ADQUEY Difamilast 10 mg/g Ointment — NDC 72893-017-08 (Billing 72893-0017-08)
This is a package of ADQUEY Difamilast 10 mg/g Ointment from Acrotech Biopharma Inc, marketed since Feb 2026 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 72893-017-08 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 72893 labeler · 017 product · 08 package
- Package marketed since
- Feb 25, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0372893017091, 0372893017084
- FDA record last changed
- Sep 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 2738419
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 9, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 72893-0017-07 72893-017-07 Main listing | 1 TUBE in 1 CARTON / 3 g in 1 TUBE | 2026-02-25 | — | Active |
| 72893-0017-08 You're viewing this | 1 TUBE in 1 CARTON / 27 g in 1 TUBE | 2026-02-25 | — | Active |
| 72893-0017-09 72893-017-09 | 1 TUBE in 1 CARTON / 85 g in 1 TUBE | 2026-02-25 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of ADQUEY Difamilast 10 mg/g Ointment?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Adquey 10 mg/gthis 72893-0017-08 | Acrotech | 1 tube | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US RE46792 ↗ | Drug substance | U-4445 | Mar 1, 2028 |
| US 10588893 ↗ | Drug substance | — | Dec 31, 2036 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | Feb 12, 2031 |
Is there a generic version of this drug?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
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UNII I9O0E3H2ZE
Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
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UNII 8D08K3S51E
Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
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UNII B6E5W8RQJ4
White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.
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UNII 7G1J5DA97F
White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Acrotech Biopharma Inc labeler code 72893
- Beleodaq Belinostat 500 mg/10mL Injection, Powder, Lyophilized, For Solution NDC 72893-002-01
- Folotyn pralatrexate 20 mg/mL Injection NDC 72893-003-01
- KHAPZORY levoleucovorin 175 mg/3.5mL Injection, Powder, Lyophilized, For Solution NDC 72893-004-01
- Folotyn pralatrexate 40 mg/2mL Injection NDC 72893-005-01
- Zevalin ibritumomab tiuxetan Kit NDC 72893-007-04
- RYZNEUTA efbemalenograstim alfa-vuxw 20 mg/mL Injection NDC 72893-016-02
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE ADQUEY is indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis. ADQUEY is a phosphodiesterase 4 inhibitor indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis. (1)
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION ADQUEY is for topical use only and not for ophthalmic, oral, or intravaginal use. Apply a thin layer of ADQUEY twice daily to affected areas and rub in completely. Wash hands after application. Avoid areas of the skin that are infected when applying ADQUEY. For topical use only. Not for ophthalmic, oral, or intravaginal use. (2) Apply a thin layer of ADQUEY twice daily to affected areas and rub in completely. (2)
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Ointment: 1% (10 mg of difamilast per gram) of white to off-white ointment. Ointment: 1%. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. (4)
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reaction occurring in ≥1% of subjects is nasopharyngitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc. at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ADQUEY was assessed in two double-blind, vehicle-controlled clinical trials (Trial 2 and Trial 3) that enrolled 532 adult and pediatric subjects 2 years of age and older in Japan with mild to moderate atopic dermatitis (AD).
Subjects applied ADQUEY or vehicle ointment topically twice daily for 4 weeks [ see Clinical Studies (14) ]. Adverse reactions reported by ≥1% of ADQUEY-treated subjects and more frequently than in subjects receiving vehicle are listed in Table 1. Table 1: Adverse Reactions Occurring in ≥1% of Adult and Pediatric Subjects 2 Years of Age and Older Treated with ADQUEY for Mild to Moderate Atopic Dermatitis (and Greater than Vehicle) through Week 4 in Trials 2 and 3 Adverse Reaction ADQUEY (N=267) n (%) Vehicle (N=265) n (%) Nasopharyngitis 16(6) 10(4) Less common (<1%) adverse reactions in subjects treated with ADQUEY in Trials 2 and 3 included application site folliculitis, contact dermatitis, application site rash, and molluscum contagiosum.
