Romosozumab
As of the edition of 20 October 2026, Romosozumab is an antibody: marketed, first approved in 2019 (JP); acts on SOST; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Antibody
- Brand name
- Evenity
- First approved
- 8 January 2019 (JP)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- UCB; 2 holders in all
- Registered trials
- 38, 1 stopped early
- Disease areas
- Bones, joints and muscles; Nutrition and metabolism; Injuries; Nervous system; Skin and connective tissue; Cancer
US protection
US protection ends in 2031.
US protection ends in 2031, 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 product1 listing counts 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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Romosozumab.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SOST | Sclerostin | Q9BQB4 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 9 | 7 | 2 | 0 |
| Phase 2 | 9 | 6 | 2 | 1 |
| Phase 3 | 10 | 8 | 2 | 0 |
| Phase 4 | 9 | 2 | 6 | 0 |
| All trials | 38 |