Fluorometholone

drug
On this page

Also known as FluatonFluor-opFluorometholone component of fml-sFluorometolonaFmlFml forteFml fteFml-neoNSC-33001OxyloneSID855588SID56422125SID91286SID144212910SID144203991SID170464629

Summary

Fluorometholone (CHEMBL1200600) is an approved small-molecule anti-inflammatory drug (ATC S01BA07) targeting NR3C1; indicated across 6 conditions including acne and eye disorder.

At a glance

  • Status: Approved (max clinical phase 4)
  • Modality: Small molecule
  • ATC class: S01BA07 (+5 more)
  • Targets: 1 (NR3C1)
  • Indications: 6 conditions
  • Clinical trials: 14
  • Chemistry: 376.5 Da · C22H29FO4

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL1200600
NameFluorometholone
TypeSmall molecule
Max phase4
FDA approvedyes
PubChem CID9878
ChEBICHEBI:31625
ATCS01BA07, D07XB04, D07AB06, D10AA01, S01CB05, C05AA06
Molecular formulaC22H29FO4
Molecular weight376.5
InChIKeyFAOZLTXFLGPHNG-KNAQIMQKSA-N

SMILES: C[C@H]1C[C@H]2[C@@H]3CC[C@@]([C@]3(C[C@@H]([C@@]2([C@@]4(C1=CC(=O)C=C4)C)F)O)C)(C(=O)C)O

IUPAC name: (6S,8S,9R,10S,11S,13S,14S,17R)-17-acetyl-9-fluoro-11,17-dihydroxy-6,10,13-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one

ChEBI definition: A member of the class of glucocorticoids that is Δ1-progesterone substituted at positions 11β and 17 by hydroxy groups, at position 6α by a methyl group and at position 9 by a fluoro group. Used for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Pharmacological roles (ChEBI): anti-inflammatory drug.

Also known as: Fluaton, Fluor-op, Fluorometholone, Fluorometholone component of fml-s, Fluorometolona, Fml, Fml forte, Fml fte, Fml-neo, NSC-33001, Oxylone, SID855588

Patent coverage: 6,921 distinct patent families (24,094 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

GeneTargetActionpAffinityCancer dependencyUniProt
NR3C1Glucocorticoid receptorAgonist8.80.9%P04150

Broader ChEMBL bioactivity targets: 9 (assay-derived). Sample: Nuclear receptor ROR-gamma, Glucocorticoid receptor, Progesterone receptor, Nuclear receptor subfamily 1 group I member 2, Lysosomal alpha-glucosidase, Androgen receptor, Nuclear receptor subfamily 1 group I member 2, Hypoxia-inducible factor 1-alpha, Huntingtin.

Bioactivity

ChEMBL activities: 17 potent at pChembl ≥ 5 of 19 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

TargetpChemblTypeValueUnitActivity ID
NR3C18.8Ki1.58nMCHEMBL_ACT_7657186
NR3C18.46IC503.47nMCHEMBL_ACT_7657185
NR3C18.4AC504nMCHEMBL_ACT_25176086
HIF1A8Potency10nMCHEMBL_ACT_4128924
HIF1A8Potency10nMCHEMBL_ACT_4520746
PGR7.28AC5053nMCHEMBL_ACT_25223239
GAA6.75Potency177.8nMCHEMBL_ACT_5009809
GAA6.75Potency177.8nMCHEMBL_ACT_5058338
Q9R1A76.4EC50400nMCHEMBL_ACT_15463736
P514506.35Potency446.7nMCHEMBL_ACT_5008570
P152076.08AC50829nMCHEMBL_ACT_25187595
P152076.07Ki857nMCHEMBL_ACT_7659320
NR1I25.89EC501300nMCHEMBL_ACT_15448163
P152075.89IC501285nMCHEMBL_ACT_7659319
P514505.75Potency1771nMCHEMBL_ACT_4535643
NR1I25.5EC503200nMCHEMBL_ACT_15463729
HTT5.2Potency6310nMCHEMBL_ACT_3753410

Target pathways

Aggregated over 1 target gene(s): NR3C1.

