NDAVAGINALCREAM
Approved
Apr 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
4/8 — Partial
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 . Approved for candidiasis, mycoses, oral candidiasis. First approved in 2000.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRIVAGIZOLE 3 is a topical vaginal cream containing clotrimazole, a broad-spectrum azole antifungal agent approved for treating candidiasis and other mycoses. The drug works by inhibiting fungal cytochrome P450-dependent lanosterol demethylase, disrupting ergosterol biosynthesis and causing fungal cell membrane damage and lysis. It exhibits fungistatic and fungicidal activity against dermatophytes, yeasts including Candida albicans, and Malassezia furfur with minimal systemic absorption.
LOE Approaching
Product is approaching loss of exclusivity with modest commercial momentum; brand teams should focus on generalization strategy and line extensions.
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.