About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Not yet reported

Dotinurad

Company: Crystalys Therapeutics
Mechanism: Mechanism not yet reported
Route: Route not yet reported
Recruiting trials: 4 recruiting

Efficacy results: Not yet reported

Find a Clinical Trial Near Me

4 recruiting studies currently listed on ClinicalTrials.gov.

Data source: ClinicalTrials.gov · trial data as of Sep 29, 2026

Trial details

Recruiting NCT NCT06834230

Effect of Dotinurad in Hyperuricemia With Hypertension

Not yet reported Saga University 360 participants Est. completion 2030-03-31 1 site Stand-alone

Other conditions: Hyperuricemia or Gout, Hypertension
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Recruiting NCT NCT07089875

A Study of Dotinurad Versus Allopurinol in Participants With Gout

Not yet reported Crystalys Therapeutics 500 participants Est. completion 2027-11-29 115 sites Stand-alone

Other conditions: Gout
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Recruiting NCT NCT07089888

A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

Not yet reported Crystalys Therapeutics 250 participants Est. completion 2027-12-31 95 sites Stand-alone

Other conditions: Tophaceous Gout
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Recruiting NCT NCT07535034

A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants

Not yet reported Crystalys Therapeutics 90 participants Est. completion 2027-08 41 sites Stand-alone

Other conditions: Gout
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Completed NCT NCT02344862

Study of FYU-981 in Hyperuricemia With or Without Gout

Not yet reported Fuji Yakuhin Co., Ltd. 80 participants Est. completion 2014-09 1 site

Other conditions: Hyperuricemia
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Completed NCT NCT02344875

Clinical Pharmacology of FYU-981 (Elder Subjects)

Not yet reported Fuji Yakuhin Co., Ltd. 24 participants Est. completion 2014-07 1 site

Other conditions: Healthy
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Completed NCT NCT02347046

Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)

Not yet reported Fuji Yakuhin Co., Ltd. 18 participants Est. completion 2015-03 1 site

Other conditions: Renal Insufficiency, Healthy
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Completed NCT NCT02348307

Single Dose Phase I Study of FYU-981

Not yet reported Fuji Yakuhin Co., Ltd. 54 participants Est. completion 2013-08 1 site

Other conditions: Healthy
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Completed NCT NCT02348333

Repeated Dose Phase I Study of FYU-981

Not yet reported Fuji Yakuhin Co., Ltd. 18 participants Est. completion 2013-12 1 site

Other conditions: Healthy
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Completed NCT NCT02416167

Study of FYU-981 in Hyperuricemia With or Without Gout

Not yet reported Fuji Yakuhin Co., Ltd. 200 participants Est. completion 2016-11 1 site

Other conditions: Hyperuricemia
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Completed NCT NCT02515864

Clinical Pharmacology of FYU-981 (Effect on QT/QTc Interval)

Not yet reported Fuji Yakuhin Co., Ltd. 48 participants Est. completion 2016-11 1 site

Other conditions: Healthy
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Completed NCT NCT02837198

Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)

Not yet reported Fuji Yakuhin Co., Ltd. 24 participants Est. completion 2018-03 1 site

Other conditions: Hyperuricemia
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Completed NCT NCT03006445

Study of FYU-981 in Hyperuricemia With or Without Gout

Not yet reported Fuji Yakuhin Co., Ltd. 330 participants Est. completion 2018-10-24 1 site

Other conditions: Hyperuricemia With or Without Gout
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Completed NCT NCT03100318

Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

Not yet reported Fuji Yakuhin Co., Ltd. 201 participants Est. completion 2018-08-31 1 site

Other conditions: Hyperuricemia With or Without Gout
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Completed NCT NCT03306667

Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)

Not yet reported Mochida Pharmaceutical Company, Ltd. 24 participants Est. completion 2018-06-25 1 site

Other conditions: Hepatic Insufficiency, Healthy
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Completed NCT NCT03350373

Clinical Pharmacology of FYU-981 (Final Formulation)

Not yet reported Mochida Pharmaceutical Company, Ltd. 12 participants Est. completion 2017-11-29 1 site

Other conditions: Healthy
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Completed NCT NCT03350386

Drug-drug Interaction Study of FYU-981 and Oxaprozin

Not yet reported Mochida Pharmaceutical Company, Ltd. 12 participants Est. completion 2017-12-05 1 site

Other conditions: Healthy
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Completed NCT NCT03372200

Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

Not yet reported Mochida Pharmaceutical Company, Ltd. 203 participants Est. completion 2018-07-05 1 site

Other conditions: Hyperuricemia With or Without Gout
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Completed NCT NCT03375632

Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)

Not yet reported Mochida Pharmaceutical Company, Ltd. 26 participants Est. completion 2018-06-05 1 site

Other conditions: Hyperuricemia With or Without Gout
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Completed NCT NCT05007392

A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout

Not yet reported Eisai Co., Ltd. 451 participants Est. completion 2023-06-14 30 sites Stand-alone

Other conditions: Gout
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Completed NCT NCT05278676

A Single and Multiple Dose Study of Dotinurad in Chinese Healthy Participants

Not yet reported Eisai Co., Ltd. 26 participants Est. completion 2022-12-13 1 site Stand-alone

Other conditions: Healthy Volunteers
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Completed NCT NCT06056570

Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia

Not yet reported, Not yet reported Urica Therapeutics Inc. 20 participants Est. completion 2024-07-09 4 sites Stand-alone

Other conditions: Gout, Hyperuricemia
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Not yet recruiting NCT NCT07661030

The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time

Not yet reported First Affiliated Hospital of Wenzhou Medical University 142 participants Est. completion 2027-07-30 Stand-alone

Other conditions: Gout
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Efficacy history

Not yet reported.

Safety

Not yet reported.

Sources

ClinicalTrials.gov — NCT07089875

Related On The Pen coverage

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This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.