P-3058 (terbinafine)

P-3058 is a topical 10% nail solution of terbinafine developed by Polichem (a subsidiary of Almirall) for the treatment of onychomycosis. The formulation utilizes a proprietary hydroxypropyl chitosan (HPCH) film-forming technology designed to enhance the delivery of the active antifungal agent through the nail plate. Terbinafine is an allylamine antifungal that inhibits squalene epoxidase, an enzyme essential for fungal sterol biosynthesis. This inhibition leads to a deficiency in ergosterol and an accumulation of squalene, resulting in fungal cell death. P-3058 was developed as a topical alternative to oral terbinafine to provide effective treatment for fungal nail infections while minimizing systemic exposure and associated risks, such as hepatotoxicity and drug-drug interactions. It has been evaluated in Phase 3 clinical trials for patients with mild-to-moderate onychomycosis.

Other names

terbinafine 10% nail solutionP-3058 10% nail solution