18 completed, 4 recruiting, 1 not yet recruiting. 10 Phase 1, 6 Phase 2, 6 Phase 3, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 10 |
| Phase 2 | 6 | Completed 5, Recruiting 1 |
| Phase 3 | 6 | Completed 4, Recruiting 2 |
| Phase 4 | 2 | Not yet recruiting 1, Recruiting 1 |
Follow dotinurad: new trials by email Literature Review of dotinurad trials Research Report on dotinurad
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time Dotinurad, colchicine, etoricoxib - Gout | Phase 4 | Not yet recruiting | First Affiliated Hospital of Wenzhou Medical University | 142 | 2026-07-30 | 2026-06-22 |
| A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants Dotinurad, Placebo - Gout | Phase 2 | Recruiting | Crystalys Therapeutics | 90 | 2026-05-08 | 2026-09-28 |
| A Study of Dotinurad Versus Allopurinol in Tophaceous Gout Allopurinol, Dotinurad - Tophaceous Gout | Phase 3 | Recruiting | Crystalys Therapeutics | 250 | 2025-08-04 | 2026-10-29 |
| A Study of Dotinurad Versus Allopurinol in Participants With Gout Allopurinol, Dotinurad - Gout | Phase 3 | Recruiting | Crystalys Therapeutics | 500 | 2025-08-01 | 2026-10-29 |
| Effect of Dotinurad in Hyperuricemia With Hypertension Dotinurad, Febuxostat - Hyperuricemia or Gout, Hypertension | Phase 4 | Recruiting | Saga University | 360 | 2025-03-28 | 2025-12-15 |
| Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia dotinurad, dotinurad + allopurinol, allopurinol - Gout, Hyperuricemia | Phase 1 / Phase 2 | Completed | Urica Therapeutics Inc. | 20 | 2023-10-04 | 2026-06-10 |
| A Single and Multiple Dose Study of Dotinurad in Chinese Healthy Participants Dotinurad - Healthy Volunteers | Phase 1 | Completed | Eisai Co., Ltd. | 26 | 2022-07-01 | 2023-09-14 |
| A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout Dotinurad, Febuxostat, Dotinurad Matched Placebo - Gout | Phase 3 | Completed | Eisai Co., Ltd. | 451 | 2021-12-21 | 2025-07-30 |
| Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout FYU-981, Febuxostat - Hyperuricemia With or Without Gout | Phase 3 | Completed | Mochida Pharmaceutical Company, Ltd. | 203 | 2018-01-09 | 2018-09-24 |
| Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types) FYU-981 - Hyperuricemia With or Without Gout | Phase 1 | Completed | Mochida Pharmaceutical Company, Ltd. | 26 | 2018-01-04 | 2018-09-24 |
| Clinical Pharmacology of FYU-981 (Final Formulation) FYU-981 - Healthy | Phase 1 | Completed | Mochida Pharmaceutical Company, Ltd. | 12 | 2017-11-06 | 2017-12-12 |
| Drug-drug Interaction Study of FYU-981 and Oxaprozin FYU-981, Oxaprozin - Healthy | Phase 1 | Completed | Mochida Pharmaceutical Company, Ltd. | 12 | 2017-11-02 | 2022-09-14 |
| Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency) FYU-981 - Hepatic Insufficiency, Healthy | Phase 1 | Completed | Mochida Pharmaceutical Company, Ltd. | 24 | 2017-10-06 | 2018-09-24 |
| Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout FYU-981, Benzbromarone - Hyperuricemia With or Without Gout | Phase 3 | Completed | Fuji Yakuhin Co., Ltd. | 201 | 2017-04-01 | 2018-09-26 |
| Study of FYU-981 in Hyperuricemia With or Without Gout FYU-981 - Hyperuricemia With or Without Gout | Phase 3 | Completed | Fuji Yakuhin Co., Ltd. | 330 | 2016-12-01 | 2018-12-06 |
| Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types) FYU-981, Topiroxostat - Hyperuricemia | Phase 2 | Completed | Fuji Yakuhin Co., Ltd. | 24 | 2016-07-01 | 2018-08-21 |
| Clinical Pharmacology of FYU-981 (Effect on QT/QTc Interval) FYU-981, Placebo, Moxifloxacin - Healthy | Phase 2 | Completed | Fuji Yakuhin Co., Ltd. | 48 | 2015-08-01 | 2017-09-08 |
| Study of FYU-981 in Hyperuricemia With or Without Gout FYU-981, Placebo - Hyperuricemia | Phase 2 | Completed | Fuji Yakuhin Co., Ltd. | 200 | 2015-05-01 | 2017-02-14 |
| Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency) FYU-981, (Oral single dosing) - Renal Insufficiency, Healthy | Phase 1 | Completed | Fuji Yakuhin Co., Ltd. | 18 | 2015-01-01 | 2015-03-06 |
| Clinical Pharmacology of FYU-981 (Elder Subjects) FYU-981, (Oral single dosing) - Healthy | Phase 1 | Completed | Fuji Yakuhin Co., Ltd. | 24 | 2014-05-01 | 2015-01-26 |
Showing 20 of 23. Sign in to see all of them.
Hyperuricemia (7) · Gout (6) · Hepatic Insufficiency (1) · Hypertension (1) · Renal Insufficiency (1)
Fuji Yakuhin Co., Ltd. (10) · Mochida Pharmaceutical Company, Ltd. (5) · Crystalys Therapeutics (3) · Eisai Co., Ltd. (2) · First Affiliated Hospital of Wenzhou Medical University (1) · Saga University (1) · Urica Therapeutics Inc. (1)
Japan (16) · United States (4) · China (2) · Poland (1) · Spain (1)
Kazuki Furuno (2) · Katsuaki Nagasawa (1) · Koichi Node, Pr.,Dr. (1) · Nagasawa Katsuaki (1) · Shigeki Matsumoto (1)
PMID 31734820, PMID 31754882, PMID 31792640, PMID 31823130, PMID 31875931, PMID 31889230, PMID 31980978, PMID 32076889, PMID 40839334, PMID 41111126