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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 diseasesD012140
immune system diseasesD007154
Trade Name
FDA
EMA
Zyflo (generic drugs available since 2017-03-17)
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
ZYFLOChiesi FarmaceuticiN-020471 RX1996-12-09
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
zileutonANDA2023-03-20
zyfloNew Drug Application2020-11-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
asthmaEFO_0000270D001249J45
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
14 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SleepD012890GO_0030431———112
MemoryD008568———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863F33.9—11——2
DementiaD003704F03——1——1
Psychophysiologic disordersD011602F45.9——1——1
SchizophreniaD012559EFO_0000692F20——1——1
Anxiety disordersD001008EFO_0006788F41.1——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sleep initiation and maintenance disordersD007319F51.01—2——24
Sleep wake disordersD012893G47—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—3————3
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeiomyomaD007889HP_0000131D25————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameZILEUTON
INNzileuton
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 class5-lipoxygenase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(c1cc2ccccc2s1)N(O)C(N)=O
Identifiers
PDB—
CAS-ID111406-87-2
RxCUI40575
ChEMBL IDCHEMBL93
ChEBI ID10112
PubChem CID60490
DrugBankDB00744
UNII IDV1L22WVE2S (ChemIDplus, GSRS)
Target
Agency Approved
ALOX5
ALOX5
Organism
Homo sapiens
Gene name
ALOX5
Gene synonyms
LOG5
NCBI Gene ID
240
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
Q5JQ14
Mouse ortholog
Alox5 (11689)
polyunsaturated fatty acid 5-lipoxygenase (Q3TB75)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,878 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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363 adverse events reported
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