aprotinin

Trade name: trasylol

Small moleculewithdrawnOrphan Drug FDA

Approved

Dec 29, 1993

The drug aprotinin, is a small protein bovine pancreatic trypsin inhibitor (BPTI), or basic trypsin inhibitor of bovine pancreas, which is an antifibrinolytic molecule that inhibits trypsin and related proteolytic enzymes. Under the trade name Trasylol, aprotinin was used as a medication administered by injection to reduce bleeding during complex surgery, such as heart and liver surgery. Its main effect is the slowing down of fibrinolysis, the process that leads to the breakdown of blood clots. The aim in its use was to decrease the need for blood transfusions during surgery, as well as end-organ damage due to hypotension as a result of marked blood loss. The drug was temporarily withdrawn worldwide in 2007 after studies suggested that its use increased the risk of complications or death; this was confirmed by follow-up studies. Trasylol sales were suspended in May 2008, except for very restricted research use. In February 2012 the European Medicines Agency (EMA) scientific committee reverted its previous standpoint regarding aprotinin, and has recommended that the suspension be lifted. Nordic became distributor of aprotinin in 2012. — Wikipedia

Clinical trial activity

16 trials · 13 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
8
Phase 3
6
Phase 4
2

Earliest trial started Jan 1, 2003 (NCT00131040)

Timeline

1990s

  1. Nov 17, 1993

    Orphan Drug Designation

  2. Dec 29, 1993

    Bayer — Earliest FDA Approval

  3. Dec 29, 1993

    Bayer — NDA Organization

2000s

  1. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • withdrawnDec 29, 1993

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • aprotinin
  • aprotinin
  • aprotinin
  • aprotinin
  • aprotinin
  • aprotinin
  • aprotinin
  • aprotinin
  • aprotinin
  • aprotinin biosynthetic
  • aprotinin bovine
  • aprotinin bovine
  • aprotinin (bovine)
  • aprotinin (bovine)
  • aprotinin concentrated solution
  • bayer-a-128
  • bayer-a-128
  • bovine aprotinin
  • bovine aprotinin
  • bovine pancreatic trypsin inhibitor
  • bovine pancreatic trypsin inhibitor
  • bpti
  • bpti
  • fibrinolysis inhibitor
  • riker 52g
  • riker 52g
  • rp-9921
  • rp-9921
  • trasylol
  • trasylol
  • trasylol
  • trasylol
  • trasylol
  • trypsin inhibitor, pancreatic basic
  • trypsin inhibitor, pancreatic basic

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04527133N/AJun 11, 2020Aviron, Clinical Hospital #1, Smolensk
NCT00892957Phase 3Jul 1, 2009Baxalta
NCT00708071Phase 2Jun 1, 2008Baxalta
NCT00681824Phase 2May 1, 2008Baxalta
NCT00611845N/AJan 29, 2008Bayer
NCT00395369N/ADec 1, 2007Ben Gurion University
NCT00354900Phase 1Jul 1, 2006Dartmouth University
NCT00327379Phase 3Feb 1, 2006Bayer
NCT00306150Phase 3Dec 1, 2005Bayer
NCT00306137Phase 3Dec 1, 2005Bayer
NCT00156520Phase 4Mar 1, 2005University of Rochester
NCT00357851Phase 1Mar 1, 2005Thomas Jefferson University
NCT00668031Phase 3Feb 1, 2005Bayer
NCT00396760Phase 3Jan 1, 2005German Heart Institute, Technical University of Munich
NCT00290836Phase 4May 1, 2004Nycomed
NCT00131040N/AJan 1, 2003British Heart Foundation, University of London
Showing 16 of 16 trials
Page 1 / 1

Organizations

Research & Development (13)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BayerFor profit5522005
BaxaltaFor profit3322008
AvironFor profit1112020
Ben Gurion UniversityAcademic/Hospital1112007
British Heart FoundationAcademic/Hospital1012003
Clinical Hospital #1, SmolenskAcademic/Hospital1012020
Dartmouth UniversityAcademic/Hospital1112006
German Heart InstituteAcademic/Hospital1112005
NycomedFor profit1112004
Technical University of MunichAcademic/Hospital1012005
Thomas Jefferson UniversityAcademic/Hospital1112005
University of LondonAcademic/Hospital1112003
University of RochesterAcademic/Hospital1112005
13 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
BayerFor profitNDADec 29, 1993