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Molecule

Difamilast

Phosphodiesterase 4 Inhibitor
Available on request
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Difamilast 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. It is available as ointment for topical use. MedsAcross supplies Difamilast for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Phosphodiesterase 4 Inhibitor, Phosphodiesterase 4 Inhibitors
US FDA first approval
12 February 2026
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Topical
Dosage forms
Ointment
Identifiers
UNII T3U32GLJ0FCAS 937782-05-3DrugBank DB14987Q105335086

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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.

Source: US FDA prescribing information

How it works

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.

Source: US FDA prescribing information

Dosing overview

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.

Source: US FDA prescribing information

Storage

Store at 20°C–25°C (68°F–77°F), excursions permitted to 15°C–30°C (59°F–86°F). Store away from direct sunlight, heat, and moisture.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Difamilast, sorted by availability.

MedicineManufacturerRegisterAvailability
Adquey 1% ointmentTopicalAcrotech BiopharmaUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 12 February 2026Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Difamilast available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Difamilast and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Difamilast have?

The catalogue lists 1 brand names for Difamilast, including Adquey.

Is Difamilast approved by the US FDA?

Yes. The US FDA first approved Difamilast on 12 February 2026, according to Drugs@FDA.

Does Difamilast need cold chain shipping?

No listed presentation of Difamilast is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. ADQUEY prescribing information (Acrotech Biopharma). U.S. National Library of Medicine, DailyMed. Retrieved 25 February 2026

Request Difamilast for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.