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| Withdrawn | EU (EMA) | Angiox | — | 2018-06-21 | europa.eu ↗ |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 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 17 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03707418 Comparator | Apr → Jun 2021 | — | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05959252 Comparator | May 2024 → Jun 2026 overdue | — | Sydney Local Health District | Recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT01848106 Comparator | Sep 2013 → Aug 2014 | coronary artery disorder | Regado Biosciences, Inc. | Terminated | No outcome recorded |
| 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 410 trials | ||||||
| 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 |
| 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 | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03537586 Background | Jun 2018 → Jun 2025 overdue | coronary microvascular disorder, myocardial ischemia | NYU Langone Health | Active not recruiting | No outcome recorded |
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” NCT00093158 ↗ “Angiomax (bivalirudin) anticoagulant” NCT00093184 ↗ “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 ↗ |