Miconazole
M-zole, Miconazole, Monistat, Oravig, Vusion (miconazole) is a small molecule pharmaceutical. Miconazole was first approved as Monistat on 1982-01-01. It is used to treat aspergillosis, cutaneous candidiasis, mycoses, tinea pedis, and tinea versicolor amongst others in the USA. It is known to target transient receptor potential cation channel subfamily M member 2 and transient receptor potential cation channel subfamily V member 5.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
M-zole, Miconazole, Monistat, Oravig (discontinued: M-zole 7 dual pack, Miconazole, Monistat, Monistat-derm)
CombinationsVusion
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Miconazole nitrate
+
White petrolatum
+
Zinc oxide
Miconazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ORAVIG | Galt Pharmaceuticals | N-022404 RX | 2010-04-16 | 1 products, RLD, RS |
Show 1 discontinued
Miconazole nitrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MONISTAT 7 | MedTech Products | N-017450 OTC | 1991-02-15 | 1 products, RLD, RS |
| MONISTAT 7 | MedTech Products | N-018520 OTC | 1991-02-15 | 1 products, RLD, RS |
| MONISTAT 3 | MedTech Products | N-018888 RX | 1984-08-15 | 1 products, RLD, RS |
| MONISTAT 7 COMBINATION PACK | MedTech Products | N-020288 OTC | 1993-04-26 | 1 products, RLD, RS |
| MONISTAT 3 COMBINATION PACK | MedTech Products | N-020670 OTC | 1996-04-16 | 1 products, RLD, RS |
| MONISTAT 3 | MedTech Products | N-020827 OTC | 1998-03-30 | 1 products, RLD, RS |
| MONISTAT 3 COMBINATION PACK (PREFILLED) | MedTech Products | N-021261 OTC | 2001-02-02 | 1 products, RLD, RS |
| MONISTAT 3 COMBINATION PACK | MedTech Products | N-021261 OTC | 2003-06-17 | 1 products, RLD |
| MONISTAT 1 COMBINATION PACK | MedTech Products | N-021308 OTC | 2001-06-29 | 1 products, RLD, RS |
Show 3 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 7 day vaginal | OTC monograph final | 2011-01-12 |
| aloe vesta | C200263 | 2024-07-02 |
| aloe vesta antifungal | OTC monograph final | 2011-04-08 |
| aloe vesta clear antifungal 141g | OTC monograph final | 2016-06-19 |
| aloe vesta clear antifungal 56g | OTC monograph final | 2016-06-18 |
| anti- fungal miconazole nitrate | C200263 | 2024-10-14 |
| anti-fungal | C200263 | 2024-05-21 |
| anti-fungal powder | C200263 | 2024-09-25 |
| anti-fungal powder miconazole nitrate | C200263 | 2024-10-14 |
| antifungal | OTC monograph final | 2021-02-09 |
Show 163 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Miconazole Nitrate / White Petrolatum / Zinc Oxide, Vusion, Mylan | |||
| 8147852 | 2028-03-30 | U-1426 | |
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AB: Antiinfectives and antiseptics for local oral treatment
— A01AB09: Miconazole
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07A: Intestinal antiinfectives
— A07AC: Imidazole derivatives, intestinal antiinfectives
— A07AC01: Miconazole
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AC: Imidazole and triazole derivatives, topical antifungals
— D01AC02: Miconazole
— D01AC52: Miconazole, combinations
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
— G01AF04: Miconazole
J: Antiinfectives for systemic use
— J02: Antimycotics for systemic use
— J02A: Antimycotics for systemic use
— J02AB: Imidazole derivatives, antimycotic for systemic use
— J02AB01: Miconazole
S: Sensory organ drugs
— S02: Otologicals
— S02A: Antiinfective drugs, otologic
— S02AA: Antiinfectives
— S02AA13: Miconazole
HCPCS
No data
Clinical
Clinical Trials
169 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 |
| Tinea | D014005 | EFO_0007510 | B35.9 | 4 | 1 | 3 | — | — | 8 |
| Otomycosis | D059249 | — | — | 1 | 2 | 3 | — | 2 | 7 |
| 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 |
| Intertrigo | D007402 | — | L30.4 | 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 |
Show 3 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 11 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Miconazole |
| INN | miconazole |
| Description | 1-[2-(2,4-dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]imidazole is a member of the class of imidazoles that is 1-(2,4-dichlorophenyl)-2-(imidazol-1-yl)ethanol in which the hydroxyl hydrogen is replaced by a 2,4-dichlorobenzyl group. It is an ether, a member of imidazoles and a dichlorobenzene. |
| Classification | Small molecule |
| Drug class | systemic antifungals (miconazole type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Clc1ccc(COC(Cn2ccnc2)c2ccc(Cl)cc2Cl)c(Cl)c1 |
Identifiers
| PDB | — |
| CAS-ID | 22832-87-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL91 |
| ChEBI ID | 82892 |
| PubChem CID | 4189 |
| DrugBank | DB01110 |
| UNII ID | 7NNO0D7S5M (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
TRPM2
TRPM2
TRPV5
TRPV5
Organism
Homo sapiens
Gene name
TRPM2
Gene synonyms
EREG1, KNP3, LTRPC2, TRPC7
NCBI Gene ID
Protein name
transient receptor potential cation channel subfamily M member 2
Protein synonyms
Estrogen-responsive element-associated gene 1 protein, Long transient receptor potential channel 2, LTrpC-2, LTrpC2, Transient receptor potential channel 7, Transient receptor potential melastatin 2, TrpC7
Uniprot ID
Mouse ortholog
Trpm2 (28240)
transient receptor potential cation channel subfamily M member 2 (Q91YD4)
Variants
No data
Financial
Revenue by drug
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Oravig – Par Pharmaceutical
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Estimated US medical usage
Miconazole
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,751 adverse events reported
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