Overview
Fluocinolone acetonide, with the formula 6-alpha, 9-alpha-difluoro-16-alpha, 17 alpha-acetonide, is a corticosteroid that presents a high lipophilicity. It has been used extensively in dermatological preparations and it has also been investigated thoroughly for its use in implantable corticosteroid devices. This type of device containing fluocinolone acetonide was developed by Taro Pharmaceuticals and approved by FDA in May 2016.
Indication
Fluocinolone acetonide has been used extensively in different medical areas. -In dermatology, it is extensively used for the relief of inflammatory dermatosis, dermatitis, psoriasis, hypertrophic tissues, keloid tissues and atopic dermatitis. -It has been used in shampoo products as a low to medium potency corticosteroid for the treatment of seborrheic dermatitis of the scalp. -In ear drops, it is used as a low to medium potency corticosteroid for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older. -As an intravitreal implant, it is indicated for the treatment of diabetic macular edema with patients that have been previously treated with a course of corticosteroids and no clinically significant rise in intraocular pressure. -Fluocinolone acetonide was announced on October 15, 2018 to be FDA approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. -Some reports have indicated the use of fluocinolone acetonide as a vasoprotective agent and for its use in the treatment of first-degree hemorrhoids.
Associated Conditions
- Acute Otitis Media (AOM)
- Allergic Skin Reaction
- Atopic Dermatitis
- Blisters
- Chronic Disease of Skin
- Dermatosis
- Diabetic Macular Edema (DME)
- External Hemorrhoid
- Fissure;Anal
- Friction and Pressure Injuries
- Hemorrhoids, Internal
- Non-infectious Posterior Uveitis Chronic Uveitis
- Otitis Externa
- Perianal erythema
- Pruritus
- Psoriasis of the scalp
- Purulent Wounds
- Scab
- Seborrheic dermatitis of the scalp
- Skin Inflammation caused by Bacterial Infections
- Skin Inflammation of the ear
- Uveitis
- Wound Infections
- Anal eczema
- Bacterial skin infections
- Chronic eczematous otitis externa
- Corticosteroid-responsive dermatoses
Research Report
A Comprehensive Monograph on Fluocinolone Acetonide (DB00591): From Topical Dermatoses to Intravitreal Implants
Overview and Key Findings
Fluocinolone acetonide is a synthetic, fluorinated corticosteroid that has been a cornerstone of anti-inflammatory therapy for over six decades. Identified by DrugBank ID DB00591 and CAS Number 67-73-2, this small molecule has demonstrated remarkable versatility, attributable to its potent intrinsic activity and its adaptability to a wide range of pharmaceutical formulations.[1] This report provides an exhaustive analysis of fluocinolone acetonide, synthesizing data from chemical databases, regulatory filings, clinical trials, and professional pharmacotherapy resources to create a definitive monograph for clinicians and researchers.
The primary mechanism of action for fluocinolone acetonide is its function as a high-affinity agonist of the intracellular glucocorticoid receptor.[1] This interaction initiates a cascade of genomic effects, leading to the upregulation of anti-inflammatory proteins like annexin-1 and the subsequent suppression of key inflammatory mediators, including prostaglandins and leukotrienes.[2] This fundamental activity translates into potent anti-inflammatory, antipruritic, and vasoconstrictive effects, which form the basis of its therapeutic utility.[4]
