What is Urece used for?

Urece is indicated for Gout, Hyperuricemia.

Urece is developed by Fuji Yakuhin.

What development phase is Urece in?

Urece is FDA-approved (marketed).

What is the generic name of Urece?

DOTINURAD is the generic (nonproprietary) name of Urece.

Last reviewed 2026-04-20 · How we verify

Urece (DOTINURAD)

Fuji Yakuhin · FDA-approved active Small molecule Quality 17/100

At a glance

Generic name	DOTINURAD
Sponsor	Fuji Yakuhin
Target	Solute carrier family 22 member 12
Modality	Small molecule
Therapeutic area	Immunology
Phase	FDA-approved

Approved indications

Gout
Hyperuricemia

Common side effects

No common side effects on file.

Key clinical trials

A Study of Dotinurad Versus Allopurinol in Tophaceous Gout (PHASE3)
A Study of Dotinurad Versus Allopurinol in Participants With Gout (PHASE3)
Effect of Dotinurad in Hyperuricemia With Hypertension (PHASE4)
A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout (PHASE3)
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with Hyperuricemia (PHASE1,PHASE2)
A Single and Multiple Dose Study of Dotinurad in Chinese Healthy Participants (PHASE1)
Drug-drug Interaction Study of FYU-981 and Oxaprozin (PHASE1)
Study of FYU-981 in Hyperuricemia With or Without Gout (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Urece CI brief — competitive landscape report
Urece updates RSS · CI watch RSS
Fuji Yakuhin portfolio CI