Drotrecogin alfa (activated)
As of the edition of 20 October 2026, Drotrecogin alfa (activated) is a protein: marketed, first approved in 2001 (US); acts on F5 and F8; US protection ended in 2013.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2001
- Kind
- Protein
- Brand name
- Xigris
- First approved
- 21 November 2001 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Eli Lilly
- Withdrawn from market
- 28 November 2011 (in some regions)
- Registered trials
- 19, 2 stopped early
- Disease areas
- Infections; Lungs and airways; Heart and blood vessels; Blood and lymph; Cancer; Digestive system
US protection
US protection ended in 2013.
US protection ended in 2013, 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 Eli Lilly. 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 product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 5 | 3 | 0 | 2 |
| Phase 3 | 4 | 4 | 0 | 0 |
| Phase 4 | 7 | 7 | 0 | 0 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Applicant and Lead sponsor of trials | 2001 to now |