Drugs / Eptifibatide
Eptifibatide
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | INTEGRILIN | — | 1999-09-20 – 2003-06-16 | fda.gov ↗ |
| Approved | EU (EMA) | Integrilin | — | 1999-07-01 | europa.eu ↗ |
| Approved | US (FDA) | INTEGRILIN | — | 1998-05-18 | fda.gov ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05415150 | Feb 2022 → Aug 2023 | ischemic stroke | Baylor College of Medicine | Unknown | No outcome recorded |
| Phase 1/2 | NCT00834899 | Jan 2009 → Mar 2012 | sickle cell disease | University of North Carolina, Chapel Hill | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00250991 | Jul 2003 → Jul 2007 | stroke disorder | University of Cincinnati | Completed | No outcome recorded |
| Phase 25 trials · 2 missed | ||||||
| Phase 2 | NCT02204852 | Sep 2014 → Aug 2016 | infectious disease with sepsis | Sisse R. Ostrowski, MD PhD DMSc | Completed | Missed primary |
| Phase 2 | NCT01977456 | Sep 2013 → Jan 2015 | brain infarction, ischemic stroke | Arthur Pancioli | Completed | No outcome recorded |
| Phase 2 | NCT01532544 | Jun 2012 → Mar 2014 | pneumonia | Thrombologic ApS | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00894803 | Jul 2009 → Oct 2012 | brain infarction, ischemic stroke | University of Cincinnati | Completed | Missed primary |
| Phase 2 | NCT00061373 | May 2003 → Dec 2009 | ischemic stroke | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 39 trials · 2 met primary · 3 missed | ||||||
| Phase 3 | NCT07347626 | Mar 2026 → Sep 2029 expected | ischemic stroke | Xinqiao Hospital of Chongqing | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03735979 | Oct 2019 → Dec 2023 | ischemic stroke | Washington University School of Medicine | Completed | Missed primary |
| Phase 3 | NCT03844594 | Apr 2019 → Jun 2020 | ischemic stroke | Ministry of Science and Technology of the People´s Republic of China | Unknown | Met primary |
| Phase 3 | NCT01076764 | Apr 2010 → May 2013 | acute coronary syndrome | Sanofi | Completed | Missed primary |
| Phase 3 | NCT00638976 | Nov 2007 → Feb 2010 | cardiovascular disorder | Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS | Completed | No outcome recorded |
| Phase 3 | NCT00812435 | Aug 2007 → Jul 2010 | myocardial infarction | Medstar Health Research Institute | Terminated | No outcome recorded |
| Phase 3 | NCT00426751 | Oct 2006 → Dec 2007 | myocardial infarction | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00251823 | Jul 2005 → Sep 2008 | myocardial infarction | Ottawa Heart Institute Research Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00089895 | Nov 2004 → Nov 2008 | acute coronary syndrome | Organon and Co | Completed | Missed primary |
| Phase 45 trials · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT01454440 | Oct 2007 → Oct 2009 | coronary artery disorder | University of Turin, Italy | Terminated | Missed primary |
| Phase 4 | NCT00370045 | Mar 2006 → ? | coronary artery disorder | LifeBridge Health | Unknown | Met primary |
| Phase 4 | NCT00289601 | Mar 2006 → Dec 2007 | — | Brigham and Women's Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT01863134 | Jan 2005 → Dec 2010 | myocardial infarction | Medical University of Silesia | Completed | No outcome recorded |
| Phase 4 | NCT00111566 | Dec 2004 → Jul 2007 | coronary artery disorder, myocardial infarction | Cardiology Research UBC | Completed | Met primary |
| Comparator or background therapy8 trials | ||||||
| Phase 2 | NCT02925923 Comparator | Nov 2016 → Jan 2018 | acute coronary syndrome, intermediate coronary syndrome | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT01919723 Comparator | Feb 2014 → Dec 2015 | acute coronary syndrome | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT01522417 Comparator | Apr 2012 → Dec 2018 | acute coronary syndrome, intermediate coronary syndrome, myocardial infarction | Medicure | Completed | Met primary |
| Phase 2 | NCT00945308 Comparator | Aug 2009 → Feb 2010 | acute myocardial infarction | Assaf-Harofeh Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT00719914 Comparator | Nov 2007 → Nov 2008 | ST-elevation myocardial infarction | Brigham and Women's Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01103440 Comparator | Apr 2007 → Jun 2009 | — | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 2 | NCT00317395 Comparator | Jun 2006 → Oct 2008 | coronary artery disorder | Sanofi | Completed | Missed primary |
| Phase 4 | NCT02739711 Comparator | Jul 2016 → May 2024 | acute myocardial infarction | University of Luebeck | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-11-04 | Medicure | Results Medicure Announces that the Shortened AGGRASTAT® Versus INTEGRILIN® in Percutaneous Coronary Intervention (SAVI-PCI) Study has Met its Primary Endpoint medicure.com ↗
Medicure Announces that the Shortened AGGRASTAT® Versus INTEGRILIN® in Percutaneous Coronary Intervention (SAVI-PCI) Study has Met its Primary Endpoint |
| 2016-02-23 | Medicure | Results Meta-Analysis of AGGRASTAT® (Tirofiban HCl) Presented at CRT 2016 Conference medicure.com ↗
Results of the analysis found that HDB tirofiban had a significant reduction in all-cause mortality when compared with both heparin and eptifibatide (Integrilin ® , Merck & Co., Inc.) (p<0.05). |
All press releases naming this drug 2 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | eptifibatide | “There is another compound eptifibatide (Integrilin), that is also a GP IIb/IIIa which is in use in acute coronary syndromes.” NCT05415150 ↗28“Patients in the treatment group (n = 62) received eptifibatide (n = 41) or tirofiban (n = 21).” PMID 39217605 ↗ Dec 2024 “Patients will be randomized to eptifibatide or no eptifibatide.” NCT00812435 ↗ “integrilin (eptifibatide)” NCT00250991 ↗ “Eptifibatide” NCT01103440 ↗ |
| Known as | Eptifibatida | ChEMBL registry synonym — accepted as the source's own label CHEMBL1174 ↗ |
| Known as | Eptifibatide accord | ChEMBL registry synonym — accepted as the source's own label CHEMBL1174 ↗ |
| Known as | Integrelin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1174 ↗ |
| Known as | Integrilin | “Eptifibatide ( Integrilin) a cyclic heptapeptide antagonist of the GP IIb/IIIa integrin receptor, is an intravenous antagonist with rapid onset and short half-life.” NCT01863134 ↗5“There is another compound eptifibatide (Integrilin), that is also a GP IIb/IIIa which is in use in acute coronary syndromes.” NCT05415150 ↗ “eptifibatide (Integrilin, GSK) vs matched placebo.” NCT00638976 ↗ “Eptifibatide (Integrilin)” NCT07347626 ↗ |
| Known as | Integrillin | “Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg orally...” NCT01863134 ↗ |
| Action | Inhibit | “another GP IIb/IIIa receptor inhibitor, eptifibatide” PMID 20670755 ↗ Aug 2010 |
| Modality | Other / unclassified | “Gp IIb/IIIa inhibitor eptifibatide” NCT00638976 ↗ |
| Route | Intravenous | “Eptifibatide administered iv according to dose escalation group.” NCT00061373 ↗ |