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Drug ReportsFluocinolone acetonide
Fluocinolone acetonide
Derma-smoothe/fs, Dermotic, Flac, Flucinolone, Fluocinolone, Fluocinonide, Iluvien, Neo-synalar, Otovel, Retisert, Synalar, Tri-luma, Yutiq (fluocinolone acetonide) is a small molecule pharmaceutical. Fluocinolone acetonide was first approved as Synalar on 1982-01-01. It is used to treat atopic dermatitis, facial dermatoses, foot dermatoses, hand dermatoses, and inflammation amongst others in the USA. The pharmaceutical is active against glucocorticoid receptor.
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Clinical
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Target
Variants
Financial
Trends
Safety
Events Timeline
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1M
3M
6M
YTD
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2Y
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EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Dermotic, Flac, Flucinolone, Fluocinolone, Fluocinonide, Iluvien, Retisert, Synalar, Yutiq (discontinued: Capex, Fluocet, Fluocinolone, Fluonid, Fluotrex, Synalar)
Combinations
Neo-synalar, Otovel, Tri-luma
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluocinolone acetonide
Tradename
Company
Number
Date
Products
ILUVIENAlimera SciencesN-201923 RX2014-09-26
1 products, RLD, RS
YUTIQAlimera SciencesN-210331 RX2018-10-12
1 products, RLD, RS
RETISERTBausch Health CompaniesN-021737 RX2005-04-08
1 products, RLD, RS
DERMA-SMOOTHE/FSHill DermaceuticalsN-019452 RX1988-02-03
2 products, RLD, RS
DERMOTICHill DermaceuticalsN-019452 RX2005-11-09
1 products, RLD, RS
SYNALARMedimetriks PharmaceuticalsN-012787 RX1982-01-01
3 products, RLD, RS
SYNALARMedimetriks PharmaceuticalsN-013960 RX1982-01-01
1 products, RLD, RS
SYNALARMedimetriks PharmaceuticalsN-015296 RX1982-01-01
1 products, RLD, RS
Show 2 discontinued
Fluocinolone acetonide
+
Hydroquinone
+
Tretinoin
Tradename
Company
Number
Date
Products
TRI-LUMAGaldermaN-021112 RX2002-01-18
1 products, RLD, RS
Ciprofloxacin hydrochloride
+
Fluocinolone acetonide
Tradename
Company
Number
Date
Products
OTOVELLaboratorios SalvatN-208251 RX2016-04-29
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ciprofloxacin and fluocinolone acetonideNDA authorized generic2024-10-09
derma-smoothe/fsNew Drug Application2024-09-12
dermoticNew Drug Application2024-05-17
flac otic oilANDA2024-11-19
fluocinol pakunapproved drug other2023-01-11
fluocinolone acetonideANDA2024-12-19
fluocinolone acetonide 0.01%NDA authorized generic2024-01-30
fluocinolone acetonide 0.01% / minoxidil 5% / tretinoin 0.025%unapproved drug other2019-05-08
fluocinolone acetonide 0.01% / minoxidil 7% / progesterone 0.1%unapproved drug other2019-05-08
fluocinolone acetonide 0.01% / niacinamide 4%unapproved drug other2019-05-13
Show 21 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
psoriasisEFO_0000676D011565L40
atopic dermatitisEFO_0000274D003876L20
pruritus—D011537L29
inflammationMP_0001845D007249—
facial dermatoses—D005148—
foot dermatoses—D005533—
hand dermatoses—D006229—
scalp dermatoses—D012536—
leg dermatoses—D007868—
acne vulgarisEFO_0003894D000152L70
Show 31 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Ciprofloxacin Hydrochloride / Fluocinolone Acetonide, Otovel, Laboratorios Salvat
89326102030-03-24DPU-1578
Fluocinolone Acetonide, Yutiq, Alimera Sciences Inc
79981082028-01-12DPU-3410
Fluocinolone Acetonide, Iluvien, Alimera Sciences Inc
88712412027-08-12DP
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
— C05AA10: Fluocinolone acetonide
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AC: Corticosteroids, potent (group iii)
— D07AC04: Fluocinolone acetonide
— D07B: Corticosteroids, combinations with antiseptics
— D07BC: Corticosteroids, potent, combinations with antiseptics
— D07BC02: Fluocinolone acetonide and antiseptics
— D07C: Corticosteroids, combinations with antibiotics
— D07CC: Corticosteroids, potent, combinations with antibiotics
— D07CC02: Fluocinolone acetonide and antibiotics
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain
— S01BA15: Fluocinolone acetonide
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA10: Fluocinolone acetonide and antiinfectives
— S02: Otologicals
— S02B: Corticosteroid otologicals
— S02BA: Corticosteroids
— S02BA08: Fluocinolone acetonide
— S02C: Corticosteroids and antiinfectives in combination, otologic
— S02CA: Corticosteroids and antiinfectives in combination
— S02CA05: Fluocinolone acetonide and antiinfectives
HCPCS
Code
Description
J7311
Injection, fluocinolone acetonide, intravitreal implant (retisert), 0.01 mg
J7313
Injection, fluocinolone acetonide, intravitreal implant (iluvien), 0.01 mg
J7314
Injection, fluocinolone acetonide, intravitreal implant (yutiq), 0.01 mg
Clinical
Clinical Trials
82 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Macular edemaD008269———13329
EdemaD004487—R60.9—132—6
UveitisD014605EFO_1001231H20.9———2—2
Posterior uveitisD015866EFO_1001119————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Retinal diseasesD012164—H35.9——1——1
Vision disordersD014786—H53.11——1——1
Low visionD015354————1——1
Radiation injuriesD011832—T66——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Macular degenerationD008268EFO_0001365H35.30—2———2
Retinal vein occlusionD012170EFO_1001157H34.81—1———1
Geographic atrophyD057092———1———1
AtrophyD001284———1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFluocinolone acetonide
INNfluocinolone acetonide
Description
Fluocinolone acetonide is a fluorinated steroid that is flunisolide in which the hydrogen at position 9 is replaced by fluorine. A corticosteroid with glucocorticoid activity, it is used (both as the anhydrous form and as the dihydrate) in creams, gels and ointments for the treatment of various skin disorders. It has a role as an anti-inflammatory drug and an antipruritic drug. It is an 11beta-hydroxy steroid, a 21-hydroxy steroid, a 20-oxo steroid, a cyclic ketal, a glucocorticoid, a fluorinated steroid, a 3-oxo-Delta(1),Delta(4)-steroid, an organic heteropentacyclic compound and a primary alpha-hydroxy ketone.
Classification
Small molecule
Drug classsteroids (not prednisolone derivatives); topical steroids (acetal derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC1(C)O[C@@H]2C[C@H]3[C@@H]4C[C@H](F)C5=CC(=O)C=C[C@]5(C)[C@@]4(F)[C@@H](O)C[C@]3(C)[C@]2(C(=O)CO)O1
Identifiers
PDB—
CAS-ID67-73-2
RxCUI—
ChEMBL IDCHEMBL989
ChEBI ID31623
PubChem CID6215
DrugBankDB00591
UNII ID0CD5FD6S2M (ChemIDplus, GSRS)
Target
Agency Approved
NR3C1
NR3C1
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
2908
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
Q6N0A4
Mouse ortholog
Nr3c1 (14815)
glucocorticoid receptor (Q61629)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Iluvien – Alimera Sciences
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,332 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,896 adverse events reported
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