Hallux Inc. is innovating in the treatment of onychomycosis through its development of Hallux Subungual Gel (HSG), a novel topical formulation of terbinafine. This gel is specifically designed to be applied directly onto the nail bed by a physician, utilizing the subungual space—a small air gap at the free edge of the toenail. This unique delivery method aims to effectively reach the infection sites beneath the nail, addressing a significant limitation of existing topical antifungal treatments that have struggled to achieve adequate therapeutic concentrations to eradicate fungal pathogens. HSG is currently undergoing a phase 2a clinical study to evaluate its efficacy, safety, and pharmacokinetics, with the potential for further well-controlled studies pending positive results.

The company recognizes the challenges faced by patients with onychomycosis, particularly the limitations of current treatment options, which often involve lengthy self-administration and systemic side effects. Hallux aims to provide a clinically proven, safe, and effective alternative that can be administered by healthcare professionals, thereby improving patient adherence and outcomes. With over eight million patients seeking treatment annually, Hallux's approach could significantly enhance the management of this common and often distressing nail disorder, offering a more accessible and reliable solution compared to existing therapies.

United States

Hallux Inc is an innovative specialty pharmaceutical company focused on developing safe and highly effective breakthrough solutions for common foot and nail conditions. They are currently investigating Hallux Subungual Gel (HSG), a new terbinafine topical product and treatment approach for onychomycosis involving periodic subungual application.

Hallux

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