FDA

FDA approves Adquey for mild-to-moderate atopic dermatitis

February 20, 2026

Brand name: Adquey

Generic name: difamilast

Manufacturer: Acrotech Biopharma Inc.

Approval date: February 12, 2026

FDA approved Adquey (difamilast), a non-steroidal, topical phosphodiesterase 4 (PDE4) inhibitor, for the treatment of mild-to-moderate atopic dermatitis (AD) in adults and pediatric patients aged 2 years and older.

Efficacy

Efficacy was assessed in three randomized, double-blind, placebo-controlled studies (NCT02068352, NCT03908970, and NCT03911401) in patients ≥2 years old with mild or moderate atopic dermatitis and affected body surface area ≥5% and ≤40%. Subjects were randomized 1:1 to receive Adquey or placebo ointment, applied topically to the entire treatment area twice daily for at least 4 weeks. The primary efficacy endpoint for all trials was the proportion of subjects who achieved Investigator’s Global Assessment (IGA) success, defined as an IGA grade of clear (0) or almost clear (1) and with a 2-grade or greater improvement from baseline, at week 4. A significantly greater proportion of Adquey‑treated patients achieved IGA success vs. placebo after 4 weeks' of treatment.

Safety

The most common adverse reaction (≥1% and greater than placebo) in the trials was nasopharyngitis. Less common (<1%) adverse reactions included application site folliculitis, contact dermatitis, application site rash, and molluscum contagiosum.

Recommended dose

Adquey (1% ointment) is applied topically twice daily to affected areas.

Sources:

Adquey (difamilast) [package insert]. Acrotech Biopharma, Inc. https://adquey.com/difamilast(ADQUEY)PI-02.2026.pdf Revised February 2026. Accessed February 19, 2026.

Acrotech Biopharma Inc. Announces FDA Approval of ADQUEYTM (difamilast 1%) Ointment for the Treatment of Mild-to-Moderate Atopic Dermatitis [News release]. 2026. https://www.aurobindo.com/api/uploads/corporateannouncements/Adquey-(Difamilast)_NDA%20Approval_PressRelease_13-Feb-26.pdf