abciximab
Trade name: Reopro
mAbapproved
Approved
Dec 22, 1994
Abciximab, a glycoprotein IIb/IIIa receptor antagonist manufactured by Janssen Biologics BV and distributed by Eli Lilly under the trade name ReoPro, is a platelet aggregation inhibitor mainly used during and after coronary artery procedures like angioplasty to prevent platelets from sticking together and causing thrombus formation within the coronary artery. It is a glycoprotein IIb/IIIa inhibitor. — Wikipedia
Clinical trial activity
49 trials · 51 clinical orgs · 2 marketing orgs
Phase 1
1
Phase 2
20
Phase 3
15
Phase 4
22
Earliest trial started Nov 1, 1991 (NCT00269893)
Timeline
1990s
- Jan 1, 1991
- Dec 22, 1994
Johnson and Johnson — Earliest FDA Approval
- Dec 22, 1994
Centocor — Marketing Organization
- Dec 22, 1994
Johnson and Johnson — NDA Secondary Org
- Dec 22, 1994
Johnson and Johnson — NDA Organization
Indications
Approved for
Studied for
- Acute Coronary Syndrome · Phase 4
- Acute Disease · Phase 3
- Anemia, Sickle Cell · Phase 2
- Angina Pectoris · Phase 2
- Angioplasty · Phase 4
- Angioplasty, Balloon, Coronary · Phase 3
- Arterial Occlusive Diseases · Phase 2/Phase 3
- Brain Ischemia · Phase 3
- Carotid Stenosis · Phase 1/Phase 2
- Constriction, Pathologic · Phase 3
- Coronary Artery Disease · Phase 4
- Coronary Disease · Phase 4
- Diabetes Mellitus · Phase 4
- Hemoglobins · Phase 2
- Infarction, Middle Cerebral Artery · Phase 4
- Ischemia · Phase 4
- Myocardial Infarction · Phase 4
- Pain · Phase 2
- Shock, Cardiogenic · Phase 4
- ST Elevation Myocardial Infarction · Phase 4
- Stroke · Phase 3
Mechanism of action
- Integrin alpha-IIbINHIBITOR
ITGA2B inhibitor
- Integrin alpha-IIb/beta-3INHIBITOR
Integrin alpha-IIb/beta-3 inhibitor
Beta subunit is binding site
- Integrin alpha-V/beta-3INHIBITOR
Integrin alpha-V/beta-3 inhibitor
Beta subunit is binding site
Approval history
- approvedDec 22, 1994
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaAbciximab ↗
- NCATSX85G7936GV ↗
- ChEMBLCHEMBL1201584 ↗
Also known as
- 7e3
- 7e3
- 7e3 antibody
- abciximab
- abciximab
- abciximab
- abciximab
- abciximab
- abciximab
- abciximab
- abciximab
- abciximab
- abxicimab
- antigpiibiiia
- c7e3
- c7e3
- c7e3
- c7e3 fab
- centorx
- chimeric 7e3 fab
- clotinab
- clotinab
- reopro
- reopro
- reopro
- reopro
- reopro
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02739711 | Phase 4 | Jul 1, 2016 | University of Lubeck |
| NCT01932554 | Phase 2 | Nov 1, 2013 | Janssen Pharmaceutica NV, St. Louis University |
| NCT02016547 | Phase 4 | Sep 1, 2013 | SOS Attaque Cérébrale |
| NCT03087539 | Phase 2 | May 1, 2013 | Chonnam National University, ISU Abxis Co., Ltd. |
| NCT02105870 | N/A | Feb 1, 2012 | University of Melbourne |
| NCT01499407 | Phase 4 | Dec 1, 2011 | CLI Foundation |
| NCT01404507 | Phase 4 | Dec 1, 2010 | Korean Society of Interventional Cardiology, Yonsei University |
| NCT01475552 | Phase 4 | Sep 1, 2010 | Seoul National University |
| NCT01158846 | Phase 4 | Aug 1, 2010 | Istituto Clinico Humanitas - Rozzano (MI), Italy, Istituto Clinico Sant'Ambrogio, University of Milan |
| NCT01080638 | Phase 4 | Oct 1, 2009 | Seoul National University |
| NCT00976521 | N/A | Sep 1, 2009 | Atrium Medical Corporation, Columbia University |
| NCT01020383 | Phase 2 | Sep 1, 2009 | Ablynx |
| NCT00894023 | Phase 3 | Jun 1, 2009 | University of Roma La Sapienza |
| NCT00929279 | Phase 4 | Nov 1, 2008 | University of Ferrara |
| NCT00927615 | N/A | Sep 1, 2008 | University of Groningen |
| NCT00712101 | Phase 3 | Jul 1, 2008 | University of Leipzig, University of Ulm |
| NCT00841438 | Phase 4 | Jul 1, 2007 | ISU ABXIS, Yonsei University |
| NCT01103440 | N/A | Apr 1, 2007 | Icahn School of Medicine at Mount Sinai |
| NCT00440778 | Phase 4 | Feb 1, 2007 | Cordis, Eli Lilly, Laval University |
| NCT00440895 | Phase 4 | Feb 1, 2007 | Cordis, Eli Lilly, Laval University |
Showing 20 of 49 trials
Page 1 / 3
Organizations
Research & Development (51)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Eli Lilly | For profit | 11 | 0 | 3 | 2002 |
| Centocor | For profit | 6 | 6 | 1 | 1991 |
| Laval University | Academic/Hospital | 3 | 3 | 1 | 2003 |
| Technical University of Munich | Academic/Hospital | 3 | 3 | 1 | 2003 |
| Cordis | For profit | 2 | 0 | 1 | 2007 |
| National Institute of Neurological Disorders and Stroke (NINDS) | Government | 2 | 2 | 1 | 2002 |
| Seoul National University | Academic/Hospital | 2 | 2 | 1 | 2009 |
| University of Ferrara | Academic/Hospital | 2 | 2 | 1 | 2004 |
| University of Leipzig | Academic/Hospital | 2 | 2 | 1 | 2006 |
| University of Tuebingen | Academic/Hospital | 2 | 2 | 2 | 2002 |
| University of Zurich | Academic/Hospital | 2 | 2 | 1 | 2004 |
| Yonsei University | Academic/Hospital | 2 | 2 | 1 | 2007 |
| Ablynx | For profit | 1 | 1 | 1 | 2009 |
| Atrium Medical Corporation | For profit | 1 | 1 | 1 | 2009 |
| Azienda Sanitaria Ospedaliera | Academic/Hospital | 1 | 1 | 1 | 2004 |
| Boehringer Ingelheim | For profit | 1 | 1 | 1 | 2000 |
| Bristol-Myers Squibb | For profit | 1 | 0 | 1 | 2003 |
| Charles University | Academic/Hospital | 1 | 1 | 1 | 2006 |
| Chonnam National University | Academic/Hospital | 1 | 0 | 1 | 2013 |
| CLI Foundation | Academic/Hospital | 1 | 1 | 1 | 2011 |
51 organizations
Page 1 / 3
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Centocor | For profit | MKTG | Dec 22, 1994 |
| Johnson and Johnson | For profit | NDA2 | Dec 22, 1994 |
| Johnson and Johnson | For profit | NDA | Dec 22, 1994 |