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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Commercial
Trade Name
FDA
EMA
Dermotic, Flac, Fluocinolone, Iluvien, Retisert, Synalar, Yutiq (discontinued: Capex, Fluocet, Fluocinolone, Fluocinonide, Fluonid, Fluotrex, Synalar)
CombinationsNeo-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 |
|---|---|---|---|---|
| ILUVIEN | Alimera Sciences | N-201923 RX | 2014-09-26 | 1 products, RLD, RS |
| YUTIQ | Alimera Sciences | N-210331 RX | 2018-10-12 | 1 products, RLD, RS |
| RETISERT | Bausch Health Companies | N-021737 RX | 2005-04-08 | 1 products, RLD, RS |
| DERMA-SMOOTHE/FS | Hill Dermaceuticals | N-019452 RX | 1988-02-03 | 2 products, RLD, RS |
| DERMOTIC | Hill Dermaceuticals | N-019452 RX | 2005-11-09 | 1 products, RLD, RS |
| SYNALAR | Medimetriks Pharmaceuticals | N-012787 RX | 1982-01-01 | 3 products, RLD, RS |
| SYNALAR | Medimetriks Pharmaceuticals | N-013960 RX | 1982-01-01 | 1 products, RLD, RS |
| SYNALAR | Medimetriks Pharmaceuticals | N-015296 RX | 1982-01-01 | 1 products, RLD, RS |
Show 2 discontinued
Fluocinolone acetonide
+
Hydroquinone
+
Tretinoin
Ciprofloxacin hydrochloride
+
Fluocinolone acetonide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OTOVEL | LAB SALVAT | N-208251 RX | 2016-04-29 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ciprofloxacin and fluocinolone acetonide | NDA authorized generic | 2024-10-09 |
| derma-smoothe/fs | New Drug Application | 2025-07-01 |
| dermotic | New Drug Application | 2025-05-09 |
| flac otic oil | ANDA | 2024-11-19 |
| fluocinolone acetonide | ANDA | 2025-11-11 |
| fluocinolone acetonide 0.01% / minoxidil 5% / tretinoin 0.025% | unapproved drug other | 2019-05-08 |
| fluocinolone acetonide 0.01% / minoxidil 7% / progesterone 0.1% | unapproved drug other | 2019-05-08 |
| fluocinolone acetonide 0.01% / niacinamide 4% | unapproved drug other | 2019-05-13 |
| fluocinolone acetonide 0.01/ niacinamide 4 | unapproved drug other | 2019-05-13 |
| fluocinolone acetonide 0.025% / lidocaine hcl monohydrate 1% | unapproved drug other | 2019-05-20 |
Show 13 more
Indications
FDA
EMA
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Agency Specific
FDA
EMA
No data
Patent Expiration
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
Clinical
Clinical Trials
75 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Uveitis | D014605 | EFO_1001231 | H20.9 | 2 | 2 | 7 | 5 | 5 | 19 |
| Macular edema | D008269 | — | — | 1 | 5 | 5 | 6 | 4 | 18 |
| Edema | D004487 | — | R60.9 | 1 | 3 | 3 | 5 | 1 | 12 |
| Posterior uveitis | D015866 | EFO_1001119 | — | 1 | 1 | 4 | 1 | 2 | 8 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | 3 | 2 | 1 | 7 |
| Melanosis | D008548 | EFO_0003963 | L81.1 | — | 1 | — | 3 | 2 | 6 |
| Eczema | D004485 | — | L30.9 | — | 1 | — | 1 | 1 | 3 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 1 | 1 | 1 | 3 |
| Alopecia | D000505 | — | L64 | — | — | — | 1 | — | 1 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | 1 | — | 1 |
Show 5 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intermediate uveitis | D015867 | EFO_1000986 | — | — | — | 3 | — | 1 | 4 |
| Pars planitis | D015868 | EFO_1001088 | H30.2 | — | — | 3 | — | 1 | 4 |
| Radiation injuries | D011832 | — | T66 | — | 1 | 2 | — | — | 2 |
| Dermatitis | D003872 | — | L30.9 | — | — | 1 | — | 1 | 2 |
| Panuveitis | D015864 | EFO_1001082 | H44.11 | 1 | — | 1 | — | — | 2 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | 1 | — | — | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | 1 | 1 | — | — | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | — | 1 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | — | — | 1 | — | — | 1 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | 3 | — | — | — | 4 |
| Retinal vein occlusion | D012170 | EFO_1001157 | H34.81 | 1 | 1 | — | — | 1 | 3 |
| Lentigo | D007911 | — | L81.4 | — | 1 | — | — | — | 1 |
| Hand-foot syndrome | D060831 | EFO_1001893 | — | — | 1 | — | — | — | 1 |
| Exanthema | D005076 | — | — | — | 1 | — | — | — | 1 |
| Pruritus | D011537 | — | L29 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Geographic atrophy | D057092 | — | — | — | 1 | — | — | — | 1 |
| Atrophy | D001284 | — | — | — | 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 | 2 | — | — | — | 1 | 3 |
| Glaucoma | D005901 | EFO_0000516 | H40 | 2 | — | — | — | — | 2 |
| Choroidal neovascularization | D020256 | — | — | 1 | — | — | — | — | 1 |
| Pathologic neovascularization | D009389 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Oral lichen planus | D017676 | — | — | — | — | — | — | 2 | 2 |
| Lichen planus | D008010 | — | L43 | — | — | — | — | 2 | 2 |
| Mycosis fungoides | D009182 | — | C84.0 | — | — | — | — | 1 | 1 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | — | — | — | — | 1 | 1 |
| Cutaneous lupus erythematosus | D008178 | EFO_0003834 | L93.1 | — | — | — | — | 1 | 1 |
| Candidiasis | D002177 | — | B37 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fluocinolone acetonide |
| INN | fluocinolone 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 class | steroids (not prednisolone derivatives); topical steroids (acetal derivatives) |
| Image (chem structure or protein) |  |
| 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-ID | 67-73-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL989 |
| ChEBI ID | 31623 |
| PubChem CID | 6215 |
| DrugBank | DB00591 |
| UNII ID | 0CD5FD6S2M (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
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Iluvien – Alimera Sciences
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Safety
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Adverse Events
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2,922 adverse events reported
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