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Nizoral (ketoconazole)
Ketoconazole (Nizoral) is primarily used as an OTC antifungal shampoo for dandruff and seborrheic dermatitis. Oral use restricted by FDA in 2013 due to hepatotoxicity. Available generically.
At a glance
| Generic name | ketoconazole |
|---|---|
| Also known as | Nizoral |
| Sponsor | Johnson & Johnson (Janssen) |
| Drug class | Azole Antifungal [EPC] |
| Target | Aldehyde oxidase, Cytochrome P450 21, Sodium/nucleoside cotransporter 1 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1981-06-26 (United States) |
Approved indications
- Blastomycosis
- Candidiasis of mouth
- Candidiasis of skin
- Chromoblastomycosis
- Coccidioidomycosis
- Disseminated candidiasis
- Histoplasmosis
- Hypercortisolism
- Paracoccidioidomycosis
- Pityriasis simplex
- Pityriasis versicolor
- Seborrheic dermatitis
- Tinea corporis
- Tinea cruris
- Tinea pedis
Common side effects
Key clinical trials
- Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ket (Phase 2)
- An Open-Label, 2-Part Study to Determine the Relative Bioavailability of a Tablet Formulation of GDC-0941 and the Effect of Ketoconazole on the Pharmacokinetics of the GDC-0941 Tablet (Phase 1)
- Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study (NA)
- A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate (Phase 3)
- A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTINÔ), in Patients With Advanced Solid Tumou (Phase 1)
- An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome (Phase 3)
- Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer (NA)
- Hormonal Mechanisms of Sleep Restriction (EARLY/Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nizoral CI brief — competitive landscape report
- Nizoral updates RSS · CI watch RSS
- Johnson & Johnson (Janssen) portfolio CI