Uloric

(Febuxostat)

ApprovedSmall molecule

Febuxostat is used to treat gout by lowering uric acid levels in the blood, which helps prevent gout attacks and reduces joint pain and swelling.[2] Uloric is currently approved and in use across 20 indications[4].[1]

Uloric is one of 506 small molecule programs targeting Hyperuricemia. It is currently in Approved.

Indications

Total Trials

Active Trials

505

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

HyperuricemiaUnknown status

HypertensionApproved

Angina PectorisApproved

Cardiovascular DiseaseApproved

NephrolithiasisApproved

Kidney DiseaseApproved

Non-Alcoholic Fatty Liver DiseaseApproved

Diabetic NephropathyActive, not recruiting

Chronic Kidney DiseaseActive, not recruiting

Intracranial HemorrhageRecruiting

HyperuricemiaApproved

Unknown status

HypertensionApproved

Approved

Angina PectorisApproved

Approved

Cardiovascular DiseaseApproved

Approved

NephrolithiasisApproved

Approved

Kidney DiseaseApproved

Approved

Non-Alcoholic Fatty Liver DiseaseApproved

Approved

Diabetic NephropathyPreclinical

Active, not recruiting

Chronic Kidney DiseasePreclinical

Active, not recruiting

Intracranial HemorrhagePhase 2

Recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

172 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Uloric

Takeda

Approved

2 2

AND017

KKind Pharmaceuticals LLC

Phase 3

3 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Vemlidy

Gilead

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Activase

Flomax

PROCRIT

1 10

Verquvo

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Gout

NCT06622603

N/ANot yet recruiting

Efficacy and Safety

NCT06653686

Phase 2Active, not recruiting

Non-Alcoholic Steatohepatitis

NCT05574036

Phase 1Not yet recruiting

Ulcerative Colitis

NCT06525974

Q1 2027

Phase 2Recruiting

Intracranial Hemorrhage

NCT07701512

Q3 2027

Phase 2Not yet recruiting

Hyperuricemia

NCT07362355

Clinical

Trials by Indication[1]

Hyperuricemia11 trials

Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

Completed·MMochida Pharmaceutical Company, Ltd.·Phase 3·NCT03372200·203 enrolled

A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT02317861·110 enrolled

Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients

Completed· Gilead logo

Gilead·Phase 2·NCT01416402·27 enrolled

Show 8 more trials

Role of Uralyt-U in Patients With Hyperuricemia

Unknown status·AAi Peng·N/A·NCT04352153·102 enrolled

Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia

Completed·NNuon Therapeutics, Inc.·Phase 2·NCT00995618·24 enrolled

The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia

Not yet recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 2·NCT07362355·340 enrolled

the Effect of Febuxostat on Coronary Plaque Volume in Patients With Chronic Stable Angina and Hyperuricemia

Terminated·YYokohama City University Medical Center·Phase 4·NCT02279342·1 enrolled

Effect of Dotinurad in Hyperuricemia With Hypertension

Recruiting·—·Phase 4·NCT06834230·360 enrolled

Phase II/III Study of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia

Active, not recruiting·GGuangzhou Ruianbo Pharmaceutical Technology Co., Ltd·Phase 2/3·NCT06603142·636 enrolled

Clinical Study of SHR4640 Tablets Combined With Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 2·NCT05513976·129 enrolled

Lowering-hyperuricemia Treatment on Cardiovascular Outcomes in Peritoneal Dialysis Patients

Unknown status·SSun Yat-sen University·Phase 4·NCT03200210·548 enrolled

Gout11 trials

Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.

Completed· Takeda logo

Takeda·Phase 3·NCT00174915·1,072 enrolled

A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout

Completed·TTWi Biotechnology, Inc.·Phase 2·NCT02287818·127 enrolled

Lesinurad and Febuxostat Combination Extension Study in Gout

Completed·AArdea Biosciences, Inc.·Phase 3·NCT01808144·196 enrolled

Show 8 more trials

A Proof-of-Concept Study of AC-201 to Prevent Gout Flares

Completed·TTWi Biotechnology, Inc.·Phase 2·NCT01712204·82 enrolled

RDEA3170 and Febuxostat Combination Study in Gout Subjects

Completed·AArdea Biosciences, Inc.·Phase 2·NCT02246673·64 enrolled

A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients

Unknown status·JJW Pharmaceutical·Phase 3·NCT05815901·588 enrolled

Long-Term Safety of Febuxostat in Subjects With Gout.

