NDATOPICALAEROSOL, FOAM
Approved
Jun 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
EXTINA (ketoconazole) by Sandoz is cytochrome p450 3a4 inhibitors [moa]. First approved in 2007.
Drug data last refreshed 14h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EXTINA (ketoconazole) is a topical antifungal foam approved in 2007 that works by inhibiting fungal cytochrome P450 3A4, disrupting ergosterol synthesis. It is indicated for seborrheic dermatitis and other fungal skin infections. The aerosol foam formulation provides convenient topical delivery to affected areas.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), indicating a contracting team and shift toward lifecycle management rather than growth initiatives.
Mechanism of Action
Cytochrome P450 3A4 Inhibitors
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.