Overview
Butenafine hydrochloride is a synthetic benzylamine antifungal agent. Butenafine's mechanism of action is believed to involve the synthesis inhibition of sterols. In particular, butenafine acts to inhibit the activity of the squalene epoxidase enzyme that is essential in the formation of sterols necessary for fungal cell membranes.
Background
Butenafine hydrochloride is a synthetic benzylamine antifungal agent. Butenafine's mechanism of action is believed to involve the synthesis inhibition of sterols. In particular, butenafine acts to inhibit the activity of the squalene epoxidase enzyme that is essential in the formation of sterols necessary for fungal cell membranes.
Indication
For the topical treatment of the following dermatologic infections: tinea (pityriasis) versicolor due to M. furfur, interdigital tinea pedis (athlete’s foot), tinea corporis (ringworm) and tinea cruris (jock itch) due to E. floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans.
Associated Conditions
- Pityriasis versicolor
- Tinea Corporis
- Tinea Cruris
- Tinea Pedis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/08/31 | Phase 3 | Completed | |||
2020/08/31 | Phase 3 | Completed | |||
2020/08/28 | Phase 3 | Completed | |||
2020/08/28 | Phase 3 | Completed | |||
2019/06/26 | Phase 2 | UNKNOWN | United Laboratories | ||
2012/04/19 | Phase 1 | Completed | |||
2010/05/10 | Phase 1 | Terminated | |||
2009/02/03 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Butenafine Hydrochloride Liniment | 国药准字H20080621 | 化学药品 | 搽剂 | 12/12/2023 | |
| Butenafine Hydrochloride Liniment | 国药准字H20040791 | 化学药品 | 搽剂 | 6/1/2020 | |
| Butenafine Hydrochloride Liniment | 国药准字H20031311 | 化学药品 | 搽剂 | 2/6/2020 | |
| Butenafine Hydrochloride Gel | 国药准字H20060783 | 化学药品 | 凝胶剂 | 6/22/2020 | |
| Butenafine Hydrochloride spray | 国药准字H20031312 | 化学药品 | 喷雾剂 | 2/6/2020 | |
| Butenafine Hydrochloride Cream | 国药准字H20031310 | 化学药品 | 乳膏剂 | 2/6/2020 | |
| Butenafine Hydrochloride Cream | 国药准字H20020025 | 化学药品 | 乳膏剂 | 9/30/2019 | |
| Butenafine Hydrochloride Cream | 国药准字H20183065 | 化学药品 | 乳膏剂 | 3/17/2023 | |
| Butenafine Hydrochloride Cream | 国药准字H20030460 | 化学药品 | 乳膏剂 | 2/16/2020 | |
| Butenafine Hydrochloride Cream | 国药准字H20040790 | 化学药品 | 乳膏剂 | 6/1/2020 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||