coagulation factor ix (Recombinant), Fc-fusion protein
Trade name: Alprolix
BiologicalapprovedOrphan Drug FDA
Approved
Mar 28, 2014
Factor IX, also known as Christmas factor, is one of the serine proteases involved in coagulation; it belongs to peptidase family S1. Deficiency of this protein causes haemophilia B. — Wikipedia
Clinical trial activity
7 trials · 6 clinical orgs · 1 marketing orgs
Phase 1
3
Phase 2
4
Phase 3
4
Phase 4
0
Earliest trial started Apr 1, 2008 (NCT00716716)
Timeline
2000s
- Jan 1, 2008
Bioverativ Therapeutics Inc. — Earliest Phase 1 Sponsor(trial)
- Oct 30, 2008
Orphan Drug Designation
- Jan 1, 2009
Bioverativ Therapeutics Inc. — Earliest Phase 3 Sponsor(trial)
2010s
- Mar 28, 2014
Bioverativ Therapeutics Inc. — Earliest FDA Approval
- Mar 28, 2014
Bioverativ Therapeutics Inc. — NDA Organization
Indications
Approved for
Mechanism of action
- Coagulation factor IXAGONIST
F9 agonist
Approval history
- approvedMar 28, 2014
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaFactor IX ↗
Also known as
- alprolix
- alprolix
- alprolix
- coagulation factor ix (recombinant), fc fusion protein
- eftrenonacog alfa
- eftrenonacog alfa
- eftrenonacog alfa
- eftrenonacog alfa
- eftrenonacog alfa
- eftrenonacog alfa (genetical recombination)
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03272568 | Early Phase 1 (Phase 1) | Feb 14, 2018 | Bioverativ Therapeutics Inc., Emory University |
| NCT03075670 | Phase 1 | Mar 7, 2017 | Novo Nordisk |
| NCT02234310 | Phase 3 | Nov 1, 2014 | Bioverativ Therapeutics Inc., Swedish Orphan Biovitrum |
| NCT01440946 | Phase 3 | Jun 1, 2012 | Biogen, Bioverativ Therapeutics Inc., Swedish Orphan Biovitrum |
| NCT01425723 | Phase 3 | Dec 1, 2011 | Bioverativ Therapeutics Inc. |
| NCT01027364 | Phase 3 | Dec 1, 2009 | Biogen, Bioverativ Therapeutics Inc., Swedish Orphan Biovitrum |
| NCT00716716 | Phase 1 | Apr 1, 2008 | Biogen, Bioverativ Therapeutics Inc., Swedish Orphan Biovitrum, Syntonix Pharmaceuticals |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bioverativ Therapeutics Inc. | For profit | 6 | 5 | 2 | 2008 |
| Swedish Orphan Biovitrum | For profit | 4 | 0 | 2 | 2008 |
| Biogen | For profit | 3 | 0 | 2 | 2008 |
| Emory University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Novo Nordisk | For profit | 1 | 1 | 1 | 2017 |
| Syntonix Pharmaceuticals | For profit | 1 | 0 | 1 | 2008 |
6 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bioverativ Therapeutics Inc. | For profit | NDA | Mar 28, 2014 |