Product Description
Vaginal miconazole is used to treat vaginal yeast infections in adults and children 12 years of age and older. Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection. (Sourced from: https://medlineplus.gov/druginfo/meds/a601203.html)
Mechanisms of Action: CYP1A2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Vaginal
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Candidiasis
Known Adverse Events: Abdominal Pain | Dysgeusia | Headache | Pain Unspecified | Diarrhea
Company: Hill Dermaceuticals
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 3
Highest Development Phases
Phase 3: Candidiasis|Otomycosis
Phase 2: Candidiasis, Vulvovaginal
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
MZ-1015-ESP3-054 | P3 |
Recruiting |
Otomycosis |
2024-09-01 |
|
MicoFlu-C | P3 |
Active, not recruiting |
Candidiasis |
2023-06-17 |
|
2021-001201-75 | P2 |
Active, not recruiting |
Candidiasis, Vulvovaginal |
2022-07-13 |