thrombin (human coagulation factor iia)
Trade name: Evithrom
Biologicalapproved
Approved
Aug 27, 2007
Clinical trial activity
13 trials · 10 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
7
Phase 3
4
Phase 4
4
Earliest trial started Dec 1, 2000 (NCT00512356)
Timeline
2000s
- Jan 1, 2000
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2004
Earliest Phase 3 Sponsor(trial)
- Aug 27, 2007
Earliest FDA Approval
- Aug 28, 2007
Omrix Biopharmaceuticals, Inc. — First NDA Organization
- Aug 28, 2007
Omrix Biopharmaceuticals, Inc. — NDA Organization
Indications
Approved for
Studied for
- Blood Loss, Surgical · Phase 4
- Burns · Phase 2/Phase 3
- Dura Mater · Phase 2
- General Surgery · Phase 4
- Hemorrhage · Phase 4
- Hemostasis · Phase 4
- Intraoperative Complications · Phase 3
- Lung Diseases · Phase 3
- Pancreatic Neoplasms · Phase 4
- Pathology · Phase 2
- Rhytidoplasty · Phase 2
- Thrombosis · Phase 4
- Tissue Adhesions · Phase 2
Mechanism of action
- ThrombinSupplementation
F2 supplementation
Approval history
- approvedAug 27, 2007
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL2108110 ↗
Also known as
- evithrom
- thrombin
- thrombin
- thrombin
- thrombin
- thrombin
- thrombin human
- thrombin (human)
- thrombin human plasma-derived
- thrombin, topical (human)
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04814433 | N/A | Mar 24, 2021 | New York University |
| NCT03461406 | Phase 3 | Dec 30, 2018 | Grifols |
| NCT03269955 | Phase 4 | Feb 27, 2017 | University of Ulsan |
| NCT02014402 | Phase 2 | Dec 1, 2013 | Grifols |
| NCT00983112 | Phase 4 | Sep 1, 2009 | Clinique Mutualiste Chirurgicale de la Loire |
| NCT00708071 | Phase 2 | Jun 1, 2008 | Baxalta |
| NCT00681824 | Phase 2 | May 1, 2008 | Baxalta |
| NCT00440401 | Phase 4 | Feb 1, 2007 | Nycomed |
| NCT00293514 | Phase 3 | Feb 1, 2006 | Nycomed |
| NCT00591916 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2006 | The University of Texas, Dallas, University of Texas, Galveston |
| NCT00196534 | Phase 3 | Nov 1, 2004 | Ethicon, Omrix Biopharmaceuticals, Inc. |
| NCT00290836 | Phase 4 | May 1, 2004 | Nycomed |
| NCT00512356 | Phase 2 | Dec 1, 2000 | Baxalta |
Showing 13 of 13 trials
Page 1 / 1
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Baxalta | For profit | 3 | 3 | 1 | 2000 |
| Nycomed | For profit | 3 | 3 | 2 | 2004 |
| Grifols | For profit | 2 | 2 | 2 | 2013 |
| Clinique Mutualiste Chirurgicale de la Loire | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Ethicon | For profit | 1 | 1 | 1 | 2004 |
| New York University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Omrix Biopharmaceuticals, Inc. | For profit | 1 | 0 | 1 | 2004 |
| The University of Texas, Dallas | Academic/Hospital | 1 | 0 | 1 | 2006 |
| University of Texas, Galveston | Academic/Hospital | 1 | 1 | 1 | 2006 |
| University of Ulsan | Academic/Hospital | 1 | 1 | 1 | 2017 |
10 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Omrix Biopharmaceuticals, Inc. | For profit | NDA | Aug 28, 2007 |