Fluorometholone
Flarex, Fluorometholone, Fml, Fml-s, Tobrasone (fluorometholone) is a small molecule pharmaceutical. Fluorometholone was first approved as Oxylone on 1982-01-01. It is used to treat conjunctivitis, inflammation, and keratitis in the USA. The pharmaceutical is active against glucocorticoid receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| eye diseases | D005128 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Flarex, Fluorometholone, Fml (discontinued: Fluor-op, Fml, Oxylone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluorometholone
Fluorometholone
+
Sulfacetamide sodium
Fluorometholone acetate
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| flarex | New Drug Application | 2025-03-31 |
| fluorometholone | NDA authorized generic | 2020-09-24 |
| fluorometholone ophthalmic suspension | ANDA | 2024-01-09 |
| fml | New Drug Application | 2023-12-15 |
| fml forte | New Drug Application | 2025-02-13 |
| fml-s | 2007-02-20 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
FLUOROMETHOLONE, FLUOROMETHOLONE, AMNEAL | |||
| 2024-07-07 | CGT | ||
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C05: Vasoprotectives
— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use
— C05AA: Corticosteroids, topical for treatment of hemorrhoids and anal fissures
— C05AA06: Fluorometholone
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AB: Corticosteroids, moderately potent (group ii)
— D07AB06: Fluorometholone
— D07C: Corticosteroids, combinations with antibiotics
— D07CB: Corticosteroids, moderately potent, combinations with antibiotics
— D07CB03: Fluorometholone and antibiotics
— D07X: Corticosteroids, other combinations
— D07XB: Corticosteroids, moderately potent, other combinations
— D07XB04: Fluorometholone
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AA: Corticosteroids, combinations for treatment of acne
— D10AA01: Fluorometholone
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain
— S01BA07: Fluorometholone
— S01BB: Corticosteroids and mydriatics in combination
— S01BB03: Fluorometholone and mydriatics
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA07: Fluorometholone and antiinfectives
— S01CB: Corticosteroids/antiinfectives/mydriatics in combination
— S01CB05: Fluorometholone
HCPCS
No data
Clinical
Clinical Trials
35 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dry eye syndromes | D015352 | — | H04.12 | — | — | 1 | 4 | 5 | 10 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | — | 1 | 1 | 4 | 6 |
| Intraocular pressure | D007429 | — | — | — | — | 1 | 3 | — | 4 |
| Corneal diseases | D003316 | — | H18.9 | — | — | — | 1 | 1 | 2 |
| Keratoconjunctivitis | D007637 | — | H16.2 | — | — | 1 | 1 | — | 2 |
| Corneal opacity | D003318 | — | — | — | 1 | 1 | 1 | — | 2 |
| Fuchs' endothelial dystrophy | D005642 | EFO_0003946 | H18.51 | — | 1 | — | 1 | — | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 2 | — | 2 |
| Infectious keratoconjunctivitis | D007639 | — | — | — | — | — | 1 | — | 1 |
| Strabismus | D013285 | — | H50.2 | — | — | — | 1 | — | 1 |
Show 9 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Trichiasis | D058457 | — | — | — | — | 1 | — | 1 | 2 |
| Eye diseases | D005128 | EFO_0003966 | H44 | — | — | 2 | — | — | 2 |
| Uveitis | D014605 | EFO_1001231 | H20.9 | — | — | 1 | — | — | 1 |
| Anterior uveitis | D014606 | EFO_1000811 | — | — | — | 1 | — | — | 1 |
| Iridocyclitis | D015863 | — | H20 | — | — | 1 | — | — | 1 |
| Fibrosis | D005355 | — | — | — | — | 1 | — | — | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | 1 | — | — | 1 |
| Trabeculectomy | D014130 | — | — | — | — | 1 | — | — | 1 |
| Eyelid diseases | D005141 | EFO_0009547 | H02.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Corneal ulcer | D003320 | — | H16.0 | — | 1 | — | — | 1 | 2 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 1 | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | — | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | — | C34.90 | — | 1 | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 1 | — | — | — | 1 |
Show 8 more
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pathologic dilatation | D004108 | — | — | — | — | — | — | 3 | 3 |
| Keratoconus | D007640 | EFO_0004223 | H18.6 | — | — | — | — | 3 | 3 |
| Regeneration | D012038 | — | — | — | — | — | — | 3 | 3 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | — | — | — | 2 | 2 |
| Syndrome | D013577 | — | — | — | — | — | — | 2 | 2 |
| Pterygium | D011625 | — | H11.0 | — | — | — | — | 1 | 1 |
| Descemet stripping endothelial keratoplasty | D057111 | — | — | — | — | — | — | 1 | 1 |
| Lipoma | D008067 | — | D17.9 | — | — | — | — | 1 | 1 |
| Lipedema | D065134 | — | — | — | — | — | — | 1 | 1 |
| Adiposis dolorosa | D000274 | — | E88.2 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fluorometholone |
| INN | fluorometholone |
| Description | Fluorometholone is a member of the class of glucocorticoids that is Delta(1)-progesterone substituted at positions 11beta and 17 by hydroxy groups, at position 6alpha 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. It has a role as an anti-inflammatory drug. It is a fluorinated steroid, an 11beta-hydroxy steroid, a 20-oxo steroid, a 3-oxo-Delta(1),Delta(4)-steroid, a glucocorticoid, a 17alpha-hydroxy steroid and a tertiary alpha-hydroxy ketone. It is functionally related to a Delta(1)-progesterone. |
| Classification | Small molecule |
| Drug class | steroids (not prednisolone derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)[C@@]1(O)CC[C@H]2[C@@H]3C[C@H](C)C4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 426-13-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200600 |
| ChEBI ID | 31625 |
| PubChem CID | 9878 |
| DrugBank | DB00324 |
| UNII ID | SV0CSG527L (ChemIDplus, GSRS) |
Target
Agency Approved
NR3C1
NR3C1
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
Protein name
glucocorticoid receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)
Uniprot ID
Mouse ortholog
Nr3c1 (14815)
glucocorticoid receptor (Q61629)
Alternate
No data
Variants
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Financial
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Estimated US medical usage
Fluorometholone
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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1,358 adverse events reported
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