Completed· Takeda logo

Takeda·Phase 2·NCT00174941·116 enrolled

The Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More

Not yet recruiting·SSeoul National University Hospital·Phase 4·NCT06622603·59 enrolled

A Phase 2, Open-label, Drug-Drug Interaction Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Arhalofenate in Combination With Febuxostat for the Treatment of Hyperuricemia in Patients With Gout

Completed· Gilead logo

Gilead·Phase 2·NCT02252835·32 enrolled

Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostate on Gouty Obese Non-Diabetic Patients

Completed·MMostafa Bahaa·Phase 2·NCT06995339·60 enrolled

A Randomized, Double-Blind, Double-Dummy, Multi-Center, Phase III Study Comparing the Efficacy and Safety of Tigulixostat (IBI128) and Febuxostat in Chinese Subjects With Gout

Active, not recruiting·IInnovent Biologics Technology Limited (Shanghai R&D Center)·Phase 3·NCT07414394·600 enrolled

Efficacy and Safety5 trials

A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects

Completed· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 2·NCT06501534·84 enrolled

Efficacy and Safety of Simiaowan in Prevention of Acute Flares in Chronic Gout Patients Initiating Febuxostat Therapy

Unknown status·GGuang'anmen Hospital of China Academy of Chinese Medical Sciences·N/A·NCT04069325·72 enrolled

Study on the Efficacy and Safety of Thermotherapy in the Treatment of Refractory Gout

Not yet recruiting·TThe First Hospital of Jilin University·N/A·NCT06653686·128 enrolled

Show 2 more trials

Efficacy and Safety of Oral Febuxostat in Participants With Gout

Completed· Takeda logo

Takeda·Phase 3·NCT00430248·2,269 enrolled

Zurig (Febuxostat) 40mg Efficacy and Safety Trial

Completed·GGetz Pharma·Phase 4·NCT02600780·50 enrolled

Blood Pressure4 trials

The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study

Terminated·UUniversity of Mississippi Medical Center·N/A·NCT01701622·1 enrolled

Effect of Febuxostat on Blood Pressure

Completed· Takeda logo

Takeda·Phase 2·NCT01496469·121 enrolled

Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure

Completed·UUniversity of California, San Diego·Phase 4·NCT01472692·47 enrolled

Show 1 more trial

Febuxostat, Blood Pressure and the Intrarenal Renin-Angiotensin System (RAS)

Completed·—·Phase 4·NCT01328769·49 enrolled

Interaction3 trials

The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT03131583·15 enrolled

Drug-Drug Interaction of JMKX003142 With Amiodarone and Febuxostat in Healthy Subjects

Not yet recruiting·JJemincare·Phase 1·NCT07181265·48 enrolled

RDEA3170 and Febuxostat Drug Interaction Study

Completed·AArdea Biosciences, Inc.·Phase 1·NCT01883167·21 enrolled

35 more indications

Safety and Efficacy3 trials

Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout

Completed· Takeda logo

Takeda·Phase 2·NCT00174967·153 enrolled

Safety and Efficacy of Oral Febuxostat in Subjects With Gout

Completed·XXijing Hospital·Phase 3·NCT02082769·504 enrolled

A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout

Completed· Astellas logo

Astellas·Phase 3·NCT01736514·109 enrolled

Chronic Kidney Disease2 trials

Effects of Febuxostat on Adipokines and Kidney Disease in Diabetic Chronic Kidney Disease

Completed·UUniversity of Utah·N/A·NCT01350388·80 enrolled

Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3

Completed·—·N/A·NCT05264584·120 enrolled

Endothelial Dysfunction2 trials

The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Participants With Chronic Stable Angina

