U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
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

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
REFLUDAN

Approved Use

Refludan is indicated for anticoagulation in patients with heparin-associated thrombocytopenia (HIT) and associated thromboembolic disease in order to prevent further thromboembolic complications.

Launch Date

8.8914238E11
PubMed

PubMed

TitleDatePubMed
[Heparin-induced thrombocytopenia type II. Intra- and postoperative lepirudin treatment in acute ischemia of the extremities].
1998 Oct 9
[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
Recombinant hirudin anticoagulation for aortic valve replacement in heparin-induced thrombocytopenia.
2000 Mar
Repetitive intraoperative use of recombinant hirudin (Lepirudin) in peripheral vascular surgery with HITT.
2001 Dec 22
Direct antithrombin agents ameliorate disseminated intravascular coagulation in suspected heparin-induced thrombocytopenia thrombosis syndrome.
2002 Jul
Venous limb gangrene during overlapping therapy with warfarin and a direct thrombin inhibitor for immune heparin-induced thrombocytopenia.
2002 Sep
Massive pulmonary embolism due to late-onset heparin-induced thrombocytopenia following coronary artery bypass graft surgery: successful treatment with lepirudin.
2003 Jul-Aug
Direct thrombin inhibitors for treatment of heparin induced thrombocytopenia, deep vein thrombosis and atrial fibrillation.
2005
[A case of heparin induced thrombocytopenia treated with lepirudin infusion: case report].
2006
Heparin-induced thrombocytopenia: treatment options and special considerations.
2007 Apr
Multivessel coronary thrombosis resulting from heparin induced thrombocytopenia.
2007 Sep
Lepirudin for treatment of acute thrombosis during pregnancy.
2008 Aug
Bivalirudin.
2008 May
Extremely low doses of lepirudin in a patient with heparin-induced thrombocytopenia, high bleeding risk and renal insufficiency.
2009 Aug
[Heparin-induced thrombocytopenia and liver hemorrhage following polytrauma].
2009 Sep
Name Type Language
LEPIRUDIN
EMA EPAR   INN   MART.   VANDF   WHO-DD  
INN  
Official Name English
LEPIRUDIN RECOMBINANT
ORANGE BOOK  
Common Name English
REFLUDAN
Brand Name English
LEPIRUDIN [VANDF]
Common Name English
Lepirudin [WHO-DD]
Common Name English
lepirudin [INN]
Common Name English
LEPIRUDIN [EMA EPAR]
Common Name English
LEPIRUDIN [MART.]
Common Name English
HIRUDIN LEPIRUDIN [MI]
Common Name English
LEPIRUDIN RECOMBINANT [ORANGE BOOK]
Common Name English
1-L-LEUCINE-2-L-THREONINE-63-DESULFOHIRUDIN (HIRUDO MEDICINALIS ISOFORM HV1)
Common Name English
Classification Tree Code System Code
NDF-RT N0000175518
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
EMA ASSESSMENT REPORTS REFLUDAN (WITHDRAWN: THROMBOEMBOLISM
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
FDA ORPHAN DRUG 102796
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
WHO-ATC B01AE02
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
NCI_THESAURUS C263
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
NDF-RT N0000009963
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
NDF-RT N0000175980
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
Code System Code Type Description
MERCK INDEX
M6025
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PRIMARY Merck Index
NCI_THESAURUS
C1839
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PRIMARY
EVMPD
SUB08435MIG
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PRIMARY
DRUG CENTRAL
2995
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PRIMARY
CAS
138068-37-8
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
PRIMARY
IUPHAR
6469
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
PRIMARY
RXCUI
237057
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PRIMARY RxNorm
ChEMBL
CHEMBL1201666
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PRIMARY
INN
7355
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PRIMARY
LACTMED
Lepirudin
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
PRIMARY
CHEBI
142437
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
PRIMARY
EPA CompTox
DTXSID50160461
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
PRIMARY
FDA UNII
Y43GF64R34
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
PRIMARY
DRUG BANK
DB00001
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
PRIMARY
WIKIPEDIA
Lepirudin
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
PRIMARY
PUBCHEM
118856773
Created by admin on Thu Jul 06 08:13:19 UTC 2023 , Edited by admin on Thu Jul 06 08:13:19 UTC 2023
PRIMARY