Clotrimazole
Clotrimazole, Trivagizole (clotrimazole) is a small molecule pharmaceutical. Clotrimazole was first approved as Mycelex on 1982-01-01. It is used to treat cutaneous candidiasis, mycoses, oral candidiasis, tinea pedis, and vulvovaginal candidiasis in the USA. It is known to target transient receptor potential cation channel subfamily M member 8, intermediate conductance calcium-activated potassium channel protein 4, transient receptor potential cation channel subfamily M member 4, nuclear receptor subfamily 1 group I member 2, transient receptor potential cation channel subfamily M member 2, and nuclear receptor subfamily 1 group I member 3.
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Commercial
Trade Name
FDA
EMA
Clotrimazole, Trivagizole (discontinued: Gyne-lotrimin, Gynix, Lotrimin, Mycelex)
CombinationsClotrimazole betamethasone (discontinued: Lotrisone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Clotrimazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRIVAGIZOLE 3 | Taro Pharmaceutical | N-021143 OTC | 2000-04-12 | 1 products |
Show 16 discontinued
Betamethasone dipropionate
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Clotrimazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LOTRISONE | Merck & Co | N-020010 DISCN | 2000-12-08 | 1 products, RLD |
| LOTRISONE | Organon | N-018827 DISCN | 1984-07-10 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 1med clotrimazole 1% antifungal cream | OTC monograph final | 2022-02-04 |
| akin anti-fungal | C200263 | 2023-11-29 |
| alevazol | unapproved drug other | 2024-01-02 |
| anti-fungal | C200263 | 2024-05-17 |
| anti-fungal cream | OTC monograph final | 2020-01-08 |
| antifungal | OTC monograph final | 2023-02-20 |
| antifungal 1% clotrimazole cream | C200263 | 2024-08-29 |
| antifungal cream | OTC monograph final | 2013-11-07 |
| aptrimazole | OTC monograph final | 2013-04-27 |
| aspiera anti-fungal | OTC monograph final | 2012-07-22 |
Show 142 more
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Agency Specific
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Patent Expiration
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ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AB: Antiinfectives and antiseptics for local oral treatment
— A01AB18: Clotrimazole
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AC: Imidazole and triazole derivatives, topical antifungals
— D01AC01: Clotrimazole
G: Genito urinary system and sex hormones
— G01: Gynecological antiinfectives and antiseptics
— G01A: Antiinfectives and antiseptics, excl. combinations with corticosteroids
— G01AF: Imidazole derivatives, gyncological antiinfectives
— G01AF02: Clotrimazole
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Clinical
Clinical Trials
170 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Candidiasis | D002177 | — | B37 | 1 | 7 | 12 | 8 | 8 | 33 |
| Mycoses | D009181 | — | B35-B49 | 2 | 5 | 5 | 2 | 9 | 22 |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | 1 | 4 | 4 | 6 | 5 | 17 |
| Infections | D007239 | EFO_0000544 | — | — | 2 | 4 | 2 | 6 | 14 |
| Invasive fungal infections | D000072742 | — | — | — | 2 | 1 | 1 | 6 | 10 |
| Communicable diseases | D003141 | — | — | — | 1 | 3 | 2 | 3 | 9 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | 2 | 1 | 2 | 2 | 1 | 8 |
| Lichen planus | D008010 | — | L43 | 1 | 1 | — | 3 | 2 | 7 |
| Onychomycosis | D014009 | — | B35.1 | — | 3 | 2 | 1 | 1 | 7 |
| Vaginal diseases | D014623 | — | — | 1 | 1 | 2 | 1 | 1 | 6 |
Show 25 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aspergillosis | D001228 | EFO_0007157 | B44 | 2 | 5 | 1 | — | 3 | 11 |
| Otomycosis | D059249 | — | — | 1 | 2 | 5 | — | 2 | 9 |
| Tinea | D014005 | EFO_0007510 | B35.9 | 4 | 1 | 3 | — | — | 8 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 1 | 4 | 1 | — | — | 6 |
| Tinea pedis | D014008 | EFO_0007512 | B35.3 | 4 | — | 2 | — | — | 6 |
| Invasive candidiasis | D058365 | EFO_1001283 | B37 | — | 1 | 1 | — | 2 | 4 |
