Palifermin
As of the edition of 20 October 2026, Palifermin is a protein: marketed, first approved in 2004 (US); acts on FGFR2; US protection ended in 2016.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2004
- Kind
- Protein
- Brand name
- Kepivance
- First approved
- 15 December 2004 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Swedish Orphan Biovitrum
- Withdrawn from market
- 1 April 2016 (in some regions)
- Registered trials
- 51, 15 stopped early
- Disease areas
- Cancer; Immune system; Blood and lymph; Mouth and teeth; Digestive system; Heart and blood vessels
US protection
US protection ended in 2016.
US protection ended in 2016, 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 Swedish Orphan Biovitrum. 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 |
|---|---|---|
| FGFR2 | Fibroblast growth factor receptor 2 | P21802 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 12 | 7 | 2 | 3 |
| Phase 2 | 31 | 11 | 8 | 11 |
| Phase 3 | 5 | 4 | 0 | 1 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 51 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Swedish Orphan Biovitrum | Applicant and Lead sponsor of trials | 2004 to now |