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bivalirudin

Trade name: angiomax

Small moleculeapproved

Approved

Dec 15, 2000

Bivalirudin is a synthetic 20 amino acid peptide rationally designed based on structural studies of hirudin, a naturally occurring anticoagulant. Bivalirudin is sold under the brand name Angiomax and is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). It is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. Bivalirudin directly inhibits thrombin by binding simultaneously to its active catalytic site and its substrate recognition site. — NCATS

Clinical trial activity

63 trials · 80 clinical orgs · 24 marketing orgs

Phase 1
3
Phase 2
25
Phase 3
20
Phase 4
27

Earliest trial started Apr 1, 1999 (NCT00043940)

Timeline

1990s

  1. Jan 1, 1999

    The Medicines Company — Earliest Phase 3 Sponsor(trial)

2000s

  1. Dec 15, 2000

    The Medicines Company — Earliest FDA Approval

  2. Dec 15, 2000

    Sandoz — NDA Secondary Org

  3. Dec 15, 2000

    The Medicines Company — NDA Organization

  4. Dec 15, 2000

    Sandoz — Marketing Organization

  5. Dec 15, 2000

    Novartis — NDA Secondary Org

  6. Jan 1, 2002

    The Medicines Company — Earliest Phase 2 Sponsor(trial)

  7. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jul 14, 2015

    Hospira — Marketing Organization

  2. Jul 14, 2015

    Pfizer — Marketing Organization

  3. Sep 14, 2016

    Pliva — Marketing Organization

  4. Sep 14, 2016

    Teva — Marketing Organization

  5. Oct 28, 2016

    Fresenius — Marketing Organization

  6. Feb 2, 2017

    Mylan — Marketing Organization

  7. May 26, 2017

    Dr. Reddy's Laboratories — Marketing Organization

  8. Jul 6, 2017

    Apotex — Marketing Organization

  9. Nov 22, 2017

    Accord Research — Marketing Organization

  10. Dec 21, 2017

    Baxalta — NDA Secondary Org

  11. Dec 21, 2017

    Shire — NDA Secondary Org

  12. Jul 16, 2018

    Meitheal — Marketing Organization

  13. Jul 16, 2018

    Cipla — Marketing Organization

  14. Jul 16, 2018

    Eu Yan Sang — Marketing Organization

  15. Jul 27, 2018

    Aurobindo Pharma — Marketing Organization

  16. Jul 27, 2018

    Eugia Pharma — Marketing Organization

  17. Jul 25, 2019

    Maia Pharms Inc — NDA Secondary Org

  18. Oct 23, 2019

    Hainan GeneralSanyang Pharmaceutical Co.,Ltd — Marketing Organization

  19. Oct 23, 2019

    Shuangcheng — Marketing Organization

2020s

  1. May 28, 2021

    Hainan Poly Pharm — Marketing Organization

  2. May 28, 2021

    SLATE RUN PHARMA — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 15, 2000

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(=O)N)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]2CCCN2C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]3CCCN3C(=O)[C@H](N)Cc4ccccc4)C(=O)N5CCC[C@H]5C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc6ccc(O)cc6)C(=O)N[C@@H](CC(C)C)C(=O)O
Mol. weight
2180.32 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • angiomax
  • angiomax
  • angiomax
  • angiomax
  • angiomax
  • angiox
  • bg8967
  • bg 8967
  • bg-8967
  • bg-8967
  • bg-8967
  • bivalirudin
  • bivalirudin
  • bivalirudin
  • bivalirudin
  • bivalirudin
  • bivalirudin
  • bivalirudin
  • bivalirudin
  • bivalirudin
  • bivalirudin
  • bivalirudin
  • bivalirudina
  • bivalirudina
  • bivalirudinum
  • bivalirudinum
  • bivalrudin
  • ctb-001
  • hirulog
  • hirulog
  • hirulog
  • hirulog
  • hirulog-1
  • l-leucine, d-phenylalanyl-l-prolyl-l-arginyl-l-prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-alpha-aspartyl-l-phenylalanyl-l-alpha-glutamyl-l-alpha-glutamyl-l-isoleucyl-l-prolyl-l-alpha-glutamyl-l-alpha-glutamyl-l-tyrosyl-
  • phe-pro-arg-pro-(gly)4-asn-gly-asp-phe-glu-glu-ile-pro-glu-glu-tyr-leu
  • phe-pro-arg-pro-(gly)4 desulfato-tyr63'-hirugen
  • phe-pro-arg-pro-(gly)4-desulfohirudin-(53-64)

