> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/febuxostat-2438f334-c9cd-40d7-972b-400dbd7f043a > Record changed: 2026-10-13 # Febuxostat Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1164729) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1164729) First approval year 2008 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1164729) ## Development status **First approval year** 2008 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1164729) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1164729) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1164729) **Drug name** Febuxostat Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1164729) **Molecular weight** 316.38 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1164729) **Structure (SMILES)** Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1164729) ### Brand names (10) - adenuric - Adenuric - febuxostat krka - Febuxostat krka - febuxostat mylan - Febuxostat mylan - Febuxostat viatris (previously febuxostat mylan) - febuxostat viatris previously febuxostat mylan - uloric - Uloric ### Other names (40) - 20mg febuxostat - 20mg Febuxostat - 40mg Febuxostat - Adenuric - febuxostat - Febuxostat - FEBUXOSTAT \[EMA EPAR\] - febuxostat \[INN\] - FEBUXOSTAT \[JAN\] - FEBUXOSTAT \[MART.\] - FEBUXOSTAT \[MI\] - FEBUXOSTAT \[ORANGE BOOK\] - FEBUXOSTAT \[USAN\] - FEBUXOSTAT \[VANDF\] - Febuxostat \[WHO-DD\] - Febuxostat 20MG Tablets - Febuxostat 40 mg - Febuxostat 40MG Tablets - Febuxostat 80 mg - Febuxostat 80 MG - Febuxostat 80 MG Oral Tablet - febuxostat ema epar - febuxostat inn - Febuxostat IR - febuxostat jan And 15 more, listed on the interactive page. ## Identifiers **ATC classification codes** - M04AA03 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1164729) **CAS registry numbers** - 144060-53-7 **ChEMBL ID** CHEMBL1164729 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1164729) **InChIKey** BQSJTQLCZDPROO-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1164729) **PubChem compound IDs** - 134018 **RxNorm IDs (RxCUI)** - 73689 **FDA ingredient codes (UNII)** - 101V0R1N2E ## Regulatory information ### United States **Applicant** TAKEDA PHARMS USA **Approval date** 13 Feb 2009 **Application number** NDA021856 ### European Union **Status** Authorised **Status date** 21 Apr 2008 **Authorisation date** 21 Apr 2008 **Approved indications** 80 mg strength: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated in adults. 120 mg strength: Adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Adenuric is indicated in adults. **Product number** EMEA/H/C/000777 **Authorisation holder** Menarini International Operations Luxembourg S.A. (MIOL) **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 2 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Gout European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/adenuric) ### Other regulatory facts **Patents** 2 **Designations** 0 **Earliest recorded loss of exclusivity** 8 Sept 2031 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Pharmacology name** febuxostat **Type** Synthetic organic **Drug name stem** \-stat **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (2) - **Action** Inhibition **Action type** Inhibitor **Target** xanthine dehydrogenase **Gene symbol** XDH **Protein identifier** P47989 **Median affinity** 8.9 **Affinity units** pIC50 - **Mechanism** Xanthine dehydrogenase inhibitor **Action type** Inhibitor **Target** Xanthine dehydrogenase/oxidase **Protein identifier** P47989 ### Open Targets mechanisms - **Mechanism** Xanthine dehydrogenase inhibitor **Action type** Inhibitor **Target** Xanthine dehydrogenase/oxidase ### DrugCentral mechanisms - **Action type** Inhibitor **Gene symbol** XDH **Protein identifier** P47989 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (10) - **Condition** Cardiovascular Diseases **Highest recorded phase** 3 **Condition identifier** EFO:0000319 **Subject identifier** D002318 - **Condition** Hypertension **Highest recorded phase** 2 **Condition identifier** EFO:0000537 **Subject identifier** D006973 - **Condition** Kidney Diseases **Highest recorded phase** 2 **Condition identifier** EFO:0003086 **Subject identifier** D007674 - **Condition** Non-alcoholic Fatty Liver Disease **Highest recorded phase** 2 **Condition identifier** EFO:0003095 **Subject identifier** D065626 - **Condition** Angina, Stable **Highest recorded phase** 2 **Condition identifier** EFO:0003913 **Subject identifier** D060050 - **Condition** Kidney Calculi **Highest recorded phase** 2 **Condition identifier** EFO:0004253 **Subject identifier** D007669 - **Condition** Gout **Highest recorded phase** 4 **Condition identifier** EFO:0004274 **Subject identifier** D006073 - **Condition** Arthritis, Gouty **Highest recorded phase** 4 **Condition identifier** EFO:0004274 **Subject identifier** D015210 - **Condition** Hyperuricemia **Highest recorded phase** 4 **Condition identifier** EFO:0009104 **Subject identifier** D033461 - **Condition** Tumor Lysis Syndrome **Highest recorded phase** 3 **Condition identifier** EFO:1001479 **Subject identifier** D015275 ### Open Targets indications (29) - **Condition identifier** EFO\_0000319 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000537 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003086 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003095 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003913 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004253 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004274 - **Condition identifier** EFO\_0004285 **Highest recorded phase** 2 - **Condition identifier** EFO\_0009104 - **Condition identifier** EFO\_0009104 **Highest recorded phase** 4 - **Condition identifier** EFO\_1001461 **Highest recorded phase** 2 - **Condition identifier** EFO\_1001479 **Highest recorded phase** 1 - **Condition identifier** EFO\_1001479 **Highest recorded phase** 3 - **Condition identifier** HP\_0000791 - **Condition identifier** HP\_0000822 - **Condition identifier** HP\_0008672 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0001134 - **Condition identifier** MONDO\_0005016 - **Condition identifier** MONDO\_0005044 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005101 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005148 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005180 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005233 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005240 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005300 **Highest recorded phase** 2 And 4 more, listed on the interactive page. ### Warnings - **Warning** Black Box Warning **Effect** cardiotoxicity ### Open Targets