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On February 12, 2026, the FDA approved Adquey (difamilast 1%) ointment from Acrotech Biopharma for the topical treatment of mild to moderate atopic dermatitis in adults and pediatric patients aged 2 years and older.
The commercial question centers on where difamilast can earn durable share against entrenched topicals. Mechanistically, difamilast is a nonsteroidal topical phosphodiesterase-4 (PDE4) inhibitor; Acrotech emphasizes activity across all PDE4 subtypes, aiming to suppress inflammatory signaling without steroid-associated adverse skin effects that drive cycling and patient reluctance to use on sensitive areas.
Clinical support comes from multiple pivotal Phase 3 vehicle-controlled trials showing a higher proportion of Investigator’s Global Assessment (IGA) success versus vehicle at four weeks. Reported tolerability was clean, with nasopharyngitis as the most common adverse reaction (≥1% and above vehicle).
In the adult Phase 3 trial, week 4 IGA success (IGA 0/1 with ≥2-grade improvement) was 38.46% with difamilast 1% versus 12.64% with vehicle (P<0.0001). In the pediatric Phase 3 trial (ages 2–14), week 4 IGA success was 47.1% with difamilast 1% versus 18.1% with vehicle (P<0.001).
Strategically, Adquey’s value will be set by formulary access, physician switching from existing nonsteroidals, and the breadth of use enabled by a label allowing use for pediatric patient usage.
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