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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Commercial
Trade Name
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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-DANDRUFF | Kramer Laboratories | N-020310 OTC | 1997-10-10 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 1% ketoconazole | C200263 | 2025-03-19 |
| 1% ketoconazole anti dandruff | C200263 | 2026-08-22 |
| anti dandruff | C200263 | 2026-08-22 |
| anti-dandruff | C200263 | 2026-06-14 |
| cysndra ketoconazole 1% medicated shampoos | C200263 | 2026-07-06 |
| danil | unapproved drug other | 2025-07-06 |
| fungifree nail fungus treatment | unapproved drug other | 2024-05-14 |
| gemachlich zuhause ketoconazole 1% anti-dandruff shampoos | C200263 | 2026-07-27 |
| gembooxt ketoconazole 1% medicated shampoos | C200263 | 2026-01-30 |
| hydrocortisone 2.5% / iodoquinol 1% / ketoconazole 2% | unapproved drug other | 2019-05-16 |
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Indications
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Agency Specific
FDA
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Patent Expiration
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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
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Clinical
Clinical Trials
218 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 21 | 4 | — | 2 | — | 27 |
| Seborrheic dermatitis | D012628 | — | L21 | 1 | 2 | 1 | 2 | 2 | 8 |
| Tinea versicolor | D014010 | EFO_0007439 | B36.0 | 1 | — | — | 4 | — | 5 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 1 | 2 | 1 | — | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | 1 | 1 | 3 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 2 | — | — | 1 | — | 3 |
| Thromboembolism | D013923 | — | — | — | 1 | — | 1 | — | 2 |
| Dermatitis | D003872 | — | L30.9 | — | — | — | 1 | 1 | 2 |
| Dyspnea | D004417 | — | R06.0 | — | — | — | 1 | — | 1 |
| Kidney transplantation | D016030 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 3 | 18 | 5 | — | 4 | 28 |
| Tinea pedis | D014008 | EFO_0007512 | B35.3 | — | 1 | 5 | — | — | 6 |
| Tinea | D014005 | EFO_0007510 | B35.4 | — | 1 | 3 | — | 1 | 5 |
| Cushing syndrome | D003480 | EFO_0003099 | E24 | — | — | 3 | — | 1 | 4 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | 1 | — | 2 | — | — | 3 |
| Syndrome | D013577 | — | — | — | — | 3 | — | — | 3 |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | — | — | 2 | — | — | 2 |
| Candidiasis | D002177 | — | B37 | — | — | 1 | — | 1 | 2 |
| Mycoses | D009181 | — | B35-B49 | — | — | 1 | — | 1 | 2 |
| Scalp dermatoses | D012536 | — | — | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 3 | 2 | — | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | — | — | — | 3 |
| Hypogonadism | D007006 | — | E23.0 | 1 | 1 | — | — | 1 | 3 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | 2 | — | — | — | 3 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 2 | — | — | — | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 1 | — | — | — | 1 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | 1 | — | — | — | 1 |
| Granulosa cell tumor | D006106 | — | — | — | 1 | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | 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 | — | — | — | 49 | — | — | — | 1 | 50 |
| Pharmacokinetics | D010599 | — | — | 6 | — | — | — | — | 6 |
| Lymphoma | D008223 | — | C85.9 | 5 | — | — | — | — | 5 |
| Drug interactions | D004347 | — | — | 4 | — | — | — | — | 4 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 3 | — | — | — | — | 3 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 2 | — | — | — | 1 | 3 |
| Hepatitis c | D006526 | — | B19.2 | 2 | — | — | — | — | 2 |
| Sleep deprivation | D012892 | — | F51.12 | 2 | — | — | — | — | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | — | — | — | — | 2 |
| Glioma | D005910 | EFO_0000520 | — | 2 | — | — | — | — | 2 |
Show 41 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tinea capitis | D014006 | — | B35.0 | — | — | — | — | 2 | 2 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Torsades de pointes | D016171 | EFO_0005307 | I47.21 | — | — | — | — | 1 | 1 |
| Gonadal disorders | D006058 | — | — | — | — | — | — | 1 | 1 |
| Kallmann syndrome | D017436 | Orphanet_478 | E23.0 | — | — | — | — | 1 | 1 |
| Dandruff | D063807 | — | L21.0 | — | — | — | — | 1 | 1 |
| Esophagitis | D004941 | HP_0100633 | K20 | — | — | — | — | 1 | 1 |
| Cryptorchidism | D003456 | EFO_0004562 | Q53.1 | — | — | — | — | 1 | 1 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | — | — | 1 | 1 |
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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 | — |
| CAS-ID | 65277-42-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL157101 |
| ChEBI ID | 48339 |
| PubChem CID | 3823 |
| DrugBank | DB01026 |
| UNII ID | R9400W927I (ChemIDplus, GSRS) |
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Ketoconazole
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Safety
Black-box Warning
Black-box warning for: Ketoconazole
Adverse Events
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8,016 adverse events reported
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