coagulation factor viia (recombinant)
Trade name: NovoSevenRT
Recombinant proteinapprovedOrphan Drug FDA
Approved
Mar 25, 1999
Clinical trial activity
74 trials · 47 clinical orgs · 2 marketing orgs
Phase 1
19
Phase 2
44
Phase 3
21
Phase 4
7
Earliest trial started Apr 1, 1998 (NCT01561391)
Timeline
1980s
- Jun 6, 1988
Orphan Drug Designation
1990s
- Mar 25, 1999
Novo Nordisk — Earliest FDA Approval
- Mar 25, 1999
Novo Nordisk — NDA Secondary Org
- Mar 25, 1999
Novo Nordisk — NDA Organization
2000s
- Jan 1, 2001
Novo Nordisk — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2001
Novo Nordisk — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2002
Novo Nordisk — Earliest Phase 3 Sponsor(trial)
2020s
- Apr 1, 2020
Laboratoire français de Fractionnement et de Biotechnologies — NDA Secondary Org
Indications
Studied for
- Blood Coagulation · Phase 1
- Blood Coagulation Disorders · Phase 3
- Burns · Phase 3
- Cerebral Hemorrhage · Phase 3
- Coronary Artery Disease · Phase 3
- Cystitis · Phase 2
- Deficiency Diseases · Phase 1
- Dengue Virus · Phase 2
- Factor VII Deficiency · Phase 3
- Factor VIII · Phase 4
- Fibrosis · Phase 2
- General Surgery · Phase 3
- Healthy Volunteers · Phase 1
- Heart Valve Diseases · Phase 3
- Hemophilia A · Phase 4
- Hemophilia B · Phase 4
- Hemorrhage · Phase 3
- Hemorrhagic Disorders · Phase 1
- Hemostasis · Phase 2
- Intracranial Hemorrhages · Phase 1
- Myocardial Ischemia · Phase 3
- Postpartum Hemorrhage · Phase 4
- Spinal Fusion · Phase 2
- Stroke · Phase 2
- Wounds and Injuries · Phase 3
Mechanism of action
- Coagulation factor VIIEXOGENOUS PROTEIN
Coagulation factor VII exogenous protein
- Coagulation factor VIISupplementation
F7 supplementation
Approval history
- approvedMar 25, 1999
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- NCATSAC71R787OV ↗
- ChEMBLCHEMBL2108405 ↗
- ChEMBLCHEMBL2108334 ↗
Also known as
- coagulation factor viia
- coagulation factor viia
- coagulation factor viia (recombinant)
- coagulation factor viia (recombinant)
- coagulation factor viia recombinant human
- coagulation factor viia recombinant human
- coagulation factor viia recombinant human
- eptacog alfa
- eptacog alfa
- eptacog alfa
- eptacog alfa
- eptacog alfa
- eptacog alfa (activated)
- eptacog alfa (activated)
- eptacog alfa (activated)
- eptacog alfa (activated)
- factor viia
- novoseven
- novoseven
- novo seven
- recombinant coagulation factor viia
- recombinant factor viia
- recombinant fviia
- recombinant human factor viia
- rfviia
- rfviia
- rviia-fp
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07227246 | Phase 3 | May 6, 2025 | Japan Agency for Medical Research and Development, National Institute of Neurological Disorders and Stroke (NINDS), Novo Nordisk, University of Cincinnati |
| NCT05487976 | Phase 3 | Apr 28, 2022 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT04563520 | Phase 3 | Dec 31, 2021 | Emory University, Takeda |
| NCT04647227 | Phase 4 | Jun 28, 2021 | American Thrombosis and Hemostasis Network, LFB Biotechnologies, SAS, Louisiana Center for Advanced Medicine, University of Minnesota |
| NCT04789954 | Early Phase 1 (Phase 1) | Dec 29, 2020 | AryoGen Pharmed Co. |
| NCT04768699 | Phase 1 | Dec 1, 2020 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT04543383 | Phase 1 | Jul 27, 2020 | Janssen Pharmaceutica NV |
| NCT03496883 | Phase 3 | Jan 31, 2020 | National Institute of Neurological Disorders and Stroke (NINDS), Novo Nordisk, University of Cincinnati |
| NCT03417102 | Phase 3 | Mar 22, 2018 | Genzyme, Sanofi |
| NCT03196284 | Phase 2 | Aug 15, 2017 | Novo Nordisk |
| NCT03079063 | Phase 3 | Mar 1, 2017 | AryoGen Pharmed Co. |
| NCT02548143 | Phase 3 | Aug 1, 2016 | Laboratoire français de Fractionnement et de Biotechnologies, LFB Biotechnologies, SAS, Memorial Hermann Health System |
| NCT02448680 | Phase 3 | Dec 1, 2015 | Laboratoire français de Fractionnement et de Biotechnologies, LFB Biotechnologies, SAS, University of Colorado, Denver |
| NCT02622321 | Phase 3 | Nov 18, 2015 | Chugai, Roche |
| NCT02484638 | Phase 2/Phase 3 (Phase 3) | Jul 1, 2015 | CSL Behring |
| NCT02470871 | Phase 1 | Jul 1, 2015 | CSL Behring |
| NCT02020369 | Phase 3 | Apr 1, 2014 | Laboratoire français de Fractionnement et de Biotechnologies, LFB Biotechnologies, SAS, University of Montpellier |
| NCT02084810 | Phase 1 | Mar 1, 2014 | Novo Nordisk |
| NCT01949792 | Phase 1 | Sep 1, 2013 | Novo Nordisk |
| NCT01757405 | Phase 3 | Feb 1, 2013 | Baxalta |
Showing 20 of 74 trials
Page 1 / 4
Organizations
Research & Development (47)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novo Nordisk | For profit | 42 | 40 | 4 | 1998 |
| LFB Biotechnologies, SAS | For profit | 5 | 4 | 3 | 2012 |
| CSL Behring | For profit | 3 | 3 | 2 | 2012 |
| Laboratoire français de Fractionnement et de Biotechnologies | For profit | 3 | 0 | 1 | 2014 |
| National Institute of Neurological Disorders and Stroke (NINDS) | Government | 3 | 0 | 2 | 2010 |
| University of Cincinnati | Academic/Hospital | 3 | 3 | 2 | 2010 |
| AryoGen Pharmed Co. | For profit | 2 | 2 | 2 | 2017 |
| Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd | For profit | 2 | 2 | 2 | 2020 |
| Tel Aviv University | Academic/Hospital | 2 | 2 | 2 | 2005 |
| University of Montpellier | Academic/Hospital | 2 | 0 | 2 | 2007 |
| American Thrombosis and Hemostasis Network | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Austin Health | Academic/Hospital | 1 | 1 | 1 | 2005 |
| Baxalta | For profit | 1 | 1 | 1 | 2013 |
| Bayer | For profit | 1 | 1 | 1 | 2012 |
| Canadian Institutes of Health Research (CIHR) | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Centre Hospitalier Universitaire de Nīmes | Academic/Hospital | 1 | 1 | 1 | 2007 |
| Chugai | For profit | 1 | 0 | 1 | 2015 |
| Emory University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Genzyme | For profit | 1 | 1 | 1 | 2018 |
| Janssen Pharmaceutica NV | For profit | 1 | 1 | 1 | 2020 |
47 organizations
Page 1 / 3
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Laboratoire français de Fractionnement et de Biotechnologies | For profit | NDA2 | Apr 1, 2020 |
| Novo Nordisk | For profit | NDA2 | Mar 25, 1999 |
| Novo Nordisk | For profit | NDA | Mar 25, 1999 |