Uloric, Adenuric(febuxostat)
Adenuric, 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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Trade Name
FDA
EMA
Uloric (generic drugs available since 2019-07-01)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Febuxostat
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ULORIC | Takeda | N-021856 RX | 2009-02-13 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| febuxostat | ANDA | 2023-05-31 |
| uloric | New Drug Application | 2021-04-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| gout | EFO_0004274 | D006073 | M10 |
Agency Specific
FDA
EMA
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HCPCS
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Clinical
Clinical Trials
82 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 | 3 | 9 | 11 | 6 | 3 | 32 |
| Hyperuricemia | D033461 | 2 | 7 | 1 | 4 | 7 | 21 | ||
| Chronic renal insufficiency | D051436 | N18 | — | — | — | 2 | 4 | 6 | |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | 2 | 1 | 4 |
| Coronary artery disease | D003324 | I25.1 | — | — | — | 2 | — | 2 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | 1 | — | 1 |
| Urolithiasis | D052878 | N20-N23 | — | — | — | 1 | — | 1 | |
| Left ventricular dysfunction | D018487 | — | — | — | 1 | — | 1 | ||
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | 1 | — | 1 |
| Prehypertension | D058246 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tumor lysis syndrome | D015275 | E88.3 | 1 | 1 | 1 | — | — | 2 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 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 | ||
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 1 | — | — | 1 | 2 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | 1 | — | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
| Kidney calculi | D007669 | EFO_0004253 | N20.0 | — | 1 | — | — | — | 1 |
| Alcoholic fatty liver | D005235 | K70.0 | — | 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 | |
| Urinary calculi | D014545 | N20.9 | — | — | — | — | 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 | 73689 |
| ChEMBL ID | CHEMBL1164729 |
| ChEBI ID | — |
| PubChem CID | 134018 |
| DrugBank | DB04854 |
| UNII ID | 101V0R1N2E (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Febuxostat, Uloric
Adverse Events
Top Adverse Reactions
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21,098 adverse events reported
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