Drugs / Abciximab
Abciximab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | REOPRO | — | 1997-11-05 – 2001-01-23 | fda.gov ↗ |
| Approved | US (FDA) | REOPRO | — | 1994-12-22 | fda.gov ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00178451 | — | carotid stenosis | University of Rochester | Withdrawn | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT01932554 | Nov 2013 → Mar 2015 | sickle cell disease | St. Louis University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03087539 | May 2013 → Dec 2016 | acute myocardial infarction | ISU Abxis Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT00163254 | Sep 2003 → Nov 2006 | — | University Hospital Tuebingen | Unknown | No outcome recorded |
| Phase 2 | NCT00046293 | Sep 2002 → Jul 2007 | cerebral infarction | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00039832 | Mar 2002 → Apr 2007 | stroke disorder | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT00299377 | Jan 2006 → Nov 2007 | myocardial infarction | University of Leipzig | Completed | Met primary |
| Phase 2/3 | NCT00156611 | Jan 2002 → Dec 2009 | arterial occlusion | University Hospital Tuebingen | Unknown | No outcome recorded |
| Phase 311 trials · 2 met primary · 4 missed | ||||||
| Phase 3 | NCT00894023 | Jun 2009 → Dec 2010 | acute myocardial infarction | Gennaro Sardella | Terminated | No outcome recorded |
| Phase 3 | NCT00712101 | Jul 2008 → Apr 2011 | ST-elevation myocardial infarction | University of Leipzig | Completed | Missed primary |
| Phase 3 | NCT00167765 | Mar → May 2005 | stroke disorder | University of Zurich | Terminated | No outcome recorded |
| Phase 3 | NCT00638638 | Jan 2005 → Aug 2009 | myocardial infarction | University Hospital, Strasbourg, France | Unknown | Missed primary |
| Phase 3 | NCT00126139 | Apr 2004 → May 2005 | internal carotid artery stenosis, ischemic stroke | University of Zurich | Terminated | No outcome recorded |
| Phase 3 | NCT00073372 | Oct 2003 → Dec 2005 | brain ischemia, stroke disorder | Centocor, Inc. | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT00046228 | Aug 2002 → Jan 2008 | myocardial infarction | Centocor, Inc. | Completed | Missed primary |
| Phase 3 | NCT00245648 | Jun 2001 → Oct 2007 | myocardial infarction | NYU Langone Health | Completed | No outcome recorded |
| Phase 3 | NCT02181985 | May 2000 → Apr 2001 | myocardial infarction | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00269906 | May 1993 → Dec 1995 | intermediate coronary syndrome | Centocor, Inc. | Completed | Met primary |
| Phase 3 | NCT00269893 | Nov 1991 → Nov 1992 | intermediate coronary syndrome | Centocor, Inc. | Completed | Met primary |
| Phase 411 trials · 1 met primary · 4 missed | ||||||
| Phase 4 | NCT01475552 | Sep 2010 → Sep 2011 | diabetes mellitus | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01080638 | Aug 2009 → Dec 2012 | myocardial infarction | Seoul National University Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT00440778 | Feb 2007 → Oct 2008 | ischemic disease, myocardial infarction | Laval University | Completed | No outcome recorded |
| Phase 4 | NCT00440895 | Feb 2007 → Oct 2012 | ischemic disease, myocardial infarction | Olivier F. Bertrand | Completed | No outcome recorded |
| Phase 4 | NCT00420030 | Sep 2006 → Jun 2009 | cardiogenic shock | Charles University, Czech Republic | Completed | Missed primary |
| Phase 4 | NCT00373451 | Jul 2006 → May 2011 | coronary artery disorder, myocardial infarction | German Heart Center Munich | Completed | Missed primary |
| Phase 4 | NCT00354406 | Apr 2006 → Nov 2008 | myocardial infarction | University of Pisa | Completed | No outcome recorded |
| Phase 4 | NCT01757457 | Apr 2006 → Apr 2008 | myocardial infarction | Azienda Ospedaliero Universitaria Maggiore della Carita | Completed | Missed primary |
| Phase 4 | NCT00320229 | Dec 2004 → Jul 2005 | coronary artery disorder, myocardial infarction | Azienda Sanitaria Ospedaliera | Terminated | No outcome recorded |
| Phase 4 | NCT00169819 | Oct 2003 → Apr 2006 | coronary artery disorder, ischemic disease | Laval University | Completed | Met primary |
| Phase 4 | NCT00133250 | Jun 2003 → Feb 2008 | myocardial infarction | German Heart Center Munich | Completed | Missed primary |
