Clinical Trials

Several Phase I and Phase II clinical trials have evaluated the therapeutic application of Verinurad (RDEA3170) in patients with gout and healthy volunteers assessed for potential utility in chronic kidney disease. Sponsored by industry leaders including Ardea Biosciences, AstraZeneca, and Parexel, all documented trials have achieved completed recruitment status. These investigations evaluated relative bioavailability, safety, and pharmacodynamic outcomes alongside specific cardiac safety parameters, such as the QTcF interval.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04256629 Completed
Healthy Volunteers (Intended Indication: Chronic Kidney Disease)
AstraZeneca|Parexel
 2020-03-03 Phase 1
NCT02498652 Completed
Gout
Ardea Biosciences Inc.
 2015-07-28 Phase 2
NCT02336594 Completed
Gout
Ardea Biosciences Inc.
 2014-11 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Verinurad (RDEA3170) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Verinurad (RDEA3170) functions as a high-affinity inhibitor of the urate transporter 1 (URAT1), directly blocking URAT1-mediated uric acid reabsorption in renal tubular epithelial cells. By suppressing renal urate reuptake and promoting urinary urate excretion, it effectively lowers circulating serum uric acid levels, providing the mechanistic basis for its clinical investigation in gout and chronic kidney disease.

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>).

Jump to

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