Zileuton
Zileuton, Zyflo (zileuton) is a small molecule pharmaceutical. Zileuton was first approved as Zyflo on 1996-12-09. It is used to treat asthma in the USA. The pharmaceutical is active against polyunsaturated fatty acid 5-lipoxygenase.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| respiratory tract diseases | D012140 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Zileuton, Zyflo (discontinued: Zileuton, Zyflo)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Zileuton
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZYFLO | Chiesi Farmaceutici | N-020471 RX | 1996-12-09 | 1 products, RLD, RS |
Show 2 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| asthma | EFO_0000270 | D001249 | J45 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
21 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 1 | 3 | — | 4 | 1 | 8 |
| Neuralgia | D009437 | EFO_0009430 | — | — | — | — | 1 | — | 1 |
| Trigeminal neuralgia | D014277 | EFO_1001219 | G50.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | 1 | — | 1 | 2 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | — | 1 | — | 1 | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | 1 | 2 | — | — | — | 2 |
| Pulmonary fibrosis | D011658 | — | — | 1 | 2 | — | — | — | 2 |
| Tobacco use disorder | D014029 | — | F17 | 1 | 2 | — | — | — | 2 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 2 | — | — | — | 2 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | 1 | — | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 1 | 1 | — | — | — | 1 |
| Hermanski-pudlak syndrome | D022861 | — | E70.331 | 1 | 1 | — | — | — | 1 |
| Oculocutaneous albinism | D016115 | — | E70.32 | 1 | 1 | — | — | — | 1 |
| Platelet storage pool deficiency | D010981 | EFO_1001112 | — | 1 | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 2 | — | — | — | — | 2 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 2 | — | — | — | — | 2 |
| Myeloid leukemia | D007951 | — | C92 | 2 | — | — | — | — | 2 |
| Pneumonia | D011014 | EFO_0003106 | — | 1 | — | — | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | 1 | — | — | — | — | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Zileuton |
| INN | zileuton |
| Description | Zileuton is a member of the class of 1-benzothiophenes that is 1-benzothiophene in which the hydrogen at position 2 is replaced by a 1-[carbamoyl(hydroxy)amino]ethyl group. A selective 5-lipoxygenase inhibitor, it inhibits the formation of leukotrienes LTB4, LTC4, LDT4, and LTE4. It is used for the management of chronic asthma. It has a role as an EC 1.13.11.34 (arachidonate 5-lipoxygenase) inhibitor, a non-steroidal anti-inflammatory drug, an anti-asthmatic drug, a leukotriene antagonist and a ferroptosis inhibitor. It is a member of ureas and a member of 1-benzothiophenes. It derives from a hydride of a 1-benzothiophene. |
| Classification | Small molecule |
| Drug class | 5-lipoxygenase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(c1cc2ccccc2s1)N(O)C(N)=O |
Identifiers
| PDB | — |
| CAS-ID | 111406-87-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL93 |
| ChEBI ID | 10112 |
| PubChem CID | 60490 |
| DrugBank | DB00744 |
| UNII ID | V1L22WVE2S (ChemIDplus, GSRS) |
Target
Agency Approved
ALOX5
ALOX5
Organism
Homo sapiens
Gene name
ALOX5
Gene synonyms
LOG5
NCBI Gene ID
Protein name
polyunsaturated fatty acid 5-lipoxygenase
Protein synonyms
5-lipoxygenase, 5-LO, Arachidonate 5-lipoxygenase, arachidonic acid 5-lipoxygenase, leukotriene A4 synthase, LOX-5
Uniprot ID
Mouse ortholog
Alox5 (11689)
polyunsaturated fatty acid 5-lipoxygenase (Q3TB75)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
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No data
Estimated US medical usage
Zileuton
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,165 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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250 adverse events reported
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