Overview
Miconazole is a broad-spectrum azole antifungal with some activity against Gram-positive bacteria as well. It is widely used to treat mucosal yeast infections, including both oral and vaginal infections; although intravenous miconazole is no longer available, a wide variety of suppositories, creams, gels, and tablet-based products are available. Miconazole is thought to act primarily through the inhibition of fungal CYP450 14α-lanosterol demethylase activity. Miconazole was first synthesized in 1969 and first granted FDA approval on January 8, 1974, for sale by INSIGHT Pharmaceuticals as a topical cream. It is currently available as a variety of prescription and over the counter products. Despite having been in clinical use for an extended period, resistance to miconazole among susceptible organisms is relatively low.
Indication
Miconazole is indicated for the local treatment of oropharyngeal candidiasis in adult patients and for the adjunctive treatment of diaper dermatitis complicated by candidiasis in immunocompetent patients aged four weeks and older. Miconazole is available as both a suppository and cream for the treatment of vaginal yeast infections and the relief of associated vulvar itching and irritation. Lastly, miconazole cream is effective in treating athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm infections (tinea corporis), pityriasis (formerly tinea) versicolor, and cutaneous candidiasis.
Associated Conditions
- Acne Vulgaris
- Dermatophytosis
- Dermatophytosis of nail
- Diaper Dermatitis
- Excessive sweating and body odor
- Fungal skin infection
- Gastrointestinal candidiasis
- Infection, Mixed
- Infections, Fungal of the Skin Folds
- Nail candida
- Oropharyngeal Candidiasis
- Pityriasis versicolor
- Ringworm
- Seborrheic Dermatitis
- Skin candida
- Tinea Capitis
- Tinea Corporis
- Tinea Cruris
- Tinea Pedis
- Vaginal Candidiasis
- Cutaneous candidiasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/06/23 | Phase 4 | Recruiting | |||
2022/12/21 | Phase 3 | Recruiting | |||
2021/03/24 | Phase 2 | UNKNOWN | Aesculape CRO Belgium BV | ||
2020/06/22 | Not Applicable | Completed | Hams Hamed Abdelrahman | ||
2020/06/16 | Phase 2 | Completed | |||
2020/03/23 | Phase 2 | UNKNOWN | Hams Hamed Abdelrahman | ||
2020/03/13 | Phase 2 | UNKNOWN | Hams Hamed Abdelrahman | ||
2017/12/02 | Phase 2 | Completed | Galeno Desenvolvimento de Pesquisas Clínicas | ||
2016/06/30 | Phase 3 | Completed | |||
2015/09/10 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| CVS Pharmacy | 69842-988 | VAGINAL | 20 mg in 100 g | 5/27/2025 | |
| Dechra Veterinary Products | 17033-173 | TOPICAL | 20 mg in 1 mL | 6/9/2025 | |
| Dechra Veterinary Products | 17033-179 | TOPICAL | 20 mg in 1 1 | 6/6/2025 | |
| Encube Ethicals Private Limited | 21922-095 | TOPICAL | 2 g in 100 g | 3/6/2025 | |
| TARGET Corporation | 11673-049 | VAGINAL | 20 mg in 1 g | 5/27/2025 | |
| Galt Pharmaceuticals, LLC | 61825-303 | BUCCAL | 50 mg in 1 1 | 1/8/2024 | |
| Actavis Pharma, Inc. | 0472-1738 | VAGINAL | 200 mg in 1 1 | 10/21/2020 | |
| Mylan Pharmaceuticals Inc. | 0378-9730 | TOPICAL | 2.5 mg in 1 g | 8/15/2018 | |
| Combe Incorporated | 11509-0825 | VAGINAL | 2 g in 100 g | 4/15/2025 | |
