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fluorometholone

Trade name: fml

Small moleculeapproved

Approved

Jan 12, 1972

Fluorometholone is a glucocorticoid employed, usually as eye drops, in the treatment of allergic and inflammatory conditions of the eye. Corticosteroids such as fluorometholone inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation 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. Corticosteroids are capable of producing a rise in intraocular pressure. In clinical studies of documented steroid-responders, fluorometholone demonstrated a significantly longer average time to produce a rise in intraocular pressure than dexamethasone phosphate. — NCATS

Clinical trial activity

19 trials · 28 clinical orgs · 10 marketing orgs

Phase 1
0
Phase 2
5
Phase 3
3
Phase 4
9

Earliest trial started Jul 1, 2005 (NCT00707421)

Timeline

1970s

  1. Jan 12, 1972

    Allergan — Earliest FDA Approval

  2. Jan 12, 1972

    Allergan — NDA Secondary Org

  3. Jan 12, 1972

    Allergan — NDA Organization

  4. Jan 12, 1972

    AbbVie — Marketing Organization

  5. Jan 12, 1972

    AbbVie — NDA Secondary Org

  6. Apr 11, 1977

    Pharmacia & Upjohn — NDA Secondary Org

1980s

  1. Sep 4, 1985

    SmithKline Beckman — NDA Secondary Org

  2. Feb 11, 1986

    Eyevance — NDA Secondary Org

  3. Feb 11, 1986

    Harrow Health — NDA Secondary Org

  4. Feb 27, 1986

    Novartis — Marketing Organization

  5. Jul 21, 1989

    Alcon — Marketing Organization

  6. Sep 29, 1989

    SmithKline Beecham — NDA Secondary Org

2000s

  1. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2009

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Jan 9, 2024

    Amneal Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJan 12, 1972

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H]1C[C@H]2[C@@H]3CC[C@](O)(C(C)=O)[C@@]3(C)C[C@H](O)[C@]2(F)[C@@]4(C)C=CC(=O)C=C14
Mol. weight
376.4617 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • (1r,2s,8s,10s,11s,14r,15s,17s)-14-acetyl-1-fluoro-14,17-dihydroxy-2,8,15-trimethyltetracyclo[8.7.0.02,7.011,15]heptadeca-3,6-dien-5-one
  • (1r,2s,8s,10s,11s,14r,15s,17s)-14-acetyl-1-fluoro-14,17-dihydroxy-2,8,15-trimethyltetracyclo[8.7.0.02,7.011,15]heptadeca-3,6-dien-5-one
  • 9-fluoro-11beta,17-dihydroxy-6alpha-methylpregna-1,4-diene-3,20-dione
  • 9-fluoro-11beta,17-dihydroxy-6alpha-methylpregna-1,4-diene-3,20-dione
  • eflone
  • flarex
  • flarex
  • fluaton
  • fluaton
  • flumetholon
  • flumetholone
  • fluormetholon
  • fluorometholon
  • fluorometholon
  • fluorometholone
  • fluorometholone
  • fluorometholone
  • fluorometholone
  • fluorometholone
  • fluorometholone
  • fluorometholone
  • fluorometholone
  • fluorometholone
  • fluorometholone
  • fluorometholone
  • fluorométholone
  • fluorométholone
  • fluorometholone acetate
  • fluorometholone acetate
  • fluorometholone acetate
  • fluorometholone acetate
  • fluorometholone acetate
  • fluorometholone acetate
  • fluorometholonum
  • fluorometholonum
  • fluorometolona
  • fluorometolona
  • fluor-op
  • fluor-op
  • flurolon
  • fml
  • fml
  • fml forte
  • fml forte
  • fml fte
  • fml-neo
  • nsc 33001
  • nsc 33001
  • oxylone
  • oxylone
  • oxylone
  • oxylone
  • oxylone acetate
  • u-17323
  • u-17323

