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AboutPricing
Drug ReportsKetoconazole
Nizoral, Ketoconazole hra(ketoconazole)
Ketoconazole, Ketozole, Nizoral Anti-dandruff (ketoconazole) is a small molecule pharmaceutical. Ketoconazole was first approved as Nizoral on 1982-01-01. It is used to treat acanthamoeba keratitis, blastomycosis, chronic mucocutaneous candidiasis, coccidioidomycosis, and cutaneous candidiasis amongst others in the USA. It has been approved in Europe to treat cushing syndrome.
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Target
Variants
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
stomatognathic diseasesD009057
respiratory tract diseasesD012140
eye diseasesD005128
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Ketoconazole, Ketozole, Nizoral anti-dandruff (discontinued: Extina, Ketoconazole, Nizoral, Xolegel)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ketoconazole
Tradename
Company
Number
Date
Products
NIZORAL ANTI-DANDRUFFKramer LaboratoriesN-020310 OTC1997-10-10
1 products, RLD, RS
Show 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
1% ketoconazoleC2002632025-03-19
1% ketoconazole anti dandruffC2002632024-12-03
dandrx 1% ketoconazole anti-dandruffC2002632025-04-08
danilunapproved drug other2025-07-06
fungifree nail fungus treatmentunapproved drug other2024-05-14
hydrocortisone 2.5% / iodoquinol 1% / ketoconazole 2%unapproved drug other2019-05-16
hydrocortisone 2.5% / ketoconazole 2%unapproved drug other2019-05-16
ketoconazoleANDA2025-10-02
ketoconazole 2% / niacinamide 4%unapproved drug other2019-05-13
ketoconazole 2% / salicylic acid 2%unapproved drug other2019-05-16
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mycoses—D009181B35-B49
oral candidiasisEFO_0007406D002180B37.0
vulvovaginal candidiasisEFO_0007543D002181B37.3
seborrheic dermatitis—D012628L21
tinea pedisEFO_0007512D014008B35.3
coccidioidomycosisEFO_0007211D003047B38
tinea versicolorEFO_0007439D014010B36.0
blastomycosisEFO_0007174D001759B40
histoplasmosisEFO_0007310D006660B39
cutaneous candidiasis—D002179—
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AC: Imidazole and triazole derivatives, topical antifungals
— D01AC08: Ketoconazole
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
— G01AF11: Ketoconazole
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02C: Antiadrenal preparations
— H02CA: Anticorticosteroids
— H02CA03: Ketoconazole
J: Antiinfectives for systemic use
— J02: Antimycotics for systemic use
— J02A: Antimycotics for systemic use
— J02AB: Imidazole derivatives, antimycotic for systemic use
— J02AB02: Ketoconazole
HCPCS
No data
Clinical
Clinical Trials
209 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tinea pedisD014008EFO_0007512B35.3——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C61—2———2
Neoplasm metastasisD009362EFO_0009708—11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
PharmacokineticsD010599——1————1
Drug interactionsD004347——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameKetoconazole
INNketoconazole
Description
1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine is a dioxolane that is 1,3-dioxolane which is substituted at positions 2, 2, and 4 by imidazol-1-ylmethyl, 2,4-dichlorophenyl, and [para-(4-acetylpiperazin-1-yl)phenoxy]methyl groups, respectively. It is an ether, a member of imidazoles, a N-arylpiperazine, a dioxolane, a dichlorobenzene and a N-acylpiperazine.
Classification
Small molecule
Drug classsystemic antifungals (miconazole type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(=O)N1CCN(c2ccc(OCC3COC(Cn4ccnc4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1
Identifiers
PDB—
CAS-ID65277-42-1
RxCUI—
ChEMBL IDCHEMBL157101
ChEBI ID48339
PubChem CID3823
DrugBankDB01026
UNII IDR9400W927I (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Ketoconazole
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 22,397 documents
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Safety
Black-box Warning
Black-box warning for: Ketoconazole
Adverse Events
Top Adverse Reactions
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7,189 adverse events reported
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