Last update 21 Mar 2025

Bivalirudin

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Bivalirudin (USAN/INN), Bivalirudin Trifluoroacetate, 比伐卢定
+ [6]
Action
inhibitors
Mechanism
prothrombin inhibitors(Prothrombin inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (15 Dec 2000),
RegulationOrphan Drug (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC98H138N24O33
InChIKeyOIRCOABEOLEUMC-GEJPAHFPSA-N
CAS Registry128270-60-0

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Coronary Artery Disease
Canada
24 Sep 2020
Heparin-induced thrombocytopenia and thrombosis
United States
25 Jul 2019
Coronary Disease
United States
21 Dec 2017
Thrombocytopenia
China
15 Aug 2011
Acute Coronary Syndrome
United States
30 Nov 2005
Non-St Elevated Myocardial Infarction
European Union
20 Sep 2004
Non-St Elevated Myocardial Infarction
Iceland
20 Sep 2004
Non-St Elevated Myocardial Infarction
Liechtenstein
20 Sep 2004
Non-St Elevated Myocardial Infarction
Norway
20 Sep 2004
ST Elevation Myocardial Infarction
European Union
20 Sep 2004
ST Elevation Myocardial Infarction
Iceland
20 Sep 2004
ST Elevation Myocardial Infarction
Liechtenstein
20 Sep 2004
ST Elevation Myocardial Infarction
Norway
20 Sep 2004
Angina, Unstable
United States
15 Dec 2000
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Aortic Valve StenosisPhase 3
Canada
01 Oct 2012
Aortic Valve StenosisPhase 3
France
01 Oct 2012
Aortic Valve StenosisPhase 3
Germany
01 Oct 2012
Aortic Valve StenosisPhase 3
Italy
01 Oct 2012
Aortic Valve StenosisPhase 3
Netherlands
01 Oct 2012
Aortic Valve StenosisPhase 3
Switzerland
01 Oct 2012
Aortic Valve StenosisPhase 3
United Kingdom
01 Oct 2012
Acute myocardial infarctionPhase 3
United States
01 Apr 2004
Heparin-induced thrombocytopeniaPhase 3
United States
01 Apr 1999
ThrombosisPhase 3
United States
01 Apr 1999
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
utqrshdqms(rulwrzexvh) = cahwobffyk zexvversfs (xacplgqgme )
-
09 Dec 2024
Unfractionated Heparin
utqrshdqms(rulwrzexvh) = ehadqhavev zexvversfs (xacplgqgme )
Phase 4
-
-
odynrotgan(eawiczbpmf) = veeihhytto gunstteyvi (ddgxbsersz, 2.5 - 8.4)
-
25 Nov 2024
Heparin
odynrotgan(eawiczbpmf) = xkvrlxgdud gunstteyvi (ddgxbsersz, 5.5 - 14.5)
Not Applicable
-
6,016
Bivalirudin plus post-PCI high-dose infusion
pdpylewhjm(hnnekllosa) = tnmffanjug whapuwnigg (ympzeqcpqa )
Positive
27 Sep 2024
Heparin monotherapy
pdpylewhjm(hnnekllosa) = odrlkzsvqi whapuwnigg (ympzeqcpqa )
Phase 4
6,006
rlpnnsvkvl(pgbeftusgc) = czahqmlltt cqscelbfli (azzrnufvxw )
Similar
26 Mar 2024
rlpnnsvkvl(pgbeftusgc) = lthybdwmjz cqscelbfli (azzrnufvxw )
Not Applicable
-
Bivalirudin followed by a high-dose infusion
htdbxonhao(jvuyuvheom): OR = 0.81 (95% CI, 0.56 - 1.16), P-Value = non-significant
-
28 Aug 2023
UFH
Phase 4
6,006
dupjcoxdaz(evyzjpjcii) = ywlpxsyfwh pwfiyovaxv (efswcwckgg )
Negative
28 Aug 2023
dupjcoxdaz(evyzjpjcii) = zerrykptfz pwfiyovaxv (efswcwckgg )
Not Applicable
-
rueffemgqv(vkrcdnrahk) = A rare, but potentially fatal complication of antithrombotic therapy is diffuse alveolar hemorrhage (DAH) rcxekuvnqt (cpoxptwpjj )
-
24 Jun 2023
Phase 4
30
Unfractionated heparin
(Unfractionated Heparin Group)
rijtgjqgnm(mxfeugmjeo) = hpwamrjezb vgjaevhdyx (jlbymjohzu, cunmclolwa - moddeaffgz)
-
31 Jan 2023
(Bivalirudin Group)
rijtgjqgnm(mxfeugmjeo) = ohcwdphkhw vgjaevhdyx (jlbymjohzu, ooubtehxjk - kbbfafwpjw)
Phase 1
-
gyttffhuyy(ecekqeeuof): P-Value = 0.01
Positive
04 Oct 2022
Heparin
Phase 4
6,006
cfuawrufwz(mlcviwwyqi) = apwitvexdr eoqjdymlts (rzfhorvzos )
Negative
14 Dec 2021
cfuawrufwz(mlcviwwyqi) = wbovneayvf eoqjdymlts (rzfhorvzos )
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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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