Clinical Trials

Numerous clinical trials spanning early- to late-phase development evaluate febuxostat primarily for hyperuricemia and gout, as well as cardiovascular endpoints such as hypertension and bioequivalence in healthy volunteers. Sponsored by academic institutions and pharmaceutical companies, these studies vary in status from completed and recruiting to terminated or not yet recruiting. Major evaluations include late-stage trials of therapeutic initiation strategies for gout alongside drug utilization studies monitoring treatment patterns relative to allopurinol.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07326839 NOT_YET_RECRUITING
Gout; Obesity
XueMei Guo
 2025-12-10
NCT07323095 NOT_YET_RECRUITING
Chronic Kidney Disease
Atom Therapeutics Co., Ltd
 2026-06-30 PHASE2
NCT06834230 RECRUITING
Hyperuricemia or Gout; Hypertension
Saga University
 2025-03-28 PHASE4
NCT07362355 RECRUITING
Primary Gout and Hyperuricemia
Jiangsu HengRui Medicine Co., Ltd.
 2026-02-09 PHASE2
NCT07369622 NOT_YET_RECRUITING
Gout Initiating Urate-loweringUrate-lowering Therapy; Gout Arthritis; Gout and Hyperuricemia
Haiphong University of Medicine and Pharmacy
 2026-01-20 PHASE4
NCT07485452 RECRUITING
Non-Small Cell Lung Cancer
Maastricht University Medical Center
 2026-06 PHASE2
NCT07414394 ACTIVE_NOT_RECRUITING
Gout
Innovent Biologics Technology Limited (Shanghai R&D Center)
 2026-03-17 PHASE3
NCT06622603 RECRUITING
Gout; Uric Acid
Seoul National University Hospital
 2025-09-10 PHASE4
NCT05109936 RECRUITING
Gout
University Hospital, Rouen
 2023-08-02 PHASE3
NCT07701512 RECRUITING
Intracranial Hemorrhage
Tanta University
 2025-11-20 PHASE2
NCT07498647 NOT_YET_RECRUITING
Gout and Hyperuricemia
BioRay Pharmaceutical Co., Ltd.
 2026-04-01 PHASE2
NCT06525974 NOT_YET_RECRUITING
Ulcerative Colitis
Tanta University
 2024-09-01 EARLY_PHASE1
NCT06995339 RECRUITING
Gout
Mostafa Bahaa
 2025-05-30 PHASE2
NCT06653686 NOT_YET_RECRUITING
Refractory Gout
The First Hospital of Jilin University
 2024-11
NCT06414837 UNKNOWN
Gout With Hyperuricemia in Adults
Jiangsu HengRui Medicine Co., Ltd.
 2024-06 PHASE3
NCT05574036 ACTIVE_NOT_RECRUITING
Non Alcoholic Steatohepatitis; Hyperuricemia
Tanta University
 2022-08-25 PHASE2
NCT07181265 NOT_YET_RECRUITING
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Jemincare
 2025-10-30 PHASE1
NCT06603142 ACTIVE_NOT_RECRUITING
Primary Gout; Hyperuricemia
Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd
 2024-04-22 PHASE2; PHASE3
NCT07170475 RECRUITING
Parkinson's Disease (PD)
Fujita Health University
 2025-06-27 PHASE1
NCT06139393 COMPLETED
Gout With Hyperuricemia in Adults
Jiangsu HengRui Medicine Co., Ltd.
 2023-12-14 PHASE3
NCT06501534 COMPLETED
Gout; Hyperuricemia
Innovent Biologics (Suzhou) Co. Ltd.
 2024-07-10 PHASE2
NCT06233162 UNKNOWN
Healthy Subjects
Bio-innova Co., Ltd
 2024-09-03 PHASE1
NCT06997952 COMPLETED
Carotid Intima- Media Thickness
Ain Shams University
 2024-05-24 PHASE1
NCT05815901 COMPLETED
Gout
JW Pharmaceutical
 2023-03-21 PHASE3
NCT04697602 TERMINATED
Gout
National Taiwan University Hospital
 2021-01-20
NCT05007392 COMPLETED
Gout
Eisai Co., Ltd.
 2021-12-21 PHASE3
NCT05513976 UNKNOWN
Primary Gout and Hyperuricemia
Jiangsu HengRui Medicine Co., Ltd.
 2022-09-15 PHASE2
NCT05474560 COMPLETED
Non-Alcoholic Fatty Liver Disease; Hyperuricemia
Ain Shams University
 2022-01-01 PHASE4
NCT03200210 UNKNOWN
Hyperuricemia
Sun Yat-sen University
 2017-07-11 PHASE4
NCT03336203 UNKNOWN
Gout; CKD Stage 1-4; SUA Level (>8 mg/dL; 480 µmol/L)
Medical Practice Prof D. Ivanov
 2017-10-30 PHASE4
NCT05324423 UNKNOWN
Gout
The Affiliated Hospital of Qingdao University
 2021-10-18 PHASE1
NCT05347498 UNKNOWN
Primary Gout With Hyperuricemia in Adults
Jiangsu HengRui Medicine Co., Ltd.
