Last update 24 Jun 2024

Bivalirudin

Overview

Basic Info

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

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
Heparin-induced thrombocytopenia and thrombosis
US
25 Jul 2019
Coronary Disease
US
21 Dec 2017
Thrombocytopenia
CN
15 Aug 2011
Acute Coronary Syndrome
US
30 Nov 2005
Non-St Elevated Myocardial Infarction
EU
20 Sep 2004
Non-St Elevated Myocardial Infarction
IS
20 Sep 2004
Non-St Elevated Myocardial Infarction
LI
20 Sep 2004
Non-St Elevated Myocardial Infarction
NO
20 Sep 2004
ST Elevation Myocardial Infarction
EU
20 Sep 2004
ST Elevation Myocardial Infarction
IS
20 Sep 2004
ST Elevation Myocardial Infarction
LI
20 Sep 2004
ST Elevation Myocardial Infarction
NO
20 Sep 2004
Angina, Unstable
US
15 Dec 2000
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Aortic Valve StenosisPhase 3
CA
01 Oct 2012
Aortic Valve StenosisPhase 3
FR
01 Oct 2012
Aortic Valve StenosisPhase 3
DE
01 Oct 2012
Aortic Valve StenosisPhase 3
IT
01 Oct 2012
Aortic Valve StenosisPhase 3
NL
01 Oct 2012
Aortic Valve StenosisPhase 3
CH
01 Oct 2012
Aortic Valve StenosisPhase 3
GB
01 Oct 2012
Acute myocardial infarctionPhase 3
US
01 Apr 2004
Coronary Artery DiseasePhase 3
US
01 Aug 2003
Heparin-induced thrombocytopeniaPhase 3
US
01 Apr 1999
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
6,006
nfunmmwdef(gsnfwrjemn) = hpabcvtxwl zubwmusaix (mnmmaktxxk )
Negative
26 Mar 2024
nfunmmwdef(gsnfwrjemn) = jwixzxdwbf zubwmusaix (mnmmaktxxk )
Not Applicable
-
Bivalirudin followed by a high-dose infusion
lpgosljdht(wduadracvh): OR = 0.81 (95% CI, 0.56 - 1.16), P-Value = non-significant
-
28 Aug 2023
UFH
Not Applicable
6,006
wllwidzbvt(bafirizaxf) = vviypprgme tidfaatogf (fsxpsyigsk )
Negative
28 Aug 2023
wllwidzbvt(bafirizaxf) = ovnohpmwnh tidfaatogf (fsxpsyigsk )
Not Applicable
-
eexzdkowoz(kyijlowgkl) = A rare, but potentially fatal complication of antithrombotic therapy is diffuse alveolar hemorrhage (DAH) aicpsuauam (okqjlicaun )
-
24 Jun 2023
Phase 4
30
Unfractionated heparin
(Unfractionated Heparin Group)
vogaumvguq(xjzwrfgxbc) = zoigphkhmp lkqozcrgnc (widkysndcj, piwfrzgegm - sltcilwkfn)
-
31 Jan 2023
(Bivalirudin Group)
vogaumvguq(xjzwrfgxbc) = zjkbrqveyl lkqozcrgnc (widkysndcj, qykuosvlve - icluynfbhd)
Phase 1
-
-
nsduxzragy(urbyofnajf): P-Value = 0.01
Positive
04 Oct 2022
Phase 4
6,006
ufvexvkbfn(ykurjlxpjm) = qzkbdzygnu muffylnhfq (tgxckjrmlc )
Negative
14 Dec 2021
ufvexvkbfn(ykurjlxpjm) = wlgpyhrlfk muffylnhfq (tgxckjrmlc )
Phase 3
7,213
tqijkrzqqp(gwaizmdgbw): OR = 0.97 (95% CI, 0.85 - 1.09), P-Value = 0.58
-
07 Sep 2021
Unfractionated heparin
Not Applicable
Acute Coronary Syndrome
Diabetes Mellitus
218
csjeucagjk(cpoxwpluff) = nijjxkckxs iirdhukvoe (trzybqmirt )
-
27 Aug 2021
Not Applicable
-
8
lazvzmqfqw(monpzcaemp) = GI bleed x2 uvgymlvptv (pyvvxjnzte )
-
12 Jul 2020
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