Drugs / Miconazole Nitrate
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | MONISTAT 1 COMBINATION PACK | — | 2004-10-01 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | MONISTAT 7 | — | 1991-02-15 – 1993-04-26 | fda.gov ↗ |
| Approved | US (FDA) | MONISTAT-DERM | — | 1974-01-08 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01230814 | Apr 2011 → Aug 2013 | bacterial vaginosis, candidiasis, trichomoniasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Mixed |
| Phase not applicable1 trial | ||||||
| — | NCT03949751 | Nov 2018 → Apr 2020 | — | Balgrist University Hospital | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT03359070 Comparator | Jan → Dec 2014 | dermatophytosis of groin and perianal area | Galeno Desenvolvimento de Pesquisas Clínicas | Completed | No outcome recorded |
| Phase 3 | NCT07311759 Comparator | Aug 2024 → Dec 2025 overdue | paronychia | Cairo University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT00702507 Comparator | May 2007 → Dec 2010 | — | Stiefel, a GSK Company | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Miconazole Nitrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01230814 ↗ |
| Known as | Miconazolnitrat | “The study specific intervention product is a combination of Benzoylperoxid and Miconazolnitrat (Widmer Acne Crème Plus, 47033 Swissmedic) to apply daily in the evening on the skin” NCT03949751 ↗ |
| Route | Topical | “Topical Application” NCT00702507 ↗ |