 2022-04-30 PHASE1
NCT05575297 COMPLETED
Drug Interaction
Seoul National University Hospital
 2021-12-20 PHASE1
NCT04398251 UNKNOWN
Hypouricemia, Renal; Urolithiasis
Xuhui Central Hospital, Shanghai
 2020-04-10 PHASE4
NCT05109936 Not yet recruiting
Gout
University Hospital Rouen
 2022-01-01 Phase 3
NCT03534037 UNKNOWN
Hyperuricemia; Metabolic Syndrome; Left Ventricular Diastolic Dysfunction
National Defense Medical Center, Taiwan
 2020-02-01 PHASE4
NCT05264584 COMPLETED
Chronic Kidney Disease stage3; Contrast-induced Nephropathy
Ain Shams University
 2020-12-01
NCT04772352 UNKNOWN
Nonalcoholic Fatty Liver Disease
Ningbo No. 1 Hospital
 2021-03-01 PHASE2
NCT02579096 COMPLETED
Gout; Chronic Kidney Diseases
VA Office of Research and Development
 2017-03-06 PHASE4
NCT04352153 UNKNOWN
Uric Acid Stones; Hyperuricemia
Ai Peng
 2020-04-01
NCT04155918 COMPLETED
Gout Patients
Arthrosi Therapeutics
 2020-02-03 PHASE2
NCT04853160 Completed
Gout|Cardiovascular Diseases
Takeda
 2020-08-15 --
NCT04180982 UNKNOWN
Hyperuricemia
Jiangsu HengRui Medicine Co., Ltd.
 2019-12-03 PHASE2
NCT04069325 UNKNOWN
Gout Flare
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
 2019-09-01
NCT04157959 UNKNOWN
Hyperuricemia
Jiangsu HengRui Medicine Co., Ltd.
 2019-10-14 PHASE1
NCT03395977 COMPLETED
Oxidative Stress; Endothelial Function; Cardiovascular System; Hypertension
Erasme University Hospital
 2018-01-03
NCT02944214 UNKNOWN
Chronic Kidney Disease; Hyperuricemia; Abnormal Renal Function
Shanghai 10th People's Hospital
 2016-10
NCT04157959 Unknown status
Hyperuricemia
Jiangsu HengRui Medicine Co. Ltd.
 2019-10-14 Phase 1
NCT03767322 UNKNOWN
Contrast-induced Nephropathy; Contrast-induced Acute Kidney Injury
Instituto Nacional de Cardiologia Ignacio Chavez
 2018-12-05 PHASE2
NCT04347005 COMPLETED
Healthy Volunteers
Arthrosi Therapeutics
 2019-01-22 PHASE1
NCT03918551 COMPLETED
Bioequivalence
Pharmtechnology LLC
 2019-05-03 PHASE1
NCT03918551 Completed
Bioequivalence
Pharmtechnology LLC|Altasciences Company Inc.
 2019-05-03 Phase 1
NCT03425708 UNKNOWN
Hyperuricemia; Chronic Renal Disease
The Affiliated Hospital of Xuzhou Medical University
 2017-01-01 PHASE4
NCT02338323 COMPLETED
Chronic Kidney Disease; Hyperuricemia; Abnormal Renal Function
Shanghai 10th People's Hospital
 2015-01
NCT03118739 COMPLETED
Hyperuricemia; Albuminuria; Type 2 Diabetes
AstraZeneca
 2017-05-18 PHASE2
NCT03605212 TERMINATED
Tumor Lysis Syndrome
Menarini Group
 2017-02-27 PHASE1; PHASE2
NCT03316131 COMPLETED
Asymptomatic Hyperuricemia
AstraZeneca
 2017-10-25 PHASE2
NCT03372200 COMPLETED
Hyperuricemia With or Without Gout
Mochida Pharmaceutical Company, Ltd.
 2018-01-09 PHASE3
NCT03131583 COMPLETED
Gout
Jiangsu HengRui Medicine Co., Ltd.
 2017-02-17 PHASE1
NCT01984749 UNKNOWN
Hyperuricemia
Freed Study Group
 2013-11
NCT01101035 COMPLETED
Cardiovascular Disease
Takeda
 2010-04-23 PHASE3
NCT02500641 COMPLETED
Gout
Menarini International Operations Luxembourg SA
 2015-08-17 PHASE4
NCT03149939 COMPLETED
Hyperuricemia; Hemodialysis Complication
Benha University
 2017-01-01
NCT02279342 TERMINATED
Coronary Artery Disease
Yokohama City University Medical Center
 2014-10 PHASE4
NCT02287818 COMPLETED
Gout
TWi Biotechnology, Inc.
 2014-12 PHASE2
NCT02866214 COMPLETED
Endothelial Dysfunction; Endstage Renal Disease
Ain Shams University
 2016-08 PHASE2; PHASE3
NCT01808144 COMPLETED
Gout
Ardea Biosciences, Inc.