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06861374N/AMay 31, 2025Jiao Tong University
NCT06275555N/AAug 1, 2024Capital Medical University
NCT05959252Phase 2Jan 1, 2024Sydney Local Health District
NCT05984537Phase 4Jul 1, 2023Peking University
NCT05334654N/AApr 20, 2022Magna Graecia University
NCT04475835N/AOct 31, 2020Hanzhong Central Hospital, Jiao Tong University, Shaanxi Provincial People's Hospital, Xianyang Central Hospital, Yan'an University Affiliated Hospital
NCT04532333Phase 3Aug 31, 2020Changhai Hospital, Shandong University, The First People's Hospital of Changzhou, Wuhan University, Zhejiang University, Zhengzhou University
NCT04445935Phase 4Jun 28, 2020Hamad Medical Corporation
NCT04195997Phase 4Feb 1, 2020Fudan University
NCT04185077Phase 4Nov 30, 2019Central South University
NCT04120961N/ASep 20, 2019Nanjing Medical University
NCT04046029Phase 4Jul 8, 2019Capital Medical University, Dalian Medical University
NCT03707418Phase 1Jun 30, 2019Johns Hopkins University
NCT03965208Phase 4May 23, 2019Legacy Health System, Pacific University
NCT03822975N/AFeb 14, 2019China Medical University
NCT03882775Phase 4Jan 16, 2019Capital Medical University, Dalian Medical University
NCT03664180Phase 4Oct 31, 2018Capital Medical University, Chinese Academy of Medical Sciences
NCT03567408Phase 2Sep 15, 2018Mianyang Central Hospital
NCT03588611Phase 4Aug 1, 2018China Medical University
NCT03537586N/AJun 29, 2018New York University
Showing 20 of 63 trials
Page 1 / 4

Organizations

Research & Development (80)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
The Medicines CompanyFor profit151431999
Capital Medical UniversityAcademic/Hospital4222018
China Medical UniversityAcademic/Hospital3322012
Icahn School of Medicine at Mount SinaiAcademic/Hospital3122012
Technical University of MunichAcademic/Hospital3312005
Chinese Academy of Medical SciencesAcademic/Hospital2012010
Dalian Medical UniversityAcademic/Hospital2212019
Duke UniversityAcademic/Hospital2022008
Jiao Tong UniversityAcademic/Hospital2212020
New York UniversityAcademic/Hospital2222013
The University of Texas, DallasAcademic/Hospital2122008
AstraZenecaFor profit1012012
Baylor UniversityAcademic/Hospital1012008
Boston Scientific CorporationFor profit1012005
Canadian VIGOUR CentreAcademic/Hospital1012013
CardioVascular Research Foundation, KoreaAcademic/Hospital1012005
Cardiovascular Research Foundation, New YorkAcademic/Hospital1112005
CCRF Consulting Co., Ltd.For profit1112010
Central South UniversityAcademic/Hospital1112019
Centre Hospitalier de PAUAcademic/Hospital1112008
80 organizations
Page 1 / 4

Marketing (29)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGNov 22, 2017
ApotexFor profitSYNJul 6, 2017
ApotexFor profitMKTGJul 6, 2017
Aurobindo PharmaFor profitMKTGJul 27, 2018
BaxaltaFor profitNDA2Dec 21, 2017
CiplaFor profitMKTGJul 16, 2018
Dr. Reddy's LaboratoriesFor profitSYNMay 26, 2017
Dr. Reddy's LaboratoriesFor profitMKTGMay 26, 2017
Eu Yan SangFor profitMKTGJul 16, 2018
Eugia PharmaFor profitMKTGJul 27, 2018
FreseniusFor profitMKTGOct 28, 2016
Hainan GeneralSanyang Pharmaceutical Co.,LtdFor profitMKTGOct 23, 2019
Hainan Poly PharmFor profitMKTGMay 28, 2021
HospiraFor profitMKTGJul 14, 2015
HospiraFor profitSYNJul 14, 2015
Maia Pharms IncFor profitNDA2Jul 25, 2019
MeithealFor profitMKTGJul 16, 2018
MylanFor profitSYNJun 1, 2018
MylanFor profitMKTGFeb 2, 2017
NovartisFor profitNDA2Dec 15, 2000
PfizerFor profitMKTGJul 14, 2015
PlivaFor profitMKTGSep 14, 2016
SLATE RUN PHARMAFor profitMKTGMay 28, 2021
SandozFor profitNDA2Dec 15, 2000
SandozFor profitMKTGDec 15, 2000
ShireFor profitNDA2Dec 21, 2017
ShuangchengFor profitMKTGOct 23, 2019
TevaFor profitMKTGSep 14, 2016
The Medicines CompanyFor profitNDADec 15, 2000