Drugs / Bivalirudin
Bivalirudin
also known as
Angiomax · Angiomax (bivalirudin) · BIV · Bivalirudin (Angiox; The Medicine Company - NJ 07054 U.S.A) · BVR
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Angiox | — | 2018-06-21 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | ANGIOMAX | — | 2005-06-13 – 2005-11-30 | fda.gov ↗ |
| Approved | EU (EMA) | Angiox | — | 2004-09-20 | europa.eu ↗ |
| Approved | US (FDA) | ANGIOMAX | — | 2000-12-15 | fda.gov ↗ |
Trials 47
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00812370 | Sep 2008 → Jan 2013 | venous thromboembolism | Children's Hospital Los Angeles | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06080074 | Apr 2025 → Sep 2027 expected | cardiogenic shock, cardiomyopathy, congenital heart disease, heart failure | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT03567408 | Sep 2018 → Aug 2019 | coronary artery disorder | Qian Gong | Unknown | No outcome recorded |
| Phase 2 | NCT00503126 | Aug 2007 → Jul 2008 | — | The Medicines Company | Completed | No outcome recorded |
| Phase 2 | NCT00043277 | Aug 2002 → Dec 2004 | thrombotic disease | The Medicines Company | Completed | No outcome recorded |
| Phase 315 trials · 2 met primary · 2 missed | ||||||
| Phase 3 | NCT04532333 | Aug 2020 → May 2021 | acquired aneurysmal subarachnoid hemorrhage | Changhai Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02897037 | Nov 2016 → Jun 2017 | acute myocardial infarction | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT02448550 | May 2015 → May 2016 | — | Kaiser Permanente | Terminated | No outcome recorded |
| Phase 3 | NCT02565147 | Dec 2014 → Jun 2016 | acute myocardial infarction | The Medicines Company | Terminated | Missed primary |
| Phase 3 | NCT01913483 | Sep 2013 → Mar 2016 | hemorrhagic disease, peripheral arterial disease | The Medicines Company | Terminated | Missed primary |
| Phase 3 | NCT01651780 | Oct 2012 → Jun 2015 | aortic valve stenosis | The Medicines Company | Completed | Mixed |
| Phase 3 | NCT01555658 | Apr → Sep 2012 | coronary artery disorder | University of Roma La Sapienza | Unknown | No outcome recorded |
| Phase 3 | NCT01087723 | Mar 2010 → Aug 2013 | acute coronary syndrome | The Medicines Company | Completed | Met primary |
| Phase 3 | NCT00616460 | Feb 2008 → Oct 2011 | hematologic disorder | HaEmek Medical Center, Israel | Completed | No outcome recorded |
| Phase 3 | NCT00079508 | Apr 2004 → Oct 2005 | cardiovascular disorder | The Medicines Company | Completed | No outcome recorded |
| Phase 3 | NCT00079586 | Apr → Nov 2004 | coronary artery intramyocardial course | The Medicines Company | Completed | No outcome recorded |
| Phase 3 | NCT00093184 | Apr 2004 → Dec 2005 | myocardial infarction | The Medicines Company | Completed | No outcome recorded |
| Phase 3 | NCT00093158 | Aug 2003 → Jan 2007 | intermediate coronary syndrome, myocardial infarction | The Medicines Company | Completed | Met primary |
| Phase 3 | NCT00073593 | Aug 2003 → May 2004 | cardiac valvular defect, coronary artery intramyocardial course | The Medicines Company | Completed | No outcome recorded |
| Phase 3 | NCT00043940 | Apr 1999 → Feb 2003 | heparin-induced thrombocytopenia | The Medicines Company | Completed | No outcome recorded |
| Phase 420 trials · 4 met primary · 5 missed | ||||||
| Phase 4 | NCT07383155 | Feb 2026 → Dec 2027 expected | acute coronary syndrome, bleeding disorder, vascular-type | Shenyang Northern Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05984537 | Jul 2023 → Dec 2025 overdue | coronary microvascular disorder | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04445935 | Jun → Sep 2020 | — | Hamad Medical Corporation | Unknown | No outcome recorded |
| Phase 4 | NCT04195997 | Feb → Dec 2020 | — | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04185077 | Nov 2019 → Dec 2020 | ST-elevation myocardial infarction | Second Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| Phase 4 | NCT03588611 | Oct 2019 → Jun 2021 | acute coronary syndrome | Han Yaling, MD | Completed | Met primary |
