Butoconazole
Gynazole (butoconazole) is a small molecule pharmaceutical. Butoconazole was first approved as Femstat on 1985-11-25. It is used to treat mycoses and vulvovaginal candidiasis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Gynazole (discontinued: Butoconazole, Femstat)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gynazole 1 | ANDA | 2023-06-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| mycoses | — | D009181 | B35-B49 |
| vulvovaginal candidiasis | EFO_0007543 | D002181 | B37.3 |
Agency Specific
FDA
EMA
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HCPCS
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Clinical
Clinical Trials
4 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vaginitis | D014627 | EFO_0005757 | N76 | — | — | 2 | — | — | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | — | 1 |
| Vulvovaginitis | D014848 | EFO_1001240 | N76.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Candidiasis | D002177 | — | B37 | — | 1 | — | — | 1 | 2 |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | — | 1 | — | — | 1 | 2 |
Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Butoconazole |
| INN | butoconazole |
| Description | Butoconazole is a member of the class of imidazoles that is 1H-imidazole in which the hydrogen attached to the nitrogen is substituted by a 4-(4-chlorophenyl)-2-[(2,6-dichlorophenyl)sulfanyl]butyl group. An antifungal agent, it is used as its nitrate salt in gynaecology for treatment of vulvovaginal infections caused by Candida species, particularly Candida albicans. It is a member of imidazoles, an aryl sulfide, a dichlorobenzene, a member of monochlorobenzenes, an imidazole antifungal drug and a conazole antifungal drug. It is a conjugate base of a butoconazole(1+). |
| Classification | Small molecule |
| Drug class | systemic antifungals (miconazole type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Clc1ccc(CCC(Cn2ccnc2)Sc2c(Cl)cccc2Cl)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 64872-76-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1295 |
| ChEBI ID | 3240 |
| PubChem CID | 47472 |
| DrugBank | DB00639 |
| UNII ID | 0Q771797PH (ChemIDplus, GSRS) |
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Estimated US medical usage
Butoconazole
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PubMed Central
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Safety
Black-box Warning
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32 adverse events reported
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