desirudin
Trade name: Ipravask
Approved
Apr 4, 2003
Desirudin (Iprivask), a recombinant hirudin, is a parenteral direct thrombin inhibitor approved to prevent venous thromboembolism in patients undergoing elective hip replacement surgery. Desirudin is a potent inhibitor of both clot-bound and freely circulating thrombin. Desirudin acts independently of anti-thrombin, forming a noncovalent irreversible complex with both the active site of thrombin as well as the fibrinogen binding site. This Desirudin–thrombin complex prevents fibrinogen cleavage and other thrombin catalyzed reactions such as the activation of clotting factors V, VIII and XIII, and thrombininduced platelet activation, resulting in a dose-dependent prolongation of activated partial thromboplastin time (aPTT). Desirudin is highly selective and has no effect on plasmin, factors IXa and Xa, tissue plasminogen activator, activated protein C, trypsin, chymotrypsin or complement activation pathways. Bleeding complications reported with the use of desirudin in patients undergoing hip-replacement surgery are similar to those reported with heparin and enoxaparin. — NCATS
Clinical trial activity
4 trials · 5 clinical orgs · 2 marketing orgs
Earliest trial started May 1, 2006 (NCT00329433)
Timeline
2000s
- Apr 4, 2003
Earliest FDA Approval
- Apr 4, 2003
Bausch Health Companies — Marketing Organization
- Apr 4, 2003
Bausch Health Companies — NDA Secondary Org
- Jan 1, 2006
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- ThrombinINHIBITOR
F2 inhibitor
Selective
Approval history
- approvedApr 4, 2003
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Discontinued
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaHirudin ↗
- NCATSU0JZ726775 ↗
- ChEMBLCHEMBL1201662 ↗
Also known as
- 63-desulfohirudin
- 63-desulfohirudin (hirudo medicinalis isoform hv1)
- 63-desulfohirudin (hirudo medicinalis isoform hv1)
- 63-desulfohirudin (recombinant)
- cgp 39393
- cgp-39393
- cgp-39393
- cgp-39393
- desirudin
- desirudin
- desirudin
- desirudin
- desirudin
- desirudin
- desirudin
- desirudin
- desirudin recombinant
- desirudin recombinant
- desirudin recombinant
- desulfatohirudin
- desulfatohirudin
- desulfatohirudin
- desulfatohirudin
- desulfatohirudin
- desulfatohirudin
- desulphatohirudin
- desulphatohirudin
- hirudin desirudin
- hirudo
- hirudo
- ik-hir02
- ik-hir02
- ipravask
- iprivask
- iprivask
- iprivask
- recombinant hv1 hirudin
- revasc
- revasc
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01918722 | Phase 4 | Oct 1, 2013 | Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou University |
| NCT00913133 | Phase 4 | Mar 1, 2010 | Canyon Pharmaceuticals, Emory University |
| NCT00787332 | Phase 4 | Sep 1, 2008 | Canyon Pharmaceuticals |
| NCT00329433 | Phase 2/Phase 3 (Phase 3) | May 1, 2006 | Canyon Pharmaceuticals, Washington University in St. Louis |
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Canyon Pharmaceuticals | For profit | 3 | 2 | 2 | 2006 |
| Emory University | Academic/Hospital | 1 | 0 | 1 | 2010 |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | Academic/Hospital | 1 | 0 | 1 | 2013 |
| Guangzhou University | Academic/Hospital | 1 | 1 | 1 | 2013 |
| Washington University in St. Louis | Academic/Hospital | 1 | 1 | 1 | 2006 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bausch Health Companies | For profit | MKTG | Apr 4, 2003 |
| Bausch Health Companies | For profit | NDA2 | Apr 4, 2003 |
| Novartis | For profit | NDA | — |