| Phase 4 | NCT04046029 | Jul 2019 → Jul 2020 | acute coronary syndrome, blood coagulation disease | The First Affiliated Hospital of Dalian Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT03965208 | May 2019 → Dec 2020 | — | Legacy Health System | Unknown | No outcome recorded |
| Phase 4 | NCT03882775 | Jan 2019 → Jul 2020 | ST-elevation myocardial infarction | The First Affiliated Hospital of Dalian Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT03664180 | Jan 2019 → Nov 2022 | ST-elevation myocardial infarction | Beijing Anzhen Hospital | Completed | Missed primary |
| Phase 4 | NCT03318393 | Mar 2018 → Oct 2021 | childhood acute lymphoblastic leukemia | University of Texas Southwestern Medical Center | Completed | Missed primary |
| Phase 4 | NCT02787317 | May 2016 → Oct 2017 | coronary artery disorder | Chinese PLA General Hospital | Unknown | Met primary |
| Phase 4 | NCT02592720 | Oct 2015 → Oct 2017 | acute coronary syndrome | Xijing Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02592694 | Oct 2015 → Oct 2017 | ST-elevation myocardial infarction | Xijing Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02311231 | Jun 2014 → Mar 2017 | ST-elevation myocardial infarction | Uppsala University | Completed | Missed primary |
| Phase 4 | NCT01696110 | Aug 2012 → Jul 2013 | acute myocardial infarction | Shenyang Northern Hospital | Completed | Met primary |
| Phase 4 | NCT00976092 | Sep 2009 → Feb 2014 | myocardial infarction | German Heart Center Munich | Unknown | Missed primary |
| Phase 4 | NCT00759083 | Sep 2008 → Sep 2009 | heparin-induced thrombocytopenia | The Medicines Company | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00370045 | Mar 2006 → ? | coronary artery disorder | LifeBridge Health | Unknown | Met primary |
| Phase 4 | NCT00262054 | Nov 2005 → Feb 2008 | coronary artery disorder | German Heart Center Munich | Completed | Missed primary |
| Phase not applicable7 trials · 1 met primary · 1 missed | ||||||
| — | NCT06861374 | May 2025 → Mar 2028 expected | ST-elevation myocardial infarction | First Affiliated Hospital Xi'an Jiaotong University | Not yet recruiting | No outcome recorded |
| — | NCT06275555 | Jun 2024 → Dec 2026 expected | — | Xiaotong Hou | Recruiting | No outcome recorded |
| — | NCT05334654 | Apr → Jun 2022 | COVID-19, acute respiratory failure | University Magna Graecia | Completed | No outcome recorded |
| — | NCT04475835 | Jan 2021 → Dec 2022 | ST-elevation myocardial infarction | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| — | NCT04120961 | Sep 2019 → Aug 2022 | coronary artery disorder | Nanjing First Hospital, Nanjing Medical University | Completed | Missed primary |
| — | NCT03822975 | Feb 2019 → May 2022 | ST-elevation myocardial infarction | Shenyang Northern Hospital | Completed | Met primary |
| — | NCT02384070 | Jan 2009 → Dec 2013 | coronary artery disorder | Odessa Heart Institute | Completed | No outcome recorded |
| Comparator or background therapy17 trials | ||||||
| Phase 1 | NCT03707418 Comparator | Apr → Jun 2021 | — | Johns Hopkins University | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05959252 Comparator | May 2024 → Jun 2026 overdue | — | Sydney Local Health District | Recruiting | No outcome recorded |
| Phase 3 | NCT01848106 Comparator | Sep 2013 → Aug 2014 | coronary artery disorder | Regado Biosciences, Inc. | Terminated | Missed primary |
| Phase 3 | NCT01465503 Comparator | Jan 2008 → Dec 2012 | hemorrhagic disease | Clinica Mediterranea | Completed | No outcome recorded |
| Phase 3 | NCT00464087 Comparator | Jun 2007 → Nov 2010 | acute coronary syndrome | Medstar Health Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT00433966 Comparator | Mar 2005 → Jun 2008 | myocardial infarction | Cardiovascular Research Foundation | Completed | No outcome recorded |
