Chemical Name:1-Piperidineethanol, a-(2,4-difluorophenyl)-b-methyl-4-methylene-a-(1H-1,2,4-triazol-1-ylmet hyl)-, (aR,bR)-
- CAS No.164650-44-6
- Molecular Formula:C18H22F2N4O
- Formula Weight:348.39904
Synonyms:KP-103; KP 103; (R,R)-2-(2,4-Difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1,2,4-triazol-1-yl)-2-butanol
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Efinaconazole, identified by the CAS number 164650-44-6, is a highly potent, third-generation triazole antifungal agent widely recognized for its efficacy in treating onychomycosis, commonly known as fungal nail infections. With a molecular formula of C23H24ClF3N4O and a molecular weight of approximately 462.9 g/mol, this compound exhibits a unique chemical structure that combines broad-spectrum activity with excellent tissue penetration capabilities. The "99% up GMP DMF" designation indicates that the product meets rigorous Good Manufacturing Practice standards, ensuring high purity suitable for pharmaceutical formulation, while the Drug Master File (DMF) status confirms its regulatory compliance and availability for use in approved drug development projects globally.
The primary mechanism of action involves the inhibition of lanosterol 14α-demethylase, a critical enzyme in the fungal cytochrome P450 system responsible for ergosterol biosynthesis. By disrupting ergosterol production, Efinaconazole compromises the integrity of the fungal cell membrane, leading to cell death. Its distinct advantage over older azoles lies in its ability to penetrate the hard keratinous matrix of the nail plate effectively without requiring systemic administration, thereby minimizing potential drug-drug interactions and hepatic toxicity associated with oral antifungals. Consequently, it is frequently formulated into topical solutions for direct application to infected nails.
Beyond clinical applications, Efinaconazole serves as a vital active pharmaceutical ingredient (API) for generic manufacturers and research institutions developing novel dermatological treatments. The availability of high-purity batches facilitates both preclinical studies and large-scale commercial production. As a key component in modern antifungal therapy, it addresses the significant unmet medical need for safe, effective, and patient-compliant treatments for stubborn nail fungal infections. Its robust profile ensures continued relevance in the global pharmaceutical market, supporting the development of advanced therapeutic solutions for dermatological conditions worldwide.
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