EN

API

Amorolfine Hydrochloride

KDMF APIs

Amorolfine Hydrochloride

Amorolfine Hydrochloride basic information

Korean name

아모롤핀염산염

Category

Integument

CAS No.

78613-35-1

KDMF registration No.

20191204-211-J-495

Manufacturer

Zhejiang Hisoar Pharmaceutical Co., Ltd

Specification

EP-In house

Product information

Amorolfine Hydrochloride product information

IUPAC Name

(2R,6S)-2,6-dimethyl-4-(2-{[4-(2-methylbutan-2-yl)phenyl]methyl}propyl)morpholine

Description

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.

Certificate of Analysis

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