fluocinolone acetonide
Small molecule targets NR3C1 via activation
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | RETISERT | — | 2008-08-05 | fda.gov ↗ |
| Label expansions (5) | US (FDA) | DERMA-SMOOTHE/FS | — | 1995-02-16 – 2007-12-12 | fda.gov ↗ |
| Approved | US (FDA) | SYNALAR | — | 1963-02-15 | fda.gov ↗ |
Trials 36 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04918121 | Jul 2021 → Jun 2027 expected | glaucoma | Sanjay Asrani | Active not recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT01946386 | Sep → Oct 2013 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01781936 | Jun 2012 → Jun 2018 | posterior uveitis | Glenn Jaffe | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06536491 | Aug 2024 → Dec 2025 overdue | diabetic macular edema | Eclipse Life Sciences, Inc. | Recruiting | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT06013540 | Aug → Dec 2022 | hyperpigmentation of the skin | Jinnah Postgraduate Medical Centre | Unknown | No outcome recorded |
| Phase 2 | NCT00770770 | May 2009 → Oct 2013 | macular retinal edema, retinal vein occlusion | Alimera Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT00695318 | Dec 2008 → Oct 2013 | age-related macular degeneration | Alimera Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT00975312 | Aug → Nov 2008 | lentigo | Pontificia Universidad Catolica de Chile | Completed | No outcome recorded |
| Phase 2 | NCT00576459 | Mar 2003 → Jun 2006 | diabetic macular edema | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT00032396 | Nov 2001 → ? | macular degeneration | Control Delivery Systems | Unknown | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT00456482 | May 2002 → Apr 2006 | uveitis | Bausch & Lomb Incorporated | Terminated | No outcome recorded |
| Phase 2/3 | NCT00468871 | Apr 2002 → Jun 2006 | uveitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2/3 | NCT00502541 | Sep 2001 → Sep 2006 | diabetic macular edema | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2/3 | NCT00407082 | Dec 2000 → Sep 2005 | posterior uveitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT05486468 | Oct 2022 → Jul 2026 overdue | anterior uveitis, intermediate uveitis, posterior uveitis | Texas Retina Associates | Recruiting | No outcome recorded |
| Phase 3 | NCT04636957 | Nov 2020 → Dec 2021 | acute otitis externa | Lee's Pharmaceutical Limited | Unknown | No outcome recorded |
| Phase 3 | NCT02748512 | Feb 2016 → Aug 2017 | uveitis | EyePoint Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02746991 | Jun 2015 → Oct 2019 | intermediate uveitis, panuveitis, posterior uveitis | EyePoint Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01694186 | Aug 2013 → Mar 2018 | uveitis | EyePoint Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01304706 | Apr 2011 → Nov 2013 | diabetic macular edema | Alimera Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00344968 | Sep 2007 → Dec 2009 | diabetic macular edema | Alimera Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00490815 | Aug 2007 → Sep 2009 | diabetic macular edema | Alimera Sciences | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT06539481 | Aug 2024 → Jul 2026 overdue | posterior uveitis | Alimera Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT05322070 | Jun 2022 → Nov 2025 overdue | posterior uveitis | Alimera Sciences | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04910503 | Oct 2021 → Apr 2030 expected | diabetic macular edema | Centre Hospitalier Universitaire Dijon | Recruiting | No outcome recorded |
| Phase 4 | NCT02902744 | Mar → Aug 2017 | diabetic macular edema | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 4 | NCT02424019 | May 2015 → Jul 2020 | diabetic macular edema | Alimera Sciences | Completed | No outcome recorded |
| Phase 4 | NCT02359526 | Oct 2014 → Mar 2016 | diabetic macular edema | Association for Innovation and Biomedical Research on Light and Image | Completed | No outcome recorded |
| Phase 4 | NCT02168478 | Jun 2014 | allergic disease | Noah Rosenberg, MD | Completed | No outcome recorded |
| Phase 4 | NCT02472366 | Jan 2014 → Mar 2015 | diabetic macular edema | Alimera Sciences | Completed | No outcome recorded |
| Phase 4 | NCT00720928 | Jul 2008 → Dec 2009 | Behcet disease, uveitis | Asan Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT00472966 | Nov 2006 → Apr 2007 | hyperpigmentation of the skin | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT00469183 | May 2006 → Apr 2007 | hyperpigmentation of the skin | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT00543296 | Mar 2004 → Jul 2007 | uveitis | Duke University | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06780644 | Feb → May 2025 overdue | hyperpigmentation of the skin | Indonesia University | Not yet recruiting | No outcome recorded |
