What Was Approved?
On February 12, 2026, the U.S. Food and Drug Administration approved Adquey (difamilast) 1% ointment for the topical treatment of mild-to-moderate atopic dermatitis in adults and pediatric patients 2 years of age and older.
How Does Adquey Work?
Adquey is a phosphodiesterase 4, or PDE4, inhibitor.
PDE4 is involved in inflammatory signaling. By inhibiting PDE4 in the skin, difamilast is intended to help reduce inflammation associated with atopic dermatitis.
How Is Adquey Used?
Apply a thin layer twice daily to affected areas and rub it in completely.
Adquey is for topical use only.
It should not be used:
- In the eyes
- By mouth
- Intravaginally
Does Adquey Have Any Contraindications?
The FDA-approved prescribing information lists no contraindications.
That does not mean every patient will respond the same way, so treatment should still follow the product label and healthcare professional guidance.
What Are the Common Side Effects?
In clinical trials, the most common adverse reaction occurring in at least 1% of patients was nasopharyngitis, commonly described as cold-like inflammation of the nose and throat.
Other adverse effects may also occur.
Is Adquey a Steroid?
No.
Adquey is not a topical corticosteroid. It is a topical PDE4 inhibitor.
This gives clinicians another nonsteroidal treatment option for eligible patients with mild-to-moderate atopic dermatitis.
Bottom Line
Adquey (difamilast) 1% ointment is a newly FDA-approved topical treatment for mild-to-moderate atopic dermatitis in adults and children age 2 and older.
It is applied twice daily and should be used only on the skin as directed.
Sources
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2026.
- U.S. Food and Drug Administration (FDA) — Adquey (difamilast) Prescribing Information, February 2026.
- U.S. Food and Drug Administration (FDA) — Adquey Labeling Review.