Adquey

(Difamilast)

Phase 3Small molecule

AAcrotech Biopharma Inc.

Adquey is one of 27 small molecule programs targeting Atopic Dermatitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Atopic DermatitisActive, not recruiting

Atopic DermatitisPhase 3

Active, not recruiting

Competition

Competitive Landscape

508 competitors in Atopic Dermatitis

#DrugCompanyPhaseTrials

Fludara

Sanofi

Phase 3

1 2

Nereus

VVanda Pharmaceuticals

Phase 3

3 3

Elidel

Bayer

Phase 3

4 4

LNK01001

LLynk Pharmaceuticals Co., Ltd

Phase 3

2 5

Adquey

AAcrotech Biopharma Inc.

Phase 3

2 6

EBGLYSS

Eli Lilly

Preclinical

23 7

Cibinqo

Pfizer

Preclinical

11 8

OPA-15406

Otsuka

Phase 3

7 9

Product 0405

FFougera Pharmaceuticals Inc.

Phase 3

3 10

Prograf

VVeloxis Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Atopic Dermatitis2 trials

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

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

Regulatory

FDA Approval Timeline[4]

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]
Open Targets Platform — Drug–disease associations for Difamilast. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219474). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Adquey. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Acrotech Biopharma Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAcrotech Biopharma Inc.

Patent Landscape[5]

Patent Cliff

Mar 1, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE46792Mar 1, 2028

10588893Dec 31, 2036

Adquey

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Atopic Dermatitis2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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