Drugs / Dotinurad
Trials 20 · a red edge is where a trial was stopped
| 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 | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 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 22 trials | ||||||
| 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 |
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 NCT02348307 ↗ |
| 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 ↗ |