human coagulation factor ix
Trade name: Mononine
Recombinant proteinapprovedOrphan Drug FDA
Approved
Dec 31, 1990
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
15 trials · 15 clinical orgs · 3 marketing orgs
Phase 1
5
Phase 2
9
Phase 3
6
Phase 4
3
Earliest trial started Mar 1, 1992 (NCT00004801)
Timeline
1980s
- Jun 27, 1989
Orphan Drug Designation
1990s
2000s
- Mar 17, 2000
CSL Behring — NDA Secondary Org
2010s
- Jan 1, 2019
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Studied for
Mechanism of action
- Coagulation factor IXAGONIST
F9 agonist
- Coagulation factor IXEXOGENOUS PROTEIN
Coagulation factor IX exogenous protein
Approval history
- approvedDec 31, 1990
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaFactor IX ↗
- NCATS6U90Y1795T ↗
- ChEMBLCHEMBL4297986 ↗
- ChEMBLCHEMBL2109098 ↗
- ChEMBLCHEMBL2108175 ↗
Also known as
- 4f-pcc
- alphanine
- alphanine
- alphanine sd
- antihemophilic factor
- antihemophilic factor/von willebrand factor complex (human)
- coagulation factor ix
- coagulation factor ix
- coagulation factor ix
- coagulation factor ix human
- coagulation factor ix (human)
- coagulation factor ix (human)
- coagulation factor ix, ii, vii and x in combination
- factor ix
- factor ix fraction
- factor ix fraction
- factor viii - von willebrand factor
- factor viii, von willebrand factor drug combination
- human coagulation factor ix
- human coagulation factor ix
- human coagulation factor ix
- konyne 80
- mononine
- mononine
- octocog alfa
- pcc
- pcc
- plasma concentrate factor ix
- plasma concentrate factor ix
- profilate heat-treated
- profilate hp
- profilate osd
- profilate sd
- profilnine
- profilnine sd
- replenine
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05281718 | Early Phase 1 (Phase 1) | Aug 1, 2022 | Genentech, Tulane University |
| NCT03995784 | Phase 2 | Jun 18, 2019 | Catalyst Biosciences |
| NCT02695160 | Phase 1 | Jun 1, 2016 | Sangamo BioSciences |
| NCT01687608 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2012 | Baxalta |
| NCT01440946 | Phase 3 | Jun 1, 2012 | Biogen, Bioverativ Therapeutics Inc., Swedish Orphan Biovitrum |
| NCT01233440 | Phase 1 | Oct 1, 2010 | CSL Behring |
| NCT01128881 | Phase 4 | May 1, 2010 | Baxalta |
| NCT02250573 | Phase 3 | Dec 1, 2005 | Bio Products Laboratory |
| NCT02263469 | Phase 3 | Aug 1, 2005 | Bio Products Laboratory |
| NCT00139828 | Phase 4 | May 1, 2003 | Sanquin, Utrecht University |
| NCT02250560 | Phase 3 | Apr 1, 2000 | Bio Products Laboratory |
| NCT01561391 | Phase 4 | Apr 1, 1998 | Novo Nordisk |
| NCT02231944 | Phase 3 | Jul 1, 1997 | Bio Products Laboratory |
| NCT02263456 | Phase 3 | Jul 1, 1997 | Bio Products Laboratory |
| NCT00004801 | Phase 1/Phase 2 (Phase 2) | Mar 1, 1992 | National Center for Research Resources (NCRR), University of North Carolina at Chapel Hill |
Showing 15 of 15 trials
Page 1 / 1
Organizations
Research & Development (15)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bio Products Laboratory | For profit | 5 | 5 | 1 | 1997 |
| Baxalta | For profit | 2 | 2 | 2 | 2010 |
| Biogen | For profit | 1 | 0 | 1 | 2012 |
| Bioverativ Therapeutics Inc. | For profit | 1 | 1 | 1 | 2012 |
| Catalyst Biosciences | For profit | 1 | 1 | 1 | 2019 |
| CSL Behring | For profit | 1 | 1 | 1 | 2010 |
| Genentech | For profit | 1 | 0 | 1 | 2022 |
| National Center for Research Resources (NCRR) | Government | 1 | 1 | 1 | 1992 |
| Novo Nordisk | For profit | 1 | 1 | 1 | 1998 |
| Sangamo BioSciences | For profit | 1 | 1 | 1 | 2016 |
| Sanquin | Academic/Hospital | 1 | 1 | 1 | 2003 |
| Swedish Orphan Biovitrum | For profit | 1 | 0 | 1 | 2012 |
| Tulane University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of North Carolina at Chapel Hill | Academic/Hospital | 1 | 0 | 1 | 1992 |
| Utrecht University | Academic/Hospital | 1 | 0 | 1 | 2003 |
15 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Baxalta | For profit | NDA | — |
| CSL Behring | For profit | NDA2 | Mar 17, 2000 |
| Grifols | For profit | NDA2 | Dec 31, 1990 |