecular template for three FDA-approved direct thrombin inhibitor drugs.
Antistasin
Factor Xa inhibitor — prototype molecule that inspired the entire DOAC drug class (rivaroxaban, apixaban).
Ghilanten
Factor Xa inhibitor with anti-metastatic activity in animal cancer models — translational dual-use compound.
Lefaxin
Factor Xa inhibitor with anti-inflammatory properties.