Febuxostat
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2008
- First approval year
- 2008
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Febuxostat
- Molecular weight
- 316.38
- Structure (SMILES)
- Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
- adenuric
- Adenuric
- febuxostat krka
- Febuxostat krka
- febuxostat mylan
- Febuxostat mylan
- Febuxostat viatris (previously febuxostat mylan)
- febuxostat viatris previously febuxostat mylan
- uloric
- Uloric
- 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.
- ATC classification codes
- M04AA03
Sources for recorded values
- CAS registry numbers
- 144060-53-7
- ChEMBL ID
- CHEMBL1164729
- InChIKey
- BQSJTQLCZDPROO-UHFFFAOYSA-N
- PubChem compound IDs
- 134018
- RxNorm IDs (RxCUI)
- 73689
- FDA ingredient codes (UNII)
- 101V0R1N2E
- Applicant
- TAKEDA PHARMS USA
- Approval date
- 13 Feb 2009
- Application number
- NDA021856
- 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
- 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 name
- febuxostat
- Type
- Synthetic organic
- Drug name stem
- -stat
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- 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
- 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
- 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
- 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
- NCT00102440
- NCT00174915
- NCT00174941
- NCT00175019
- NCT00430248
- NCT00821392
- NCT01510769
- NCT01563432
- NCT01654276
- NCT01712204
- NCT01736514
- NCT01808144
- NCT02060552
- NCT02082769
- NCT02139046
- NCT02246673
- NCT02287818
- NCT02374164
- NCT02500641
- NCT03131583
- NCT03336203
- NCT04155918
- NCT05007392
- NCT05109936
- NCT05815901
And 13 more, listed on the interactive page.
- Dose
- 40 mg or 80 mg
- How often
- Once daily
Conditions of use
- Take without regard to food or antacid use
- 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
- 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.
- Recorded assays
- 1,150
- Active assays
- 103
- Confirmatory
- Screening
- Summary
- Gout Suppressants
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)
In development for (6)
- Cardiovascular disorder Phase 3
- Hypertensive disorder Phase 2
- Kidney disorder Phase 2
- Metabolic dysfunction-associated steatotic liver disease Phase 2
- Nephrolithiasis Phase 2
- Tumor lysis syndrome Phase 3
Targets (1)
- XDH Xanthine dehydrogenase inhibitor