antihemophilic factor viii human
Trade name: Hemofil M
Biologicalapproved
Approved
Mar 11, 1966
Coagulation factor VIII is an essential blood clotting protein. In humans, it is encoded by F8 gene. Defects in this gene result in hemophilia A, an X-linked bleeding disorder. — Wikipedia
Clinical trial activity
75 trials · 49 clinical orgs · 4 marketing orgs
Phase 1
7
Phase 2
39
Phase 3
31
Phase 4
22
Earliest trial started Jul 1, 1997 (NCT01085344)
Timeline
1960s
- Mar 11, 1966
Earliest FDA Approval
1970s
2000s
- Apr 11, 2000
CSL Behring — NDA Secondary Org
- Jan 1, 2001
Earliest Phase 3 Sponsor(trial)
- Mar 14, 2001
Takeda — NDA Secondary Org
- Jan 1, 2004
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2005
Earliest Phase 1 Sponsor(trial)
2010s
- Dec 20, 2010
Octapharma — NDA Secondary Org
Indications
Approved for
Studied for
- Blood Coagulation Disorders · Phase 4
- Blood Loss, Surgical · Phase 2
- Blood Platelet Disorders · Phase 4
- General Surgery · Phase 3
- Healthy Volunteers · Phase 1
- Hematologic Diseases · Phase 4
- Hemophilia A · Phase 4
- Hemophilia B · Phase 4
- Liver Transplantation · Phase 4
- Pharmacokinetics · Phase 4
- von Willebrand Diseases · Phase 4
Mechanism of action
- Coagulation factor VIIIAGONIST
F8 agonist
Approval history
- approvedMar 11, 1966
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaFactor VIII ↗
- NCATS839MOZ74GK ↗
- ChEMBLCHEMBL2109098 ↗
- ChEMBLCHEMBL2108175 ↗
Also known as
- alphanate
- alphanate
- alphanate
- alphanate
- antihemophilic factor
- antihemophilic factor
- antihemophilic factor
- antihemophilic factor b
- antihemophilic factor human
- antihemophilic factor (human)
- antihemophilic factor,human
- antihemophilic factor, human
- antihemophilic factor, human
- antihemophilic factor viii human
- bioclate
- bioclate
- coagulation factor viii
- coagulation factor viii
- coagulation factor viii, procoagulant component (hemophilia a) protein, human
- f8b protein, human
- f8 protein, human
- f8 protein, human
- factor viii
- factor viii (antihaemophilic factor)
- factor viii (human)
- factor viii, human
- fviii protein, human
- haemate p
- haemate-p
- helixate
- helixate
- hemofil
- hemofil hm
- hemofil m
- hemofil m
- hemofil m
- hemophil
- humafac
- human coagulation factor viii
- human coagulation factor viii
- humate-p
- humate-p
- koate-hp
- kogenate
- kogenate
- kogenate
- kogenate
- kogenate fs
- kovaltry
- proplex t
- xyntha
- xyntha
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07265843 | Phase 4 | Jan 1, 2026 | Trauma Hemostatis and Oxygenation Research (THOR) Network |
| NCT06764927 | Phase 4 | Oct 31, 2025 | University of Pittsburgh |
| NCT06297655 | Phase 3 | Apr 30, 2024 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT03622476 | Phase 4 | Jun 30, 2018 | Capital Medical University |
| NCT03095287 | Phase 2 | Jun 1, 2017 | Grifols |
| NCT02888223 | Phase 1 | Sep 1, 2016 | Central South University, Sinocelltech Ltd. |
| NCT02930317 | Phase 3 | Aug 1, 2016 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT03598725 | Phase 4 | Jan 1, 2016 | Capital Medical University |
| NCT02586012 | Phase 2 | Sep 1, 2015 | University of Pittsburgh |
| NCT02461992 | Phase 1 | Jul 1, 2015 | Pfizer |
| NCT02727647 | Phase 4 | May 1, 2015 | Chulalongkorn University |
| NCT02492984 | Phase 4 | Apr 1, 2015 | Pfizer |
| NCT02256917 | Phase 3 | Mar 1, 2015 | Georgetown University, Octapharma |
| NCT02479087 | Phase 4 | Jan 1, 2015 | Bankura Sammilani Medical College, Sintesi Research Srl, University of Milan |
| NCT02280265 | N/A | Nov 1, 2014 | Nanjing Medical University |
| NCT01992549 | Phase 3 | Apr 1, 2014 | Octapharma |
| NCT02472665 | Phase 4 | Dec 1, 2013 | Grifols |
| NCT01863758 | Phase 3 | Aug 1, 2013 | Octapharma |
| NCT01811875 | Phase 4 | Jun 1, 2013 | Bio Products Laboratory |
| NCT01619046 | Phase 3 | Mar 1, 2013 | Atlantic Research Group, Green Cross Corporation, University of Oxford |
Showing 20 of 75 trials
Page 1 / 4
Organizations
Research & Development (49)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bayer | For profit | 13 | 13 | 4 | 2004 |
| Bio Products Laboratory | For profit | 8 | 8 | 3 | 2001 |
| Octapharma | For profit | 8 | 8 | 2 | 2010 |
| Pfizer | For profit | 8 | 8 | 3 | 2002 |
| Grifols | For profit | 6 | 4 | 3 | 2003 |
| Baxalta | For profit | 5 | 5 | 3 | 2003 |
| CSL Behring | For profit | 5 | 1 | 3 | 2001 |
| Wyeth | For profit | 5 | 0 | 2 | 2002 |
| University of Pittsburgh | Academic/Hospital | 3 | 3 | 3 | 2012 |
| Biogen | For profit | 2 | 0 | 1 | 2010 |
| Biotest Pharmaceuticals | For profit | 2 | 0 | 1 | 2009 |
| Bioverativ Therapeutics Inc. | For profit | 2 | 2 | 1 | 2010 |
| Capital Medical University | Academic/Hospital | 2 | 2 | 1 | 2016 |
| Charta Fondazione | Academic/Hospital | 2 | 0 | 1 | 2009 |
| City of Hope National Medical Center | Academic/Hospital | 2 | 2 | 1 | 2009 |
| Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd | For profit | 2 | 2 | 1 | 2016 |
| Sintesi Research Srl | For profit | 2 | 0 | 1 | 2010 |
| Swedish Orphan Biovitrum | For profit | 2 | 0 | 1 | 2010 |
| University of Manchester | Academic/Hospital | 2 | 0 | 2 | 2002 |
| University of Milan | Academic/Hospital | 2 | 1 | 1 | 2010 |
49 organizations
Page 1 / 3
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| CSL Behring | For profit | NDA2 | Apr 11, 2000 |
| Grifols | For profit | NDA2 | Jan 24, 1974 |
| Grifols | For profit | NDA | Jan 24, 1974 |
| Octapharma | For profit | NDA2 | Dec 20, 2010 |
| Takeda | For profit | NDA2 | Mar 14, 2001 |