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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 candidiasisD002179
mycosesD009181B35-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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Mock data
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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
CandidiasisD002177B371214
Invasive fungal infectionsD000072742123
OnychomycosisD014009B35.1112
Hyperlipoproteinemia type iiD006938EFO_0004911E78.0011
BurnsD002056T30.011
Atopic dermatitisD003876EFO_0000274L2011
Eczematous skin diseasesD01744311
Chronic kidney failureD007676EFO_0003884N18.611
Show 2 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MycosesD009181B35-B492326
OtomycosisD0592492326
Oral candidiasisD002180EFO_0007406B37.01214
Tinea pedisD014008EFO_0007512B35.3314
Hiv infectionsD015658EFO_0000764B20213
TineaD014005EFO_0007510B35.422
Tinea crurisD000084002B35.6112
Denture stomatitisD013282EFO_1000893K12.1112
Intraabdominal infectionsD05941311
FolliculitisD005499111
Show 4 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Invasive pulmonary aspergillosisD055744B44.0123
Sickle cell anemiaD000755EFO_0000697D571112
Myelodysplastic syndromesD009190D46112
StomatitisD013280EFO_1001904K12.122
NeoplasmsD009369C8011
LeukemiaD007938C9511
Hematologic neoplasmsD01933711
Graft vs host diseaseD006086D89.8111
Kidney diseasesD007674EFO_0003086N08111
Kidney transplantationD016030111
Show 7 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients112
Myeloid leukemia acuteD015470C92.0112
EndometriosisD004715EFO_0001065N8011
HivD006678O98.711
IntertrigoD007402L30.411
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Invasive candidiasisD058365EFO_1001283B3711
Type 1 diabetes mellitusD003922EFO_0001359E1011
Invasive hydatidiform moleD002820D39.211
FusariosisD060585EFO_100179511
HypercholesterolemiaD006937HP_000312411
Corneal ulcerD003320H16.011
SepsisD018805A41.911
Laser therapyD05368511
Lichen planusD008010L4311
RecurrenceD01200811
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
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
Clinical Variant
No data
Financial
Oravig - Par Pharmaceutical
$
£
Mock data
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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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