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Adquey

(Difamilast)

Small molecule

AAcrotech Biopharma Inc.

0

Indications

2

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

2

Patents

Clinical

Trials by Indication[1]

Atopic Dermatitis2 trials

A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis

Completed·AAcrotech Biopharma Inc.·Phase 3·NCT05571943·542 enrolled

This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)

Completed·AAcrotech Biopharma Inc.·Phase 3·NCT05608343·153 enrolled

Regulatory

FDA Approval Timeline[3]

Feb 12, 2026

ADQUEY

NDA NDA219474

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Difamilast. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Difamilast compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA219474). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Adquey. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Acrotech Biopharma Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: AAcrotech Biopharma Inc.

Patent Landscape[4]

Patent Cliff

Mar 1, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE46792Mar 1, 2028

10588893Dec 31, 2036

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