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bromfenac

Trade name: xibrom

Small moleculeapproved

Approved

Mar 24, 2005

Bromfenac is a topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. It is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. The most commonly reported adverse reactions in 3 to 8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia and vision blurred. — NCATS

Clinical trial activity

56 trials · 45 clinical orgs · 22 marketing orgs

Phase 1
5
Phase 2
22
Phase 3
14
Phase 4
27

Earliest trial started May 1, 2003 (NCT00198445)

Timeline

2000s

  1. Jan 1, 2003

    Bausch & Lomb — Earliest Phase 3 Sponsor(trial)

  2. Mar 24, 2005

    ISTA Pharmaceuticals — Earliest FDA Approval

  3. Mar 24, 2005

    ISTA Pharmaceuticals — NDA Organization

  4. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 2007

    Bausch & Lomb — Earliest Phase 2 Sponsor(trial)

2010s

  1. May 11, 2011

    Coastal Pharmaceutical — Marketing Organization

  2. Jan 9, 2013

    Amring Pharmaceticals — Marketing Organization

  3. Apr 5, 2013

    Bausch & Lomb — NDA Secondary Org

  4. Jan 22, 2014

    Hi Tech Pharmaceuticals — Marketing Organization

  5. Jan 22, 2014

    Akorn, Inc. — Marketing Organization

  6. Jan 22, 2014

    SENTISS — Marketing Organization

  7. Jun 19, 2014

    Apotex — Marketing Organization

  8. Feb 10, 2015

    Novitium Pharma — Marketing Organization

  9. Feb 10, 2015

    Chartwell Pharmaceuticals — Marketing Organization

  10. Feb 10, 2015

    Paddock Laboratories — Marketing Organization

  11. Feb 10, 2015

    VistaPharm, Inc. — Marketing Organization

  12. Apr 8, 2016

    Sun Pharmaceuticals — Marketing Organization

  13. Apr 8, 2016

    Sun Pharmaceuticals — NDA Secondary Org

  14. Jun 3, 2019

    Rising Pharmaceuticals — Marketing Organization

  15. Jun 3, 2019

    InnoPharma — Marketing Organization

  16. Jun 3, 2019

    Mylan — Marketing Organization

  17. Jun 21, 2019

    Alembic — Marketing Organization

2020s

  1. Mar 17, 2020

    Gland Pharma Ltd — Marketing Organization

  2. Mar 17, 2020

    Fosun — Marketing Organization

  3. Mar 18, 2022

    Eugia Pharma — Marketing Organization

  4. Aug 15, 2023

    Lupin — Marketing Organization

  5. Jul 29, 2024

    Amneal Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMar 24, 2005

Chemistry & pharmacology

Loading structure…

SMILES

Nc1c(CC(=O)O)cccc1C(=O)c1ccc(Br)cc1
Mol. weight
334.17 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 2-amino-3-(4-bromobenzoyl)benzeneacetic acid
  • 2-amino-3-(4-bromobenzoyl)benzeneacetic acid
  • [2-amino-3-(4-bromo-benzoyl)-phenyl]-acetic acid
  • [2-amino-3-(4-bromo-benzoyl)-phenyl]-acetic acid
  • ahr-10282
  • ahr-10282b
  • ahr-10282b
  • bromday
  • bromday
  • bromday
  • bromefenac
  • bromfenac
  • bromfenac
  • bromfenac
  • bromfenac
  • bromfenac
  • bromfenac
  • bromfenac
  • bromfenac
  • bromfenac
  • bromfenac
  • bromfenaco
  • bromfenaco
  • bromfenac sodium
  • bromfenac sodium
  • bromfenac sodium
  • bromfenac sodium
  • bromfenac sodium
  • bromfenac sodium hydrate
  • bromfenac sodium hydrate
  • bromfenac sodium sesquihydrate
  • bromfenac sodium sesquihydrate
  • bromfenac sodium sesquihydrate
  • bromfenacum
  • bromfenacum
  • duract
  • isv 101
  • isv 101
  • pro-155
  • prolensa
  • sodium bromfenac
  • wyeth brand of sodium bromfenac
  • xibrom
  • xibrom
  • xibrom
  • xibrom
  • xibrom
  • xibrom
  • yellox
  • yellox
  • yellox
  • yellox
  • yellox