In Trial 1, a vehicle-controlled dose ranging trial, 43 subjects 10 years of age and older in the United States, Australia, and Poland received ADQUEY topically twice daily for 8 weeks and the safety profile was consistent with Trials 2 and 3. In two additional vehicle-controlled dose ranging trials (Trial 4 and Trial 5), 92 subjects 2 years of age and older in Japan received ADQUEY topically twice daily for 4 weeks (Trial 4) and twice daily for 8 weeks (Trial 5) and the safety profile was consistent with Trials 2 and 3.
In open-label trials of both Japanese and United States (US) subjects, 857 adult and pediatric subjects continued twice-daily treatment with ADQUEY for up to 52 weeks. The following application site adverse reactions occurred that led to drug discontinuation: pain, pruritus, vesicles, blistering, erythema, burning and contact dermatitis.
6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of ADQUEY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General disorders and administration site condition : application site swelling.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary The available data on the use of topical difamilast during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, difamilast administered subcutaneously to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities at doses up to 30 and 3 times the maximum recommended human dose (MRHD), respectively. Difamilast induced increased post-implantation loss, decreased fetal weight, retarded ossification and increased visceral abnormalities in rats at subcutaneous dose 263 times the MRHD.
Difamilast induced increased skeletal variations in rabbits at subcutaneous doses 14 times the MRHD ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study, pregnant rats were dosed subcutaneously during the period of organogenesis with up to 100 mg/kg/day difamilast (263 times the MRHD based on AUC comparison). Increased post-implantation loss, decreased fetal weight, retarded ossification, and increased visceral abnormalities (membranous ventricular septum defect) were noted at 100 mg/kg/day (263 times the MRHD based on AUC comparison).
No embryo-fetal toxicity was observed at 10 mg/kg/day (30 times the MRHD based on AUC comparison). In an embryo-fetal development study in rabbits, pregnant does were dosed subcutaneously during the period of organogenesis with up to 3 mg/kg/day difamilast (14 times the MRHD based on AUC comparison). Increased skeletal variations (increased supernumerary lumbar vertebra) were observed at 3 mg/kg/day (14 times the MRHD based on AUC comparison).
No embryo-fetal toxicity was observed at 1 mg/kg/day (3 times the MRHD based on AUC comparison). In a pre- and post-natal development study in rats, dams were dosed subcutaneously with up to 3 mg/kg/day difamilast during the periods of organogenesis and lactation. No treatment-related adverse effects on reproductive functions of dams, or pre- and post-natal development of offspring were observed at 3 mg/kg/day (13 times the MRHD based on AUC comparison).
8.2Lactation Risk Summary There are no data on the presence of difamilast or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Difamilast and/or its metabolites are excreted into the milk of lactating rats ( see Data ). When a drug is present in animal milk, it is likely that the drug will be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ADQUEY and any potential adverse effects on the breastfed infant from ADQUEY or from the underlying maternal condition. Clinical Considerations To minimize potential infant exposure, advise breastfeeding women not to apply ADQUEY directly to the nipple or areola. If applied to the patient's chest, avoid exposure via direct contact with the infant's skin.
Data When 14 C-difamilast was subcutaneously administered to lactating rats at a single dose of 3 mg/kg, the concentration of radioactivity in milk was higher than that in blood (with milk/blood ratios at C max and AUC∞ of 13.7 and 5.4, respectively). The concentration of difamilast in animal milk does not necessarily predict the concentration of drug in human milk.
8.4Pediatric Use The safety and effectiveness of ADQUEY for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 2 years of age and older. Use of ADQUEY in this age group is supported… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The available data on the use of topical difamilast during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, difamilast administered subcutaneously to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities at doses up to 30 and 3 times the maximum recommended human dose (MRHD), respectively. Difamilast induced increased post-implantation loss, decreased fetal weight, retarded ossification and increased visceral abnormalities in rats at subcutaneous dose 263 times the MRHD.