| Phase 4 | NCT01848899 Background | Feb → Nov 2013 | coronary artery disorder | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT01642238 Comparator | Jul 2012 → Mar 2013 | acute coronary syndrome | Juan J Badimon | Completed | No outcome recorded |
| Phase 4 | NCT01519518 Comparator | Feb 2012 → Dec 2013 | ST-elevation myocardial infarction | Liverpool Heart and Chest Hospital NHS Foundation Trust | Completed | No outcome recorded |
| Phase 4 | NCT01158846 Comparator | Aug 2010 → Jun 2011 | ST-elevation myocardial infarction, strictly posterior acute myocardial infarction | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio | Unknown | No outcome recorded |
| Phase 4 | NCT01157455 Background | May 2010 → Mar 2012 | coronary artery disorder | CCRF Consulting Co., Ltd. | Unknown | No outcome recorded |
| Phase 4 | NCT01084993 Comparator | Mar 2010 → Sep 2018 | coronary artery disorder | Laval University | Unknown | No outcome recorded |
| Phase 4 | NCT01464671 Comparator | Jul 2009 → Sep 2014 | coronary artery disorder | Stony Brook University | Terminated | No outcome recorded |
| Phase 4 | NCT00669149 Comparator | Jun 2008 → Aug 2013 | coronary artery disorder | Centre Hospitalier de PAU | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00448461 Comparator | Mar 2007 → Jun 2008 | coronary artery disorder | Careggi Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00373451 Comparator | Jul 2006 → May 2011 | coronary artery disorder, myocardial infarction | German Heart Center Munich | Completed | Missed primary |
| — | NCT03537586 Background | Jun 2018 → Jun 2025 overdue | coronary microvascular disorder, myocardial ischemia | NYU Langone Health | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2009-06-14 | Sequella, Inc. | Regulatory Woman CEO's Proving Glass Ceiling Can be Broken sequella.com ↗
With that additional six months of exclusivity, the FDA will not authorize commercialization of generic versions of bivalirudin prior to September 2010. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2009-06-14 | Sequella, Inc. | Woman CEO's Proving Glass Ceiling Can be Broken sequella.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 66 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bivalirudin | “In the bivalirudin group, an intravenous bolus dose of bivalirudin 0.75 mg/kg will be administered, followed by an intravenous infusion of 1.75 mg/(kg·h).” NCT07383155 ↗63“Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration” NCT02592694 ↗ “cocktail (tirofiban, bivalirudin, tenecteplase)” NCT02592720 ↗ |
| Known as | Angiomax | “A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)” NCT00079586 ↗5“Drug: Bivalirudin Injection [Angiomax]” NCT03707418 ↗ “Angiomax (bivalirudin) anticoagulant” NCT00093184 ↗ “Angiomax (bivalirudin) anticoagulant” NCT00093158 ↗ “Angiomax (bivalirudin)” NCT00079508 ↗ “Angiomax (bivalirudin)” NCT00043277 ↗ |
| Known as | Angiomax (bivalirudin) | “Angiomax (bivalirudin)” NCT01642238 ↗ |
| Known as | BIV | “Bivalirudin (BIV) a synthetic, bivalent, 20-amino acid direct thrombin inhibitor, was found to have the advantages of inhibiting fibrin-bound thrombin” NCT04185077 ↗ |
| Known as | Bivalirudin (Angiox; The Medicine Company - NJ 07054 U.S.A) | “Bivalirudin (Angiox; The Medicine Company - NJ 07054 U.S.A)” NCT01465503 ↗ |
| Known as | BVR | “Bivalirudin (BVR) is a direct thrombin inhibitor used as an adjunctive antithrombotic agent in combination with aspirin and an ADP-receptor blocker in patients with acute...” PMID 24219045 ↗ Dec 2013 |
| Action | Inhibit | “direct thrombin inhibitor” PMID 17368152 ↗ Mar 2007 |
| Modality | Peptide | “Bivalirudin (BIV) a synthetic, bivalent, 20-amino acid direct thrombin inhibitor” NCT04185077 ↗ |
| Route | Intravenous | “intravenous bolus and 1.75-mg/kg/h intravenous infusion” NCT00043940 ↗ |