desirudin

Trade name: Ipravask

Biologicalapproved

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

Phase 1
0
Phase 2
0
Phase 3
1
Phase 4
3

Earliest trial started May 1, 2006 (NCT00329433)

Timeline

2000s

  1. Apr 4, 2003

    Earliest FDA Approval

  2. Apr 4, 2003

    Bausch Health Companies — Marketing Organization

  3. Apr 4, 2003

    Bausch Health Companies — NDA Secondary Org

  4. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Mechanism of action

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

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 IDPhaseStart dateSponsor(s)
NCT01918722Phase 4Oct 1, 2013Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou University
NCT00913133Phase 4Mar 1, 2010Canyon Pharmaceuticals, Emory University
NCT00787332Phase 4Sep 1, 2008Canyon Pharmaceuticals
NCT00329433Phase 2/Phase 3 (Phase 3)May 1, 2006Canyon Pharmaceuticals, Washington University in St. Louis
Showing 4 of 4 trials
Page 1 / 1

Organizations

Research & Development (5)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Canyon PharmaceuticalsFor profit3222006
Emory UniversityAcademic/Hospital1012010
Guangdong Provincial Hospital of Traditional Chinese MedicineAcademic/Hospital1012013
Guangzhou UniversityAcademic/Hospital1112013
Washington University in St. LouisAcademic/Hospital1112006
5 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Bausch Health CompaniesFor profitMKTGApr 4, 2003
Bausch Health CompaniesFor profitNDA2Apr 4, 2003
NovartisFor profitNDA