Difamilast induced increased skeletal variations in rabbits at subcutaneous doses 14 times the MRHD ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study, pregnant rats were dosed subcutaneously during the period of organogenesis with up to 100 mg/kg/day difamilast (263 times the MRHD based on AUC comparison). Increased post-implantation loss, decreased fetal weight, retarded ossification, and increased visceral abnormalities (membranous ventricular septum defect) were noted at 100 mg/kg/day (263 times the MRHD based on AUC comparison).
No embryo-fetal toxicity was observed at 10 mg/kg/day (30 times the MRHD based on AUC comparison). In an embryo-fetal development study in rabbits, pregnant does were dosed subcutaneously during the period of organogenesis with up to 3 mg/kg/day difamilast (14 times the MRHD based on AUC comparison). Increased skeletal variations (increased supernumerary lumbar vertebra) were observed at 3 mg/kg/day (14 times the MRHD based on AUC comparison).
No embryo-fetal toxicity was observed at 1 mg/kg/day (3 times the MRHD based on AUC comparison). In a pre- and post-natal development study in rats, dams were dosed subcutaneously with up to 3 mg/kg/day difamilast during the periods of organogenesis and lactation. No treatment-related adverse effects on reproductive functions of dams, or pre- and post-natal development of offspring were observed at 3 mg/kg/day (13 times the MRHD based on AUC comparison).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of ADQUEY for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 2 years of age and older. Use of ADQUEY in this age group is supported by data from five vehicle-controlled trials, which included 236 subjects 2 to less than 17 years of age, of whom 119 received ADQUEY and 117 received vehicle [ see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) and Clinical Studies (14) ]. The safety and effectiveness of ADQUEY have not been established in pediatric patients younger than 2 years of age.
🧓 Geriatric Use ▾
8.5Geriatric Use In clinical trials of ADQUEY in subjects with mild to moderate atopic dermatitis, 2 subjects were 65 years of age or older, and 0 were aged 75 years and older. Clinical trials of ADQUEY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Difamilast is an inhibitor of phosphodiesterase-4 (PDE-4). Difamilast’s inhibition of PDE-4 (a major cyclic adenosine monophosphate (AMP)-metabolizing enzyme) activity leads to accumulation of intracellular cyclic AMP and decreased productions of various cytokines and chemokines. However, the specific mechanism(s) by which difamilast exerts its therapeutic action is not well defined.
12.2Pharmacodynamics The pharmacodynamics of ADQUEY ointment in the treatment of atopic dermatitis is not known. Cardiac Electrophysiology ADQUEY ointment is not expected to cause clinically significant QTc interval prolongation at the recommended dosages.
12.3Pharmacokinetics Absorption The pharmacokinetics (PK) of ADQUEY were investigated in 31 pediatric subjects 2 years of age and older with moderate to severe atopic dermatitis and a mean ± SD body surface area (BSA) involvement of 44 ± 13% (range 25% to 80%). In this trial, subjects applied an average of approximately 4.3 g of ADQUEY ointment, 1% (dose range was 1.7 to 11.7 g per application) twice daily for 2 weeks. Plasma concentrations were quantifiable in all the subjects.
On Day 15, the mean ± SD maximum plasma concentration (C max ) and area under the concentration time curve from 0 to 8 hours post dose (AUC 0-8 ) for difamilast were 16.9 ± 21.9 ng/mL and 86.2 ± 79.6 ng*h/mL, respectively. Systemic concentrations of difamilast were at steady state by Day 15, with no evidence of accumulation. The PK of ADQUEY were investigated in 31 adult subjects with mild to moderate atopic dermatitis and a mean ± SD BSA involvement of 6 ± 3% (range 3% to 19%).
