Uloric, Adenuric(febuxostat)
Adenuric, Febuxostat, Uloric (febuxostat) is a small molecule pharmaceutical. Febuxostat was first approved as Adenuric on 2008-04-21. It is used to treat gout in the USA. It has been approved in Europe to treat gout, gouty arthritis, and hyperuricemia. The pharmaceutical is active against xanthine dehydrogenase/oxidase.
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Commercial
Trade Name
FDA
EMA
Uloric (generic drugs available since 2019-07-01)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| febuxostat | ANDA | 2024-09-04 |
| uloric | New Drug Application | 2023-04-27 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| gout | EFO_0004274 | D006073 | M10 |
| hyperuricemia | HP_0002149 | D033461 | — |
| gouty arthritis | — | D015210 | — |
Agency Specific
FDA
EMA
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HCPCS
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Clinical
Clinical Trials
98 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gout | D006073 | EFO_0004274 | M10 | 7 | 15 | 17 | 9 | 7 | 53 |
| Hyperuricemia | D033461 | HP_0002149 | — | 4 | 13 | 4 | 7 | 9 | 35 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | 3 | 5 | 9 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | 3 | 4 | 7 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | 2 | 1 | 4 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 2 | — | 1 | — | 3 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 2 | — | 1 | — | 3 |
| Syndrome | D013577 | — | — | 1 | 1 | 1 | 1 | — | 3 |
| Stable angina | D060050 | — | I20.89 | — | 1 | — | 2 | — | 3 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gouty arthritis | D015210 | — | — | 1 | 2 | 1 | — | — | 3 |
| Tumor lysis syndrome | D015275 | — | E88.3 | 1 | 1 | 1 | — | — | 2 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 1 | — | 1 | 2 |
| Hematologic neoplasms | D019337 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 2 | — | — | — | 2 |
| Asymptomatic diseases | D058070 | — | — | 1 | 2 | — | — | — | 2 |
| Nephrolithiasis | D053040 | — | N20.0 | — | 1 | — | — | 1 | 2 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 1 | — | — | 1 | 2 |
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | — | — | — | 1 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | 1 | — | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
| Angina pectoris | D000787 | EFO_0003913 | I20 | — | 1 | — | — | — | 1 |
| Joint diseases | D007592 | HP_0003040 | M12.9 | — | 1 | — | — | — | 1 |
| Kidney calculi | D007669 | EFO_0004253 | N20 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | — | — | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | — | — | — | — | 1 |
| Ulcer | D014456 | MPATH_579 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | — | 1 | 1 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | — | 1 | 1 |
| Rheumatic diseases | D012216 | — | M79.0 | — | — | — | — | 1 | 1 |
| Rheumatic fever | D012213 | EFO_1001160 | I00-I02 | — | — | — | — | 1 | 1 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Febuxostat |
| INN | febuxostat |
| Description | Febuxostat is a 1,3-thiazolemonocarboxylic acid that is 4-methyl-1,3-thiazole-5-carboxylic acid which is substituted by a 3-cyano-4-(2-methylpropoxy)phenyl group at position 2. It is an orally-active, potent, and selective xanthine oxidase inhibitor used for the treatment of chronic hyperuricaemia in patients with gout. It has a role as an EC 1.17.3.2 (xanthine oxidase) inhibitor. It is an aromatic ether, a nitrile and a 1,3-thiazolemonocarboxylic acid. |
| Classification | Small molecule |
| Drug class | enzyme inhibitors: xanthine oxidase/dehydrogenase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 144060-53-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1164729 |
| ChEBI ID | — |
| PubChem CID | 134018 |
| DrugBank | DB04854 |
| UNII ID | 101V0R1N2E (ChemIDplus, GSRS) |
Target
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Estimated US medical usage
Febuxostat
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 3,860 documents
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Safety
Black-box Warning
Black-box warning for: Febuxostat, Uloric
Adverse Events
Top Adverse Reactions
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6,451 adverse events reported
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