Overview
Ciclopirox olamine (used in preparations called Batrafen, Loprox, Mycoster, Penlac and Stieprox) is a synthetic antifungal agent for topical dermatologic treatment of superficial mycoses. In particular, the agent is especially effective in treating Tinea versicolor.
Indication
Used as a topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum.
Associated Conditions
- Fungal skin infection
- Pityriasis versicolor
- Seborrheic dermatitis of the scalp
- Tinea Corporis
- Tinea Cruris
- Tinea Pedis
- Vulvovaginal Candidiasis
- Cutaneous candidiasis
- Mild Onychomycosis
- Moderate Onychomycosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/04/12 | Phase 4 | Not yet recruiting | |||
2022/12/12 | Phase 1 | Completed | Atlas Molecular Pharma | ||
2022/08/01 | N/A | Active, not recruiting | University of Rome Tor Vergata | ||
2016/11/11 | Phase 3 | UNKNOWN | |||
2016/08/15 | Phase 3 | Completed | |||
2016/02/11 | Phase 4 | Completed | |||
2016/01/01 | Phase 2 | UNKNOWN | |||
2012/07/20 | Phase 4 | Terminated | |||
2011/08/18 | Phase 4 | Completed | |||
2008/12/08 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Medimetriks Pharmaceuticals, Inc. | 43538-500 | TOPICAL | 2.28 g in 1 mL | 12/21/2020 | |
| Akorn | 50383-419 | TOPICAL | 71.3 mg in 1 mL | 5/26/2022 | |
| Bausch Health US, LLC | 99207-010 | TOPICAL | 10 mg in 0.96 mL | 5/1/2019 | |
| A-S Medication Solutions | 50090-6562 | TOPICAL | 80 mg in 1 mL | 10/23/2019 | |
| Teligent Pharma, Inc. | 52565-032 | TOPICAL | 10 mg in 0.96 mL | 9/9/2019 | |
| Padagis Israel Pharmaceuticals Ltd | 45802-141 | TOPICAL | 80 mg in 1 mL | 6/7/2017 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-455 | TOPICAL | 7.7 mg in 1 g | 1/13/2017 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-1351 | TOPICAL | 10 mg in 0.96 mL | 12/2/2015 | |
| Bryant Ranch Prepack | 72162-2076 | TOPICAL | 80 mg in 1 mL | 8/17/2023 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-5302 | TOPICAL | 80 mg in 1 mL | 12/4/2019 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| REJUVENAIL ANTI-FUNGAL NAIL LACQUER ciclopirox 80mg/g solution bottle | 197723 | A Menarini Australia Pty Ltd | Medicine | A | 5/22/2012 |
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