Drug intelligence / Profile preview

terbinafine hydrochloride patch

Development stage
Phase 2
Lead developer
Hisamitsu Pharmaceutical
Modality
Small Molecules
Administration
Transdermal, Topical
01

Overview

HTU-520 is a transdermal patch formulation containing terbinafine hydrochloride, developed for the treatment of tinea unguium (onychomycosis), a fungal infection of the nails. The drug leverages the patch modality to deliver high concentrations of terbinafine directly into the nail plate, aiming to improve efficacy and safety compared to oral or topical formulations. Terbinafine acts as an antifungal agent by inhibiting squalene monooxygenase in fungi, disrupting ergosterol synthesis and compromising fungal cell membrane integrity. The product was developed by Hisamitsu Pharmaceutical and underwent Phase II and III clinical trials in Japan and the United States but did not achieve expected efficacy endpoints in late-stage studies[1][2][3][6][8].

Other names
HTU-520HTU520HTU 520terbinafine transdermalterbinafine-hydrochloride-patch
02

Targets

SQLE (Squalene monooxygenase)

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