Miconazole
As of the edition of 20 October 2026, Miconazole is a small molecule: marketed, first approved in 1972 (CH).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Monistat-Derm
- First approved
- 10 March 1972 (CH)
- Approvals on record
- 30 in 7 regions
- Holder of the most recent approval
- KENVUE LTDA.; 14 holders in all
- Registered trials
- 15, 0 stopped early
- Disease areas
- Infections; Pregnancy and women's health; Urinary and reproductive; Mouth and teeth; Skin and connective tissue; Heart and blood vessels
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 3 | 0 | 0 |
| Phase 1 | 4 | 3 | 0 | 0 |
| Phase 2 | 4 | 1 | 0 | 0 |
| Phase 4 | 4 | 2 | 0 | 0 |
| All trials | 15 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Insight Therapeutics | Applicant | 1978 to now |
| Almirall | Applicant | 1993 to now |
| Personal | Acquired holder | 2003 to now |
| Johnson & Johnson | Applicant, Later holder and Lead sponsor of trials | 2009 to now |
| Medtech | Acquired holder | 2015 to now |
| Sosei | Applicant | 2018 to now |
| Galt Pharmaceuticals | Acquired holder | 2020 to now |