NDATOPICALSHAMPOO
Approved
Oct 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
NIZORAL ANTI-DANDRUFF (ketoconazole) by Fabre-Kramer Pharmaceuticals is cytochrome p450 3a4 inhibitors [moa]. First approved in 1997.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NIZORAL (ketoconazole) is a topical azole antifungal shampoo approved in 1997 for the treatment of dandruff and seborrheic dermatitis of the scalp. It works by inhibiting fungal cytochrome P450 3A4 enzymes, disrupting ergosterol synthesis and fungal cell membrane integrity. This over-the-counter product addresses a large, chronic consumer health indication with high repeat-purchase rates.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand defense and transition planning are active priorities for commercial teams.
Mechanism of Action
Cytochrome P450 3A4 Inhibitors
Pharmacologic Class:
Azole Antifungal
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
The Effectiveness of Itraconazole Pulse Therapy vs Topical 2% Ketoconazole in the Treatment of Moderate to Severe Seborrheic Dermatitis of Scalp.
Started Jan 2026
80 enrolled
Seborrheic Dermatitis
Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis
Started Jun 2019
125 enrolled
Tinea
Non-inferiority Trial of Dapaconazole Versus Ketoconazole
Started Nov 2017
360 enrolled
Tinea Pedis
Oral Calcitriol With Ketoconazole in CRPC
Started Jan 2017
1 enrolled
Castration-resistant Prostate Cancer
Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis
Started Jun 2016
0Tinea Pedis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.