Chemistry:Difamilast
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| Trade names | Moizerto, others |
| Other names | OPA-15406 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a626032 |
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| Routes of administration | Topical |
| Drug class | PDE4 inhibitor, dermatologic agent |
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| Formula | C23H24F2N2O5 |
| Molar mass | 446.451 g·mol−1 |
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Difamilast, sold under the brand name Moizerto among others, is a medication used for the treatment of atopic dermatitis.[1] Difamilast is a non-steroidal topical phosphodiesterase 4 (PDE4) inhibitor.[1] Difamilast was discovered and developed by Otsuka Pharmaceutical.[2][3][4][5]
Difamilast was approved for medical use in Japan in September 2021,[2] and in the United States in February 2026.[3][6]
Medical uses
Difamilast is indicated for the topical treatment of people with mild to moderate atopic dermatitis.[1]
Society and culture
Legal status
Difamilast was approved for medical use in Japan in September 2021,[2] and in the United States in February 2026.[3]
Names
Difamilast is the international nonproprietary name.[7]
Difamilast is sold under the brand names Moizerto (JP)[2] and Adquey (US).[3]
References
- ↑ 1.0 1.1 1.2 1.3 "Adquey- difamilast ointment". 25 February 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=46c95e41-fa29-4e11-9d94-0fd4f0291c34.
- ↑ 2.0 2.1 2.2 2.3 2.4 "Otsuka's Moizerto Ointment Granted Approval in Japan as a Treatment for Atopic Dermatitis". Otsuka Pharmaceutical (Press release). 27 September 2021. Archived from the original on 9 December 2025. Retrieved 15 February 2026.
- ↑ 3.0 3.1 3.2 3.3 "Acrotech Biopharma Inc., Announces FDA Approval of Adquey (difamilast 1%) Ointment for the Treatment of Mild-to-Moderate Atopic Dermatitis" (PDF) (Press release). Aurobindo Pharma. 13 February 2026. Retrieved 15 February 2026.
- ↑ "Clinical efficacy and safety of topical difamilast in the treatment of patients with atopic dermatitis: a systematic review and meta-analysis of randomized controlled trials". Expert Review of Clinical Pharmacology 15 (12): 1471–1478. December 2022. doi:10.1080/17512433.2022.2134114. PMID 36210241.
- ↑ "Difamilast for the treatment of atopic dermatitis". The Journal of International Medical Research 51 (6). June 2023. doi:10.1177/03000605231169445. PMID 37389929.
- ↑ "Novel Drug Approvals for 2026". 13 February 2026. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80". WHO Drug Information 32 (3). 2018.
External links
- Clinical trial number NCT02068352 for "A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis" at ClinicalTrials.gov
- Clinical trial number NCT03908970 for "Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic Dermatitis Syndrome" at ClinicalTrials.gov
- Clinical trial number NCT03911401 for "Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis" at ClinicalTrials.gov
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