Top Reactome pathways

8 total, by targets touching each:

PathwayTargetsGenes
HSP90 chaperone cycle for steroid hormone receptors (SHR) in the presence of ligand1NR3C1
Nuclear Receptor transcription pathway1NR3C1
SUMOylation of intracellular receptors1NR3C1
PTK6 Expression1NR3C1
Regulation of RUNX2 expression and activity1NR3C1
FOXO-mediated transcription of oxidative stress, metabolic and neuronal genes1NR3C1
Potential therapeutics for SARS1NR3C1
Regulation of NPAS4 gene transcription1NR3C1

Dominant GO biological processes

GO termTargets
negative regulation of transcription by RNA polymerase II1
regulation of gluconeogenesis1
chromatin organization1
regulation of DNA-templated transcription1
regulation of transcription by RNA polymerase II1
apoptotic process1
chromosome segregation1
signal transduction1
glucocorticoid metabolic process1
response to wounding1
gene expression1
microglia differentiation1
adrenal gland development1
nuclear receptor-mediated steroid hormone signaling pathway1
regulation of glucocorticoid biosynthetic process1

Indications & clinical

Indications

6 indications (4 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

IndicationTrial phaseMONDOEFO
acne4MONDO:0011438EFO:0003894
eye disorder4MONDO:0005328EFO:0005752
hemorrhoid4MONDO:0004872EFO:0009552
dry eye syndrome3MONDO:0006733EFO:1000906

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 14.

Phase distribution

PhaseTrials
PHASE46
PHASE33
Not specified3
PHASE2/PHASE31
PHASE21

Top trials by phase / activity

NCTPhaseStatusTitle
NCT05716945PHASE4RECRUITINGThe OPTIMISE Study
NCT02816905PHASE4COMPLETEDOcular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery
NCT03747614PHASE4UNKNOWNOcular Micro-vascular Research Base on Functional Slip Lamp Biomicroscopy
NCT05587231PHASE4UNKNOWNComparison of the Postoperative Use of Dextenza vs a Standard Regimen After PRK
NCT06876116PHASE4COMPLETEDOnce-daily Fluorometholone vs Twice-daily Cyclosporine in Dry Eye Disease
NCT07588074PHASE4COMPLETEDTolerability Comparison of Flarex to Lotemax SM
NCT00707421PHASE3COMPLETEDUsefulness of Topical Non-Steroidal Anti-Inflammatory Drugs or Steroids Before Trabeculectomy and Clinical Outcomes
NCT02030990PHASE2/PHASE3UNKNOWNThe Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements
NCT02051023PHASE3COMPLETEDEfficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca)
NCT04149210PHASE3COMPLETEDFLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial
NCT01448213PHASE2COMPLETEDComparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)
NCT01288404Not specifiedCOMPLETEDRandomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium
NCT01949454Not specifiedCOMPLETEDFluorometholone as Ancillary Therapy for TT Surgery
NCT05313828Not specifiedUNKNOWNEffect of Various Treatment Modalities on Dendritic Vial Ulcer

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.

173 molecules share ≥1 primary target. Top 60 by shared-target count:

