Febuxostat
As of the edition of 20 October 2026, Febuxostat is a small molecule: marketed, first approved in 2008 (EU); acts on XDH.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Uloric
- First approved
- 21 April 2008 (EU)
- Approvals on record
- 7 in 3 regions
- Holder of the most recent approval
- Teijin Pharma; 3 holders in all
- Registered trials
- 70, 4 stopped early
- Disease areas
- Nutrition and metabolism; Inherited and neonatal; Bones, joints and muscles; Pregnancy and women's health; Urinary and reproductive; Heart and blood vessels
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
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 Febuxostat.
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 |
|---|---|---|
| XDH | Xanthine dehydrogenase/oxidase [Includes: Xanthine dehydrogenase | P47989 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 3 | 1 | 1 |
| Phase 1 | 10 | 7 | 3 | 0 |
| Phase 2 | 23 | 16 | 3 | 2 |
| Phase 3 | 14 | 13 | 1 | 0 |
| Phase 4 | 13 | 9 | 0 | 1 |
| All trials | 70 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Applicant and Lead sponsor of trials | 2001 to now |
| Menarini | Applicant | 2008 to now |
| Teijin Pharma | Applicant | 2011 to now |