Completed· Takeda logo

Takeda·Phase 4·NCT01763996·30 enrolled

Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

Completed·—·Phase 2/3·NCT02866214·57 enrolled

Trial2 trials

Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010

Completed· Takeda logo

Takeda·Phase 3·NCT00175019·1,086 enrolled

Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

Completed· Takeda logo

Takeda·Phase 3·NCT00102440·760 enrolled

Tumor Lysis Syndrome2 trials

Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults

Terminated· Menarini logo

Menarini·Phase 1/2·NCT03605212·30 enrolled

Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies

Completed· Menarini logo

Menarini·Phase 3·NCT01724528·346 enrolled

Treatment1 trial

A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout

Completed· Eisai logo

Eisai·Phase 3·NCT05007392·451 enrolled

Tophaceous Gout1 trial

Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat

Completed·AArdea Biosciences, Inc.·Phase 3·NCT01510769·330 enrolled

Type 1 Diabetes1 trial

The Effect of Uric Acid Lowering in Type 1 Diabetes

Completed·UUniversity Health Network, Toronto·Phase 4·NCT02344602·73 enrolled

Ulcerative Colitis1 trial

Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine

Not yet recruiting·TTanta University·Phase 1·NCT06525974·46 enrolled

Cardiovascular1 trial

Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)

Completed· Takeda logo

Takeda·Phase 3·NCT01101035·6,198 enrolled

Inflammation1 trial

An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.

Completed·UUniversity of South Florida·Phase 4·NCT01112982·74 enrolled

Excretion1 trial

Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion

Completed·LLandspitali University Hospital·Phase 4·NCT02752633·9 enrolled

Effectiveness1 trial

HLA-B*58:01-Guided Therapy for Gout: Effectiveness, Safety, and Cost-Effectiveness

Not yet recruiting·HHaiphong University of Medicine and Pharmacy·Phase 4·NCT07369622·228 enrolled

Prevention1 trial

Febuxostat for Cerebral and caRdiorenovascular Events prEvEntion stuDy

Unknown status·FFreed Study Group·N/A·NCT01984749·1,000 enrolled

MPA1 trial

Compare the Renal Protective Effects of Febuxostat and Benzbromarone

Completed·SShanghai 10th People's Hospital·N/A·NCT02338323·160 enrolled

Chronic Renal Disease1 trial

Effect of Hyperuricaemia on Chronic Renal Disease

Unknown status·TThe Affiliated Hospital of Xuzhou Medical University·Phase 4·NCT03425708·400 enrolled

Acute Kidney Injury1 trial

Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)

Unknown status·IInstituto Nacional de Cardiologia Ignacio Chavez·Phase 2·NCT03767322·558 enrolled

Parkinson's Disease1 trial

A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease

Recruiting·FFujita Health University·Phase 1·NCT07170475·24 enrolled

CKD1 trial

Compare the Renal Protective Effects of Febuxostat and Benzbromarone in CKD Chinese Patients

Unknown status·SShanghai 10th People's Hospital·N/A·NCT02944214·800 enrolled

Diabetic Nephropathy1 trial

Hyperuricemia and Diabetic Nephropathy

Unknown status·—··NCT04799925·200 enrolled

Left ventricular diastolic dysfunction1 trial

Urate Lowering Therapies and Left Ventricular Diastolic Dysfunction

Unknown status·NNational Defense Medical Center, Taiwan·Phase 4·NCT03534037·120 enrolled

Methotrexate1 trial

A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects

Completed·SSeoul National University Hospital·Phase 1·NCT05575297·12 enrolled

Non-Alcoholic Steatohepatitis1 trial

Comparative Study Between Febuxostat Versus Vitamin E in Non-alcoholic Steatohepatitis Patients With Hyperuricemia

Active, not recruiting·TTanta University·Phase 2·NCT05574036·70 enrolled

Dapagliflozin1 trial

A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT03316131·36 enrolled

Acute Lymphoblastic Leukemia1 trial

Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones

Completed· Takeda logo

Takeda·Phase 2·NCT01077284·99 enrolled

Joint1 trial

Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout

Completed· Takeda logo

Takeda·Phase 2·NCT01078389·314 enrolled

Chronic Stable Angina1 trial

Effect of Febuxostat Compared to Placebo on Exercise Tolerance in Participants With Chronic Stable Angina

