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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
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-DANDRUFF | Kramer Laboratories | N-020310 OTC | 1997-10-10 | 1 products, RLD, RS |
Show 5 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 1% ketoconazole | C200263 | 2025-03-19 |
| 1% ketoconazole anti dandruff | C200263 | 2024-12-03 |
| dandrx 1% ketoconazole anti-dandruff | C200263 | 2025-04-08 |
| danil | unapproved drug other | 2025-07-06 |
| fungifree nail fungus treatment | unapproved drug other | 2024-05-14 |
| hydrocortisone 2.5% / iodoquinol 1% / ketoconazole 2% | unapproved drug other | 2019-05-16 |
| hydrocortisone 2.5% / ketoconazole 2% | unapproved drug other | 2019-05-16 |
| ketoconazole | ANDA | 2025-09-02 |
| ketoconazole 2% / niacinamide 4% | unapproved drug other | 2019-05-13 |
| ketoconazole 2% / salicylic acid 2% | unapproved drug other | 2019-05-16 |
Show 12 more
Indications
FDA
EMA
Show 4 more
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
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 21 | 3 | — | 2 | — | 26 |
| Dermatitis | D003872 | — | L30.9 | — | 2 | 2 | 1 | 2 | 7 |
| Seborrheic dermatitis | D012628 | — | L21 | — | 2 | 1 | 1 | 2 | 6 |
| Tinea versicolor | D014010 | EFO_0007439 | B36.0 | 1 | — | — | 3 | — | 4 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 1 | 1 | 1 | — | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | 1 | 1 | 3 |
| Recurrence | D012008 | — | — | 2 | — | — | 1 | — | 3 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 2 | — | — | 1 | — | 3 |
| Thromboembolism | D013923 | — | — | — | 1 | — | 1 | — | 2 |
| Pityriasis | D010915 | — | — | — | — | — | 2 | — | 2 |
Show 11 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 3 | 18 | 6 | — | 4 | 29 |
| Tinea | D014005 | EFO_0007510 | B35.4 | 1 | 1 | 6 | — | 1 | 9 |
| Tinea pedis | D014008 | EFO_0007512 | B35.3 | — | 1 | 5 | — | — | 6 |
| Syndrome | D013577 | — | — | — | — | 4 | — | 1 | 5 |
| Candidiasis | D002177 | — | B37 | — | — | 3 | — | 1 | 4 |
| Cushing syndrome | D003480 | EFO_0003099 | E24 | — | — | 3 | — | 1 | 4 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | 1 | — | 2 | — | — | 3 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 2 | 1 | — | — | 3 |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | — | — | 2 | — | — | 2 |
| Scalp dermatoses | D012536 | — | — | — | — | 1 | — | 1 | 2 |
Show 13 more
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 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 2 | 2 | — | — | — | 3 |
| Leukemia | D007938 | — | C95 | 2 | 1 | — | — | — | 2 |
| Adenocarcinoma | D000230 | — | — | 1 | 2 | — | — | — | 2 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 2 | — | — | — | 2 |
| Carcinoma | D002277 | — | C80.0 | 1 | 2 | — | — | — | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 1 | — | — | — | 1 |
| Granulosa cell tumor | D006106 | — | — | — | 1 | — | — | — | 1 |
Show 15 more
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 |
| Infections | D007239 | EFO_0000544 | — | 2 | — | — | — | 1 | 3 |
| Hepatitis c | D006526 | — | B19.2 | 2 | — | — | — | — | 2 |
| Sleep deprivation | D012892 | — | F51.12 | 2 | — | — | — | — | 2 |
| Glioma | D005910 | EFO_0000520 | — | 2 | — | — | — | — | 2 |
Show 36 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Tinea capitis | D014006 | — | B35.0 | — | — | — | — | 1 | 1 |
| Cryptorchidism | D003456 | EFO_0004562 | Q53.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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) |
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)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 21,992 documents
View more details
Safety
Black-box Warning
Black-box warning for: Ketoconazole
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
7,189 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use