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
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Trivagizole (generic drugs available since 1993-07-16, discontinued: Gyne-lotrimin, Gynix, Lotrimin, Mycelex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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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Clotrimazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRIVAGIZOLE 3 | Taro Pharmaceutical | N-021143 OTC | 2000-04-12 | 1 products |
Show 16 discontinued
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 | OTC monograph final | 2022-03-11 |
| anti-fungal cream | OTC monograph final | 2020-01-08 |
| antifungal | OTC monograph final | 2023-02-20 |
| antifungal 1% clotrimazole cream | C200263 | 2024-01-19 |
| antifungal clotrimazole | OTC monograph final | 2013-11-13 |
| antifungal cream | OTC monograph final | 2013-11-07 |
| aptrimazole | OTC monograph final | 2013-04-27 |
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Agency Specific
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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
HCPCS
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Clinical
Clinical Trials
164 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | 1 | 3 | 3 | 5 | 2 | 12 |
| Mycoses | D009181 | — | B35-B49 | 2 | 3 | 3 | 1 | 3 | 11 |
| Invasive fungal infections | D000072742 | — | — | — | 1 | 1 | 1 | 3 | 6 |
| Candidiasis | D002177 | — | B37 | — | 3 | 3 | 1 | — | 6 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | 1 | 1 | 2 | 1 | 1 | 6 |
| Onychomycosis | D014009 | — | B35.1 | — | 2 | 2 | 1 | 1 | 6 |
| Oral lichen planus | D017676 | — | — | — | 1 | — | 3 | — | 4 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | 1 | 2 | 3 |
| Fungemia | D016469 | — | B49 | — | — | — | 1 | — | 1 |
| Central nervous system fungal infections | D020314 | — | — | — | — | — | 1 | — | 1 |
Show 9 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Otomycosis | D059249 | — | — | — | 2 | 5 | — | 2 | 8 |
| Tinea pedis | D014008 | EFO_0007512 | B35.3 | 3 | — | 2 | — | — | 5 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | 4 | 1 | — | — | 5 |
| Oral candidiasis | D002180 | EFO_0007406 | B37.0 | — | 1 | 2 | — | 1 | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 2 | — | 1 | 3 |
| Invasive candidiasis | D058365 | EFO_1001283 | B37 | — | — | 1 | — | 1 | 2 |
| Tinea | D014005 | EFO_0007510 | B35.4 | — | — | 2 | — | — | 2 |
| Tinea cruris | D000084002 | — | B35.6 | — | 1 | 1 | — | — | 2 |
| Vaginitis | D014627 | EFO_0005757 | N76 | — | — | 2 | — | — | 2 |
| Denture stomatitis | D013282 | EFO_1000893 | K12.1 | — | 1 | 1 | — | — | 2 |
Show 8 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Invasive pulmonary aspergillosis | D055744 | — | B44.0 | 2 | 1 | — | — | 2 | 5 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 3 | 2 | — | — | 1 | 4 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 2 | — | — | 1 | 3 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 1 | 2 | — | — | — | 3 |
| Leukemia | D007938 | — | C95 | — | 2 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | 1 | — | — | 1 | 2 |
| Graft vs host disease | D006086 | — | D89.81 | — | 2 | — | — | — | 2 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | 1 | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | — | 1 | — | — | — | 1 |
Show 13 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 |
| 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 |
| Foot ulcer | D016523 | — | — | 1 | — | — | — | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Hiv | D006678 | — | O98.7 | 1 | — | — | — | — | 1 |
Show 1 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | — | — | — | — | 1 | 1 |
| Fusariosis | D060585 | EFO_1001795 | — | — | — | — | — | 1 | 1 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | — | — | — | 1 | 1 |
| Corneal ulcer | D003320 | — | H16.0 | — | — | — | — | 1 | 1 |
| Acute-on-chronic liver failure | D065290 | — | — | — | — | — | — | 1 | 1 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 1 | 1 |
| Laser therapy | D053685 | — | — | — | — | — | — | 1 | 1 |
| Lichen planus | D008010 | — | L43 | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | — | — | 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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Financial
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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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3,640 adverse events reported
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