| — | NCT06516419 | Feb 2024 → Mar 2025 overdue | hyperpigmentation of the skin | Indonesia University | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 16 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00605423 Comparator | Jan 2008 → Nov 2011 | age-related macular degeneration | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03238157 Comparator | Feb → Sep 2022 | retinal vascular disorder | The Cleveland Clinic | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT03784443 Comparator | Sep 2019 → Sep 2022 | diabetes mellitus, diabetic macular edema | Imperial College London | Withdrawn | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT05844982 Comparator | Nov 2023 → Dec 2029 expected | retinal vascular disorder, vision disorder | Jaeb Center for Health Research | Recruiting | No outcome recorded |
| Phase 3 | NCT05070728 Comparator | Oct 2021 → Apr 2023 | intermediate uveitis, posterior uveitis | EyePoint Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT03568318 Background | Aug 2018 → Feb 2021 overdue | atopic eczema | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03196973 Comparator | Jul 2017 → Aug 2018 | acute otitis externa | Salvat | Completed | No outcome recorded |
| Phase 3 | NCT01404611 Comparator | Jun 2011 → May 2013 | otitis media | Salvat | Completed | No outcome recorded |
| Phase 3 | NCT00967317 Comparator | Dec 2009 → Mar 2010 | ear infection | Laboratorios Osorio de Moraes Ltda. | Unknown | No outcome recorded |
| Phase 3 | NCT01867164 Background | Dec 2007 → Dec 2008 | infective vaginitis | Janssen-Cilag, S.A. | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04469595 Comparator | Aug 2020 → Dec 2024 overdue | diabetic macular edema | Alimera Sciences | Active not recruiting | No outcome recorded |
| Phase 4 | NCT00669071 Comparator | Jan → Oct 2008 | hyperpigmentation of the skin | Galderma R&D | Terminated | No outcome recorded |
| Phase 4 | NCT00132691 Comparator | Sep 2005 → Dec 2010 | uveitis | JHSPH Center for Clinical Trials | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07485777 Comparator | Jul → Dec 2026 expected | hyperpigmentation of the skin | Foundation University Islamabad | Not yet recruiting | No outcome recorded |
| — | NCT06932848 Comparator | Jun 2025 → Jun 2026 overdue | oral erosive lichen | Chulalongkorn University | Recruiting | No outcome recorded |
| — | NCT07345507 Comparator | Feb → Aug 2025 | hyperpigmentation of the skin | Jinnah Postgraduate Medical Centre | Completed | No outcome recorded |
Evidence & citations 39 cited values
Every value below carries the sentence it was read from. 55 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fluocinolone acetonide | “OBJECTIVE: To evaluate the efficacy and safety of topical ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution relative to ciprofloxacin, 0.3%, otic solution...” PMID 28006041 ↗ Apr 201742“Ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution seems to be efficacious and safe in treating acute otitis externa (AOE) compared with ciprofloxacin,...” PMID 35834251 ↗ Jul 2022 “Apply triple combination cream (Refaquin) containing hydroquinone 40 mg, tretinoin 0.5 mg, and fluocinolone acetonide 0.1 mg at night all over the face except the area around...” NCT06516419 ↗ “Apply triple combination cream containing hydroquinone 40 mg, tretinoin 0.5 mg, and fluocinolone acetonide 0.1 mg at night all over the face except the area around the eyes, 1...” NCT06780644 ↗ “Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as...” NCT03568318 ↗ “A 48 hour patch test performed in healthy volunteers to determine the presensitization (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base),...” NCT02168478 ↗ “The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of...” NCT02748512 ↗ “One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days.” NCT01867164 ↗ “following the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN®) and incisional intraocular pressure (IOP)-lowering surgery in diabetic macular edema.” PMID 38189802 ↗ Jan 2024 “The triple combination cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) was applied on the whole back of one hand.” NCT00975312 ↗ “The 0.2-μg/day Fluocinolone Acetonide Intravitreal Implant in Chronic Noninfectious Posterior Uveitis: A 3-year Randomized Trial in India.” PMID 38027419 ↗ Sep 2023 “Kligman's regimen - a combination of hydroquinone, tretinoin, and fluocinolone acetonide - remains the gold standard for treatment” NCT07485777 ↗ “YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection” NCT05486468 ↗ “Fluocinolone acetonide (FA) intravitreal 0.05 mg insert (Yutiq 0.05 mg)” NCT05070728 ↗ “EC-104-6M high-dose (fluocinolone acetonide [FA] 0.14 mg) implant” NCT06536491 ↗ “injectable fluocinolone acetonide intravitreal (FAI) insert” NCT01694186 ↗ “0.19 mg Fluocinolone Acetonide Intravitreal Implant” NCT04469595 ↗ |