| Keratitis | D007634 | HP_0000491 | H16 | — | — | 1 | — | 2 | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 2 | — | 1 | 3 |
| Corneal ulcer | D003320 | — | H16.0 | — | — | 1 | — | 1 | 2 |
| Immunocompromised host | D016867 | — | D84.9 | 1 | — | 1 | — | — | 2 |
Show 19 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 4 | 6 | — | — | 1 | 9 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 3 | — | — | 1 | 6 |
| Myeloid leukemia | D007951 | — | C92 | 3 | 3 | — | — | 1 | 5 |
| Invasive pulmonary aspergillosis | D055744 | — | B44.0 | 2 | 1 | — | — | 2 | 5 |
| Mucositis | D052016 | EFO_1001898 | — | 1 | 3 | — | — | 1 | 5 |
| Neoplasms | D009369 | — | C80 | 1 | 2 | — | — | — | 3 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 2 | — | — | 1 | 3 |
| Hematologic neoplasms | D019337 | — | — | — | 2 | — | — | 1 | 3 |
| Syndrome | D013577 | — | — | — | 1 | — | — | 2 | 3 |
| Lymphoma | D008223 | — | C85.9 | — | 2 | — | — | 1 | 3 |
Show 34 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | 1 | 4 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | — | — | — | — | 2 |
| Liver failure | D017093 | HP_0001399 | K72.9 | 1 | — | — | — | 1 | 2 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | 1 | 2 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | — | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | — | — | — | — | 1 |
| Diabetic foot | D017719 | EFO_1001459 | — | 1 | — | — | — | — | 1 |
| Wound infection | D014946 | — | — | 1 | — | — | — | — | 1 |
| Foot ulcer | D016523 | — | — | 1 | — | — | — | — | 1 |
Show 2 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tachycardia | D013610 | HP_0001649 | R00.0 | — | — | — | — | 2 | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | — | — | — | — | 1 | 1 |
| Fusariosis | D060585 | EFO_1001795 | — | — | — | — | — | 1 | 1 |
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | — | — | — | — | 1 | 1 |
| Acute-on-chronic liver failure | D065290 | — | — | — | — | — | — | 1 | 1 |
| Laser therapy | D053685 | — | — | — | — | — | — | 1 | 1 |
| Critical illness | D016638 | — | — | — | — | — | — | 1 | 1 |
| Trichomonas vaginitis | D014247 | EFO_0007521 | — | — | — | — | — | 1 | 1 |
| Sezary syndrome | D012751 | — | C84.1 | — | — | — | — | 1 | 1 |
Show 12 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Clotrimazole |
| INN | clotrimazole |
| Description | Clotrimazole is a member of the class of imidazoles that is 1H-imidazole in which the hydrogen attached to a nitrogen is replaced by a monochlorotrityl group. It has a role as an antiinfective agent, an environmental contaminant and a xenobiotic. It is a member of imidazoles, a member of monochlorobenzenes, a conazole antifungal drug and an imidazole antifungal drug. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Clc1ccccc1C(c1ccccc1)(c1ccccc1)n1ccnc1 |
Identifiers
| PDB | — |
| CAS-ID | 23593-75-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL104 |
| ChEBI ID | 3764 |
| PubChem CID | 2812 |
| DrugBank | DB00257 |
| UNII ID | G07GZ97H65 (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
NR1I3
NR1I3
Organism
Homo sapiens
Gene name
NR1I3
Gene synonyms
CAR
NCBI Gene ID
Protein name
nuclear receptor subfamily 1 group I member 3
Protein synonyms
CAR, Constitutive activator of retinoid response, constitutive active receptor, Constitutive active response, Constitutive androstane receptor, orphan nuclear hormone receptor, Orphan nuclear receptor MB67
Uniprot ID
Mouse ortholog
Nr1i3 (12355)
nuclear receptor subfamily 1 group I member 3 (O35627)
Variants
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Estimated US medical usage
Clotrimazole
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Betamethasone
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Clotrimazole
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Safety
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4,907 adverse events reported
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