FEBUXOSTAT · Sun Pharma
Febuxostat is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Limitations of Use : Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.
Details
- Status
- Prescription
- First Approved
- 2009-02-13
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
FEBUXOSTAT Approval History
What FEBUXOSTAT Treats
2 indicationsFEBUXOSTAT is approved for 2 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyperuricemia
- Gout
Same approved indications as ULORIC (same active ingredient).
FEBUXOSTAT Boxed Warning
CARDIOVASCULAR DEATH Gout patients with established cardiovascular (CV) disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions (5.1) ] . Consider the risks and benefits of febuxostat tablets when deciding to prescribe or continue patients on febuxostat tablets. Febuxostat tablets should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol,...
WARNING: CARDIOVASCULAR DEATH Gout patients with established cardiovascular (CV) disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions (5.1) ] . Consider the risks and benefits of febuxostat tablets when deciding to prescribe or continue patients on febuxostat tablets. Febuxostat tablets should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable [see Indications and Usage (1) ] . WARNING: CARDIOVASCULAR DEATH See full prescribing information for complete boxed warning. Gout patients with established cardiovascular (CV) disease treated with febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study. ( 5.1 ) Consider the risks and benefits of febuxostat when deciding to prescribe or continue patients on febuxostat . Febuxostat should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ( 1 )
Sun Pharma's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
42 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06622603 TARGET | TARGET-V1-01 | Ph 4 | recruiting | the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More |
| NCT07362355 | SHR4640-204 | Ph 2 | recruiting | The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia |
| NCT07498647 BR2251-201 | BR2251-201 | Ph 2 | not yet recruiting | Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia |
| NCT07414394 | CIBI128A301 | Ph 3 | recruiting | Tigulixostat (IBI128) vs Febuxostat in Gout |
| NCT07369622 HLA-SCREEN | HLA-GOUT-SCARS-2026 HPMU-HLA-GOUT | Ph 4 | not yet recruiting | HLA-B*58:01-Guided Therapy for Gout: Effectiveness, Safety, and Cost-Effectiveness |
| NCT06834230 DIANA-NEXT | 00003 | Ph 4 | recruiting | Effect of Dotinurad in Hyperuricemia With Hypertension |
| NCT07170475 iFRESH-PD | FU-PD-i01 | Ph 1 | recruiting | A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease |
| NCT05007392 results posted | FYU-981-J086-301 | Ph 3 | completed | A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout |
| NCT06501534 | CIBI128A201 | Ph 2 | completed | A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects |
| NCT02752633 results posted | RDCRN Protocol #6412 2013-000975-33, U54DK083908 | Ph 4 | completed | Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion |
| NCT01654276 results posted | MSA-FEB-137 | Ph 4 | completed | Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome |
| NCT02287818 results posted | AC-201-GOU-002 | Ph 2 | completed | A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout |
| NCT03605212 FLORET results posted | FLO-02 2016-001445-61 | Ph 1, Ph 2 | terminated | Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults |
| NCT01472692 results posted | 110806 | Ph 4 | completed | Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure |
| NCT03316131 results posted | D5495C00001 | Ph 2 | completed | A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA |
| NCT03131583 | SHR4640-103 | Ph 1 | completed | The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout |
| NCT01112982 results posted | Pro00000136 | Ph 4 | completed | An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels. |
| NCT02600780 ZEST | DUHS-GTZ-MD-001-13 | Ph 4 | completed | Zurig (Febuxostat) 40mg Efficacy and Safety Trial |
| NCT03918551 | PTL-P1-099 (v. 1.0 03/15/2019) | Ph 1 | completed | 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 |
| NCT03372200 | FYU-981-014 | Ph 3 | completed | Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout |
| NCT01101035 CARES results posted | TMX-67_301 U1111-1114-4194 | Ph 3 | completed | Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES) |
| NCT01712204 results posted | AC-201-GOU-001 | Ph 2 | completed | A Proof-of-Concept Study of AC-201 to Prevent Gout Flares |
| NCT01808144 results posted | RDEA594-307 2012-004390-54 | Ph 3 | completed | Lesinurad and Febuxostat Combination Extension Study in Gout |
| NCT02344602 | 12-5427-A | Ph 4 | completed | The Effect of Uric Acid Lowering in Type 1 Diabetes |
| NCT02866214 | phCL 35 | Ph 2, Ph 3 | completed | Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients. |
| NCT02279342 | D1407027 | Ph 4 | terminated | the Effect of Febuxostat on Coronary Plaque Volume in Patients With Chronic Stable Angina and Hyperuricemia |
| NCT01510769 CRYSTAL results posted | RDEA594-304 2011-003768-55 | Ph 3 | completed | Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat |
| NCT01763996 results posted | CCR-FEB-002 U1111-1136-2270 | Ph 4 | completed | The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Participants With Chronic Stable Angina |
| NCT02082769 results posted | SFDA2010L04287 | Ph 3 | completed | Safety and Efficacy of Oral Febuxostat in Subjects With Gout |
| NCT01328769 results posted | 42916 | Ph 4 | completed | Febuxostat, Blood Pressure and the Intrarenal Renin-Angiotensin System (RAS) |
| NCT01496469 results posted | TMX-67_206 U1111-1124-4638 | Ph 2 | completed | Effect of Febuxostat on Blood Pressure |
| NCT02317861 | D5491L00001 RDEA3170-205 | Ph 1, Ph 2 | completed | A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients |
| NCT02252835 | CB102-21426 | Ph 2 | completed | Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout |
| NCT01416402 | M102-21124 | Ph 2 | completed | Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients |
| NCT01724528 FLORENCE results posted | FLO-01 2012-000776-42 | Ph 3 | completed | Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies |
| NCT01736514 | TMXALL-1001-TW | Ph 3 | completed | A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout |
| NCT01078389 results posted | TMX-67_204 U1111-1113-8098 | Ph 2 | completed | Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout |
| NCT02060552 | Diagout1 | Ph 4 | completed | Immune Molecular and Inflammatory Cytokines Dysfunction Analysis in Gout Patients With Different Urate Levels |
| NCT01549977 results posted | TMX-67_207 U1111-1125-1278 | Ph 2 | terminated | Effect of Febuxostat Compared to Placebo on Exercise Tolerance in Participants With Chronic Stable Angina |
| NCT01082640 results posted | TMX-67_203 U1111-1113-8008 | Ph 2 | completed | Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment |
| NCT01077284 results posted | TMX-67_201 U1111-1113-6322 | Ph 2 | completed | Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones |
| NCT00995618 | A3006GT | Ph 2 | completed | Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FEBUXOSTAT FDA Label Details
Indications & Usage
Febuxostat is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Limitations of Use : Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose o...
WARNING: CARDIOVASCULAR DEATH Gout patients with established cardiovascular (CV) disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions (5.1) ] . Consider the risks and benefits of febuxost...
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ULORIC
Full clinical data, patents, trials, and competitive landscape for febuxostat.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.