Zafirlukast
Accolate, Zafirlukast (zafirlukast) is a small molecule pharmaceutical. Zafirlukast was first approved as Accolate on 1996-09-26. It is used to treat asthma in the USA. The pharmaceutical is active against cysteinyl leukotriene receptor 1. In addition, it is known to target bifunctional epoxide hydrolase 2, cysteinyl leukotriene receptor 2, and peroxisome proliferator-activated receptor gamma.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| respiratory tract diseases | D012140 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Accolate, Zafirlukast
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Zafirlukast
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACCOLATE | Strides Pharma Global | N-020547 RX | 1996-09-26 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| accolate | New Drug Application | 2025-03-21 |
| zafirlukast | New Drug Application | 2025-07-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| asthma | EFO_0000270 | D001249 | J45 |
Agency Specific
FDA
EMA
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Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Zafirlukast |
| INN | zafirlukast |
| Description | Zafirlukast is a member of indoles, a carbamate ester and a N-sulfonylcarboxamide. It has a role as an anti-asthmatic agent and a leukotriene antagonist. |
| Classification | Small molecule |
| Drug class | antiasthmatics/antiallergics (not acting primarily as antihistamines): leukotriene receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1cc(C(=O)NS(=O)(=O)c2ccccc2C)ccc1Cc1cn(C)c2ccc(NC(=O)OC3CCCC3)cc12 |
Identifiers
| PDB | — |
| CAS-ID | 107753-78-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL603 |
| ChEBI ID | 10100 |
| PubChem CID | 5717 |
| DrugBank | DB00549 |
| UNII ID | XZ629S5L50 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
EPHX2
EPHX2
Organism
Homo sapiens
Gene name
EPHX2
Gene synonyms
NCBI Gene ID
Protein name
bifunctional epoxide hydrolase 2
Protein synonyms
epoxide hydratase, epoxide hydrolase 2, cytoplasmic, epoxide hydrolase 2, cytosolic, epoxide hydrolase, soluble
Uniprot ID
Mouse ortholog
Ephx2 (13850)
bifunctional epoxide hydrolase 2 (P34914)
Variants
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Financial
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Estimated US medical usage
Zafirlukast
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,559 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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662 adverse events reported
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