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Miconazole
M-zole, 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
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
M-zole, Monistat, Monistat 3 (prefilled), Oravig (generic drugs available since 1993-11-19, discontinued: M-zole 7 dual pack, 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
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 PACKMedTech ProductsN-021261 OTC2003-06-17
1 products, RLD
MONISTAT 3 COMBINATION PACK (PREFILLED)MedTech ProductsN-021261 OTC2001-02-02
1 products, RLD, RS
MONISTAT 1 COMBINATION PACKMedTech ProductsN-021308 OTC2001-06-29
1 products, RLD, RS
Show 3 discontinued
Miconazole nitrate
+
White petrolatum
+
Zinc oxide
Tradename
Company
Number
Date
Products
VUSIONMylanN-021026 RX2006-02-16
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
miconazole nitrateOTC monograph final2023-06-19
monistat 3 combination packNew Drug Application2023-05-15
monistat-derm2007-04-17
oravigNew Drug Application2022-01-01
vusionNDA authorized generic2018-08-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
aspergillosisEFO_0007157D001228B44
cutaneous candidiasis—D002179—
mycoses—D009181B35-B49
tinea pedisEFO_0007512D014008B35.3
tinea versicolorEFO_0007439D014010B36.0
vulvovaginal candidiasisEFO_0007543D002181B37.3
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
92 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 candidiasisD002181EFO_0007543B37.31335111
Bacterial vaginosisD016585EFO_0003932111115
CandidiasisD002177B37—121—4
Invasive fungal infectionsD000072742———123
OnychomycosisD014009B35.1———112
Hyperlipoproteinemia type iiD006938EFO_0004911E78.00———1—1
BurnsD002056T30.0———1—1
Atopic dermatitisD003876EFO_0000274L20———1—1
Eczematous skin diseasesD017443———1—1
Chronic kidney failureD007676EFO_0003884N18.6———1—1
Show 2 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MycosesD009181B35-B49—23—26
OtomycosisD059249—23—26
Oral candidiasisD002180EFO_0007406B37.0—12—14
Tinea pedisD014008EFO_0007512B35.33—1——4
Hiv infectionsD015658EFO_0000764B20——2—13
TineaD014005EFO_0007510B35.4——2——2
Tinea crurisD000084002B35.6—11——2
Denture stomatitisD013282EFO_1000893K12.1—11——2
Intraabdominal infectionsD059413——1——1
FolliculitisD005499—11——1
Show 4 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Invasive pulmonary aspergillosisD055744B44.0—1——23
Sickle cell anemiaD000755EFO_0000697D5711——12
Myelodysplastic syndromesD009190D46—1——12
StomatitisD013280EFO_1001904K12.1—2———2
NeoplasmsD009369C80—1———1
LeukemiaD007938C95—1———1
Hematologic neoplasmsD019337—1———1
Graft vs host diseaseD006086D89.81—1———1
Kidney diseasesD007674EFO_0003086N0811———1
Kidney transplantationD01603011———1
Show 7 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1———12
Myeloid leukemia acuteD015470C92.01———12
EndometriosisD004715EFO_0001065N801————1
HivD006678O98.71————1
IntertrigoD007402L30.41————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Invasive candidiasisD058365EFO_1001283B37————11
Type 1 diabetes mellitusD003922EFO_0001359E10————11
Invasive hydatidiform moleD002820D39.2————11
FusariosisD060585EFO_1001795————11
HypercholesterolemiaD006937HP_0003124————11
Corneal ulcerD003320H16.0————11
SepsisD018805A41.9————11
Laser therapyD053685————11
Lichen planusD008010L43————11
RecurrenceD012008————11
Show 2 more
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)
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
Clinical Variant
No data
Financial
Oravig - Par Pharmaceutical
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,886 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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29,798 adverse events reported
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