New Prescription Ointment for Mild-to-Moderate Eczema Ages 2 and Up

Adquey (difamilast) ointment, 1%, is a prescription topical phosphodiesterase-4 (PDE4) inhibitor. On 12 February 2026, FDA approved NDA 219474 for topical treatment of mild to moderate atopic dermatitis in adults and pediatric patients 2 years of age and older. Prescribing Information issued 02/2026 (DailyMed SPL setid 46c95e41-fa29-4e11-9d94-0fd4f0291c34, published 25 Aug 2026 update retrieved for this draft).

Distinct path — not this carton door (fact-only): Everyday moisturisers, topical corticosteroids, calcineurin inhibitors, and injectable or oral medicines for moderate-to-severe atopic dermatitis are not this labelled Adquey ointment door. Crisaborole topical ointment is another US-labelled PDE4 cream/ointment for mild-to-moderate AD — a different active ingredient and brand. Japanese Moizerto (difamilast, Otsuka) is a Japan carton. Compounded PDE4 products are not this NDA. Today’s US labelled Adquey door is Acrotech Biopharma Inc. NDA 219474 difamilast 1% ointment.

Manufactured for: Acrotech Biopharma Inc., East Windsor, NJ 08520 USA (USPI / DailyMed). Label note: (Made in Canada) on the Patient Information block — that is a manufacturing statement, not Health Canada marketing authorisation for Adquey.

Where this is taking place

Commercial labelled door today: United States — FDA-labelled Adquey ointment for mild to moderate atopic dermatitis, ages 2+, thin layer twice daily to affected areas. Suspected adverse reactions: Acrotech Biopharma Inc. 1-888-292-9617 or FDA MedWatch 1-800-FDA-1088 / www.fda.gov/medwatch. This is a dermatology / paediatric eczema prescription conversation — not a DIY import and not an over-the-counter moisturiser.

Outside the United States: Japan — difamilast is marketed as Moizerto ointment (Otsuka) after Japanese approval announced 27 September 2021 for atopic dermatitis in patients 2 years and older. Health Canada / EMA/EC / MHRA / TGA / Swissmedic: Adquey brand authorisation not confirmed on sources used here. Do not import on your own. A US or Japanese tube is not automatically your country’s carton.

Pivotal evidence programmes (USPI §14 + CT.gov):

• Trial 1 — NCT02068352 — Phase 2 multinational (US / Australia / Poland); ages 10+; COMPLETED; sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
• Trial 2 — NCT03908970 — Phase 3 Japan adults (15–70); COMPLETED; sponsor Otsuka Pharmaceutical Co., Ltd.
• Trial 3 — NCT03911401 — Phase 3 Japan children 2–14; COMPLETED; sponsor Otsuka Pharmaceutical Co., Ltd.

Honesty: These pivotal records are COMPLETED — they are not walk-in research enrolment for commercial Adquey. Labelled access in the US is through a prescribing clinician and pharmacy supply of the Acrotech carton.

Approval matrix

Access by country

• United States: Ask a dermatologist, paediatrician, or primary clinician who manages eczema about labelled Adquey for mild to moderate atopic dermatitis if you (or your child 2+) may be a fit. Path: confirm diagnosis and severity → review other topicals already tried → prescribe Adquey BID → pharmacy fills 27 g or 85 g tube → reassess response and skin care plan. AE: 1-888-292-9617. No list price or copay dollars in this article. This is US labelled pharmacy supply, not a DIY import.

• Canada: Adquey authorisation not confirmed. Ask the Canadian clinic what legal paths exist in Canada when a Canadian Adquey label does not yet exist. Do not import on your own.

• Japan: Ask the local dermatology clinic about labelled Moizerto (difamilast) under Japanese rules — separate from US Adquey branding and US pharmacy supply.

• European Union / United Kingdom / Australia / other countries: Confirm your local regulator’s current status with the treating centre. Do not import on your own.

• If your regulator has not authorised it: do not import on your own. Ask the local clinician about documented special-access / named-patient rules, referral to a centre in a labelled country, or waiting.

Who is eligible (from FDA USPI)

This is a prescription topical conversation — not established as labelled for every severity of eczema.

