CDEK
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thrombin (bovine)

Trade name: Thrombostat

Animal productapproved

Approved

Jul 1, 1943

Prothrombin is encoded in the human by the F2-gene. It is proteolytically cleaved during the clotting process by the prothrombinase enzyme complex to form thrombin. — Wikipedia

Clinical trial activity

9 trials · 25 clinical orgs · 5 marketing orgs

Phase 1
1
Phase 2
7
Phase 3
5
Phase 4
0

Earliest trial started Mar 1, 2002 (NCT00161759)

Timeline

1940s

  1. Jul 1, 1943

    Earliest FDA Approval

1980s

  1. Feb 3, 1986

    GenTrac, Inc. — First NDA Organization

  2. Feb 3, 1986

    GenTrac, Inc. — NDA Secondary Org

  3. Feb 3, 1986

    GenTrac, Inc. — NDA Organization

2000s

  1. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  2. Mar 21, 2003

    Omrix Biopharmaceuticals, Inc. — NDA Secondary Org

  3. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  4. Mar 19, 2008

    Baxter — NDA Secondary Org

2010s

  1. Jan 1, 2013

    Grifols — Earliest Phase 2 Sponsor(trial)

  2. Apr 30, 2015

    International Minerals and Chemical Corporation — NDA Secondary Org

  3. Nov 1, 2017

    Grifols — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJul 1, 1943

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • bovine thrombin
  • thrombin
  • thrombin
  • thrombin
  • thrombin
  • thrombin
  • thrombin bovine
  • thrombin topical (bovine)
  • thrombin, topical (bovine)
  • thrombostat
  • thrombostat

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04403503N/AJul 1, 2018Hacettepe University
NCT02802995Phase 3May 1, 2016University of the Witwatersrand
NCT02014402Phase 2Dec 1, 2013Grifols
NCT01717612Phase 3Oct 1, 2012Government of Taiwan, I-Shou University
NCT00892957Phase 3Jul 1, 2009Baxalta
NCT00814333N/ADec 1, 2008Pfizer, University of Kansas
NCT00245336Phase 3Oct 1, 2005Indiana Spine Group, University of Southern California, Washington University in St. Louis, ZymoGenetics
NCT00196534Phase 3Nov 1, 2004Ethicon, Omrix Biopharmaceuticals, Inc.
NCT00161759Phase 1/Phase 2 (Phase 2)Mar 1, 2002Baxalta, Doctors Hospital, August, GA, Loyola University, University of Arizona, University of California, Davis, University of California, Irvine, University of California, San Diego, University of Cincinnati, University of South Alabama, University of Washington, Wright State University, Yale University
Showing 9 of 9 trials
Page 1 / 1

Organizations

Research & Development (25)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BaxaltaFor profit2222002
Doctors Hospital, August, GAAcademic/Hospital1012002
EthiconFor profit1112004
Government of TaiwanGovernment1112012
GrifolsFor profit1112013
Hacettepe UniversityAcademic/Hospital1112018
Indiana Spine GroupAcademic/Hospital1012005
I-Shou UniversityAcademic/Hospital1012012
Loyola UniversityAcademic/Hospital1012002
Omrix Biopharmaceuticals, Inc.For profit1012004
PfizerFor profit1012008
University of ArizonaAcademic/Hospital1012002
University of California, DavisAcademic/Hospital1012002
University of California, IrvineAcademic/Hospital1012002
University of California, San DiegoAcademic/Hospital1012002
University of CincinnatiAcademic/Hospital1012002
University of KansasAcademic/Hospital1112008
University of South AlabamaAcademic/Hospital1012002
University of Southern CaliforniaAcademic/Hospital1012005
University of the WitwatersrandAcademic/Hospital1112016
25 organizations
Page 1 / 2

Marketing (6)

OrganizationOrg typeRelationshipDate
BaxterFor profitNDA2Mar 19, 2008
GenTrac, Inc.For profitNDA2Feb 3, 1986
GenTrac, Inc.For profitNDAFeb 3, 1986
GrifolsFor profitNDA2Nov 1, 2017
International Minerals and Chemical CorporationFor profitNDA2Apr 30, 2015
Omrix Biopharmaceuticals, Inc.For profitNDA2Mar 21, 2003