aprotinin
Trade name: trasylol
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 The drug was temporarily withdrawn worldwide in 2007 after studies suggested that its use increased the risk of complications or death; this was confirmed by follow-up studies.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
Earliest trial started Jan 1, 2003 (NCT00131040)
Timeline
Indications
Approved for
Studied for
Mechanism of action
- PlasminogenINHIBITOR
PLG inhibitor
- Plasma kallikreinINHIBITOR
KLKB1 inhibitor
Approval history
- withdrawnDec 29, 1993
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaAprotinin ↗
- NCATS04XPW8C0FL ↗
- ChEMBLCHEMBL1201619 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04527133 | N/A | Jun 11, 2020 | Aviron, Clinical Hospital #1, Smolensk |
| NCT00892957 | Phase 3 | Jul 1, 2009 | Baxalta |
| NCT00708071 | Phase 2 | Jun 1, 2008 | Baxalta |
| NCT00681824 | Phase 2 | May 1, 2008 | Baxalta |
| NCT00611845 | N/A | Jan 29, 2008 | Bayer |
| NCT00395369 | N/A | Dec 1, 2007 | Ben Gurion University |
| NCT00354900 | Phase 1 | Jul 1, 2006 | Dartmouth University |
| NCT00327379 | Phase 3 | Feb 1, 2006 | Bayer |
| NCT00306150 | Phase 3 | Dec 1, 2005 | Bayer |
| NCT00306137 | Phase 3 | Dec 1, 2005 | Bayer |
| NCT00156520 | Phase 4 | Mar 1, 2005 | University of Rochester |
| NCT00357851 | Phase 1 | Mar 1, 2005 | Thomas Jefferson University |
| NCT00668031 | Phase 3 | Feb 1, 2005 | Bayer |
| NCT00396760 | Phase 3 | Jan 1, 2005 | German Heart Institute, Technical University of Munich |
| NCT00290836 | Phase 4 | May 1, 2004 | Nycomed |
| NCT00131040 | N/A | Jan 1, 2003 | British Heart Foundation, University of London |
Organizations
Research & Development (13)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bayer | For profit | 5 | 5 | 2 | 2005 |
| Baxalta | For profit | 3 | 3 | 2 | 2008 |
| Aviron | For profit | 1 | 1 | 1 | 2020 |
| Ben Gurion University | Academic/Hospital | 1 | 1 | 1 | 2007 |
| British Heart Foundation | Academic/Hospital | 1 | 0 | 1 | 2003 |
| Clinical Hospital #1, Smolensk | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Dartmouth University | Academic/Hospital | 1 | 1 | 1 | 2006 |
| German Heart Institute | Academic/Hospital | 1 | 1 | 1 | 2005 |
| Nycomed | For profit | 1 | 1 | 1 | 2004 |
| Technical University of Munich | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Thomas Jefferson University | Academic/Hospital | 1 | 1 | 1 | 2005 |
| University of London | Academic/Hospital | 1 | 1 | 1 | 2003 |
| University of Rochester | Academic/Hospital | 1 | 1 | 1 | 2005 |
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bayer | For profit | NDA | Dec 29, 1993 |