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Miconazole Nitrate 2%
Miconazole nitrate disrupts fungal cell membrane integrity by inhibiting ergosterol synthesis, leading to cell death.
Miconazole nitrate disrupts fungal cell membrane integrity by inhibiting ergosterol synthesis, leading to cell death. Used for Topical fungal infections including tinea pedis, tinea corporis, tinea cruris, and candidiasis, Pityriasis versicolor.
At a glance
| Generic name | Miconazole Nitrate 2% |
|---|---|
| Sponsor | Aesculape CRO Belgium BV |
| Drug class | Imidazole antifungal |
| Target | Lanosterol 14α-demethylase (CYP51) |
| Modality | Small molecule |
| Therapeutic area | Dermatology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Miconazole is an imidazole antifungal that inhibits the fungal cytochrome P450 enzyme lanosterol 14α-demethylase, blocking the conversion of lanosterol to ergosterol. This disrupts the fungal cell membrane structure and permeability, ultimately causing fungal cell death. It is effective against a broad spectrum of dermatophytes, yeasts, and other fungi.
Approved indications
- Topical fungal infections (dermatophytosis, candidiasis, tinea pedis, tinea corporis, tinea cruris)
- Pityriasis versicolor
Common side effects
- Local irritation or burning at application site
- Erythema
- Pruritus
- Contact dermatitis
Key clinical trials
- Safety and Efficacy of Intralesional 0.5% Triamcinolone Acetonide in 0.2% Fluconazole Solution vs 0.1% Topical Mometasone Furoate With 2% Miconazole Nitrate Cream in the Treatment of Chronic Paronychia: An Intraindividual Randomized Controlled Trial. (PHASE3)
- Efficacy of Tropical Sertaconazole Nitrate 2% Vs Clotrimazole 1% for Tinea Pedis (PHASE4)
- Different Treatment Modalities for Oral Lichen Plan (PHASE1)
- Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis (PHASE3)
- Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis) (PHASE2, PHASE3)
- Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis (PHASE2)
- Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis (PHASE2)
- Glutamine With Topical Corticosteroids for Lichen Planus Treatment (NA)
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 |
|---|---|
| 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:
- Miconazole Nitrate 2% CI brief — competitive landscape report
- Miconazole Nitrate 2% updates RSS · CI watch RSS
- Aesculape CRO Belgium BV portfolio CI