MoleculeSourceStatusShared targets
FULVESTRANTChEMBL + PubChemPhase 4 (approved)NR3C1
PODOFILOXChEMBL + PubChemPhase 4 (approved)NR3C1
REGORAFENIBChEMBL + PubChemPhase 4 (approved)NR3C1
ACENOCOUMAROLChEMBLPhase 4 (approved)NR3C1
ALCLOMETASONE DIPROPIONATEChEMBLPhase 4 (approved)NR3C1
AMCINONIDEChEMBLPhase 4 (approved)NR3C1
AMIODARONEChEMBLPhase 4 (approved)NR3C1
APREPITANTChEMBLPhase 4 (approved)NR3C1
AURANOFINChEMBLPhase 4 (approved)NR3C1
BAZEDOXIFENEChEMBLPhase 4 (approved)NR3C1
BECLOMETHASONE DIPROPIONATEChEMBLPhase 4 (approved)NR3C1
BENZBROMARONEChEMBLPhase 4 (approved)NR3C1
BETAMETHASONEChEMBLPhase 4 (approved)NR3C1
BETAMETHASONE DIPROPIONATEChEMBLPhase 4 (approved)NR3C1
BETAMETHASONE PHOSPHORIC ACIDChEMBLPhase 4 (approved)NR3C1
BETAMETHASONE VALERATEChEMBLPhase 4 (approved)NR3C1
BUDESONIDEChEMBLPhase 4 (approved)NR3C1
BUTOCONAZOLEChEMBLPhase 4 (approved)NR3C1
CANDESARTAN CILEXETILChEMBLPhase 4 (approved)NR3C1
CANRENONEChEMBLPhase 4 (approved)NR3C1
CHLORMADINONEChEMBLPhase 4 (approved)NR3C1
CICLESONIDEChEMBLPhase 4 (approved)NR3C1
CLOBETASOL PROPIONATEChEMBLPhase 4 (approved)NR3C1
CLOFAZIMINEChEMBLPhase 4 (approved)NR3C1
CLOTRIMAZOLEChEMBLPhase 4 (approved)NR3C1
CORTISONEChEMBLPhase 4 (approved)NR3C1
DANAZOLChEMBLPhase 4 (approved)NR3C1
DAUNORUBICINChEMBLPhase 4 (approved)NR3C1
DEFLAZACORTChEMBLPhase 4 (approved)NR3C1
DESOGESTRELChEMBLPhase 4 (approved)NR3C1
DESONIDEChEMBLPhase 4 (approved)NR3C1
DESOXIMETASONEChEMBLPhase 4 (approved)NR3C1
DESOXYCORTICOSTERONE PIVALATEChEMBLPhase 4 (approved)NR3C1
DEXAMETHASONEChEMBLPhase 4 (approved)NR3C1
DEXTROTHYROXINEChEMBLPhase 4 (approved)NR3C1
DIENESTROLChEMBLPhase 4 (approved)NR3C1
DIETHYLSTILBESTROLChEMBLPhase 4 (approved)NR3C1
DIFLORASONE DIACETATEChEMBLPhase 4 (approved)NR3C1
DOXORUBICINChEMBLPhase 4 (approved)NR3C1
DROSPIRENONEChEMBLPhase 4 (approved)NR3C1
ECONAZOLEChEMBLPhase 4 (approved)NR3C1
EFAVIRENZChEMBLPhase 4 (approved)NR3C1
ENZALUTAMIDEChEMBLPhase 4 (approved)NR3C1
EPLERENONEChEMBLPhase 4 (approved)NR3C1
ESTRADIOLChEMBLPhase 4 (approved)NR3C1
ESTRIOLChEMBLPhase 4 (approved)NR3C1
ETHINYL ESTRADIOLChEMBLPhase 4 (approved)NR3C1
EXEMESTANEChEMBLPhase 4 (approved)NR3C1
FELODIPINEChEMBLPhase 4 (approved)NR3C1
FLUDROCORTISONEChEMBLPhase 4 (approved)NR3C1
FLUNISOLIDEChEMBLPhase 4 (approved)NR3C1
FLUOCINOLONE ACETONIDEChEMBLPhase 4 (approved)NR3C1
FLUOCINONIDEChEMBLPhase 4 (approved)NR3C1
FLUOXYMESTERONEChEMBLPhase 4 (approved)NR3C1
FLURANDRENOLIDEChEMBLPhase 4 (approved)NR3C1
FLUTICASONE FUROATEChEMBLPhase 4 (approved)NR3C1
FLUTICASONE PROPIONATEChEMBLPhase 4 (approved)NR3C1
GLUCAGONChEMBLPhase 4 (approved)NR3C1
HALCINONIDEChEMBLPhase 4 (approved)NR3C1
HYDROCORTISONEChEMBLPhase 4 (approved)NR3C1