antithrombin iii (human)
Trade name: thrombate iii
BiologicalapprovedOrphan Drug FDA
Approved
Dec 30, 1991
Antithrombin (AT) is a small glycoprotein that inactivates several enzymes of the coagulation system. It is a 464-amino-acid protein produced by the liver. It contains three disulfide bonds and a total of four possible glycosylation sites. α-Antithrombin is the dominant form of antithrombin found in blood plasma and has an oligosaccharide occupying each of its four glycosylation sites. A single glycosylation site remains consistently un-occupied in the minor form of antithrombin, β-antithrombin. Its activity is increased manyfold by the anticoagulant drug heparin, which enhances the binding of antithrombin to factor IIa (thrombin) and factor Xa. — Wikipedia
Clinical trial activity
34 trials · 33 clinical orgs · 1 marketing orgs
Phase 1
9
Phase 2
19
Phase 3
12
Phase 4
4
Earliest trial started Dec 1, 2002 (NCT00056550)
Timeline
1980s
- Nov 26, 1984
Orphan Drug Designation
1990s
Indications
Approved for
Studied for
- Acute Coronary Syndrome · Phase 4
- Antithrombin III Deficiency · Phase 4
- Aortic Valve Insufficiency · Phase 4
- Aortic Valve Stenosis · Phase 4
- Blood Coagulation · Phase 3
- Cardiopulmonary Bypass · Phase 3
- Coronary Artery Bypass · Phase 2
- COVID-19 · Phase 2
- Deficiency Diseases · Phase 2
- Disseminated Intravascular Coagulation · Phase 2
- Drugs, Investigational · Phase 1
- Extracorporeal Membrane Oxygenation · Phase 3
- Healthy Volunteers · Phase 1
- Heart Defects, Congenital · Phase 1
- Hemophilia A · Phase 3
- Hepatic Veno-Occlusive Disease · Phase 2
- Liver Cirrhosis · Phase 1
- Mitral Valve Insufficiency · Phase 4
- Mitral Valve Stenosis · Phase 4
- Neonatology · Phase 4
- Postoperative Hemorrhage · Phase 1
- Pre-Eclampsia · Phase 3
- Reperfusion Injury · Phase 2
- Thoracic Surgery · Phase 2
- Thromboembolism · Phase 2
- Thrombosis · Phase 3
- Traumatology · Phase 2
- Venous Thromboembolism · Phase 2
Mechanism of action
- AntithrombinAGONIST
antithrombin/ AT agonist
Approval history
- approvedDec 30, 1991
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaAntithrombin ↗
- NCATSAWV6I5L6H2 ↗
- ChEMBLCHEMBL2108574 ↗
- ChEMBLCHEMBL1201554 ↗
- NCATST0LTO7L82X ↗
Also known as
- antithrombin alfa
- antithrombin alfa
- antithrombin alfa
- antithrombin alfa
- antithrombin iii
- antithrombin iii
- antithrombin iii
- antithrombin iii
- antithrombin iii human
- antithrombin iii human
- antithrombin iii (human)
- antithrombin iii (human)
- antithrombin iii,human
- antithrombin iii, human
- antithrombin iii human plasma-derived
- at iii
- at-iii
- heparin cofactor b
- human anti-thrombin-iii
- human antithrombin iii
- kybernin
- npb-06
- thrombate iii
- thrombate iii
- thrombate iii
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07285460 | Phase 3 | Dec 19, 2025 | Sanofi |
| NCT06145373 | Phase 1 | Dec 15, 2023 | Sanofi |
| NCT05794165 | Phase 2 | Sep 5, 2023 | University of Texas at Houston |
| NCT05662319 | Phase 3 | Jan 13, 2023 | Sanofi |
| NCT04918173 | Phase 3 | Oct 31, 2021 | Octapharma |
| NCT04899232 | Phase 2 | Jul 6, 2021 | Grifols, University of Miami |
| NCT04055389 | Phase 1 | Jan 31, 2020 | Grifols, Pennsylvania State University |
| NCT04219579 | N/A | Jan 1, 2020 | Seoul National University |
| NCT04182373 | Phase 3 | Nov 30, 2019 | Japan Blood Products Organization, Kyowa Hakko Kirin |
| NCT03208270 | Phase 3 | Jul 28, 2017 | The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, University of Milan, University of Turin |
| NCT03090893 | Early Phase 1 (Phase 1) | Jul 1, 2017 | LFB Biotechnologies, SAS, Mayo Clinic |
| NCT02278575 | Phase 4 | Jan 1, 2016 | Octapharma, University of Gothenburg, Vastra Gotaland Region |
| NCT02631174 | Phase 1 | Jun 1, 2015 | Grifols, University of Cincinnati |
| NCT02251041 | Phase 2 | Sep 1, 2014 | Katholieke Universiteit Leuven |
| NCT02250391 | Phase 3 | Sep 1, 2014 | Nihon Pharmaceutical Co., Ltd |
| NCT02059135 | Phase 3 | Jul 11, 2014 | LFB Biotechnologies, SAS, Yale University |
| NCT02103114 | Phase 2 | Jun 1, 2014 | Duke University, Grifols |
| NCT02037555 | Phase 2 | Mar 1, 2014 | Grifols |
| NCT01886443 | Phase 1 | Aug 1, 2013 | Katholieke Universiteit Leuven |
| NCT01913444 | Phase 4 | Jul 1, 2013 | University of Southern California |
Showing 20 of 34 trials
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Organizations
Research & Development (33)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Grifols | For profit | 7 | 3 | 3 | 2006 |
| LFB Biotechnologies, SAS | For profit | 7 | 3 | 3 | 2002 |
| Sanofi | For profit | 3 | 3 | 2 | 2023 |
| Katholieke Universiteit Leuven | Academic/Hospital | 2 | 2 | 2 | 2013 |
| Kyowa Hakko Kirin | For profit | 2 | 2 | 1 | 2011 |
| Mayo Clinic | Academic/Hospital | 2 | 2 | 2 | 2012 |
| Octapharma | For profit | 2 | 1 | 2 | 2016 |
| Seoul National University | Academic/Hospital | 2 | 2 | 2 | 2013 |
| University of Glasgow | Academic/Hospital | 2 | 0 | 1 | 2002 |
| Children's National Medical Center | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Duke University | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Japan Blood Products Organization | For profit | 1 | 0 | 1 | 2019 |
| Korea University | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Leo Pharma | For profit | 1 | 1 | 1 | 2007 |
| Medical College of Wisconsin | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Nihon Pharmaceutical Co., Ltd | For profit | 1 | 1 | 1 | 2014 |
| Pennsylvania State University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| SK Chemicals | For profit | 1 | 1 | 1 | 2008 |
| The Mediterranean Institute for Transplantation and Advanced Specialized Therapies | Academic/Hospital | 1 | 0 | 1 | 2017 |
33 organizations
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