Durezol

(Difluprednate Ophthalmic)

Phase 3

Novartis

Durezol is one of 5 small molecule programs targeting Bacterial Keratitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Bacterial KeratitisActive, not recruiting

Bacterial KeratitisPhase 3

Active, not recruiting

Competition

Competitive Landscape

4 competitors in Bacterial Keratitis

#DrugCompanyPhaseTrials

Avelox

Bayer

Phase 3

1 2

Durezol

Novartis

Phase 3

1 3

Durezol

Novartis

Phase 3

1 4

Rose Bengal

UUniversity of California, San Francisco

Phase 3

1 5

Moxifloxacin Ophthalmic

UUniversity of California, San Francisco

Phase 3

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

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Bacterial Keratitis

NCT06271772

Clinical

Trials by Indication[1]

Bacterial Keratitis1 trial

Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II

Active, not recruiting·UUniversity of California, San Francisco·Phase 3·NCT06271772·60 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 23, 2008

DUREZOL

NDA NDA022212

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Difluprednate Ophthalmic. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Difluprednate Ophthalmic compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Difluprednate Ophthalmic. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022212). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Highest Phase: Phase 3[1]
Company: Novartis

Durezol

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

Bacterial Keratitis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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