Treats mild to moderate atopic dermatitis. Sold as Adquey. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Difamilast (sold as Adquey), first approved Feb 12, 2026, with 0 new uses approved and 0 published complete response letters.
| A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic DermatitisAtopic Dermatitis (AD) · Otsuka Pharmaceutical Co., Ltd. | Phase 3 | Not yet recruiting | Sep 22, 2025 |
| A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic DermatitisAtopic Dermatitis (AD) · Otsuka Pharmaceutical Co., Ltd. | Phase 3 | Not yet recruiting | Sep 15, 2025 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Feb 12, 2026 | AdqueyNDA 219474 · New molecular entity | Acrotech Biopharma | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
