protamine sulfate
Small moleculeapproved
Approved
Aug 13, 1969
Protamine sulfate is a medication that is used to reverse the effects of heparin. It is specifically used in heparin overdose, in low molecular weight heparin overdose, and to reverse the effects of heparin during delivery and heart surgery. It is given by injection into a vein. The onset of effects is typically within five minutes. — Wikipedia
Clinical trial activity
14 trials · 20 clinical orgs · 6 marketing orgs
Phase 1
1
Phase 2
3
Phase 3
2
Phase 4
8
Earliest trial started Aug 1, 2003 (NCT00073593)
Timeline
1980s
- Nov 5, 1986
West-Ward Pharmaceutical — Marketing Organization
- Nov 5, 1986
Hikma — Marketing Organization
- Apr 7, 1987
Fresenius — Marketing Organization
Indications
Approved for
Studied for
- Anticoagulants · Phase 4
- Aortic Valve Stenosis · Phase 4
- Atrial Fibrillation · Phase 4
- Blood Coagulation · Phase 4
- Cardiopulmonary Bypass · Phase 4
- Catheter Ablation · Phase 4
- Coronary Artery Bypass · Phase 3
- Coronary Artery Disease · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Heart Valve Diseases · Phase 3
- Obesity · Phase 4
- Thoracic Surgery · Phase 4
Mechanism of action
- HeparinINHIBITOR
Heparin inhibitor
Approval history
- approvedAug 13, 1969
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaProtamine sulfate ↗
- NCATS72G3UY6T4N ↗
- ChEMBLCHEMBL2108125 ↗
- ChEMBLCHEMBL1201651 ↗
Also known as
- prosulf
- protamin
- protamine
- protamine
- protamine
- protamine
- protamine
- protamine hydrochloride
- protamine sulfate
- protamine sulfate
- protamine sulfate
- protamine sulfate
- protamine sulfate
- protamine sulfate
- protamine sulfate
- protamine sulfate
- protamine sulfates
- protamine sulphate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06215378 | Phase 3 | Oct 1, 2024 | Action Research Group, Assistance Publique - Hôpitaux de Paris |
| NCT06254404 | N/A | Mar 15, 2024 | University of Liege |
| NCT05774691 | Phase 4 | Nov 1, 2023 | St. Antonius Hospital, Nieuwegein |
| NCT05426031 | Phase 4 | Jun 28, 2022 | University of Miami |
| NCT04628884 | Phase 4 | Nov 15, 2020 | Fundacion Abood Shaio, Fundacion Clinica Shaio, Bogota, Colombia, Universidad El Bosque, Bogotá |
| NCT03787641 | N/A | Sep 20, 2018 | University of Western Ontario |
| NCT03140631 | Phase 4 | Mar 23, 2017 | University of Michigan |
| NCT02974660 | Phase 4 | Dec 1, 2016 | Medical University of Warsaw |
| NCT02675647 | Phase 4 | Dec 1, 2015 | University of Strasbourg |
| NCT01267487 | Phase 4 | Jul 1, 2009 | Federal University of Rio Grande do Sul, SANE-Society of Anesthesiology |
| NCT00684450 | N/A | Jun 1, 2008 | Organon, University of Montreal |
| NCT00669149 | Phase 4 | Jun 1, 2008 | Centre Hospitalier de PAU, CH de Pau |
| NCT02452307 | Phase 1/Phase 2 (Phase 2) | Apr 1, 2004 | University of Tuebingen |
| NCT00073593 | Phase 3 | Aug 1, 2003 | The Medicines Company |
Showing 14 of 14 trials
Page 1 / 1
Organizations
Research & Development (20)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Action Research Group | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Centre Hospitalier de PAU | Academic/Hospital | 1 | 1 | 1 | 2008 |
| CH de Pau | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Federal University of Rio Grande do Sul | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Fundacion Abood Shaio | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Fundacion Clinica Shaio, Bogota, Colombia | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Medical University of Warsaw | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Organon | For profit | 1 | 0 | 1 | 2008 |
| SANE-Society of Anesthesiology | Academic/Hospital | 1 | 1 | 1 | 2009 |
| St. Antonius Hospital, Nieuwegein | Academic/Hospital | 1 | 1 | 1 | 2023 |
| The Medicines Company | For profit | 1 | 1 | 1 | 2003 |
| Universidad El Bosque, Bogotá | Academic/Hospital | 1 | 0 | 1 | 2020 |
| University of Liege | Academic/Hospital | 1 | 1 | 1 | 2024 |
| University of Miami | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of Michigan | Academic/Hospital | 1 | 1 | 1 | 2017 |
| University of Montreal | Academic/Hospital | 1 | 1 | 1 | 2008 |
| University of Strasbourg | Academic/Hospital | 1 | 1 | 1 | 2015 |
| University of Tuebingen | Academic/Hospital | 1 | 1 | 1 | 2004 |
| University of Western Ontario | Academic/Hospital | 1 | 1 | 1 | 2018 |
20 organizations
Page 1 / 1
Marketing (7)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Athenex, Inc. | For profit | MKTG | — |
| Eli Lilly | For profit | NDA | Aug 13, 1969 |
| Fresenius | For profit | MKTG | Apr 7, 1987 |
| Hikma | For profit | SYN | Nov 5, 1986 |
| Hikma | For profit | MKTG | Nov 5, 1986 |
| Pharmacia & Upjohn | For profit | NDA2 | — |
| West-Ward Pharmaceutical | For profit | MKTG | Nov 5, 1986 |