Bivalirudin
Synthetic 20-amino-acid hirudin analog — FDA-approved direct thrombin inhibitor for PCI anticoagulation ($636M peak revenue).
Mechanistic Evidence Box
Studied off-label- Page type
- Compound profile
- Evidence type
- Synthetic 20-amino-acid hirudin analog — FDA-approved direct thrombin inhibitor for PCI anticoagulation ($636M peak revenue).
- Evidence level
- FDA-cleared regulatory context
- Drug vs leech
- Synthetic analog
- Safety domains
- Bleeding
Clinical translation limit
Bivalirudin is an FDA-approved synthetic 20-amino-acid analog derived from hirudin's active sequence. Its clinical use in PCI and HIT is supported by its own RCT evidence base (HORIZONS-AMI, etc.); this evidence does NOT extend to claims about whole medicinal-leech therapy. The drug is chemically distinct from natural hirudin and from whole-leech secretion.
Molecular Profile
- Category
- Anticoagulant
- Evidence tier
- Tier A — FDA-approved derivative
- Molecular weight
- 2,180 Da
- Source species
- Synthetic (hirudin-derived)
- Discovered
- 1990 · John Maraganore (The Medicines Company / Biogen)
- PubChem CID
- 16129704
- Derived FDA-approved drug
- Angiomax / Angiox (FDA approved Dec 2000)
Biological Targets
- → thrombin (Factor IIa)
Key Citations
- Maraganore JM et al. (1990), Biochemistry · PMID 2223763
- Stone GW et al. (HORIZONS-AMI) (2008), N Engl J Med · PMID 18499566
External Resources
Related Anticoagulant Compounds
Hirudin
The most potent natural thrombin inhibitor — and the molecular template for three FDA-approved direct thrombin inhibitor drugs.
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Ghilanten
Factor Xa inhibitor with anti-metastatic activity in animal cancer models — translational dual-use compound.
Lefaxin
Factor Xa inhibitor with anti-inflammatory properties.