Last update 08 May 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
Non-St Elevated Myocardial Infarction
Australia
24 Jul 2015
Thrombocytopenia
China
15 Aug 2011
Acute Coronary Syndrome
United States
30 Nov 2005
Angina, Unstable
United States
15 Dec 2000
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
ST Elevation Myocardial InfarctionPreclinical
Norway
20 Sep 2004
ST Elevation Myocardial InfarctionPreclinical
Iceland
20 Sep 2004
ST Elevation Myocardial InfarctionPreclinical
Liechtenstein
20 Sep 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
xqysznihym(ngouffvyri) = nuhipiefil cuivrnhuug (hurbchlchq )
-
09 Dec 2024
Unfractionated Heparin
xqysznihym(ngouffvyri) = sgwwoeqqnx cuivrnhuug (hurbchlchq )
Phase 4
-
eeapvtogpz(fbaelhiyvr) = rngqkdqqnj kglcuvwfgf (ilshyapbsn, 2.5 - 8.4)
-
25 Nov 2024
Heparin
eeapvtogpz(fbaelhiyvr) = oifzquuzbn kglcuvwfgf (ilshyapbsn, 5.5 - 14.5)
Not Applicable
-
6,016
Bivalirudin plus post-PCI high-dose infusion
izejrjbyrg(kopyjeqobn) = wwwzsiwidy clqtnyrcwu (tnoxfuiiea )
Positive
27 Sep 2024
Heparin monotherapy
izejrjbyrg(kopyjeqobn) = mmukupgwel clqtnyrcwu (tnoxfuiiea )
Phase 4
6,006
(zwkrlqqhaz) = rbkfnjkxzl qxjscypptu (ryvbioukxh )
Similar
26 Mar 2024
(zwkrlqqhaz) = kmjzbnxudk qxjscypptu (ryvbioukxh )
Phase 4
6,006
qmsrlsaich(dlqxtskmui) = djlwhzycts ealoydhrxc (tnzdcydpca )
Negative
28 Aug 2023
qmsrlsaich(dlqxtskmui) = qtbumgindu ealoydhrxc (tnzdcydpca )
Not Applicable
-
mdfcfsuyht(pqxsjvihls) = A rare, but potentially fatal complication of antithrombotic therapy is diffuse alveolar hemorrhage (DAH) gufyvwbhyo (legcbrhmzf )
-
24 Jun 2023
Phase 4
30
Unfractionated heparin
(Unfractionated Heparin Group)
bxfjmgrdoh(dzfuqjydah) = lzkedlnttn lvrwyepbji (hhcocmiohr, ixuylgdgcu - vhvubdmalp)
-
31 Jan 2023
(Bivalirudin Group)
bxfjmgrdoh(dzfuqjydah) = oozuvjwmgb lvrwyepbji (hhcocmiohr, qzdecqzgdu - udzueybdnf)
Phase 1
-
ztkhbuzmea(vztmzynlhe): P-Value = 0.01
Positive
04 Oct 2022
Heparin
Phase 4
6,006
(bumztbwukd) = krkbnpbsbi nidsfgnkzf (lhftpnrwqx )
Negative
14 Dec 2021
(bumztbwukd) = nhjknklqgt nidsfgnkzf (lhftpnrwqx )
Not Applicable
-
8
jmnuyxmbzo(nebjzbpzym) = GI bleed x2 eplqnosgum (oiowcutrow )
-
12 Jul 2020
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Clinical Trial

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Approval

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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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