United States (USPI 02/2026):

• Indication: Topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis.
• Regimen: Thin layer twice daily to affected areas; rub in completely; wash hands after application; avoid applying to infected skin; topical use only (not ophthalmic, oral, or intravaginal).
• Contraindications: None listed in USPI §4.
• Most common adverse reaction (≥1% and greater than vehicle) in Trials 2+3: nasopharyngitis 6% (16/267) vs 4% (10/265) vehicle.
• Less common (<1%) in Trials 2+3: application-site folliculitis, contact dermatitis, application-site rash, molluscum contagiosum.
• Open-label continuation: application-site reactions that led to discontinuation included pain, pruritus, vesicles, blistering, erythema, burning, contact dermatitis.
• Pediatrics: Established 2 years and older; not established under age 2 (PREA study deferred for 3 months–<2 years).
• Pregnancy / lactation: Human data insufficient; breastfeeding — avoid applying directly to nipple/areola; avoid infant contact with treated skin.
• Geriatrics: Too few subjects ≥65 in trials to determine difference from younger adults.

Not labelled on sources confirmed for this draft:

• Severe atopic dermatitis as the US labelled population (sentence is mild to moderate).
• Children younger than 2 years.
• Canadian or EU Adquey marketing authorisation (not confirmed here).
• Treating COMPLETED research records as open commercial trial recruitment.

How to access (United States)

1. Confirm mild to moderate atopic dermatitis with a clinician who manages eczema (dermatology or paediatric / primary care as appropriate).
2. Ask whether Adquey (difamilast) 1% ointment is a fit versus moisturisers, steroids, calcineurin inhibitors, or other non-steroid topicals already in use.
3. If prescribed, apply a thin layer twice daily only to affected skin; keep away from eyes/mouth/vagina; wash hands after use.
4. Plan follow-up for response, skin infection checks, and whether another labelled path is needed if disease is more severe than “mild to moderate.”
5. Pharmacies order labelled tubes (NDC 72893-017-08 27 g; 72893-017-09 85 g).
6. Authorised is not funded — insurance, prior authorisation, and out-of-pocket paths vary; no prices in this article.

Evidence snapshot (labelled pivotal)

USPI Table 2 — IGA success at Week 4 (IGA 0 or 1 with ≥2-grade improvement; missing = failure):

Design notes (USPI §14): IGA mild (2) or moderate (3) at baseline; affected BSA roughly 5–40% (face/neck/head exclusions differ by trial); concomitant AD treatment prohibited in the controlled periods; twice-daily application for ≥4 weeks.

CT.gov named status: all three pivotal IDs COMPLETED (retrieved 22 Sep 2026). Not walk-in enrolment.

How to talk with a doctor

Bring this page and ask a dermatologist / paediatric clinician:

1. “I (or my child 2+) have mild to moderate atopic dermatitis. Is labelled US Adquey a fit?”
2. “How does Adquey compare with moisturisers, topical steroids, or other non-steroid ointments we have already used?”
3. “What does twice-daily application look like on the areas we would treat, and when should we reassess?”
4. “If this is more than mild-to-moderate disease, what labelled options are appropriate instead?”
5. If outside the US: “Has our regulator authorised difamilast / Adquey, or what legal special-access options exist?”

Who is involved (from primary sources)

• US NDA applicant / manufactured for: Acrotech Biopharma Inc., East Windsor, NJ 08520 USA (approval letter; USPI / DailyMed).
• FDA signatory (approval letter): Nikolay P. Nikolov, MD, Director, Office of Immunology and Inflammation, Office of New Drugs, CDER (12 Feb 2026).
• Letter addressee: Ashish Anvekar, President, Acrotech Biopharma Inc., 279 Princeton Hightstown Road, East Windsor, NJ 08520.
• Development / pivotal sponsors (CT.gov): Otsuka Pharmaceutical Development & Commercialization, Inc. (NCT02068352); Otsuka Pharmaceutical Co., Ltd. (NCT03908970, NCT03911401).
• Japan marketed brand (separate carton): Moizerto (difamilast) — Otsuka Pharmaceutical Co., Ltd. (company approval announcement 27 Sep 2021).
• AE contact (US label): Acrotech Biopharma Inc. 1-888-292-9617; FDA MedWatch 1-800-FDA-1088.

Primary sources

1. FDA approval letter — NDA 219474 — PDF (signed 12 Feb 2026).
2. FDA Prescribing Information — label PDF / DailyMed setid 46c95e41-fa29-4e11-9d94-0fd4f0291c34.
3. ClinicalTrials.gov — NCT02068352, NCT03908970, NCT03911401.
4. FDA Novel Drug Approvals 2026 table — Adquey / difamilast listed as novel approval #2 (12 Feb 2026).
5. Otsuka Pharmaceutical — Moizerto ointment Japan approval news release (27 Sep 2021).

Not medical advice. Status: Unpublished. Do not publish.