Terminated· Takeda logo

Takeda·Phase 2·NCT01549977·1 enrolled

Renal Impairment1 trial

Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment

Completed· Takeda logo

Takeda·Phase 2·NCT01082640·96 enrolled

Metabolic Syndrome1 trial

Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT01654276·24 enrolled

Uric Acid1 trial

Uric Acid Effects on Endothelium and Oxydative Stress

Completed·EErasme University Hospital·N/A·NCT03395977·53 enrolled

Inflammatory Cytokines1 trial

Immune Molecular and Inflammatory Cytokines Dysfunction Analysis in Gout Patients With Different Urate Levels

Completed·TTongji Hospital·Phase 4·NCT02060552·96 enrolled

Phase II1 trial

Phase III Trial of Febuxostat in Korea Gout Patients

Completed·SSK Chemicals Co., Ltd.·Phase 3·NCT00821392·181 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Two Formulations of Febuxostat 120 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions

Completed·PPharmtechnology LLC·Phase 1·NCT03918551·50 enrolled

Carotid Intima- Media Thickness1 trial

Impact of Febuxostat on Disease Progression and Carotid Intima-Media Thickness in Patients With Chronic Kidney Disease

Completed·AAin Shams University·Phase 1·NCT06997952·50 enrolled

Intracranial Hemorrhage1 trial

Clinical Study to Evaluate the Efficacy of Febuxostat in the Treatment of Conservatively Managed Intracranial Hemorrhage Patients

Recruiting·TTanta University·Phase 2·NCT07701512·46 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 13, 2009

ULORIC

NDA NDA021856

Feb 13, 2009

ULORIC

NDA NDA021856

Jan 28, 2011

ULORIC

NDA NDA021856

Nov 1, 2012

ULORIC

NDA NDA021856

Dec 12, 2013

ULORIC

NDA NDA021856

Oct 23, 2014

ULORIC

NDA NDA021856

Feb 12, 2016

ULORIC

NDA NDA021856

Aug 15, 2017

ULORIC

NDA NDA021856

Feb 6, 2018

ULORIC

NDA NDA021856

Feb 21, 2019

ULORIC

NDA NDA021856

Apr 17, 2023

ULORIC

NDA NDA021856

Sources

References

[1]
ClinicalTrials.gov — 75 trial records for Febuxostat. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Uloric drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Febuxostat compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Febuxostat. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021856). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Uloric. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Xanthine Dehydrogenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Takeda

Patent Landscape[6]

Patent Cliff

Sep 8, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8372872Sep 8, 2031

9107912Sep 8, 2031

Uloric

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Hyperuricemia11 trials

Gout11 trials

Efficacy and Safety5 trials

Blood Pressure4 trials

Interaction3 trials

Safety and Efficacy3 trials

Chronic Kidney Disease2 trials

Endothelial Dysfunction2 trials

Trial2 trials

Tumor Lysis Syndrome2 trials

Treatment1 trial

Tophaceous Gout1 trial

Type 1 Diabetes1 trial

Ulcerative Colitis1 trial

Cardiovascular1 trial

Inflammation1 trial

Excretion1 trial

Effectiveness1 trial

Prevention1 trial

MPA1 trial

Chronic Renal Disease1 trial

Acute Kidney Injury1 trial

Parkinson's Disease1 trial

CKD1 trial

Diabetic Nephropathy1 trial

Left ventricular diastolic dysfunction1 trial

Methotrexate1 trial

Non-Alcoholic Steatohepatitis1 trial

Dapagliflozin1 trial

Acute Lymphoblastic Leukemia1 trial

Joint1 trial

Chronic Stable Angina1 trial

Renal Impairment1 trial

Metabolic Syndrome1 trial

Uric Acid1 trial

Inflammatory Cytokines1 trial

Phase II1 trial

Fasting Conditions1 trial

Carotid Intima- Media Thickness1 trial

Intracranial Hemorrhage1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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