On February 12, 2026, the FDA approved Adquey (difamilast), a new topical phosphodiesterase 4 (PDE4) inhibitor for the treatment of mild-to-moderate atopic dermatitis (eczema) in patients aged 2 years and older. Developed by Japan Tobacco / Torii Pharmaceutical, Adquey has been available in Japan since 2021 under the brand name Moizerto, and its U.S. approval adds another non-steroidal option to the growing arsenal of eczema treatments.
What Is Adquey?
Adquey is the brand name for difamilast, a topical cream that works by inhibiting the enzyme phosphodiesterase 4 (PDE4). PDE4 is responsible for breaking down cyclic adenosine monophosphate (cAMP) inside inflammatory cells. By blocking PDE4, difamilast increases intracellular cAMP levels, which in turn suppresses the production of pro-inflammatory cytokines — the chemical signals that drive the redness, itching, and scaling of eczema.
Difamilast is a second-generation PDE4 inhibitor and is structurally distinct from crisaborole (Eucrisa), the first topical PDE4 inhibitor approved for eczema in the U.S. In preclinical studies, difamilast demonstrated greater PDE4 selectivity and potency compared to crisaborole, though head-to-head clinical trials have not been conducted.
FDA Approval Details
Indication
Topical treatment of mild-to-moderate atopic dermatitis in patients aged 2 years and older.
Formulations
- Adquey 1% cream — for patients aged 12 years and older
- Adquey 0.3% cream — for pediatric patients aged 2 to 11 years
Dosing
Apply a thin layer to affected areas twice daily. Not for use on open wounds or mucosal surfaces.
Approval Date
February 12, 2026
Clinical Trial Results
The FDA approval was based on two pivotal Phase 3 randomized, vehicle-controlled trials enrolling over 800 patients with mild-to-moderate atopic dermatitis.
Key Efficacy Endpoints
| Endpoint (Week 4) | Adquey 1% | Vehicle (placebo) |
|---|---|---|
| IGA Success (clear/almost clear + ≥2-grade improvement) | 38.3% | 15.7% |
| EASI-50 (50% improvement in eczema severity) | 58.4% | 32.1% |
| Itch reduction (≥4-point NRS improvement) | 34.2% | 18.5% |
At week 4, nearly 40% of patients on Adquey 1% achieved treatment success (clear or almost clear skin), more than double the vehicle group. Itch improvement was rapid, with significant differences from vehicle observed as early as week 1.
Pediatric Data
In children aged 2–11 using the 0.3% formulation, efficacy was similar, with IGA success rates of approximately 33% at week 4. The lower concentration was well tolerated in this population.
How Adquey Compares to Other Non-Steroidal Topicals
| Medication | Mechanism | Approved For | Age Range | Dosing | Notable Side Effects |
|---|---|---|---|---|---|
| Adquey (difamilast) | PDE4 inhibitor | Mild-moderate AD | ≥2 years | Twice daily | Mild application site reactions |
| Eucrisa (crisaborole) | PDE4 inhibitor | Mild-moderate AD | ≥3 months | Twice daily | Application site pain/stinging (common) |
| Vtama (tapinarof) | AhR agonist | Mild-moderate AD (adults) | ≥18 years | Once daily | Folliculitis (common) |
| Zoryve (roflumilast) | PDE4 inhibitor | Mild-moderate AD | ≥6 years | Once daily | Application site reactions |
| Protopic (tacrolimus) | Calcineurin inhibitor | Moderate-severe AD | ≥2 years | Twice daily | Burning/stinging, FDA boxed warning |
| Elidel (pimecrolimus) | Calcineurin inhibitor | Mild-moderate AD | ≥2 years | Twice daily | Burning, FDA boxed warning |
Key Differentiators
Adquey vs. Eucrisa: The most direct comparison. Both are topical PDE4 inhibitors applied twice daily. Eucrisa is notorious for causing application site stinging and burning — a side effect reported in approximately 29% of patients in clinical trials, which has limited its real-world uptake. Adquey has a markedly lower rate of application site pain (under 5% in trials), making it better tolerated. This alone may make Adquey the preferred PDE4 option for many patients, particularly children.
Adquey vs. Zoryve: Zoryve (roflumilast) is also a PDE4 inhibitor but has the advantage of once-daily dosing. Adquey requires twice-daily application. However, Adquey's approval for patients as young as 2 years old (compared to Zoryve's approval for ages 6+) gives it a wider pediatric indication.
Adquey vs. Vtama: Vtama (tapinarof) uses a different mechanism entirely (aryl hydrocarbon receptor agonism) and is currently only approved for adults. Its once-daily dosing and non-PDE4 mechanism make it complementary rather than directly competitive with Adquey.
Side Effects and Safety
In clinical trials, Adquey was well tolerated. The most common adverse events included:
- Application site reactions (4.3% vs 2.1% vehicle) — primarily mild erythema or irritation
- Nasopharyngitis (2.8%)
- Upper respiratory tract infection (1.9%)
Importantly, the rate of application site pain or stinging — the side effect that plagued Eucrisa — was very low with Adquey, occurring at rates comparable to vehicle. This is a clinically meaningful advantage for patient compliance, especially in pediatric patients who may resist applying a medication that stings.
No systemic safety signals, laboratory abnormalities, or immunosuppression concerns were identified. Adquey does not carry a boxed warning, unlike the calcineurin inhibitors tacrolimus and pimecrolimus.
Cost and Insurance Coverage
Pricing for Adquey has not been officially confirmed at the time of writing, but based on the topical dermatology market, the estimated wholesale acquisition cost is expected to fall in the $600–$900 per tube range, similar to Eucrisa and Zoryve. Manufacturer copay assistance programs are expected to reduce commercially insured patient costs to $0–$35 per prescription.
Insurance coverage decisions are ongoing. Payers may require prior authorization or step therapy (trial and failure of topical corticosteroids) before approving Adquey, consistent with policies for other non-steroidal topicals.
Who Should Consider Adquey?
Adquey is best suited for:
- Patients with mild-to-moderate eczema seeking a non-steroidal alternative
- Patients who experienced stinging or burning with Eucrisa and want a better-tolerated PDE4 option
- Pediatric patients aged 2–5 who are too young for Zoryve (approved for ages 6+) or Vtama (adults only)
- Patients who prefer to avoid calcineurin inhibitors (Protopic, Elidel) due to boxed warning concerns
- Patients using topical steroids who want a steroid-sparing maintenance option for sensitive areas (face, skin folds)
The Bottom Line
Adquey adds a welcome new option to the non-steroidal topical treatment landscape for eczema. It does not revolutionize atopic dermatitis management — the efficacy is in line with other non-steroidal topicals, not with systemic therapies — but its improved tolerability profile compared to Eucrisa and its approval for patients as young as 2 make it a practical and well-positioned alternative. For patients and parents frustrated by stinging creams and steroid fears, Adquey offers a gentler path.
Use the MedSwitcher comparison tool to compare Adquey with other eczema treatments side-by-side.
Sources
- FDA Press Release: Approval of Adquey (difamilast), February 12, 2026.
- Japan Tobacco / Torii Pharmaceutical Phase 3 trial publications.
- Eucrisa, Zoryve, Vtama, Protopic, and Elidel prescribing information.
- MedSwitcher editorial analysis, April 2026.