antihemophilic factor viii (Recombinant), Fc-fusion protein
Trade name: Eloctate
Recombinant proteinapprovedOrphan Drug FDA
Approved
Jun 6, 2014
Clinical trial activity
21 trials · 14 clinical orgs · 2 marketing orgs
Phase 1
5
Phase 2
14
Phase 3
12
Phase 4
2
Earliest trial started Dec 1, 2009 (NCT01027377)
Timeline
2000s
- Jan 1, 2009
Bioverativ Therapeutics Inc. — Earliest Phase 1 Sponsor(trial)
2010s
- Jan 1, 2010
Bioverativ Therapeutics Inc. — Earliest Phase 3 Sponsor(trial)
- Nov 23, 2010
Orphan Drug Designation
- Jun 6, 2014
Biogen-IDEC — Earliest FDA Approval
- Jun 6, 2014
Biogen-IDEC — NDA Organization
- Jun 6, 2014
Bioverativ Therapeutics Inc. — NDA Secondary Org
- Jan 1, 2018
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Coagulation factor VIIIAGONIST
F8 agonist
Approval history
- approvedJun 6, 2014
Chemistry & pharmacology
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Also known as
- antihemophilic factor (recombinant bdd), fc fusion protein
- antihemophilic factor (recombinant, fc fusion protein)
- antihemophilic factor (recombinant), fc fusion protein
- biib031
- biib031
- coagulation factor viii recombinant immunoglubulin g1 fusion protein
- efmoroctocog alfa
- efmoroctocog alfa
- efmoroctocog alfa
- efmoroctocog alfa
- efraloctocog alfa
- elocta
- elocta
- eloctate
- eloctate
- eloctate
- eloctate
- factor viii fc fusion protein
- factor viii-fc fusion protein
- rfviiifc protein
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06142552 | Phase 3 | Nov 30, 2023 | Chinese Academy of Medical Sciences, Jiangsu Gensciences lnc. |
| NCT06136507 | Phase 3 | Nov 25, 2023 | Jiangsu Gensciences lnc. |
| NCT06137092 | Phase 3 | Jul 22, 2023 | AryoGen Pharmed Co., Iran University of Medical Sciences |
| NCT05251090 | Phase 1 | Apr 30, 2022 | Capital Medical University, Jiangsu Gensciences lnc. |
| NCT05265286 | Phase 2 | Apr 14, 2022 | Chinese Academy of Medical Sciences, Jiangsu Gensciences lnc. |
| NCT04864743 | Phase 1 | Jun 22, 2021 | Chinese Academy of Medical Sciences, Jiangsu Gensciences lnc. |
| NCT04845399 | Phase 3 | Apr 16, 2021 | Chinese Academy of Medical Sciences, Government of China, Jiangsu Gensciences lnc. |
| NCT04690322 | Phase 4 | Apr 15, 2021 | The University of Texas, Dallas |
| NCT04728217 | Phase 4 | Apr 15, 2021 | The League of Clinical Research, Russia |
| NCT04456387 | Phase 3 | Oct 15, 2020 | Chinese Academy of Medical Sciences, Government of China, Jiangsu Gensciences lnc. |
| NCT04303572 | Phase 3 | Jun 30, 2020 | Health Resources and Services Administration (HRSA), University of Pittsburgh |
| NCT04303559 | Phase 3 | Jun 30, 2020 | Health Resources and Services Administration (HRSA), University of Pittsburgh |
| NCT02196207 | Phase 2 | Mar 1, 2018 | University of Pittsburgh |
| NCT03272568 | Early Phase 1 (Phase 1) | Feb 14, 2018 | Bioverativ Therapeutics Inc., Emory University |
| NCT02502149 | Phase 3 | Aug 1, 2015 | Bioverativ Therapeutics Inc., Swedish Orphan Biovitrum |
| NCT02234323 | Phase 3 | Jan 1, 2015 | Bioverativ Therapeutics Inc., Swedish Orphan Biovitrum |
| NCT02083965 | Phase 1 | Mar 1, 2014 | Biogen |
| NCT01458106 | Phase 3 | Nov 1, 2012 | Biogen, Bioverativ Therapeutics Inc., Swedish Orphan Biovitrum |
| NCT01454739 | Phase 3 | Dec 1, 2011 | Bioverativ Therapeutics Inc. |
| NCT01181128 | Phase 3 | Nov 1, 2010 | Biogen, Bioverativ Therapeutics Inc., Swedish Orphan Biovitrum |
Showing 20 of 21 trials
Page 1 / 2
Organizations
Research & Development (14)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bioverativ Therapeutics Inc. | For profit | 7 | 6 | 2 | 2009 |
| Jiangsu Gensciences lnc. | For profit | 7 | 5 | 3 | 2020 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 5 | 0 | 3 | 2020 |
| Swedish Orphan Biovitrum | For profit | 4 | 0 | 1 | 2010 |
| Biogen | For profit | 3 | 1 | 2 | 2010 |
| University of Pittsburgh | Academic/Hospital | 3 | 3 | 2 | 2018 |
| Government of China | Government | 2 | 2 | 1 | 2020 |
| Health Resources and Services Administration (HRSA) | Government | 2 | 0 | 1 | 2020 |
| AryoGen Pharmed Co. | For profit | 1 | 1 | 1 | 2023 |
| Capital Medical University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Emory University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Iran University of Medical Sciences | Academic/Hospital | 1 | 0 | 1 | 2023 |
| The League of Clinical Research, Russia | Academic/Hospital | 1 | 1 | 1 | 2021 |
| The University of Texas, Dallas | Academic/Hospital | 1 | 1 | 1 | 2021 |
14 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Biogen-IDEC | For profit | NDA | Jun 6, 2014 |
| Bioverativ Therapeutics Inc. | For profit | NDA2 | Jun 6, 2014 |