| Known as | Acetonide de fluocinolone | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Acetonido de fluocinolona | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Capex | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Derma-smoothe/fs | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Dermotic | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | EC-104-6M | “EC-104-6M high-dose (fluocinolone acetonide [FA] 0.14 mg) implant” NCT06536491 ↗ |
| Known as | FAc | “following the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN®) and incisional intraocular pressure (IOP)-lowering surgery in diabetic macular edema.” PMID 38189802 ↗ Jan 2024 |
| Known as | FAI Insert | “The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of...” NCT02748512 ↗ |
| Known as | flucinolone acetonide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00720928 ↗ |
| Known as | Fluocet | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Fluocinolide (acetate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Fluocinolone acetonide component of iluvien | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Fluocinolone acetonide component of neo-synalar | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Fluocinolone acetonide component of otovel | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Fluocinolone acetonide component of tri-luma | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Fluocinolone Acetonide Intravitreal (FAI) | “Fluocinolone Acetonide Intravitreal (FAI)” NCT02748512 ↗ |
| Known as | Fluonid | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Fluotrex | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Fs shampoo | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | ILUVIEN | “Comparison of data characterizing the clinical effectiveness of the fluocinolone intravitreal implant (ILUVIEN) in patients with diabetic macular edema from the real world,...” PMID 30569759 ↗ Jan 20197“following the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN®) and incisional intraocular pressure (IOP)-lowering surgery in diabetic macular edema.” PMID 38189802 ↗ Jan 2024 “0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months” NCT05844982 ↗ “0.5 µg/Day and 0.2 µg/Day Iluvien™ (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg” NCT00770770 ↗ |
| Known as | Medidur | “Fluocinolone Acetonide/Medidur” NCT00605423 ↗ |
| Known as | Medidur FA | “This study will compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.” NCT00695318 ↗ |
| Known as | NSC-92339 | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Otosynalar | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00967317 ↗ |
| Known as | Retisert | “RETISERT™ (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a...” NCT00132691 ↗2“Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study.” PMID 16690128 ↗ May 2006 |
| Known as | Synalar | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01946386 ↗ |
| Known as | Synalar fte | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Synalar-c | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Synalar-hp | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Synalar-n | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Synandone | ChEMBL registry synonym — accepted as the source's own label CHEMBL989 ↗ |
| Known as | Yutiq | “YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection” NCT05486468 ↗2“Fluocinolone acetonide (FA) intravitreal 0.05 mg insert (Yutiq 0.05 mg)” NCT05070728 ↗ |
| Action | Activate | “Glucocorticoid receptor agonist” CHEMBL989 ↗ |
| Action | Inhibit | “reducing the expression of vascular endothelial growth factor (VEGF)” NCT02902744 ↗ |
| Modality | Other / unclassified | “a low dose, sustained release corticosteroid insert” NCT02902744 ↗ |
| Modality | Small molecule | — CHEMBL989 ↗ |
| Route | Intravitreal | “fluocinolone acetonide intravitreal implant” NCT00132691 ↗ |
| Target | NR3C1 | “Glucocorticoid receptor agonist” CHEMBL989 ↗ |