Dotinurad
As of the edition of 20 October 2026, Dotinurad is a small molecule: marketed, first approved in 2020 (JP); acts on SLC22A12.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Urece
- First approved
- 23 January 2020 (JP)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Fuji Yakuhin
- Registered trials
- 20, 0 stopped early
- Disease areas
- Bones, joints and muscles; Inherited and neonatal; Nutrition and metabolism; Digestive system; Heart and blood vessels; Pregnancy and women's health
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
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 Dotinurad.
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 |
|---|---|---|
| SLC22A12 | Solute carrier family 22 member 12 | Q96S37 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 7 | 7 | 0 | 0 |
| Phase 2 | 5 | 4 | 1 | 0 |
| Phase 3 | 6 | 4 | 2 | 0 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Fuji Yakuhin | Applicant and Lead sponsor of trials | 2014 to now |