Burosumab
As of the edition of 20 October 2026, Burosumab is an antibody: marketed, first approved in 2018 (EU); acts on FGF23; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Antibody
- Brand name
- Crysvita
- First approved
- 19 February 2018 (EU)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Kyowa Kirin; 2 holders in all
- Registered trials
- 28, 0 stopped early
- Disease areas
- Inherited and neonatal; Bones, joints and muscles; Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive; Cancer
US protection
US protection ends in 2030.
US protection ends in 2030, 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 Kyowa Kirin. 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 Burosumab.
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 |
|---|---|---|
| FGF23 | Fibroblast growth factor 23 | Q9GZV9 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 9 | 9 | 0 | 0 |
| Phase 3 | 8 | 8 | 0 | 0 |
| Phase 4 | 6 | 5 | 0 | 0 |
| All trials | 28 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Kyowa Kirin | Applicant and Lead sponsor of trials | 2014 to now |