| Crown Laboratories, Inc. | 0316-0255 | TOPICAL | 20 mg in 1 g | 3/24/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TINAZOL CREAM 2% w/w | SIN06466P | CREAM | 2.00% w/w | 7/24/1991 | |
| MYNAZOLE CREAM 2% w/w | SIN14797P | CREAM | 2% w/w | 6/22/2015 | |
| DECOCORT CREAM | SIN10564P | CREAM | 2% w/w | 12/18/1998 | |
| RESOLVE TINEA POWDER 2% w/w | SIN10835P | POWDER | 2% w/w | 3/24/1999 | |
| MYCOBAN CREAM 2% | SIN07246P | CREAM | 2% w/w | 11/20/1992 | |
| ANTIFUNGAL CREAM 20 mg/g | SIN07963P | CREAM | 20 mg/g | 12/15/1994 | |
| RESOLVE SOLUTION 2% w/w | SIN10836P | SOLUTION | 2% w/w | 3/24/1999 | |
| SW MICONAZOLE CREAM 2% w/w | SIN03904P | CREAM | 2% w/w | 2/21/1990 | |
| CANDIPLAS CREAM 2% w/w | SIN00966P | CREAM | 2% w/w | 5/10/1988 | |
| GUARDIAN ANTIFUNGAL CREAM 2 % | SIN08172P | CREAM | 2% w/w | 5/12/1995 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Miconazole Nitrate Capsules | 国药准字H22020193 | 化学药品 | 胶囊剂 | 2/19/2020 | |
| Miconazole Nitrate Capsules | 国药准字H13020876 | 化学药品 | 胶囊剂 | 3/29/2021 | |
| Miconazole Nitrate Capsules | 国药准字H13021853 | 化学药品 | 胶囊剂 | 7/27/2020 | |
| Miconazole Nitrate Solution | 国药准字H20066892 | 化学药品 | 搽剂 | 6/15/2021 | |
| Miconazole Nitrate Solution | 国药准字H31022700 | 化学药品 | 溶液剂 | 1/19/2020 | |
| Miconazole Nitrate Liniment | 国药准字H20094102 | 化学药品 | 搽剂 | 2/18/2021 | |
| Miconazole Nitrate Liniment | 国药准字H44024675 | 化学药品 | 搽剂 | 9/12/2019 | |
| Miconazole Nitrate Powder | 国药准字H10930213 | 化学药品 | 散剂 | 5/28/2020 | |
| Miconazole Nitrate Vaginal Tablets | 国药准字H20030405 | 化学药品 | 阴道片 | 7/21/2020 | |
| Miconazole Nitrate Vaginal Effervescent Tablets | 国药准字H20080186 | 化学药品 | 片剂 | 2/27/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| LONGAXON CREAM | N/A | N/A | N/A | 1/14/1997 | |
| MICROTIN CREAM 2% | N/A | N/A | N/A | 6/23/1997 | |
| PROMAX CREAM | N/A | N/A | N/A | 12/29/2004 | |
| TINAZOL CREAM | N/A | N/A | N/A | 1/24/1992 | |
| CORAL CREAM | N/A | N/A | N/A | 1/28/2010 | |
| YIDUN ANTIFUNGAL VAGINAL TABLETS 100MG | N/A | N/A | N/A | 12/9/2024 | |
| MICONAZOLE CREAM 2% | N/A | N/A | N/A | 7/10/1996 | |
| TINACORT CREAM | N/A | N/A | N/A | 9/28/2009 | |
| DAFRIN CREAM 2% | N/A | N/A | N/A | 8/13/1982 | |
| POTADERM-FORTE CREAM | N/A | N/A | N/A | 1/28/2010 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| RESOLVE SOLUTION miconazole 2% bottle | 54039 | Medicine | A | 12/4/1995 | |
| RESOLVE TINEA CREAM miconazole nitrate 2% w/w tube | 46316 | Medicine | A | 9/3/1993 | |
| DECOZOL miconazole 2% w/w oral gel tube | 231828 | Medicine | A | 12/15/2014 | |
| DAKTARIN (EU) PRESSURISED SPRAY | 285096 | Ensign Laboratories Pty Ltd | Medicine | A | 1/31/2017 |
| DAKTARIN PRESSURISED SPRAY miconazole nitrate 20 mg/g aerosol can | 51659 | Medicine | A | 3/9/1995 | |
| LANADERM BROAD SPECTRUM ANTIFUNGAL 20mg/g | 48324 | Milpharma Pty Ltd | Medicine | A | 2/28/1994 |
| DAKTARIN ORAL GEL miconazole 20mg/g gel tube | 13287 | Medicine | A | 8/28/1991 | |
| DAKTARIN POWDER miconazole nitrate 20mg/g bottle | 13288 | Medicine | A | 8/28/1991 | |
| RESOLVE PLUS 0.5 cream tube | 75602 | Medicine | A | 8/30/2000 | |
| DAKTOZIN ointment tube | 47360 | Medicine | A | 3/1/1994 |
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