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07308938Phase 2Mar 31, 2026University of Pittsburgh
NCT06498440Phase 4Sep 1, 2024University of Western Ontario
NCT05716945Phase 4Mar 1, 2023Maastricht University
NCT05587231Phase 4Oct 31, 2022United States Navy
NCT06876116Phase 4Sep 1, 2022Korea University, Taejoon Pharm Co., Ltd.
NCT04839549Phase 4May 31, 2021Eye Associates of Central Texas
NCT04149210Phase 4Jul 1, 2020Berhan Public Health and Eye Care Consultancy PLC, Harvard University, The Fred Hollows Foundation, University of London, University of Pennsylvania
NCT03747614Phase 4Jun 30, 2017Sun Yat-Sen University
NCT02974387Phase 4Apr 1, 2017Dr Salouti Eye Research Center, University of Tehran
NCT02816905Phase 4Oct 1, 2015Cairo University
NCT02030990Phase 2/Phase 3 (Phase 3)Aug 1, 2014United States Navy
NCT02051023Phase 3Feb 1, 2014Instituto Universitario de Oftalmobiología Aplicada
NCT01949454N/ANov 1, 2013Berhan Public Health and Eye Care Consultancy PLC, Grarbet Tehadiso Mahber, Lions Clubs International Foundation (funding), University of Pennsylvania
NCT02147509N/AMar 1, 2013Wenzhou Medical University
NCT01682421N/ASep 1, 2012Aarhus University
NCT01448213Phase 2Oct 1, 2011Price Vision Group, University of Erlangen-Nuremberg
NCT00824811Phase 2Jun 1, 2009Allergan, University of Texas at Houston
NCT01288404N/AJan 1, 2008Mahidol University
NCT00707421Phase 3Jul 1, 2005Funding for Research in Ophthalmology (FRO), Katholieke Universiteit Leuven
Showing 19 of 19 trials
Page 1 / 1

Organizations

Research & Development (28)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Berhan Public Health and Eye Care Consultancy PLCAcademic/Hospital2022013
United States NavyGovernment2222014
University of PennsylvaniaAcademic/Hospital2122013
Aarhus UniversityAcademic/Hospital1112012
AllerganFor profit1012009
Cairo UniversityAcademic/Hospital1112015
Dr Salouti Eye Research CenterAcademic/Hospital1112017
Eye Associates of Central TexasAcademic/Hospital1112021
Funding for Research in Ophthalmology (FRO)Academic/Hospital1012005
Grarbet Tehadiso MahberAcademic/Hospital1012013
Harvard UniversityAcademic/Hospital1112020
Instituto Universitario de Oftalmobiología AplicadaAcademic/Hospital1112014
Katholieke Universiteit LeuvenAcademic/Hospital1112005
Korea UniversityAcademic/Hospital1112022
Lions Clubs International Foundation (funding)Academic/Hospital1012013
Maastricht UniversityAcademic/Hospital1112023
Mahidol UniversityAcademic/Hospital1112008
Price Vision GroupAcademic/Hospital1112011
Sun Yat-Sen UniversityAcademic/Hospital1112017
Taejoon Pharm Co., Ltd.For profit1012022
28 organizations
Page 1 / 2

Marketing (12)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGJan 12, 1972
AbbVieFor profitNDA2Jan 12, 1972
AlconFor profitMKTGJul 21, 1989
AllerganFor profitNDA2Jan 12, 1972
AllerganFor profitNDAJan 12, 1972
Amneal PharmaceuticalsFor profitMKTGJan 9, 2024
EyevanceFor profitNDA2Feb 11, 1986
Harrow HealthFor profitNDA2Feb 11, 1986
NovartisFor profitMKTGFeb 27, 1986
Pharmacia & UpjohnFor profitNDA2Apr 11, 1977
SmithKline BeckmanFor profitNDA2Sep 4, 1985
SmithKline BeechamFor profitNDA2Sep 29, 1989