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HTS-519 is a subungual insert device developed for the treatment of mild to moderate onychomycosis (toenail fungus), specifically targeting the big toenail. The device delivers terbinafine, a well-established antifungal agent, directly to the site of infection in the toenail bed. This localized delivery aims to maximize antifungal efficacy while minimizing systemic side effects associated with oral terbinafine therapy. The product has been evaluated in open-label phase 2 clinical trials and is not yet approved for marketing[1][2][3][5]. Hallux is developing this novel drug-device combination as an alternative to oral and topical therapies for onychomycosis.
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