ADQUEY (Difamilast) 1% ointment was approved by the FDA on February 12, 2026 to treat mild-moderate atopic dermatitis.
Indications: Indicated to treat mild to moderate atopic dermatitis in adults and pediatric patients greater than 2 years of age.
Dosage and administration :
- Difamilast (1% - 10mg of difamilast per gram ) should be used topically; a thin layer of the ointment should be applied on the affected area.
- Wash your hands properly after application.
- Avoid infected areas while applying.
Adverse reactions :
-
Clinical trial experience: Nasopharyngitis - 16%, Less common(<1%): Application site folliculitis, contact dermatitis, application site rash, molluscum contagiosum.
-
Postmarketing experience: General disorders and administration site conditions: Application site swelling.
Mechanism of action: Difamilast is an inhibitor of phosphodiesterase-4 (PDE-4). PDE-4 is a major cyclic adenosine monophosphate (cyclic-AMP) metabolising enzyme. Inhibition of PDE-4 leads to the accumulation of intracellular cyclic AMP and reduces the production of various inflammatory cytokines and chemokines that cause inflammation.
Use in pregnancy and lactation period :
Pregnancy: There is insufficient data to evaluate for a drug-associated risk for birth defects, miscarriage or other maternal or fetal adverse outcomes.
Animal reproductive studies :
-
Difamilast was administered at doses up to 30 and 3 times the maximum recommended human dose(MRHD) to pregnant rats and rabbits, respectively, during the period of organogenesis; no fetal structural abnormalities were observed.
-
Increased post-implantation loss, decreased fetal weight, and increased visceral abnormalities were observed in pregnant rats when administered with a subcutaneous dose 263times the MHRD.
-
Difamilast induced skeletal variations were observed in rabbits at subcutaneous doses 14times the MRHD
Lactation: No data suggest the presence of difamilast or its metabolites in human milk and its effect on breastfeeding infants.
Animal studies: In animal studies, the data suggest that difamilast or its metabolites are excreted into the milk of lactating rats.
Clinical considerations :
For the safe use of difamilast in breastfeeding women :
- Avoid direct application of difamilast ointment to the nipples.
- If difamilast ointment is applied to the patient’s chest, avoid direct contact with the infant’s skin.
Can this drug be a better alternative for atopic dermatitis than other drugs available in the market? What’s your opinion?
MBH/PS