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P-3058 is a topical 10% nail solution formulation of the antifungal agent terbinafine, originally developed by Polichem S.A. (now a subsidiary of Almirall). It is specifically designed for the treatment of onychomycosis, a fungal infection of the fingernails or toenails. Terbinafine belongs to the allylamine class of antifungals and exerts its therapeutic effect by inhibiting squalene epoxidase (squalene monooxygenase), a key enzyme in the fungal ergosterol biosynthesis pathway. This inhibition leads to a deficiency in ergosterol, an essential component of fungal cell membranes, and a toxic accumulation of squalene within the fungal cell, ultimately resulting in cell death. The P-3058 formulation is engineered to enhance the penetration of terbinafine through the nail plate to reach the site of infection in the nail bed. It has been evaluated in Phase 3 clinical trials for the treatment of mild-to-moderate onychomycosis.
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