 2013-03-01 PHASE3
NCT02139046 COMPLETED
Gout
Takeda
 2014-04 PHASE3
NCT02344602 COMPLETED
Type 1 Diabetes Mellitus
University Health Network, Toronto
 2012-12-18 PHASE4
NCT02128490 COMPLETED
Gout; Moderate Renal Impairment
Takeda
 2014-05 PHASE2
NCT02504320 COMPLETED
Healthy Volunteers
Takeda
 2015-08 PHASE1
NCT02246673 COMPLETED
Gout
Ardea Biosciences, Inc.
 2014-10 PHASE2
NCT02317861 COMPLETED
Gout and Asymptomatic Hyperuricemia
AstraZeneca
 2014-12 PHASE1; PHASE2
NCT02382640 COMPLETED
Healthy Volunteers
Takeda
 2015-03 PHASE1
NCT02752633 COMPLETED
Adenine Phosphoribosyltransferase Deficiency
Landspitali University Hospital
 2013-05 PHASE4
NCT01763996 COMPLETED
Coronary Artery Disease
Takeda
 2013-05 PHASE4
NCT01654276 COMPLETED
Gout
University of Texas Southwestern Medical Center
 2012-05 PHASE4
NCT02374164 COMPLETED
Gout
Takeda
 2015-02 PHASE1
NCT02252835 COMPLETED
Gout; Hyperuricemia
Gilead Sciences
 2014-08 PHASE2
NCT01112982 COMPLETED
Gout
University of South Florida
 2010-05 PHASE4
NCT02600780 COMPLETED
Hyperuricemia
Getz Pharma
 2013-11 PHASE4
NCT01496469 COMPLETED
Hypertension
Takeda
 2012-02 PHASE2
NCT01510769 COMPLETED
Tophaceous Gout
Ardea Biosciences, Inc.
 2012-01 PHASE3
NCT01472692 COMPLETED
Prehypertension; Gout; Pulse Wave Velocity; Hypertension; 24 Hour Blood Pressure
University of California, San Diego
 2011-10 PHASE4
NCT02060552 COMPLETED
Primary Gout
Tongji Hospital
 2013-01 PHASE4
NCT01350388 COMPLETED
Chronic Kidney Disease; Diabetes
University of Utah
 2011-05
NCT02082769 COMPLETED
Gout
Xijing Hospital
 2011-07 PHASE3
NCT01724528 COMPLETED
Tumor Lysis Syndrome
Menarini Group
 2012-10 PHASE3
NCT01712204 COMPLETED
Gout Flares
TWi Biotechnology, Inc.
 2013-01 PHASE2
NCT01328769 COMPLETED
Hypertension
Paul N. Hopkins
 2011-03 PHASE4
NCT01883167 COMPLETED
Healthy
Ardea Biosciences, Inc.
 2013-06 PHASE1
NCT01078389 COMPLETED
Joint Damage
Takeda
 2010-03 PHASE2
NCT01549977 TERMINATED
Angina
Takeda
 2012-07 PHASE2
NCT01082640 COMPLETED
Renal Impairment
Takeda
 2010-04 PHASE2
NCT01563432 COMPLETED
Gout
SK Chemicals Co., Ltd.
 2012-01 PHASE1
NCT01736514 COMPLETED
Gout
Astellas Pharma Taiwan, Inc.
 2011-03 PHASE3
NCT01077284 COMPLETED
Hyperuricosuria; Kidney Stones
Takeda
 2010-02 PHASE2
NCT01416402 COMPLETED
Hyperuricemia; Gout
Gilead Sciences
 2011-08 PHASE2
NCT01701622 TERMINATED
Blood Pressure; Gout
University of Mississippi Medical Center
 2010-01
NCT00995618 COMPLETED
Gout; Hyperuricemia
Nuon Therapeutics, Inc.
 2009-09 PHASE2
NCT00430248 COMPLETED
Gout
Takeda
 2007-02 PHASE3
NCT00821392 COMPLETED
Gout
SK Chemicals Co., Ltd.
 2006-08 PHASE3
NCT00175019 COMPLETED
Gout
Takeda
 2003-07 PHASE3
NCT00174941 COMPLETED
Gout
Takeda
 2001-03 PHASE2
NCT00174915 COMPLETED
Gout
Takeda
 2003-02 PHASE3
NCT00102440 COMPLETED
Gout
Takeda
 2002-07 PHASE3
NCT00174967 COMPLETED
Gout
Takeda
 2001-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-01-08)

Check the Febuxostat (TEI-6720) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Febuxostat acts as a selective, non-purine inhibitor of xanthine oxidase that non-competitively blocks the substrate channel leading to the active site of the enzyme, thereby preventing the sequential oxidation of hypoxanthine and xanthine to uric acid. By suppressing xanthine oxidase activity and significantly reducing systemic uric acid production, febuxostat provides a targeted therapeutic mechanism for the clinical management of 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.