Fluorometholone
Flarex, 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
Trade Name
FDA
EMA
Flarex, Fml (discontinued: Fluor-op, 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
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FML-S | Allergan | N-019525 DISCN | 1989-09-29 | 1 products |
Hide discontinued
Fluorometholone acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FLAREX | Eyevance | N-019079 RX | 1986-02-11 | 1 products, RLD, RS |
Fluorometholone acetate
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Tobramycin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TOBRASONE | Eyevance | N-050628 DISCN | 1989-07-21 | 1 products |
Hide discontinued
Agency Specific
FDA
EMA
No data
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
8 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | — | 2 | — | 3 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Exanthema | D005076 | R21 | — | 1 | — | — | — | 1 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | — | — | — | — | 1 |
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 | 4491 |
| 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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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473 adverse events reported
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