Nizoral, Ketoconazole hra(ketoconazole)
Extina, 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. It is known to target potassium voltage-gated channel subfamily A member 10 and lanosterol 14-alpha demethylase.
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Commercial
Trade Name
FDA
EMA
Extina, Nizoral anti-dandruff (generic drugs available since 1999-06-15, discontinued: Nizoral, Xolegel)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nizoral | New Drug Application | 2022-06-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| acanthamoeba keratitis | EFO_0007126 | D015823 | — |
| blastomycosis | EFO_0007174 | D001759 | B40 |
| chronic mucocutaneous candidiasis | Orphanet_1334 | D002178 | B37.2 |
| coccidioidomycosis | EFO_0007211 | D003047 | B38 |
| cutaneous candidiasis | — | D002179 | — |
| histoplasmosis | EFO_0007310 | D006660 | B39 |
| leishmaniasis | EFO_0005044 | D007896 | B55 |
| mycoses | — | D009181 | B35-B49 |
| oral candidiasis | EFO_0007406 | D002180 | B37.0 |
| paracoccidioidomycosis | EFO_0007417 | D010229 | B41 |
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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
165 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Seborrheic dermatitis | D012628 | L21 | — | 2 | 1 | 1 | 1 | 5 | |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 2 | — | — | 1 | — | 3 |
| Kidney transplantation | D016030 | — | — | — | 1 | — | 1 | ||
| Tinea versicolor | D014010 | EFO_0007439 | B36.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | C61 | 3 | 16 | 5 | — | 2 | 24 | |
| Tinea pedis | D014008 | EFO_0007512 | B35.3 | — | 1 | 5 | — | — | 6 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | — | 2 | — | — | 2 | |
| Candidiasis | D002177 | B37 | — | — | 1 | — | 1 | 2 | |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | — | — | 1 | — | — | 1 |
| Tinea | D014005 | EFO_0007510 | B35.4 | — | — | 1 | — | — | 1 |
| Burns | D002056 | T30.0 | — | 1 | 1 | — | — | 1 | |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | 1 | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 15 | 3 | — | — | — | 18 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 3 | 1 | — | — | — | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Thromboembolism | D013923 | HP_0001907 | — | 1 | — | — | — | 1 | |
| Neoplasm metastasis | D009362 | EFO_0009708 | 1 | 1 | — | — | — | 1 | |
| Castration-resistant prostatic neoplasms | D064129 | — | 1 | — | — | — | 1 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | 1 | 1 | — | — | — | 1 | ||
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | — | — | — | 1 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 41 | — | — | — | 1 | 42 | ||
| Pharmacokinetics | D010599 | 6 | — | — | — | — | 6 | ||
| Drug interactions | D004347 | 3 | — | — | — | — | 3 | ||
| Lymphoma | D008223 | C85.9 | 3 | — | — | — | — | 3 | |
| Neuroblastoma | D009447 | EFO_0000621 | 2 | — | — | — | 1 | 3 | |
| Hepatitis c | D006526 | B19.2 | 2 | — | — | — | — | 2 | |
| Hypogonadism | D007006 | E23.0 | 1 | — | — | — | 1 | 2 | |
| Glioma | D005910 | EFO_0000520 | 2 | — | — | — | — | 2 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 2 | — | — | — | — | 2 | |
| Asthma | D001249 | EFO_0000270 | J45 | 2 | — | — | — | — | 2 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gonadal disorders | D006058 | — | — | — | — | 1 | 1 | ||
| Kallmann syndrome | D017436 | Orphanet_478 | E23.0 | — | — | — | — | 1 | 1 |
| Tinea capitis | D014006 | B35.0 | — | — | — | — | 1 | 1 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | KETOCONAZOLE |
| INN | ketoconazole |
| 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 class | systemic antifungals (miconazole type) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)N1CCN(c2ccc(OCC3COC(Cn4ccnc4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1 |
Identifiers
| PDB | 3LD6 |
| CAS-ID | 65277-42-1 |
| RxCUI | 6135 |
| ChEMBL ID | CHEMBL157101 |
| ChEBI ID | 48339 |
| PubChem CID | 3823 |
| DrugBank | DB01026 |
| UNII ID | R9400W927I (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
KCNA10
KCNA10
CYP51A1
CYP51A1
Organism
Homo sapiens
Gene name
KCNA10
Gene synonyms
NCBI Gene ID
Protein name
potassium voltage-gated channel subfamily A member 10
Protein synonyms
cyclic GMP gated potassium channel, potassium channel, voltage gated shaker related subfamily A, member 10, potassium voltage-gated channel, shaker-related subfamily, member 10, Voltage-gated potassium channel subunit Kv1.8
Uniprot ID
Mouse ortholog
Kcna10 (242151)
potassium voltage-gated channel subfamily A member 10 (B2RXZ4)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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23,324 adverse events reported
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