New Topical PDE4 Inhibitor Gets Green Light From FDA

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Source: MedPage Today

Original: https://www.medpagetoday.com/dermatology/atopy/119913...

Published: Tue, 17 Feb 2026 13:29:17 -0500

The FDA has approved a new topical medication, difamilast (Adquey), for the treatment of mild to moderate atopic dermatitis (AD) in adults and children 2 years of age and older[1]. Difamilast is an inhibitor of phosphodiesterase 4 (PDE4), an enzyme involved in inflammatory processes[3]. The drug acts by suppressing the formation of inflammatory mediators and has antipruritic (against itching) and anti-inflammatory properties with a rapid onset of action[5]. In phase 3 clinical trials, difamilast was shown to be effective and well tolerated in AD patients, with statistically significant differences compared to placebo[3]. The safety profile was favorable with a low incidence of adverse effects, with only 16 patients experiencing mild side effects such as transient burning and stinging[6]. Difamilast represents a new alternative to standard treatments, which often contain corticosteroids and calcineurin inhibitors[6]. In Japan, difamilast was already approved in 2021 as the first PDE4 inhibitor for the treatment of AD[5].