Alefacept
As of the edition of 20 October 2026, Alefacept is a protein: marketed, first approved in 2003 (US); acts on CD2; US protection ended in 2015.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2003
- Kind
- Protein
- Brand name
- Amevive
- First approved
- 30 January 2003 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Astellas
- Registered trials
- 34, 12 stopped early
- Disease areas
- Skin and connective tissue; Immune system; Blood and lymph; Inherited and neonatal; Lungs and airways; Bones, joints and muscles
US protection
US protection ended in 2015.
US protection ended in 2015, 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 Astellas. 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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CD2 | T-cell surface antigen CD2 | P06729 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 4 | 0 | 5 |
| Phase 1 | 4 | 2 | 0 | 2 |
| Phase 2 | 9 | 7 | 0 | 2 |
| Phase 3 | 5 | 4 | 0 | 1 |
| Phase 4 | 7 | 5 | 0 | 2 |
| All trials | 34 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Astellas | Applicant and Lead sponsor of trials | 2001 to now |