Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 4 evaluate dotinurad primarily for hyperuricemia, gout, tophaceous gout, and associated hypertension, alongside pharmacokinetic assessments in healthy volunteers. Sponsored by pharmaceutical companies and academic medical centers, these studies range from completed early-phase drug-interaction trials to actively recruiting and upcoming Phase 2 through Phase 4 studies. Collectively, they focus on evaluating long-term safety, comparative efficacy, and gout flare resolution.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07089888 RECRUITING
Tophaceous Gout
Crystalys Therapeutics
 2025-08-04 PHASE3
NCT07089875 RECRUITING
Gout
Crystalys Therapeutics
 2025-08-01 PHASE3
NCT06834230 RECRUITING
Hyperuricemia or Gout; Hypertension
Saga University
 2025-03-28 PHASE4
NCT07661030 NOT_YET_RECRUITING
Gout
First Affiliated Hospital of Wenzhou Medical University
 2026-07-30 PHASE4
NCT07535034 RECRUITING
Gout
Crystalys Therapeutics
 2026-05-08 PHASE2
NCT06056570 COMPLETED
Gout; Hyperuricemia
Urica Therapeutics Inc.
 2023-10-04 PHASE1; PHASE2
NCT05007392 COMPLETED
Gout
Eisai Co., Ltd.
 2021-12-21 PHASE3
NCT05278676 COMPLETED
Healthy Volunteers
Eisai Co., Ltd.
 2022-07-01 PHASE1
NCT05278676 Completed
Healthy Volunteers
Eisai Co. Ltd.|Eisai Inc.
 2022-07-01 Phase 1
NCT02901366 Completed
Healthy Male Subjects
Fuji Yakuhin Co. Ltd.|Mochida Pharmaceutical Company Ltd.
 2016-09 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the Dotinurad (FYU-981) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dotinurad selectively binds to and inhibits urate transporter 1 (URAT1) with an IC50 of 37.2 nM, thereby blocking the reabsorption of uric acid in the renal proximal tubules. By suppressing renal urate reabsorption and promoting urinary urate excretion, dotinurad lowers serum uric acid concentrations, offering therapeutic efficacy for clinical conditions such as hyperuricemia and gout.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.