Subjects applied an average of approximately 0.9 g of ADQUEY ointment, 1% (dose range was 0.1 to 3.8 g per application) twice daily for 4 weeks. On Day 29, the mean ± SD C max and AUC 0-12 for difamilast were 0.76 ± 1.16 ng/mL and 6.10 ± 8.85 ng*h/mL, respectively. Distribution Difamilast serum protein binding is 99% and is not concentration-dependent, in vitro.
Elimination Metabolism Difamilast is substantially metabolized to form three major metabolites in the plasma via CYP3A4-mediated O-deethylation (Metabolite 1), CYP1A2-mediated hydroxylation (Metabolite 2), and enzymatic hydrolysis (Metabolite 3). Excretion After both single dosing and twice daily administration of difamilast ointment 1% in healthy Japanese subjects for 2 weeks, difamilast and Metabolite 1 were undetectable in urine. The urinary excretion ratios of all the other metabolites were less than 0.1% of the administered dose.
Specific Populations No dedicated clinical trials have been conducted to assess the impact of intrinsic factors on the PK of difamilast. Based on cross-study analyses, no substantial differences in the PK of difamilast were observed based on age (2-70 years), sex, race, mild or moderate renal impairment, or mild or moderate hepatic impairment. The effect of severe renal impairment (eGFR < 30 mL/min), or severe (Child-Pugh Class C) hepatic impairment on difamilast PK is unknown.
Pediatric Patients The plasma difamilast trough concentration corrected by dose in pediatric patients was 1.3 to 1.9 times higher than that in adults (on Day 1 and Day 15, respectively). Drug Interaction Studies Clinical Studies No clinical drug interaction trials have been conducted with topical difamilast. In Vitro Studies CYP450 Enzymes: Difamilast is a substrate of CYP3A4 and CYP1A2.
Difamilast is not expected to inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 at clinically relevant concentrations. Induction of CYP1A2, CYP2B6, CYP2C9, and CYP3A4 by difamilast is expected to be low at clinically relevant concentrations. Transporter Systems: Difamilast is a substrate of breast cancer resistance protein (BCRP),but is not a substrate of P-glycoprotein (P-gp), OATP1B1, or OATP1B3.
Difamilast is not expected to inhibit P-gp, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, or MATE2-K at clinica… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Difamilast is an inhibitor of phosphodiesterase-4 (PDE-4). Difamilast’s inhibition of PDE-4 (a major cyclic adenosine monophosphate (AMP)-metabolizing enzyme) activity leads to accumulation of intracellular cyclic AMP and decreased productions of various cytokines and chemokines. However, the specific mechanism(s) by which difamilast exerts its therapeutic action is not well defined.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How supplied ADQUEY (difamilast) ointment, 1% is a white to off-white ointment supplied in the following packages: 27 g tube (NDC 72893-017-08) 85 g tube (NDC 72893-017-09) Storage and Handling Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F). [see USP Controlled Room Temperature]. Store away from direct sunlight, heat, and moisture. Keep tube tightly closed.
📋 Description ▾
11 DESCRIPTION ADQUEY (difamilast) ointment contains difamilast as the active ingredient. Difamilast, is a phosphodiesterase-4 (PDE-4) inhibitor. Difamilast is described chemically as N-({2-[4-(Difluoromethoxy)-3-(propan-2-yloxy)phenyl]-1,3-oxazol-4-yl}methyl)-2-ethoxybenzamide.
The empirical formula is C 23 H 24 F 2 N 2 O 5 and the molecular weight is 446.44 g/mol. The structural formula is represented below: Difamilast occurs as white (or practically white) crystals or crystalline powder. It is very soluble in N-methylpyrrolidone, freely soluble in methanol and ethanol (99.5), and practically insoluble in water.
It shows crystal polymorphism. Each gram of ADQUEY contains 1% difamilast (w/w) in a wax-based, white to off-white ointment containing the following inactive ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax. Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients or caregivers to read the FDA-approved patient labeling (Patient Information). Administration Advise patients or caregivers that ADQUEY is for topical use only and is not for ophthalmic, oral, or intravaginal use [see Dosage and Administration (2) ]. Lactation Advise breastfeeding women not to apply ADQUEY directly to the nipple or areola to minimize potential infant exposure.
