MedPath

Amorolfine

Generic Name
Amorolfine
Drug Type
Small Molecule
Chemical Formula
C21H35NO
CAS Number
78613-35-1
Unique Ingredient Identifier
AB0BHP2FH0

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.
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