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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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Target
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Financial
Trends
Safety
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1M
3M
6M
YTD
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2Y
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EMA approval 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
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
81 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
UveitisD014605HP_0000554H20.92385520
Macular edemaD008269——1556418
EdemaD004487HP_0000969R60.91555215
Atopic dermatitisD003876EFO_0000274L20—23218
DermatitisD003872HP_0011123L30.9—23218
Posterior uveitisD015866EFO_1001119—114128
EczemaD004485HP_0000964L30.9—22217
MelanosisD008548HP_0001480L81.1—1—416
Alopecia areataD000506EFO_0004192L63———1—1
AlopeciaD000505HP_0002293L64———1—1
Show 2 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50131——5
Intermediate uveitisD015867EFO_1000986———3—14
Pars planitisD015868EFO_1001088H30.2——3—14
Retinal diseasesD012164HP_0000479H35.9—12——2
Radiation injuriesD011832———12——2
PanuveitisD015864EFO_1001082H44.111—1——2
InflammationD007249MP_0001845———1—12
Diabetes mellitusD003920HP_0000819E08-E13—11——1
InfectionsD007239EFO_0000544———1——1
Communicable diseasesD003141————1——1
Show 12 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Macular degenerationD008268EFO_0001365H35.3013———4
Retinal vein occlusionD012170EFO_1001157H34.8111——13
LentigoD007911—L81.4—1——12
NeoplasmsD009369—C8011———2
Neoplasm metastasisD009362EFO_0009708—11———2
Hand-foot syndromeD060831EFO_1001893——1———1
ExanthemaD005076HP_0000988——1———1
Geographic atrophyD057092———1———1
AtrophyD001284———1———1
Lymphatic metastasisD008207EFO_1001364——1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L402———13
GlaucomaD005901EFO_0000516H402————2
Choroidal neovascularizationD020256——1————1
Pathologic neovascularizationD009389——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Oral lichen planusD017676——————22
Lichen planusD008010—L43————22
MycosesD009181—B35-B49————11
LymphomaD008223—C85.9————11
T-cell lymphomaD016399——————11
T-cell lymphoma peripheralD016411——————11
Mycosis fungoidesD009182—C84.0————11
T-cell lymphoma cutaneousD016410——————11
Cutaneous lupus erythematosusD008178EFO_0003834L93.1————11
CandidiasisD002177—B37————11
Show 1 more
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
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
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 5,312 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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