Difamilast

(Adquey®)

Difamilast

Drug updated on 3/11/2026

Dosage FormTopical (ointment; 1%)
Drug ClassPhosphodiesterase 4 inhibitor
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis.

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Summary
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  • This summary is based on the review of four systematic reviews/meta-analyses. [1-4]
  • Adquey (difamilast) is indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis.
  • In patients with mild-to-moderate atopic dermatitis, difamilast 0.3% and 1% improved Eczema Area and Severity Index (EASI) scores; compared with vehicle, difamilast was associated with a significant decrease in day 28 EASI scores (mean difference [MD], -4.10; 95% confidence interval [CI]: -5.32 to -2.87).
  • Difamilast 1% improved Investigator Global Assessment (IGA) score success rates; compared with vehicle, difamilast was associated with a significantly higher success rate according to the IGA score at week 4 (relative risk, 2.82; 95% CI: 2.11–3.77).
  • Difamilast was associated with decreases in verbal rating scale scores (MD, -0.51; 95% CI: -0.71 to -0.32), visual analog scale scores (MD, -12.15; 95% CI: -19.70 to -4.61), patient-oriented eczema measure values (MD, -3.99; 95% CI: -4.91 to -3.07), and total affected body surface area (MD, -6.48; 95% CI: -8.09 to -4.87).
  • Difamilast showed no statistically significant difference in the incidence of serious adverse events compared to placebo or other comparators, and no difference in treatment-related adverse events compared with the vehicle.
  • Difamilast 1% BID showed a significantly lower incidence of acne than delgocitinib 0.3% BID, and local adverse effects such as application-site reactions were not significantly different compared to placebo or other comparators.
  • Studies included patients with mild-to-moderate atopic dermatitis, predominantly adults, with some studies limited to children aged under 12 years; participants included both male and female individuals across multiple ethnic groups but were predominantly white. The studies reported no specific findings relevant to differences in effectiveness or safety among population types or subgroups.