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Drug ReportsMiconazole
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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Drug
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Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
M-zole, Miconazole, Monistat, Oravig (discontinued: M-zole 7 dual pack, Miconazole, Monistat, Monistat-derm)
Combinations
Vusion
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
Tradename
Company
Number
Date
Products
VUSIONMylanN-021026 RX2006-02-16
1 products, RLD, RS
Miconazole
Tradename
Company
Number
Date
Products
ORAVIGGalt PharmaceuticalsN-022404 RX2010-04-16
1 products, RLD, RS
Show 1 discontinued
Miconazole nitrate
Tradename
Company
Number
Date
Products
MONISTAT 7MedTech ProductsN-017450 OTC1991-02-15
1 products, RLD, RS
MONISTAT 7MedTech ProductsN-018520 OTC1991-02-15
1 products, RLD, RS
MONISTAT 3MedTech ProductsN-018888 RX1984-08-15
1 products, RLD, RS
MONISTAT 7 COMBINATION PACKMedTech ProductsN-020288 OTC1993-04-26
1 products, RLD, RS
MONISTAT 3 COMBINATION PACKMedTech ProductsN-020670 OTC1996-04-16
1 products, RLD, RS
MONISTAT 3MedTech ProductsN-020827 OTC1998-03-30
1 products, RLD, RS
MONISTAT 3 COMBINATION PACK (PREFILLED)MedTech ProductsN-021261 OTC2001-02-02
1 products, RLD, RS
MONISTAT 3 COMBINATION PACKMedTech ProductsN-021261 OTC2003-06-17
1 products, RLD
MONISTAT 1 COMBINATION PACKMedTech ProductsN-021308 OTC2001-06-29
1 products, RLD, RS
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
aloe vestaC2002632024-07-02
aloe vesta antifungalOTC monograph final2011-04-08
aloe vesta clear antifungal 141gOTC monograph final2016-06-19
aloe vesta clear antifungal 56gOTC monograph final2016-06-18
anti- fungal miconazole nitrateC2002632024-10-14
anti-fungalC2002632024-12-03
anti-fungal powderC2002632024-12-04
anti-fungal powder miconazole nitrateC2002632024-10-14
antifungalC2002632025-04-28
antifungal athletes footC2002632024-10-14
Show 170 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mycoses—D009181B35-B49
aspergillosisEFO_0007157D001228B44
vulvovaginal candidiasisEFO_0007543D002181B37.3
tinea pedisEFO_0007512D014008B35.3
tinea versicolorEFO_0007439D014010B36.0
cutaneous candidiasis—D002179—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Miconazole Nitrate / White Petrolatum / Zinc Oxide, Vusion, Mylan
81478522028-03-30U-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
178 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TineaD014005EFO_0007510B35.43————3
Tinea pedisD014008EFO_0007512B35.33————3
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMiconazole
INNmiconazole
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 classsystemic antifungals (miconazole type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Clc1ccc(COC(Cn2ccnc2)c2ccc(Cl)cc2Cl)c(Cl)c1
Identifiers
PDB—
CAS-ID22832-87-7
RxCUI—
ChEMBL IDCHEMBL91
ChEBI ID82892
PubChem CID4189
DrugBankDB01110
UNII ID7NNO0D7S5M (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
7226
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
Q96Q93
Mouse ortholog
Trpm2 (28240)
transient receptor potential cation channel subfamily M member 2 (Q91YD4)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Oravig – Par Pharmaceutical
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Estimated US medical usage
Miconazole
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,087 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,165 adverse events reported
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