Drugs / Lepirudin
Lepirudin
also known as
Refludan · Hirudin lepirudin · Lepirudin recombinant · Lepirudina · Lepirudine · Recombinant Desulfato Hirudin
Protein / enzyme biologic targets F2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Refludan | — | 2012-04-24 | europa.eu ↗ |
| Approved | EU (EMA) | Refludan | — | 1997-03-13 | europa.eu ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00003726 | Nov 1998 → Jul 2001 | lung cancer | Dartmouth-Hitchcock Medical Center | Terminated | No outcome recorded Stop: Business |
| Phase 21 trial | ||||||
| Phase 2 | NCT00039767 | May 2002 → Apr 2006 | thrombotic disease | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT00798525 Comparator | Jan 2009 → Mar 2012 | heparin-induced thrombocytopenia | Heinrich-Heine University, Duesseldorf | Terminated | No outcome recorded |
| Phase 4 | NCT00603824 Comparator | Jan 2008 → Jul 2009 | heparin-induced thrombocytopenia | Methodist Healthcare - Memphis | Withdrawn | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | lepirudin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00003726 ↗ |
| Known as | Hirudin lepirudin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201666 ↗ |
| Known as | Lepirudin recombinant | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201666 ↗ |
| Known as | Lepirudina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201666 ↗ |
| Known as | Lepirudine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201666 ↗ |
| Known as | Recombinant Desulfato Hirudin | “A Phase I/II Study of Recombinant Desulfato Hirudin, Lepirudin (Refludan) in Small Cell Lung Cancer Patients Previously Treated With Chemotherapy” NCT00003726 ↗ |
| Known as | Refludan | “A Phase I/II Study of Recombinant Desulfato Hirudin, Lepirudin (Refludan) in Small Cell Lung Cancer Patients Previously Treated With Chemotherapy” NCT00003726 ↗1“Patients treated with Lepirudin (Refludan®), a direct thrombin inhibitor” NCT00798525 ↗ |
| Action | Inhibit | “lepirudin should be more effective in preventing accumulation of fibrin at the catheter tip because it can counteract the potent clotting enzyme thrombin that is bound in the fibrin” NCT00039767 ↗1“Thrombin inhibitor” CHEMBL1201666 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant Desulfato Hirudin” NCT00003726 ↗ |
| Route | Subcutaneous | “Patients receive dose escalated lepirudin subcutaneously” NCT00003726 ↗ |
| Target | F2 | “Thrombin inhibitor” CHEMBL1201666 ↗ |