Drugs / Protamine Sulfate
Protamine Sulfate
also known as
Protamine · Novo protamine sulfate · Prosulf · Protamine sulphate · Protamines · Protamini sulfas · Sulfate de protamine · Sulfato de protamina
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | PROTAMINE SULFATE | — | 1969-08-13 | fda.gov ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT06215378 | May 2025 → Mar 2027 expected | aortic valve stenosis | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05426031 | Jun 2022 → Jun 2023 | disseminated intravascular coagulation | University of Miami | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07477977 | Mar → Jun 2026 overdue | — | Sohag University | Recruiting | No outcome recorded |
| — | NCT06254404 | Mar → Oct 2024 | hyperheparinemia | University of Liege | Unknown | No outcome recorded |
| — | NCT03787641 | Sep 2018 → Dec 2019 | — | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Unknown | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 3 | NCT00073593 Comparator | Aug 2003 → May 2004 | cardiac valvular defect, coronary artery intramyocardial course | The Medicines Company | Completed | No outcome recorded |
| Phase 4 | NCT05774691 Comparator | Nov 2023 → Jan 2026 | aortic valve stenosis | St. Antonius Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04628884 Comparator | Nov 2020 → Nov 2021 | poisoning | Fundación Clínica Shaio | Unknown | No outcome recorded |
| Phase 4 | NCT03140631 Comparator | Mar → Nov 2017 | atrial fibrillation | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT02974660 Comparator | Dec 2016 → Jul 2020 | aortic valve stenosis | Medical University of Warsaw | Completed | No outcome recorded |
| Phase 4 | NCT01267487 Comparator | Jul 2009 → Mar 2010 | — | SANE-Society of Anesthesiology | Completed | No outcome recorded |
| Phase 4 | NCT00253851 Background | Jul 2003 → May 2011 | osteoarthritis, venous thromboembolism | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| — | NCT00684450 Comparator | Jun 2008 → Jun 2011 | hemorrhagic disease | Montreal Heart Institute | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Protamine Sulfate | “The second syringe will contain either protamine sulfate (1.0 mg/kg) to reverse the systemic heparin for patients in the treatment group, or normal saline for the control group” NCT00253851 ↗6“Protamine Sulfate will be administered via an infusion pump to administer a 50 mg test doze, then 100 mg after 5 min waiting period.” NCT03787641 ↗ |
| Known as | Novo protamine sulfate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201651 ↗ |
| Known as | Prosulf | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201651 ↗ |
| Known as | Protamine | “Protamine reverses the effect of heparin by binding to each heparin molecule” NCT04628884 ↗ |
| Known as | Protamine sulphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201651 ↗ |
| Known as | Protamines | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201651 ↗ |
| Known as | Protamini sulfas | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201651 ↗ |
| Known as | Sulfate de protamine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201651 ↗ |
| Known as | Sulfato de protamina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201651 ↗ |
| Modality | Protein / enzyme biologic | “Protamine sulfate is a highly basic protein” NCT03140631 ↗ |
| Route | Intravenous | “Following cuff inflation, the contents of a second syringe will be administered IV over a 5 minute period” NCT00253851 ↗ |