Adquey (difamilast): FDA approval, pivotal trial and safety
Approved
Type
New molecular entity · Topical
FDA-approved use
To treat mild to moderate atopic dermatitisWording from FDA's list of novel approvals.
FDA review
Standard review
Company
Acrotech Biopharma
Application
NDA 219474
Specialty
Dermatology
At a glance
Adquey (difamilast) is a topical phosphodiesterase-4 inhibitor approved by the FDA on February 12, 2026 for mild to moderate atopic dermatitis in adults and children 2 years and older. In three vehicle-controlled trials, more patients reached IGA success at Week 4 with Adquey than with vehicle; the difference was 18 percentage points in Trial 1, 26 in Trial 2 and 29 in Trial 3. There is no boxed warning, and the most common adverse reaction was nasopharyngitis.
What it is and how it works
Difamilast inhibits phosphodiesterase-4, an enzyme that breaks down cyclic AMP. Blocking it raises intracellular cyclic AMP and lowers production of several cytokines and chemokines. The label states that the exact way it works in atopic dermatitis is not well defined. It is a nonsteroidal ointment, so it offers a different mechanism from topical corticosteroids and calcineurin inhibitors.
Multicenter, randomized, double-blind, parallel-group, vehicle-controlled trial in the United States, Australia and Poland. Treatment was applied twice daily for at least 4 weeks. Concomitant atopic dermatitis treatment was prohibited.
Patients
80 patients (43 Adquey, 37 vehicle), aged 10 years and older, with mild (29%) or moderate (71%) atopic dermatitis and 5% to 40% body surface area affected, excluding the face, neck and head. Median age was 30 years.
Compared with
Vehicle ointment
Primary endpoint
IGA success at Week 4, defined as clear or almost clear with at least a 2-grade improvement from baseline.
Result
IGA success was 21% (9 of 43) with Adquey and 3% (1 of 37) with vehicle. The difference was 18% (95% CI 5 to 31).
Other results
Not described in the available label text.
Safety in the trial
Trial 1 was not part of the label's safety pool. Safety was assessed in Trials 2 and 3.
How does Adquey (difamilast) compare with the alternatives (Topical corticosteroids, Topical calcineurin inhibitors (tacrolimus, pimecrolimus), Crisaborole) for mild to moderate atopic dermatitis? Summarize head-to-head and indirect evidence, efficacy, safety and where each fits, with citations.
Two multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials in Japan, with 1:1 randomization. Treatment was applied twice daily for at least 4 weeks. Trial 2 enrolled patients 15 years and older. Trial 3 enrolled children 2 to 14 years.
Patients
Trial 2: 364 patients (182 per arm), median age 30 years, 85% with moderate disease. Trial 3: 168 patients (85 Adquey, 83 vehicle), median age 7 years, 85% with moderate disease. All were Asian, with 5% to 40% body surface area affected, excluding the scalp.
Compared with
Vehicle ointment
Primary endpoint
IGA success at Week 4, defined as clear or almost clear with at least a 2-grade improvement from baseline.
Result
Trial 2: IGA success was 38% (70 of 182) with Adquey and 13% (23 of 182) with vehicle; difference 26% (95% CI 17 to 34). Trial 3: 47% (40 of 85) with Adquey and 18% (15 of 83) with vehicle; difference 29% (95% CI 15 to 42).
Other results
Not described in the available label text.
Safety in the trial
In the pooled safety population of 532 patients (267 Adquey, 265 vehicle), nasopharyngitis occurred in 6% with Adquey and 4% with vehicle. It was the most common adverse reaction at 1% or more.
Adquey has no boxed warning. In the two trials used for the safety assessment (Trials 2 and 3, 532 patients in Japan, 4 weeks of treatment), the only adverse reaction listed in the available label text at 1% or more and more often than with vehicle was nasopharyngitis, in 6% with Adquey and 4% with vehicle. The available label excerpt is cut off after this table, so warnings and less common reactions are not covered here. Safety data come from short, vehicle-controlled trials, and rates may differ in practice. Clinicians should check the full label for warnings and precautions.
What it competes with
Mild to moderate atopic dermatitis is treated with emollients and skin care plus topical anti-inflammatory therapy. Choice depends on the patient's age, the body site and how long treatment is needed.
Topical corticosteroidsLong-standing first-line anti-inflammatory therapy for flares. Potency is matched to age and body site, and prolonged use on thin skin needs care.
Topical calcineurin inhibitors (tacrolimus, pimecrolimus)Nonsteroidal options often used on the face and skin folds or for steroid-sparing. Application-site burning is a common complaint.
CrisaboroleAnother topical PDE-4 inhibitor approved for mild to moderate atopic dermatitis. It is nonsteroidal.
Ruxolitinib creamA topical JAK inhibitor for mild to moderate disease. Its label carries class safety warnings.
Emollients and skin careBase of all treatment to restore the skin barrier and reduce flares. Used alongside drug therapy.
Bottom line for clinicians
Adquey is a nonsteroidal topical option for patients 2 years and older with mild to moderate atopic dermatitis. Consider it when a topical steroid or calcineurin inhibitor is unsuitable or undesirable. Weigh that the pivotal data are 4-week, vehicle-controlled results, that Trial 1 was small, that two of the three trials were run only in Japan, and that there are no head-to-head comparisons with other topical agents in these sources.
Dosing, contraindications and full warnings are in the prescribing information.
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Last updated October 28, 2026 by 2 Minute Medicine.
For healthcare professionals. A summary of public FDA documents and published trials, not medical advice. Check the full prescribing information before prescribing.
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