Drugs / Dotinurad
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT05278676 | Jul → Dec 2022 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03375632 | Jan → May 2018 | gout | Mochida Pharmaceutical Company, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03350373 | Nov 2017 | — | Mochida Pharmaceutical Company, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03350386 | Nov → Dec 2017 | — | Mochida Pharmaceutical Company, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03306667 | Oct 2017 → Jun 2018 | liver disorder | Mochida Pharmaceutical Company, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02347046 | Jan → Mar 2015 | impaired renal function disease | Fuji Yakuhin Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02344875 | May → Jun 2014 | — | Fuji Yakuhin Co., Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06056570 | Oct 2023 → Jun 2024 | gout | Urica Therapeutics Inc. | Completed | Mixed |
| Phase 24 trials | ||||||
| Phase 2 | NCT07535034 | May 2026 → Jul 2027 expected | gout | Crystalys Therapeutics | Recruiting | No outcome recorded |
| Phase 2 | NCT02901366 | Sep 2016 → Jan 2017 | — | Fuji Yakuhin Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02837198 | Jul 2016 → Aug 2017 | — | Fuji Yakuhin Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02515864 | Aug 2015 → Mar 2016 | — | Fuji Yakuhin Co., Ltd. | Completed | No outcome recorded |
| Phase 36 trials · 2 met primary | ||||||
| Phase 3 | NCT07089888 | Aug 2025 → Dec 2027 expected | gout | Crystalys Therapeutics | Recruiting | No outcome recorded |
| Phase 3 | NCT07089875 | Aug 2025 → Nov 2027 expected | gout | Crystalys Therapeutics | Recruiting | No outcome recorded |
| Phase 3 | NCT05007392 | Dec 2021 → Jun 2023 | gout | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT03372200 | Jan → Jun 2018 | gout | Mochida Pharmaceutical Company, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03100318 | Apr 2017 → Apr 2018 | gout | Fuji Yakuhin Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT03006445 | Dec 2016 → Aug 2018 | gout | Fuji Yakuhin Co., Ltd. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07661030 | Jul 2026 → Jul 2027 expected | gout | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06834230 | Mar 2025 → Jul 2027 expected | gout, hypertensive disorder | Saga University | Recruiting | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT02348333 Comparator | Sep → Nov 2013 | — | Fuji Yakuhin Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02348307 Comparator | Mar → Jun 2013 | — | Fuji Yakuhin Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02416167 Comparator | May 2015 → May 2016 | — | Fuji Yakuhin Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02344862 Comparator | Jan → Jul 2014 | — | Fuji Yakuhin Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-07-01 | Mochida Pharmaceutical Company, Ltd. | Regulatory 痛風・高尿酸血症治療剤「ユリス錠」の小児に対する用法・用量追加の承認事項一部変更承認申請のお知らせ mochida.co.jp ↗ |
| 2024-12-11 | Eisai Inc. | Regulatory “URECE®” (DOTINURAD) APPROVED IN CHINA FOR GOUT PATIENTS WITH HYPERURICEMIA eisai.com ↗ |
| 2024-10-08 | Eisai Inc. | Regulatory “URECE® TABLETS” (DOTINURAD) APPROVED IN THAILAND FOR GOUT AND HYPERURICEMIA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received approval for “URECE ® Tablets” (dotinurad) in Thailand as a treatment for gout and hyperuricemia. |
| 2020-01-23 | Mochida Pharmaceutical Company, Ltd. | Regulatory 選択的尿酸再吸収阻害薬「ユリス錠」の日本における製造販売承認取得のお知らせ mochida.co.jp ↗ |
| 2018-12-25 | Mochida Pharmaceutical Company, Ltd. | Regulatory 痛風・高尿酸血症治療剤「FYU-981（一般名：ドチヌラド）」の日本における製造販売承認申請のお知らせ mochida.co.jp ↗ |
All press releases naming this drug 8 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dotinurad | “Dotinurad (1 mg) was administered once, orally to subjects with mild (estimated glomerular filtration rate [eGFR], ≥ 60 to < 90 mL/min/1.73 m2) or moderate (eGFR, ≥ 30 to < 60...” PMID 31823130 ↗ Dec 201913“Dotinurad, a novel selective urate reabsorption inhibitor (SURI), reduces serum uric acid levels by selectively inhibiting urate transporter 1 (URAT1) for the treatment of...” PMID 31792640 ↗ Dec 2019 “Dotinurad is a novel, selective urate reabsorption inhibitor, which reduces serum uric acid levels by inhibiting the urate transporter 1.” PMID 32076889 ↗ Feb 2020 “Dotinurad, a novel selective urate reabsorption inhibitor (SURI), increases urinary uric acid excretion.” PMID 31734820 ↗ Nov 2019 “Clinical pharmacological study of dotinurad administered to male and female elderly or young subjects.” PMID 31889230 ↗ Dec 2019 “Dotinurad, a novel selective urate reabsorption inhibitor (SURI)” PMID 31754882 ↗ Nov 2019 |
| Known as | 14C-FYU-981 | “14C-FYU-981, (Oral single dosing)” NCT02901366 ↗ |
| Known as | FYU-981 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02348333 ↗ |
| Action | Inhibit | “reduces serum uric acid levels by selectively inhibiting urate transporter 1 (URAT1).” PMID 31754882 ↗ Nov 20191“Solute carrier family 22 member 12 inhibitor” CHEMBL4594446 ↗ |
| Modality | Small molecule | — CHEMBL4594446 ↗ |
| Route | Oral | “single oral administration of dotinurad 1 mg” PMID 31889230 ↗ Dec 2019 |
| Target | SLC22A12 | “Solute carrier family 22 member 12 inhibitor” CHEMBL4594446 ↗ |