BB2603-10

BB2603-10 is a topical nano-formulation of terbinafine hydrochloride, developed for the treatment of onychomycosis (fungal nail infection). It utilizes a proprietary nano-delivery platform to enhance penetration through the nail and deliver terbinafine directly to the site of infection. The formulation includes polyhexamethylene biguanide (PHMB) as an excipient to improve solubility and drug delivery. Administered as a cutaneous spray, BB2603-10 allows for shorter treatment durations (three months) compared to other topical agents (~11 months), while maintaining high efficacy and minimizing systemic exposure. In Phase 2b clinical trials, BB2603-10 demonstrated significant efficacy in achieving negative fungal cultures and mycological cure rates with an excellent safety profile—no drug-related adverse events or detectable systemic exposure were observed[1][6][2]. The product is being developed by Blueberry Therapeutics primarily for onychomycosis but may also have potential in other superficial fungal infections such as tinea pedis[4][2].