| Phase not applicable2 trials · 1 met primary | ||||||
| — | NCT02105870 | Feb 2012 → Jun 2014 | coronary artery disorder, myocardial infarction | University of Melbourne | Unknown | No outcome recorded |
| — | NCT00976521 | Sep 2009 → Feb 2012 | acute myocardial infarction | Atrium Medical Corporation | Completed | Met primary |
| Comparator or background therapy13 trials | ||||||
| Phase 2 | NCT01020383 Comparator | Sep 2009 → Apr 2011 | intermediate coronary syndrome, myocardial infarction | Ablynx, a Sanofi company | Completed | No outcome recorded |
| Phase 2 | NCT01103440 Comparator | Apr 2007 → Jun 2009 | — | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 3 | NCT00426751 Comparator | Oct 2006 → Dec 2007 | myocardial infarction | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00269880 Comparator | Feb → Dec 1995 | — | Centocor, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01499407 Comparator | Dec 2011 → Dec 2012 | ST-elevation myocardial infarction | CLI Foundation | Unknown | No outcome recorded |
| Phase 4 | NCT01404507 Comparator | Dec 2010 → Feb 2012 | acute myocardial infarction | Yonsei University | 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 | NCT00929279 Comparator | Nov 2008 → May 2009 | acute coronary syndrome | Università degli Studi di Ferrara | Completed | No outcome recorded |
| Phase 4 | NCT00986050 Comparator | Jan 2006 → May 2008 | acute myocardial infarction | Catharina Ziekenhuis Eindhoven | Completed | No outcome recorded |
| Phase 4 | NCT00383136 Comparator | Jun 2003 → Sep 2007 | acute myocardial infarction | University of Bologna | Completed | Missed primary |
| Phase 4 | NCT00133003 Comparator | Mar 2003 → Jan 2006 | intermediate coronary syndrome | German Heart Center Munich | Completed | No outcome recorded |
| — | NCT00927615 Comparator | Sep 2008 → May 2010 | ST-elevation myocardial infarction | University Medical Center Groningen | Unknown | No outcome recorded |
| — | NCT00685464 Comparator | Jan 2006 → Dec 2008 | atherosclerosis, ischemic disease | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2004-07-16 | Eli Lilly and Company | New Treatment Guidelines Cite ReoPro Favorably for PCI in Acute Heart Attack Patients lilly.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 47 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Abciximab | “The GUSTO (Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes) V Investigators studied standard-dose reteplase vs standard-dose abciximab plus...” PMID 17954798 ↗ Oct 200742“10 patients who received a bolus of IC abciximab (0.25 mg/kg); 10 patients who received only AT; and 20 patients who received both treatments.” PMID 24719126 ↗ Apr 2014 “All patients in both arms will receive intravenous abciximab infusion following the PCI for 12 hours per standard practice.” NCT00894023 ↗ “Abciximab bolus of 0.25mg /Kg, followed by a 12-h infusion 0.125 microg/Kg/min” NCT00929279 ↗ “a fixed dose of abciximab for ischemic stroke” NCT00046293 ↗ “Abciximab” NCT01103440 ↗ |
| Known as | Abciximab (genetical recombination) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201584 ↗ |
| Known as | Abciximab (ReoPro) | “Abciximab (ReoPro)” NCT00440778 ↗1“Abciximab (ReoPro)” NCT00440895 ↗ |
| Known as | C7E3 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201584 ↗ |
| Known as | Clotinab | “Exploratory P2 Trial to Evaluate Efficacy and Safety of Clotinab® (Abciximab) in Acute MI Patients” NCT03087539 ↗ |
| Known as | ReoPro | “This study will evaluate the safety and effectiveness of two types of blood thinners, abciximab (ReoPro) and reteplase (Retavase) for restoring normal brain blood flow after...” NCT00039832 ↗4“Abciximab (ReoPro) in Acute Ischemic Stroke: A Phase III, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Trial.” NCT00073372 ↗ “Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI” NCT01757457 ↗ |
| Action | Inhibit | “abciximab, a blocker of platelet glycoprotein (GP) IIb/IIIa receptors” NCT00126139 ↗ |
| Modality | Monoclonal antibody | “abciximab (a monoclonal-antibody Fab fragment directed against the receptor)” PMID 9182212 ↗ Jun 1997 |
| Route | Intravenous | “Patients will receive either abciximab and reteplease or abciximab and placebo into a vein in their arm for up to 12 hours.” NCT00046228 ↗ |