Clinical Trials

Numerous clinical trials spanning Phase 1 to Phase 4 have evaluated lesinurad in healthy subjects as well as patients with hyperuricemia, gout, tophaceous gout, and gout associated with chronic kidney disease. Supported by industry sponsors including Ardea Biosciences, AstraZeneca, and Ironwood Pharmaceuticals, the majority of these studies have been completed, though a subset was terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03226899 TERMINATED
Gout; Chronic Kidney Disease (CKD)
Ironwood Pharmaceuticals, Inc.
 2017-07-19 PHASE4
NCT03272425 COMPLETED
Gout
Ardea Biosciences, Inc.
 2017-08-14 PHASE1
NCT02888054 COMPLETED
Healthy
Ardea Biosciences, Inc.
 2016-08-30 PHASE1
NCT01808144 COMPLETED
Gout
Ardea Biosciences, Inc.
 2013-03-01 PHASE3
NCT01808131 COMPLETED
Gout
Ardea Biosciences, Inc.
 2013-02 PHASE3
NCT02581553 COMPLETED
Healthy
Ardea Biosciences, Inc.
 2015-10 PHASE1
NCT01510158 COMPLETED
Gout
Ardea Biosciences, Inc.
 2012-01 PHASE3
NCT02127775 COMPLETED
Healthy
Ardea Biosciences, Inc.
 2014-04 PHASE1
NCT01510769 COMPLETED
Tophaceous Gout
Ardea Biosciences, Inc.
 2012-01 PHASE3
NCT01493531 COMPLETED
Gout
Ardea Biosciences, Inc.
 2011-12 PHASE3
NCT01650246 COMPLETED
Gout
Ardea Biosciences, Inc.
 2012-08 PHASE3
NCT01986556 COMPLETED
Healthy
Ardea Biosciences, Inc.
 2013-11 PHASE1
NCT02039700 COMPLETED
Healthy
Ardea Biosciences, Inc.
 2014-01 PHASE1
NCT01982201 COMPLETED
Healthy
Ardea Biosciences, Inc.
 2013-11 PHASE1
NCT02028689 COMPLETED
Healthy
Ardea Biosciences, Inc.
 2013-10 PHASE1
NCT01508702 COMPLETED
Gout
Ardea Biosciences, Inc.
 2012-01 PHASE3
NCT01908257 COMPLETED
Healthy
Ardea Biosciences, Inc.
 2013-07 PHASE1
NCT01884272 COMPLETED
Gout
Ardea Biosciences, Inc.
 2013-06 PHASE1
NCT01744379 COMPLETED
Gout
Ardea Biosciences, Inc.
 2012-12 PHASE1
NCT01001338 Completed
Gout
Ardea Biosciences Inc.
 2009-10 Phase 2
NCT00955981 Completed
Hyperuricemia
Ardea Biosciences Inc.
 2009-07 Phase 2

(data from https://clinicaltrials.gov, updated on 2021-11-04)

Check the Lesinurad product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lesinurad acts as a selective uric acid reabsorption inhibitor by targeting and inhibiting the renal transporter URAT1 along with organic anion transporters OAT1 and OAT3, thereby blocking the reabsorption of uric acid in the proximal renal tubules. This inhibition promotes renal uric acid excretion and lowers serum uric acid concentrations, directly mitigating hyperuricemia and preventing urate crystal deposition in clinical conditions such as gout and tophaceous 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.