Instruct patients to avoid inadvertent contact of treated areas with the infant’s skin [see Use in Specific Populations (8.2) ]. (Made in Canada) Manufactured for: Acrotech Biopharma Inc East Windsor, NJ 08520 USA PATIENT INFORMATION ADQUEY TM (ahd kway) (difamilast) ointment, for topical use Important information: ADQUEY is for use on the skin (topical use) only. Do not use ADQUEY near or in your eyes, mouth, or vagina.
What is ADQUEY? ADQUEY is a prescription medicine used on the skin (topical) to treat adults and children 2 years of age and older with mild to moderate atopic dermatitis. It is not known if ADQUEY is safe and effective in children younger than 2 years of age.
Before using ADQUEY, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if ADQUEY will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ADQUEY passes into your breast milk or if it may harm your baby.
Talk to your healthcare provider about the best way to feed your baby during treatment with ADQUEY. Breastfeeding women using ADQUEY should not apply ADQUEY directly to the nipple or areola to avoid contact with your baby. Avoid contact between your baby and any skin areas treated with ADQUEY.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use ADQUEY? Use ADQUEY exactly as your healthcare provider tells you to use it.
Apply a thin layer of ADQUEY to the affected areas 2 times a day. Rub the ointment in completely until you no longer see it on your skin. Avoid applying ADQUEY to areas of the skin that are red, warm, swollen or painful.
Wash your hands after applying ADQUEY. If someone else applies ADQUEY for you, they should wash their hands after applying it. What are the possible side effects of ADQUEY?
The most common side effects of ADQUEY include: pain or swelling in the nose and throat (nasopharyngitis). These are not all of the possible side effects of ADQUEY. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. How should I store ADQUEY? Store ADQUEY at room temperature between 68°F to 77°F (20°C to 25°C).
Store ADQUEY away from direct sunlight, heat and moisture. Keep ADQUEY tube tightly closed after each use. Keep ADQUEY and all medicines out of the reach of children.
General information about the safe and effective use of ADQUEY. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ADQUEY for a condition for which it was not prescribed.
Do not give ADQUEY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ADQUEY that is written for health professionals.
What are the ingredients in ADQUEY? Active ingredient: difamilast Inactive ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax. (Made in Canada) Manufactured for:Acrotech Biopharma Inc, East Windsor, NJ 08520 USA For more information, call 1-888-292-9617 or go to www.ADQUEY.com.
This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 02/2026
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption The pharmacokinetics (PK) of ADQUEY were investigated in 31 pediatric subjects 2 years of age and older with moderate to severe atopic dermatitis and a mean ± SD body surface area (BSA) involvement of 44 ± 13% (range 25% to 80%). In this trial, subjects applied an average of approximately 4.3 g of ADQUEY ointment, 1% (dose range was 1.7 to 11.7 g per application) twice daily for 2 weeks. Plasma concentrations were quantifiable in all the subjects.
On Day 15, the mean ± SD maximum plasma concentration (C max ) and area under the concentration time curve from 0 to 8 hours post dose (AUC 0-8 ) for difamilast were 16.9 ± 21.9 ng/mL and 86.2 ± 79.6 ng*h/mL, respectively. Systemic concentrations of difamilast were at steady state by Day 15, with no evidence of accumulation. The PK of ADQUEY were investigated in 31 adult subjects with mild to moderate atopic dermatitis and a mean ± SD BSA involvement of 6 ± 3% (range 3% to 19%).
Subjects applied an average of approximately 0.9 g of ADQUEY ointment, 1% (dose range was 0.1 to 3.8 g per application) twice daily for 4 weeks. On Day 29, the mean ± SD C max and AUC 0-12 for difamilast were 0.76 ± 1.16 ng/mL and 6.10 ± 8.85 ng*h/mL, respectively. Distribution Difamilast serum protein binding is 99% and is not concentration-dependent, in vitro.
