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← All drugs Report issue

difluprednate

Trade name: durezol

Small moleculeapproved

Approved

Jun 23, 2008

Difluprednate is a corticosteroid used as an anti-inflammatory steroidal drug used primarily in ocular surgery. It is thought to act by the induction of phospholipase A2 inhibitory proteins (lipocortins). It is postulated that these proteins control the biosynthesis of potent mediators of infammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. It is marketed by Alcon under the tradename Durezol. — NCATS

Clinical trial activity

23 trials · 22 clinical orgs · 11 marketing orgs

Phase 1
0
Phase 2
17
Phase 3
13
Phase 4
6

Earliest trial started Dec 1, 1999 (NCT00407225)

Timeline

1990s

  1. Jan 1, 1999

    Sirion Therapeutics — Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Sirion Therapeutics — Earliest Phase 3 Sponsor(trial)

  2. Jun 23, 2008

    Sirion Therapeutics — Earliest FDA Approval

  3. Jun 23, 2008

    Novartis — NDA Secondary Org

  4. Jun 23, 2008

    Novartis — Marketing Organization

  5. Jun 23, 2008

    Sirion Therapeutics — NDA Organization

  6. Jun 23, 2008

    Sandoz — Marketing Organization

2020s

  1. Aug 9, 2021

    Cipla — Marketing Organization

  2. Nov 17, 2021

    Amneal Pharmaceuticals — Marketing Organization

  3. Nov 16, 2022

    Dr. Reddy's Laboratories — Marketing Organization

  4. May 14, 2024

    Epic Pharma Llc — Marketing Organization

  5. Dec 13, 2024

    Caplin Point Laboratories — Marketing Organization

  6. Feb 11, 2025

    Upsher-Smith Laboratories — Marketing Organization

  7. Mar 20, 2025

    Mylan — Marketing Organization

  8. Jan 26, 2026

    Alembic — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJun 23, 2008

Chemistry & pharmacology

Loading structure…

SMILES

CCCC(=O)O[C@@]1(CC[C@H]2[C@@H]3C[C@H](F)C4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]12C)C(=O)COC(C)=O
Mol. weight
508.5515 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Prodrug

Sources

Also known as

  • 6 alpha-9-difluoroprednisolone 21-acetate 17-butyrate
  • c.m.9155
  • dfba
  • dfba
  • difluoroprednisolone butyrate acetate
  • difluoroprednisolone butyrate acetate
  • difluprednate
  • difluprednate
  • difluprednate
  • difluprednate
  • difluprednate
  • difluprednate
  • difluprednate
  • difluprednate
  • difluprednate
  • difluprednate
  • durezol
  • durezol
  • durezol
  • durezol
  • epitopic
  • w-6309
  • w-6309

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06271772Phase 3Jul 1, 2024Aravind Eye Hospital, Federal University of Sao Paulo, Stanford University, University of California, San Francisco
NCT05649111Phase 4Nov 1, 2022Kafrelsheikh University
NCT04687800Phase 4Jan 4, 2021Ocular Therapeutix, Inc., The Eye Associates, The Eye Associates of Manatee
NCT04097730Phase 4Jan 1, 2020Aravind Eye Hospital, Kaiser Permanente, National Eye Institute (NEI), University of California, San Francisco
NCT04631315Phase 4Mar 24, 2019Laboratorios Poen
NCT03693989Phase 3Oct 1, 2018Laboratorios Sophia S.A de C.V.
NCT03426267Phase 3Aug 30, 2018SPARC
NCT01939691Phase 4Dec 1, 2017University of California, San Francisco
NCT01276223Phase 2Feb 1, 2011Alcon
NCT01201798Phase 3Oct 1, 2010Alcon
NCT01124045Phase 3Aug 1, 2010Alcon
NCT01244334Phase 4Mar 1, 2009Alcon, Carolina Eyecare Physicians, LLC, Ophthalmic Consultants of Long Island, Parsons Medical Communications, SironRX Therapeutics, Inc., University of Cincinnati
NCT00616993Phase 3Jan 1, 2008Sirion Therapeutics
NCT00616070Phase 3Dec 1, 2007Sirion Therapeutics
NCT00501579Phase 3Jul 13, 2007Sirion Therapeutics
NCT00429923Phase 3Jan 31, 2007Sirion Therapeutics, SironRX Therapeutics, Inc.
NCT00430092Phase 3Jan 30, 2007Sirion Therapeutics, SironRX Therapeutics, Inc.
NCT00406341Phase 3Apr 1, 2004Hokkaido University, Sirion Therapeutics
NCT00406497Phase 2Apr 1, 2003Hokkaido University, Sirion Therapeutics
NCT00407056Phase 3Aug 1, 2002Hokkaido University, Sirion Therapeutics
Showing 20 of 23 trials
Page 1 / 2

Organizations

Research & Development (22)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Sirion TherapeuticsFor profit111121999
AlconFor profit4332009
Hokkaido UniversityAcademic/Hospital4022002
SironRX Therapeutics, Inc.For profit3022007
University of California, San FranciscoAcademic/Hospital3322017
Aravind Eye HospitalAcademic/Hospital2022020
Kanto Rosai HospitalAcademic/Hospital2011999
Carolina Eyecare Physicians, LLCAcademic/Hospital1012009
Federal University of Sao PauloAcademic/Hospital1012024
Kafrelsheikh UniversityAcademic/Hospital1112022
Kaiser PermanenteAcademic/Hospital1012020
Laboratorios PoenFor profit1112019
Laboratorios Sophia S.A de C.V.For profit1112018
National Eye Institute (NEI)Government1012020
Ocular Therapeutix, Inc.For profit1012021
Ophthalmic Consultants of Long IslandAcademic/Hospital1012009
Parsons Medical CommunicationsFor profit1012009
SPARCFor profit1112018
Stanford UniversityAcademic/Hospital1012024
The Eye AssociatesAcademic/Hospital1112021
22 organizations
Page 1 / 2

Marketing (12)

OrganizationOrg typeRelationshipDate
AlembicFor profitMKTGJan 26, 2026
Amneal PharmaceuticalsFor profitMKTGNov 17, 2021
Caplin Point LaboratoriesFor profitMKTGDec 13, 2024
CiplaFor profitMKTGAug 9, 2021
Dr. Reddy's LaboratoriesFor profitMKTGNov 16, 2022
Epic Pharma LlcFor profitMKTGMay 14, 2024
MylanFor profitMKTGMar 20, 2025
NovartisFor profitNDA2Jun 23, 2008
NovartisFor profitMKTGJun 23, 2008
SandozFor profitMKTGJun 23, 2008
Sirion TherapeuticsFor profitNDAJun 23, 2008
Upsher-Smith LaboratoriesFor profitMKTGFeb 11, 2025