Benzbromarone Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Benzbromarone has been evaluated across multiple clinical trials spanning Phase 1 through Phase 4, primarily targeting hyperuricemia and gout alongside type 2 diabetes, idiopathic pulmonary arterial hypertension, chronic kidney disease, and cardiovascular conditions such as heart failure and left ventricular diastolic dysfunction. Sponsored by academic research institutes, university medical centers, and commercial pharmaceutical organizations, these investigations include both completed studies and protocols with unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05504083	COMPLETED	Hyperuricemia	InventisBio Co., Ltd	2022-09-28	PHASE2
NCT03534037	UNKNOWN	Hyperuricemia; Metabolic Syndrome; Left Ventricular Diastolic Dysfunction	National Defense Medical Center, Taiwan	2020-02-01	PHASE4
NCT05210517	COMPLETED	Type 2 Diabetes	Amsterdam UMC, location VUmc	2020-10-01	PHASE4
NCT02944214	UNKNOWN	Chronic Kidney Disease; Hyperuricemia; Abnormal Renal Function	Shanghai 10th People's Hospital	2016-10
NCT02338323	COMPLETED	Chronic Kidney Disease; Hyperuricemia; Abnormal Renal Function	Shanghai 10th People's Hospital	2015-01
NCT03185793	COMPLETED	Hyperuricemia	Jiangsu HengRui Medicine Co., Ltd.	2017-07-20	PHASE2
NCT03100318	COMPLETED	Hyperuricemia With or Without Gout	Fuji Yakuhin Co., Ltd.	2017-04-01	PHASE3
NCT02790450	COMPLETED	Idiopathic Pulmonary Arterial Hypertension	Medical University of Graz	2015-10	PHASE2
NCT02317861	COMPLETED	Gout and Asymptomatic Hyperuricemia	AstraZeneca	2014-12	PHASE1; PHASE2
NCT00422318	COMPLETED	Heart Failure; Hyperuricemia	Tottori University Hospital	2004-01	PHASE4

(data from https://clinicaltrials.gov, updated on 2024-10-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Benzbromarone binds to cytochrome P450 2C9 (CYP2C9) with a Ki value of 19.3 nM and inhibits urate transporter function, blocking renal tubular uric acid reabsorption. By suppressing urate reuptake and promoting urinary uric acid excretion, the compound lowers serum urate concentrations, directly supporting its clinical evaluation for hyperuricemia, gout, and related cardiovascular and renal disorders.

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>).