coagulation factor ix (Recombinant)
Trade name: Rixubis
Recombinant proteinapprovedOrphan Drug FDA
Approved
Feb 11, 1997
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
25 trials · 14 clinical orgs · 5 marketing orgs
Phase 1
3
Phase 2
15
Phase 3
16
Phase 4
5
Earliest trial started Dec 1, 2001 (NCT00581126)
Timeline
1990s
- Oct 3, 1994
Orphan Drug Designation
- Feb 11, 1997
Earliest FDA Approval
- Feb 11, 1997
American Home Products — NDA Secondary Org
2010s
- Jan 1, 2010
Earliest Phase 1 Sponsor(trial)
- Jun 26, 2013
Takeda — NDA Secondary Org
- Apr 29, 2015
Medexus — NDA Secondary Org
- May 31, 2017
Novo Nordisk — NDA Secondary Org
Indications
Approved for
Studied for
Mechanism of action
- Coagulation factor IXEXOGENOUS PROTEIN
Coagulation factor IX exogenous protein
- Coagulation factor IXSupplementation
F9 supplementation
Approval history
- approvedFeb 11, 1997
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaFactor IX ↗
- NCATS382L14738L ↗
- ChEMBLCHEMBL3039538 ↗
- ChEMBLCHEMBL2109205 ↗
Also known as
- bax326
- benefix
- benefix
- benefix
- coagulation factor ix (recombinant)
- coagulation factor ix (recombinant)
- coagulation factor ix recombinant human
- factor ix (recombinant)
- ib1001
- ib1001
- nonacog alfa
- nonacog alfa
- nonacog alfa
- nonacog alfa
- nonacog alfa
- nonacog gamma
- recombinant coagulation factor ix
- recombinant factor ix
- rixubis
- rixubis
- trenonacog alfa
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04286412 | Phase 4 | Feb 10, 2020 | Pfizer |
| NCT03855280 | Phase 3 | Aug 15, 2019 | Aptevo Therapeutics |
| NCT03565237 | Phase 4 | Aug 28, 2018 | Shire |
| NCT03417245 | Phase 3 | Jul 2, 2018 | Genzyme, Sanofi |
| NCT02213250 | Phase 1 | Mar 1, 2015 | Pfizer |
| NCT02336178 | Phase 4 | Jan 1, 2015 | Pfizer |
| NCT02048111 | Phase 3 | Mar 1, 2014 | Cangene |
| NCT01507896 | Phase 3 | Dec 1, 2011 | Baxalta |
| NCT01488994 | Phase 2/Phase 3 (Phase 3) | Dec 1, 2011 | Baxalta |
| NCT01335061 | Phase 3 | Sep 1, 2011 | Pfizer |
| NCT01286779 | Phase 3 | Apr 12, 2011 | Baxalta, Shire |
| NCT01272206 | Phase 1 | Jan 1, 2011 | Novo Nordisk |
| NCT01271868 | Phase 3 | Nov 1, 2010 | Aptevo Therapeutics |
| NCT01233440 | Phase 1 | Oct 1, 2010 | CSL Behring |
| NCT01174446 | Phase 3 | Jul 1, 2010 | Baxalta |
| NCT01027364 | Phase 3 | Dec 1, 2009 | Biogen, Bioverativ Therapeutics Inc., Swedish Orphan Biovitrum |
| NCT00866606 | Phase 3 | Feb 1, 2009 | Pfizer |
| NCT00768287 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2009 | Aptevo Therapeutics |
| NCT00749476 | Phase 4 | Apr 1, 2008 | Pfizer, Wyeth |
| NCT00364182 | Phase 3 | May 1, 2007 | Pfizer |
Showing 20 of 25 trials
Page 1 / 2
Organizations
Research & Development (14)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Pfizer | For profit | 11 | 11 | 3 | 2001 |
| Wyeth | For profit | 5 | 0 | 2 | 2001 |
| Baxalta | For profit | 4 | 4 | 1 | 2010 |
| Aptevo Therapeutics | For profit | 3 | 3 | 1 | 2009 |
| Shire | For profit | 2 | 1 | 2 | 2011 |
| Biogen | For profit | 1 | 0 | 1 | 2009 |
| Bioverativ Therapeutics Inc. | For profit | 1 | 1 | 1 | 2009 |
| Cangene | For profit | 1 | 1 | 1 | 2014 |
| CSL Behring | For profit | 1 | 1 | 1 | 2010 |
| Genzyme | For profit | 1 | 1 | 1 | 2018 |
| Grifols | For profit | 1 | 1 | 1 | 2005 |
| Novo Nordisk | For profit | 1 | 1 | 1 | 2011 |
| Sanofi | For profit | 1 | 0 | 1 | 2018 |
| Swedish Orphan Biovitrum | For profit | 1 | 0 | 1 | 2009 |
14 organizations
Page 1 / 1
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| American Home Products | For profit | NDA2 | Feb 11, 1997 |
| Baxalta | For profit | NDA | — |
| Medexus | For profit | NDA2 | Apr 29, 2015 |
| Novo Nordisk | For profit | NDA2 | May 31, 2017 |
| Takeda | For profit | NDA2 | Jun 26, 2013 |