Drug intelligence / Profile preview

P-3058 (terbinafine) (Polichem)

Development stage
Unknown
Lead developer
Polichem
Modality
Small Molecules
Administration
Topical
01

Overview

P-3058 is a topical nail solution formulation of terbinafine, an allylamine antifungal agent, developed by Polichem (a subsidiary of Almirall) for the treatment of onychomycosis. The formulation utilizes a proprietary hydroxypropyl chitosan (HPCH) technology designed to enhance the transungual delivery of terbinafine, allowing the drug to penetrate the nail plate effectively without the need for mechanical debridement or filing. Terbinafine acts by inhibiting the enzyme squalene epoxidase (squalene monooxygenase) in the fungal cell membrane. This inhibition blocks the synthesis of ergosterol, an essential component of fungal cell walls, and leads to an intracellular accumulation of squalene, which is toxic to the fungi, resulting in a fungicidal effect against dermatophytes and certain other fungi. P-3058 has been evaluated in Phase 3 clinical trials for both adult and pediatric populations affected by mild-to-moderate onychomycosis.

Other names
terbinafine nail solutionterbinafine 5% nail solution
02

Targets

SQLE (Squalene monooxygenase)

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