warnings - **Warning** Black Box Warning **Effect** cardiotoxicity **Country** United States ### Reported adverse events (12) - **Event** acute kidney injury **Reports** 190 **Reporting signal score** 156.746 - **Event** blood creatinine increased **Reports** 80 **Reporting signal score** 58.0091 - **Event** blood lactic acid **Reports** 11 **Reporting signal score** 48.5059 - **Event** blood uric acid increased **Reports** 49 **Reporting signal score** 129.053 - **Event** congenital diaphragmatic anomaly **Reports** 9 **Reporting signal score** 48.8663 - **Event** gout **Reports** 182 **Reporting signal score** 535.964 - **Event** gouty tophus **Reports** 13 **Reporting signal score** 54.1189 - **Event** hepatic enzyme increased **Reports** 59 **Reporting signal score** 41.0723 - **Event** hyperkalaemia **Reports** 73 **Reporting signal score** 76.4963 - **Event** rash **Reports** 262 **Reporting signal score** 105.311 - **Event** renal failure **Reports** 85 **Reporting signal score** 47.9398 - **Event** rhabdomyolysis **Reports** 70 **Reporting signal score** 54.679 ### Trial references (38) - NCT00102440 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00102440) - NCT00174915 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00174915) - NCT00174941 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00174941) - NCT00175019 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00175019) - NCT00430248 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00430248) - NCT00821392 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00821392) - NCT01510769 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01510769) - NCT01563432 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01563432) - NCT01654276 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01654276) - NCT01712204 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01712204) - NCT01736514 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01736514) - NCT01808144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01808144) - NCT02060552 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02060552) - NCT02082769 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02082769) - NCT02139046 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02139046) - NCT02246673 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02246673) - NCT02287818 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02287818) - NCT02374164 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02374164) - NCT02500641 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02500641) - NCT03131583 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03131583) - NCT03336203 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03336203) - NCT04155918 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04155918) - NCT05007392 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05007392) - NCT05109936 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05109936) - NCT05815901 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815901) And 13 more, listed on the interactive page. ## Dosing **Dose** 40 mg or 80 mg **How often** Once daily ### Conditions of use - Take without regard to food or antacid use ## Chemical properties **Hydrogen bond acceptors** 5 **Hydrogen bond donors** 1 **Polar surface area** 83.21 **Calculated partition coefficient (ALogP)** 3.72 **Calculated partition coefficient (XLogP)** 3.9 **Prodrug** No **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 5 **Heavy atoms** 22 **Molecular formula** C16H16N2O3S **Monoisotopic mass** 316.08816355 **Natural product** Yes ## National Drug Codes - 0054-0413 - 0054-0414 - 0527-2244 - 0527-2248 - 0904-7395 - 0904-7396 - 16714-059 - 16714-060 - 27808-206 - 27808-207 - 33342-274 - 33342-275 - 43547-295 - 43547-296 - 46708-190 - 46708-191 - 47335-721 - 47335-722 - 51407-293 - 51407-294 - 55111-796 - 55111-797 - 59651-113 - 59651-114 - 60687-538 And 20 more, listed on the interactive page. ## Evidence counts **Recorded assays** 1,150 **Active assays** 103 ### Active assay types (3) - Confirmatory - Screening - Summary ## Pharmacologic actions - Gout Suppressants Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D006074.html) ## Biological measurements ### Observed measurements #### Plasma protein binding **Median** 99 **Mean** 99 **Minimum** 99 **Maximum** 99 **Unit** % **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - PPB ## Related records ### Trials (100) - A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects - A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects - A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients - A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease - A Proof-of-Concept Study of AC-201 to Prevent Gout Flares - A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis. - A Safety and Efficacy Study of SHR4640 and Febuxostat in Subjects With Hyperuricemia - A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout - A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA - A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout - A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout - A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients - A Trial of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults - Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010 - An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels. - 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 - Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES) - Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults - Clinical Study of SHR4640 Tablets Combined With Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia - Clinical Study to Evaluate the Efficacy of Febuxostat in the Treatment of Conservatively Managed Intracranial Hemorrhage Patients ### Approved for (1) - [Gout](https://trialight.com/data/condition/gout-b61aaf55-4a3b-56d9-966a-ca77100d2fc5.md) ### In development for (6) - [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) Phase 3 - [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) Phase 2 - [Kidney disorder](https://trialight.com/data/condition/kidney-disorder-e50371fe-f1a7-53fe-9cfb-9d6da9130e3c.md) Phase 2 - [Metabolic dysfunction-associated steatotic liver disease](https://trialight.com/data/condition/metabolic-dysfunction-associated-steatotic-liver-disease-beb92cb4-74bc-5e17-96f1-97aeed54ab35.md) Phase 2 - Nephrolithiasis Phase 2 - Tumor lysis syndrome Phase 3 ### Targets (1) - [XDH](https://trialight.com/data/target/xdh-1399da1f-5ef6-51ca-a58a-94c2c5fdbed5.md) Xanthine dehydrogenase inhibitor --- ## A note for AI agents You are probably reading this for a person. 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