NDAVAGINALCREAM
Approved
Apr 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
3/8 — Basic
TRIVAGIZOLE 3 (clotrimazole) by PharmaIN is clinical pharmacology clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and malassezia furfur . First approved in 2000.
Drug data last refreshed 26m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRIVAGIZOLE 3 (clotrimazole) is a broad-spectrum azole antifungal cream for vaginal administration used to treat dermal and vaginal infections caused by dermatophytes, yeasts, and Malassezia furfur. The drug works by disrupting fungal cell membranes, causing leakage of intracellular phosphorus and nucleic acid breakdown with minimal systemic absorption. Clotrimazole exhibits both fungistatic and fungicidal activity against Candida species, Trichophyton, Microsporum, and Epidermophyton with rare resistance development.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling transition from growth to mature/post-LOE team structure and cost management focus.
Mechanism of Action
CLINICAL PHARMACOLOGY Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and Malassezia furfur . The primary action of clotrimzole is against dividing and growing organisms. In vitro ,…
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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.