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Monistat (miconazole)
Miconazole (Monistat/Micatin) is one of the most used OTC antifungals, developed by Janssen. Available in topical, vaginal, and buccal formulations. Available generically.
At a glance
| Generic name | miconazole |
|---|---|
| Also known as | Monistat, Micatin, Daktarin |
| Sponsor | Johnson & Johnson (Janssen) |
| Drug class | Imidazole antifungal |
| Target | 7-alpha-hydroxycholest-4-en-3-one 12-alpha-hydroxylase, Malate dehydrogenase cytoplasmic , 5-hydroxytryptamine receptor 6 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1974-01-01 (United States) |
Approved indications
- Candidal vulvovaginitis
- Candidiasis of mouth
- Candidiasis of skin
- Deep mycosis
- Diaper rash
- Onychomycosis due to dermatophyte
- Oropharyngeal Candidiasis
- Pityriasis versicolor
- Tinea corporis
- Tinea cruris
- Tinea pedis
Common side effects
Key clinical trials
- Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections Who Have no Other Treatment Options (N/A)
- Determining Elements of Anti-Fungal Immunity in BURN Patients (N/A)
- An Open-Label, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of DIC075V in Subjects With Mild or Moderate Chronic Renal Insufficiency and in Subjects With Mild Chronic Hepatic Impairme (Phase 1)
- Randomized Clinical Trial of a Mucoadhesive Gel Containing EPP-AF in Patients Diagnosed With Vulvovaginal Candidiasis (Phase 1)
- Alterations in the Human Microbiome With Commonly Used Topical Medications (Phase 1)
- OptiLink HF Study (Optimization of Heart Failure Management Using Medtronic OptiVol® Fluid Status Monitoring and Medtronic CareLink® Network) (Phase 4)
- Screen-and-treat Strategy for Vaginal Flora Abnormalities by Multiplex Molecular Biology Using POC Technology in Pregnant Women at High Risk of Preterm Birth: A Multicentre, Randomized Study (AUTOP2) (Phase 4)
- An Open-label, Randomized, Three-period Crossover Trial in Healthy HIV-negative Women to Assess the Drug-drug Interaction Between Dapivirine Vaginal Ring-004 and Miconazole Nitrate (Phase 1)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Monistat CI brief — competitive landscape report
- Monistat updates RSS · CI watch RSS
- Johnson & Johnson (Janssen) portfolio CI