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07178639N/AAug 1, 2025Nemocnice Kolín
NCT06978244Phase 1Jul 29, 2025Bausch & Lomb
NCT06785090Phase 4May 1, 2023University of Baghdad
NCT05626478Phase 4Dec 1, 2022Advanced Vision Care
NCT05107921Phase 2Nov 1, 2021Seoul National University
NCT05158699Phase 3Oct 13, 2021European Society of Cataract and Refractive Surgeons, Maastricht University
NCT05006911Phase 1Aug 14, 2021Optall Vision
NCT04940338Phase 4May 1, 2021Klinički Bolnički Centar Zagreb, University of Zagreb
NCT06130384Phase 4Mar 1, 2021Thomas Jefferson University
NCT04343222Phase 4Jun 27, 2019University of Wisconsin
NCT03751059Phase 4May 31, 2019Glaucoma Research Society of Canada, Ivey Eye Institute
NCT03578276Phase 4Jun 22, 2018Carolina Eyecare Physicians, LLC, Harrow Health, Science in Vision
NCT03597867Phase 3Apr 25, 2018University of Trieste
NCT03831984Phase 4Mar 1, 2018Hospital Virgen de la Luz
NCT01478555Phase 2Jan 1, 2018InSite Vision
NCT03521791Phase 4Dec 13, 2017Laboratorios Sophia S.A de C.V.
NCT03317847Phase 4Oct 16, 2017Santa Maria Nuova Hospital IRCCS, University of Modena and Reggio Emilia
NCT04022811Phase 4Oct 31, 2016Sun Yat-Sen University
NCT05715385Phase 4Nov 30, 2014Babasaheb Ambedkar Memorial Hospital
NCT02681679N/AOct 1, 2014Government of China, Sun Yat-Sen University
Showing 20 of 56 trials
Page 1 / 3

Organizations

Research & Development (45)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bausch & LombFor profit151052003
ISTA PharmaceuticalsFor profit7022003
Bp Consulting, IncFor profit5512008
InSite VisionFor profit5522010
Bucci Laser Vision InstituteAcademic/Hospital4312006
AllerganFor profit3012009
Laboratorios Sophia S.A de C.V.For profit3332011
Discover Vision CentersAcademic/Hospital2122010
European Society of Cataract and Refractive SurgeonsAcademic/Hospital2012013
Innovative Medical Research of South Florida, IncFor profit2212006
Maastricht UniversityAcademic/Hospital2212013
Ophthalmic Consultants of BostonAcademic/Hospital2122006
Sun Yat-Sen UniversityAcademic/Hospital2222014
University of Modena and Reggio EmiliaAcademic/Hospital2212013
Advanced Vision CareAcademic/Hospital1112022
Babasaheb Ambedkar Memorial HospitalAcademic/Hospital1112014
Carolina Eyecare Physicians, LLCAcademic/Hospital1112018
Center For Excellence In Eye CareAcademic/Hospital1112007
Churchhill CommunicationsFor profit1012013
Coburn-Kleinfeldt Eye ClinicAcademic/Hospital1012009
45 organizations
Page 1 / 3

Marketing (29)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitMKTGJan 22, 2014
AlembicFor profitMKTGJun 21, 2019
AlembicFor profitSYNJun 21, 2019
Amneal PharmaceuticalsFor profitMKTGJul 29, 2024
Amring PharmaceticalsFor profitMKTGJan 9, 2013
ApotexFor profitMKTGJun 19, 2014
ApotexFor profitSYNJun 19, 2014
Bausch & LombFor profitNDA2Apr 5, 2013
Bausch & LombFor profitSYNMar 24, 2005
Chartwell PharmaceuticalsFor profitMKTGFeb 10, 2015
Coastal PharmaceuticalFor profitMKTGMay 11, 2011
Eugia PharmaFor profitMKTGMar 18, 2022
FosunFor profitMKTGMar 17, 2020
Gland Pharma LtdFor profitMKTGMar 17, 2020
Gland Pharma LtdFor profitSYNMar 17, 2020
Hi Tech PharmaceuticalsFor profitMKTGJan 22, 2014
ISTA PharmaceuticalsFor profitNDAMar 24, 2005
InnoPharmaFor profitMKTGJun 3, 2019
LupinFor profitMKTGAug 15, 2023
LupinFor profitSYNAug 15, 2023
MylanFor profitMKTGJun 3, 2019
Novitium PharmaFor profitMKTGFeb 10, 2015
Paddock LaboratoriesFor profitMKTGFeb 10, 2015
Rising PharmaceuticalsFor profitMKTGJun 3, 2019
Rising PharmaceuticalsFor profitSYNJun 3, 2019
SENTISSFor profitMKTGJan 22, 2014
Sun PharmaceuticalsFor profitMKTGApr 8, 2016
Sun PharmaceuticalsFor profitNDA2Apr 8, 2016
VistaPharm, Inc.For profitMKTGFeb 10, 2015