Lepirudin is a direct thrombin inhibitor obtained by recombinant technology from the medicinal leech and used for treatment of heparin-induced thrombocytopenia (HIT). Lepirudin was the first direct thrombin inhibitor approved and most frequently used for the treatment of patients with HIT. The efficacy of lepirudin for HIT has been shown to improve general outcomes in patients with HIT, reducing a primary composite endpoint of new thrombosis, all-cause amputation, and all-cause death. Lepirudin forms a stable non-covalent complex with alpha-thrombin, thereby abolishing its ability to cleave fibrinogen and initiate the clotting cascade. It is a highly potent, selective, and essentially irreversible inhibitor of thrombin and clot-bond thrombin. Lepirudin is identical to natural hirudin except for substitution of leucine for isoleucine at the N-terminal end of the molecule and the absence of a sulfate group on the tyrosine at position 63.
Approval Year
Conditions
Condition | Modality | Targets | Highest Phase | Product |
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Primary | REFLUDAN Approved UseRefludan is indicated for anticoagulation in patients with heparin-associated thrombocytopenia (HIT) and associated thromboembolic disease in order to prevent further thromboembolic complications. Launch Date1998 |
PubMed
Title | Date | PubMed |
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[Heparin-induced thrombocytopenia type II. Intra- and postoperative lepirudin treatment in acute ischemia of the extremities]. | 1998 Oct 9 |
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[Heparin-induced thrombocytopenia type II with early aortocoronary bypass occlusion and stent thrombosis after PTCA of the RCA--treatment with lepirudin (Refludan) and abciximab (Reo pro) during recanalization of the RCA]. | 1999 Feb |
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Direct thrombin inhibitor therapy in the cardiovascular patient. | 2003 Oct 15 |
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Effect of direct thrombin inhibitors, bivalirudin, lepirudin, and argatroban, on prothrombin time and INR values. | 2004 Apr |
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[A case of heparin induced thrombocytopenia treated with lepirudin infusion: case report]. | 2006 |
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Lepirudin for treatment of acute thrombosis during pregnancy. | 2008 Aug |
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Extremely low doses of lepirudin in a patient with heparin-induced thrombocytopenia, high bleeding risk and renal insufficiency. | 2009 Aug |
Substance Class |
Protein
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Sequence Type | COMPLETE |
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Y43GF64R34
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N0000175518
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EMA ASSESSMENT REPORTS |
REFLUDAN (WITHDRAWN: THROMBOEMBOLISM
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FDA ORPHAN DRUG |
102796
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WHO-ATC |
B01AE02
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NCI_THESAURUS |
C263
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N0000009963
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N0000175980
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1_6 | 1_14 |
1_16 | 1_28 |
1_22 | 1_39 |
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TARGET -> INHIBITOR |
IRREVERSIBLE INHIBITOR
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ACTIVE MOIETY |
Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
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MOL_WEIGHT:SEQUENCE(CALCULATED) | CHEMICAL |
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Molecular Formula | CHEMICAL |
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