Overview
Amorolfine or amorolfin, is a morpholine antifungal drug that inhibits the fungal enzymes D14 reductase and D7-D8 isomerase. This inhibition affects fungal sterol synthesis pathways, depleting ergosterol and causing ignosterol to accumulate in the fungal cytoplasmic cell membranes. Amorolfine is marketed as Curanail, Loceryl, Locetar, and Odenil. It is available in the form of a 5% amorolfine nail lacquer used to treat onychomycosis (fungal infection of the toe- and fingernails). Amorolfine 5% nail lacquer in once or twice weekly applications is 60-71% effective in treating toenail onychomycosis; complete cure rates three months after stopping treatment (after six months of treatment) were 38-46%. However, full experimental details of these trials were not available and since they were first reported in 1992 there have been no subsequent trials. It is a topical solution for the treatment of toenail infections. Systemic treatments may be considered more effective. It is approved for sale over the counter in Australia and the UK (recently re-classified to over the counter status), and is approved for the treatment of toenail fungus by prescription in other countries. It is not approved for the treatment of onychomycosis in the United States or Canada.
Background
Amorolfine or amorolfin, is a morpholine antifungal drug that inhibits the fungal enzymes D14 reductase and D7-D8 isomerase. This inhibition affects fungal sterol synthesis pathways, depleting ergosterol and causing ignosterol to accumulate in the fungal cytoplasmic cell membranes. Amorolfine is marketed as Curanail, Loceryl, Locetar, and Odenil. It is available in the form of a 5% amorolfine nail lacquer used to treat onychomycosis (fungal infection of the toe- and fingernails). Amorolfine 5% nail lacquer in once or twice weekly applications is 60-71% effective in treating toenail onychomycosis; complete cure rates three months after stopping treatment (after six months of treatment) were 38-46%. However, full experimental details of these trials were not available and since they were first reported in 1992 there have been no subsequent trials. It is a topical solution for the treatment of toenail infections. Systemic treatments may be considered more effective. It is approved for sale over the counter in Australia and the UK (recently re-classified to over the counter status), and is approved for the treatment of toenail fungus by prescription in other countries. It is not approved for the treatment of onychomycosis in the United States or Canada.
Indication
外用于治疗由皮肤癣菌如红色毛癣菌、须癣毛癣菌、絮状表皮癣菌和犬小孢子菌等所致的浅表皮肤真菌感染,如手癣、足癣(尤其是角化增厚型)、体癣、股癣;亦可用于头癣;也适用于治疗甲真菌病。外用于由念珠菌如白色念珠菌等所致的皮肤念珠菌感染和念珠菌性外阴阴道炎。外用于由马拉色菌属所致的花斑癣。
Associated Conditions
- Fungal skin infection
- Fungus, Nail
- Pityriasis versicolor
- Tinea Corporis
- Tinea Cruris
- Tinea Pedis
- Tinea inguinalis
- Tinea manuum
- Cutaneous candidiasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/11/15 | Not Applicable | Recruiting | |||
2024/02/12 | Not Applicable | Not yet recruiting | |||
2022/08/01 | N/A | Active, not recruiting | University of Rome Tor Vergata | ||
2021/07/14 | Not Applicable | Completed | |||
2017/12/26 | Not Applicable | Completed | |||
2017/09/21 | Not Applicable | Completed | |||
2017/03/31 | Not Applicable | UNKNOWN | |||
2016/06/23 | Phase 4 | Completed | |||
2016/03/10 | Phase 4 | Completed | |||
2016/02/11 | Phase 4 | 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 |
---|---|---|---|---|---|
LOCERYL NAIL LACQUER 5% | SIN07506P | SOLUTION | 5% w/v | 9/28/1993 | |
AMOROLFINE NAIL LACQUER 5%W/V | SIN14604P | SOLUTION | 50.00mg/ml | 9/5/2014 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Amorolfine Hydrochloride Cream | 国药准字H20249772 | 化学药品 | 乳膏剂 | 12/25/2024 | |
Amorolfine Hydrochloride Cream | H20140118 | 化学药品 | 乳膏剂 | 6/19/2020 | |
Amorolfine Hydrochloride Cream | 国药准字H20133066 | 化学药品 | 乳膏剂 | 8/22/2022 | |
Amorolfine Hydrochloride Liniment | 国药准字H20253230 | 化学药品 | 搽剂 | 1/24/2025 | |
Amorolfine Hydrochloride Liniment | 国药准字H20065886 | 化学药品 | 搽剂 | 4/23/2021 | |
Amorolfine Hydrochloride Liniment | 国药准字H20123162 | 化学药品 | 搽剂 | 11/8/2021 | |
Amorolfine Hydrochloride Liniment | 国药准字H20183363 | 化学药品 | 搽剂 | 3/21/2023 | |
Amorolfine Hydrochloride Liniment | 国药准字HJ20181200 | 化学药品 | 搽剂 | 3/20/2023 |
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. |