Next Treatments
Back to Eczema

Adquey

Also known as difamilast

TypeTopical StageApproved
Picture from the US label: Adquey TM (difamilast) Ointment 1% NDC; 72893-017-08 - 27g
From the labelA picture from the US label, as DailyMed publishes it.

What stands out

  • Blocks PDE4 to lower inflammation in the body
Derived from US label · MedlinePlus: Difamilast Topical · This is a summary of public records for informational purposes only. It is not medical advice.

Results: FDA Review

Clear or almost clear skinThe label calls this “IGA success”After 4 weeks
Trial 1Ages 10+ · United States, Australia, Poland
Vehicle (the ointment without the drug)37 people
3 in 100
Adquey43 people
21 in 100
02040
+18
more people in 100 reached it on Adquey than on vehicle.
The label’s 95% confidence range is 5 to 31 more (out of 100).
Trial 2Ages 15+ · Japan
Vehicle (the ointment without the drug)182 people
13 in 100
Adquey182 people
38 in 100
02040
+26
more people in 100 reached it on Adquey than on vehicle.
The label’s 95% confidence range is 17 to 34 more (out of 100).
Trial 3Ages 2–14 · Japan
Vehicle (the ointment without the drug)83 people
18 in 100
Adquey85 people
47 in 100
03060
+29
more people in 100 reached it on Adquey than on vehicle.
The label’s 95% confidence range is 15 to 42 more (out of 100).
FDA’s review of these trials · This is a summary of trial data for informational purposes only. It is not medical advice.
What is IGA?
  • IGA stands for Investigator's Global Assessment.
  • The IGA included an overall assessment of atopic dermatitis (erythema, induration/papulation, and oozing/crusting) on a severity scale of 0 to 4.
  • IGA success is defined as an IGA score of 0 or 1 and with ≥ 2-grade improvement from baseline.

From the Adquey (difamilast) US label

All 3 Adquey trials
PostedTrialPhaseAgesPeople
Mar 2025NCT05372653Phase 33 months–241
Nov 2021NCT02068352Phase 210–70121
Nov 2021NCT03961529Phase 32+366

Side effects

The most common adverse reaction occurring in ≥1% of subjects is nasopharyngitis.

FDA label dated Feb 25, 2026

History

Earliest recorded event: Jun 20, 2014. This timeline shows events collected by Eczema Radar and may not include the treatment’s full history. Study details reflect the latest registry record available here.

  • Feb 12, 2026FDA approval for eczema FDA approval letter
  • Sep 22, 2025Phase 3 trial postedA Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis ClinicalTrials.gov NCT07184645
  • Sep 15, 2025Phase 3 trial postedA Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis ClinicalTrials.gov NCT07173478
  • Mar 30, 2025Phase 3 results postedA Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis ClinicalTrials.gov NCT05372653
  • Jan 15, 2025Phase 3 trial completedTo Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD ClinicalTrials.gov NCT05650320
  • Nov 29, 2024Phase 3 trial completedTo Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD ClinicalTrials.gov NCT05667623
  • Jul 31, 2024Phase 3 trial completedA Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis ClinicalTrials.gov NCT05571943
  • Jul 21, 2024Phase 3 main data collectedTo Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD ClinicalTrials.gov NCT05650320
  • Jun 17, 2024Phase 3 main data collectedTo Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD ClinicalTrials.gov NCT05667623
  • Nov 29, 2023Phase 3 trial completedA Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis ClinicalTrials.gov NCT05372653
  • Feb 17, 2023Phase 3 trial startedTo Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD ClinicalTrials.gov NCT05650320
  • Feb 6, 2023Phase 3 trial startedTo Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD ClinicalTrials.gov NCT05667623
  • Dec 29, 2022Phase 3 main data collectedA Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis ClinicalTrials.gov NCT05372653
  • Sep 15, 2022Phase 3 trial startedA Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis ClinicalTrials.gov NCT05571943
  • May 23, 2022Phase 3 trial startedA Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis ClinicalTrials.gov NCT05372653
  • Nov 23, 2021Phase 2 results postedA Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis ClinicalTrials.gov NCT02068352
  • Nov 19, 2021Phase 3 results postedLong-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis ClinicalTrials.gov NCT03961529
  • Nov 11, 2020Phase 3 trial completedLong-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis ClinicalTrials.gov NCT03961529
  • May 14, 2019Phase 3 trial startedLong-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis ClinicalTrials.gov NCT03961529
  • Feb 3, 2015Phase 2 trial completedA Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis ClinicalTrials.gov NCT02068352
  • Jan 28, 2015Phase 2 main data collectedA Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis ClinicalTrials.gov NCT02068352
  • Jun 20, 2014Phase 2 trial startedA Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis ClinicalTrials.gov NCT02068352

Sources

From the FDA
Trials
For patients