Aprotinin
As of the edition of 20 October 2026, Aprotinin is a drug: marketed, first approved in 1977 (CH); acts on KLKB1 and PLG; US protection ended in 2005.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Unknown
- Brand name
- Trasylol
- First approved
- 16 March 1977 (CH)
- Approvals on record
- 12 in 5 regions
- Holder of the most recent approval
- Baxter Healthcare; 4 holders in all
- Withdrawn from market
- 1 January 2007 (in some regions)
- Registered trials
- 14, 4 stopped early
- Disease areas
- Lungs and airways; Cancer; Digestive system; Heart and blood vessels; Infections; Skin and connective tissue
US protection
US protection ended in 2005.
US protection ended in 2005, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Bayer. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Aprotinin.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 2 | 0 | 0 |
| Phase 1 | 2 | 1 | 0 | 1 |
| Phase 3 | 6 | 1 | 1 | 3 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant and Lead sponsor of trials | 1993 to now |
| Baxter Healthcare | Applicant | 1994 to now |