thrombin (human coagulation factor iia) (Recombinant)
Trade name: Recothrom
Recombinant proteinapproved
Approved
Jan 17, 2008
Clinical trial activity
8 trials · 9 clinical orgs · 2 marketing orgs
Phase 1
1
Phase 2
6
Phase 3
4
Phase 4
2
Earliest trial started Oct 1, 2005 (NCT00245336)
Timeline
2000s
- Jan 1, 2005
ZymoGenetics — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2006
ZymoGenetics — Earliest Phase 2 Sponsor(trial)
- Jan 17, 2008
ZymoGenetics — Earliest FDA Approval
- Jan 17, 2008
ZymoGenetics — NDA Organization
- Jan 17, 2008
Baxter — NDA Secondary Org
2010s
- Jan 1, 2017
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Mechanism of action
- FibrinogenSupplementation
Fibrinogen supplementation
Approval history
- approvedJan 17, 2008
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- NCATS25ADE2236L ↗
- ChEMBLCHEMBL2108110 ↗
- NCATS6K15ABL77G ↗
Also known as
- recothrom
- thrombin
- thrombin
- thrombin
- thrombin
- thrombin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04459871 | Phase 3 | Nov 8, 2019 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd, Zhejiang University |
| NCT03461406 | Phase 3 | Dec 30, 2018 | Grifols |
| NCT03611426 | Phase 1/Phase 2 (Phase 2) | Nov 29, 2017 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd, Zhejiang University |
| NCT00859547 | Phase 4 | Mar 1, 2009 | University of Arizona, ZymoGenetics |
| NCT00813904 | Phase 4 | Jan 1, 2009 | Lotus Clinical Research, ZymoGenetics |
| NCT00491608 | Phase 3 | Jun 1, 2007 | ZymoGenetics |
| NCT00371215 | Phase 2 | Aug 1, 2006 | ZymoGenetics |
| NCT00245336 | Phase 3 | Oct 1, 2005 | Indiana Spine Group, University of Southern California, Washington University in St. Louis, ZymoGenetics |
Showing 8 of 8 trials
Page 1 / 1
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| ZymoGenetics | For profit | 5 | 5 | 3 | 2005 |
| Suzhou Zelgen Biopharmaceuticals Co.,Ltd | For profit | 2 | 2 | 2 | 2017 |
| Zhejiang University | Academic/Hospital | 2 | 0 | 2 | 2017 |
| Grifols | For profit | 1 | 1 | 1 | 2018 |
| Indiana Spine Group | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Lotus Clinical Research | For profit | 1 | 0 | 1 | 2009 |
| University of Arizona | Academic/Hospital | 1 | 0 | 1 | 2009 |
| University of Southern California | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Washington University in St. Louis | Academic/Hospital | 1 | 0 | 1 | 2005 |
9 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Baxter | For profit | NDA2 | Jan 17, 2008 |
| ZymoGenetics | For profit | NDA | Jan 17, 2008 |