Elimination Metabolism Difamilast is substantially metabolized to form three major metabolites in the plasma via CYP3A4-mediated O-deethylation (Metabolite 1), CYP1A2-mediated hydroxylation (Metabolite 2), and enzymatic hydrolysis (Metabolite 3). Excretion After both single dosing and twice daily administration of difamilast ointment 1% in healthy Japanese subjects for 2 weeks, difamilast and Metabolite 1 were undetectable in urine. The urinary excretion ratios of all the other metabolites were less than 0.1% of the administered dose.
Specific Populations No dedicated clinical trials have been conducted to assess the impact of intrinsic factors on the PK of difamilast. Based on cross-study analyses, no substantial differences in the PK of difamilast were observed based on age (2-70 years), sex, race, mild or moderate renal impairment, or mild or moderate hepatic impairment. The effect of severe renal impairment (eGFR < 30 mL/min), or severe (Child-Pugh Class C) hepatic impairment on difamilast PK is unknown.
Pediatric Patients The plasma difamilast trough concentration corrected by dose in pediatric patients was 1.3 to 1.9 times higher than that in adults (on Day 1 and Day 15, respectively). Drug Interaction Studies Clinical Studies No clinical drug interaction trials have been conducted with topical difamilast. In Vitro Studies CYP450 Enzymes: Difamilast is a substrate of CYP3A4 and CYP1A2.
Difamilast is not expected to inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 at clinically relevant concentrations. Induction of CYP1A2, CYP2B6, CYP2C9, and CYP3A4 by difamilast is expected to be low at clinically relevant concentrations. Transporter Systems: Difamilast is a substrate of breast cancer resistance protein (BCRP),but is not a substrate of P-glycoprotein (P-gp), OATP1B1, or OATP1B3.
Difamilast is not expected to inhibit P-gp, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, or MATE2-K at clinically relevant concentrations.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics The pharmacodynamics of ADQUEY ointment in the treatment of atopic dermatitis is not known. Cardiac Electrophysiology ADQUEY ointment is not expected to cause clinically significant QTc interval prolongation at the recommended dosages.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The efficacy of ADQUEY for the treatment of mild to moderate atopic dermatitis was assessed in three multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials (Trial 1 [NCT02068352], Trial 2 [NCT03908970], and Trial 3 [NCT03911401]) that treated a total of 612 subjects. Trial 1 enrolled adult and pediatric subjects 10 years of age and older in the United States, Australia, and Poland. Trial 2 enrolled adult and pediatric subjects 15 years of age and older in Japan, and Trial 3 enrolled pediatric subjects 2 to 14 years of age in Japan.
In these trials, subjects were randomized 1:1 to receive ADQUEY or vehicle ointment, applied topically to the entire treatment area twice daily for at least 4 weeks. The trials enrolled subjects with an Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate) atopic dermatitis and affected body surface area (BSA) (excluding the face, neck, and head [Trial 1]; excluding the scalp [Trials 2 and 3]) of ≥ 5% and ≤ 40%. The IGA included an overall assessment of atopic dermatitis (erythema, induration/papulation, and oozing/crusting) on a severity scale of 0 to 4.
At baseline, 29%, 15%, and 15% of the subjects had an IGA of mild, and 71%, 85%, and 85% had an IGA of moderate in Trials 1, 2, and 3, respectively. Concomitant treatment for atopic dermatitis was prohibited. In Trial 1, 56% of the subjects were female, 73% were White, 20% were Black or African American, and 4% were Asian; for ethnicity, 18% of the subjects identified as Hispanic or Latino.
