Denosumab
As of the edition of 20 October 2026, Denosumab is an antibody: marketed, first approved in 2010 (EU); acts on TNFSF11; US protection ended in 2022.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Antibody
- Brand name
- Prolia
- First approved
- 26 May 2010 (EU)
- Approvals on record
- 10 in 4 regions
- Holder of the most recent approval
- Amgen; 2 holders in all
- Registered trials
- 197, 24 stopped early
- Disease areas
- Bones, joints and muscles; Nutrition and metabolism; Cancer; Skin and connective tissue; Urinary and reproductive; Injuries
US protection
US protection ended in 2022.
US protection ended in 2022, 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 Amgen. 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.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Denosumab.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TNFSF11 | Tumor necrosis factor ligand superfamily member 11 | O14788 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 22 | 11 | 5 | 0 |
| Phase 1 | 27 | 17 | 1 | 4 |
| Phase 2 | 53 | 31 | 7 | 10 |
| Phase 3 | 67 | 45 | 5 | 7 |
| Phase 4 | 28 | 11 | 10 | 3 |
| All trials | 197 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Applicant and Lead sponsor of trials | 2002 to now |