In Trials 2 and 3, the majority of the subjects were male (54% in Trial 2 and 58% in Trial 3), 100% were Asian, and 100% identified as Not Hispanic or Latino. The median age of enrolled subjects at baseline was 30 years (range 10 to 67 years), 30 years (range 15 to 65 years), and 7 years (range 2 to 14 years) in Trials 1, 2, and 3, respectively. The primary efficacy endpoint for all trials was the proportion of subjects who achieved IGA success, defined as an IGA grade of clear (0) or almost clear (1) and with a 2-grade or greater improvement from baseline, at Week 4.
The efficacy results at Week 4 are shown in Table 2. Table 2: Efficacy Results at Week 4 in Adult and Pediatric Subjects 2 Years of Age and Older with Mild to Moderate Atopic Dermatitis in Trials 1, 2, and 3 Trial 1 (Multinational‡) Trial 2 (Japan) Trial 3 (Japan) ADQUEY (N = 43) Vehicle (N = 37) ADQUEY (N = 182) Vehicle (N = 182) ADQUEY (N = 85) Vehicle (N = 83) IGA Success†, n (%) 9 (21) 1 (3) 70 (38) 23 (13) 40 (47) 15 (18) Difference, % from Vehicle (95% CI) 18 (5, 31) 26 (17, 34) 29 (15, 42) † IGA success is defined as an IGA score of 0 or 1 and with ≥ 2-grade improvement from baseline. ‡ Trial 1 enrolled subjects from the United States, Australia, and Poland.
Subjects with missing IGA scores were imputed as failures.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility In a 2-year dermal carcinogenicity study in rats, no test article-related neoplastic findings were observed in male or female rats that received difamilast at dermal doses up to 3% ointment applied at 0.008 ml/cm 2 (4 times the MRHD based on AUC comparison). In a 2-year dermal carcinogenicity study in mice, no test article-related neoplastic findings were observed in male or female mice that received difamilast at dermal doses up to 3% ointment applied at 0.008 ml/cm 2 (4 times the MRHD based on AUC comparison).
Difamilast was not genotoxic in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian cell mutation test in mouse lymphoma cells, or an in vivo rat bone marrow micronucleus test. In a fertility and early embryonic development study in rats, irregular estrus cycles, sperm abnormalities, increased preimplantation loss, and decreased copulation and fertility indexes were observed at a subcutaneous dose of 100 mg/kg/day difamilast (116 times the MRHD for males and 263 times the MRHD for females, respectively, based on AUC comparison).
No treatment-related adverse effects on fertility or early embryonic development were observed at 10 mg/kg/day for males and females (20 times the MRHD for males and 30 times the MRHD for females, respectively, based on AUC comparison).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility In a 2-year dermal carcinogenicity study in rats, no test article-related neoplastic findings were observed in male or female rats that received difamilast at dermal doses up to 3% ointment applied at 0.008 ml/cm 2 (4 times the MRHD based on AUC comparison). In a 2-year dermal carcinogenicity study in mice, no test article-related neoplastic findings were observed in male or female mice that received difamilast at dermal doses up to 3% ointment applied at 0.008 ml/cm 2 (4 times the MRHD based on AUC comparison).
Difamilast was not genotoxic in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian cell mutation test in mouse lymphoma cells, or an in vivo rat bone marrow micronucleus test. In a fertility and early embryonic development study in rats, irregular estrus cycles, sperm abnormalities, increased preimplantation loss, and decreased copulation and fertility indexes were observed at a subcutaneous dose of 100 mg/kg/day difamilast (116 times the MRHD for males and 263 times the MRHD for females, respectively, based on AUC comparison).
No treatment-related adverse effects on fertility or early embryonic development were observed at 10 mg/kg/day for males and females (20 times the MRHD for males and 30 times the MRHD for females, respectively, based on AUC comparison).
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Adquey TM (difamilast) Ointment 1% NDC; 72893-017-09 - 85g Adquey TM (difamilast) Ointment 1% NDC; 72893-017-08 - 27g AdqueyTM(difamilast) Ointment 1% NDC; 72893-017-07 - 3g PHYSICIAN SAMPLE LABEL (CARTON) 85g-carton 27g-carton 3g-carton
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