A defining characteristic of fluocinolone acetonide is the critical role that pharmaceutical formulation plays in dictating its clinical application and safety profile. The same active pharmaceutical ingredient is engineered into a spectrum of products, from low-potency topical creams, oils, and shampoos for the management of dermatological conditions such as atopic dermatitis and psoriasis, to sophisticated, long-acting intravitreal implants for chronic, sight-threatening ocular diseases like diabetic macular edema (DME) and non-infectious posterior uveitis.[2]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/05/06 | Phase 3 | Recruiting | Jaeb Center for Health Research | ||
2022/10/25 | N/A | Recruiting | Tianjin Medical University | ||
2022/08/03 | Phase 3 | Recruiting | |||
2021/06/08 | Early Phase 1 | Active, not recruiting | Sanjay Asrani | ||
2020/07/14 | Phase 4 | Active, not recruiting | |||
2020/04/09 | N/A | Recruiting | |||
2018/12/21 | Phase 2 | Withdrawn | |||
2017/06/23 | Phase 3 | Completed | Salvat | ||
2016/09/16 | Phase 4 | Withdrawn | |||
2015/06/15 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Bryant Ranch Prepack | 72162-1271 | TOPICAL | 0.1 mg in 1 mL | 3/11/2024 | |
Bryant Ranch Prepack | 72162-1434 | TOPICAL | 0.01 mg in 100 mL | 3/12/2024 | |
Royal Pharmaceuticals | 68791-101 | TOPICAL | 0.11 mg in 1 mL | 4/15/2018 | |
Sincerus Florida, LLC | 72934-1083 | TOPICAL | 0.025 g in 100 g | 5/20/2019 | |
Rising Pharmaceuticals, Inc. | 64980-329 | AURICULAR (OTIC) | 0.11 mg in 1 mL | 10/25/2018 | |
Lupin Pharmaceuticals,Inc. | 43386-069 | TOPICAL | 0.1 mg in 1 mL | 2/21/2019 | |
Amneal Pharmaceuticals LLC | 65162-703 | TOPICAL | 0.11 mg in 118.28 mL | 12/18/2023 | |
Medimetriks Pharmaceuticals | 43538-940 | TOPICAL | 0.25 mg in 1 g | 1/10/2023 | |
EyePoint Pharmaceuticals, Inc | 71879-136 | INTRAOCULAR | 0.18 mg in 1 1 | 12/13/2023 | |
Amneal Pharmaceuticals LLC | 65162-702 | AURICULAR (OTIC) | 0.11 mg in 20 mL | 12/18/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
FLUNOLONE-V CREAM 0.25 mg/g | ATLANTIC LABORATORIES CORPN LTD | SIN04897P | CREAM | 0.25 mg/g | 7/5/1990 |
SUPRICORT CREAM 0.025% w/w | SIN03907P | CREAM | 0.025% w/w | 2/21/1990 | |
TRI-LUMA CREAM | SIN12607P | CREAM | 0.1 mg/g | 10/19/2004 | |
CETRAXAL PLUS EAR DROPS SOLUTION | SIN14597P | SOLUTION | 0.25mg | 8/29/2014 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
FLUOCINOLONE CREAM 0.0125% (VIDA) | N/A | N/A | N/A | 9/25/2000 | |
FLUOCINOLONE ACETONIDE OINT 0.03% | N/A | N/A | N/A | 10/25/1986 | |
CINO-N CREAM | N/A | N/A | N/A | 3/5/1987 | |
SYNCO-CFN CREAM | N/A | N/A | N/A | 7/15/1993 | |
NEO-CINOLONE CREAM | N/A | N/A | N/A | 5/18/1984 | |
UNI-CINOLONE CREAM 0.025% | N/A | N/A | N/A | 10/14/1992 | |
FLUOCINOLONE CREAM 0.0125% W/W | N/A | N/A | N/A | 7/13/2015 | |
CATELONE-N CREAM | N/A | N/A | N/A | 3/5/1987 | |
FLU-N CREAM | N/A | N/A | N/A | 5/19/1979 | |
FLUOCINOLONE CREAM 0.025% (VIDA) | N/A | N/A | N/A | 9/25/2000 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ILUVIEN fluocinolone acetonide 190 mcg intravitreal implant in applicator | 306543 | Medicine | A | 8/6/2019 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SYNALAR CREAM 0.025% | medicis canada ltd. | 00030422 | Cream - Topical | 0.025 % | 12/31/1970 |
SYNALAR CREAM MILD 0.01% | medicis canada ltd. | 00030414 | Cream - Topical | 0.01 % | 12/31/1967 |
DERMA SMOOTHE/FS LIQ 0.01% | Hill Dermaceuticals Inc | 00873292 | Emulsion - Topical | 0.01 % | 12/31/1991 |
SYNALAR BI-OTIC SOLUTION | medicis canada ltd. | 00189499 | Solution - Otic | 0.25 MG / ML | 12/31/1986 |
SYNALAR ONT REGULAR 0.025% | syntex inc. | 00030406 | Ointment - Topical | .025 % | 12/31/1963 |
FS SHAMPOO-0.01% | Hill Dermaceuticals Inc | 02129078 | Shampoo - Topical | .01 % | 12/31/1994 |
SYNALAR OINTMENT MILD 0.01% | medicis canada ltd. | 00030392 | Ointment - Topical | 0.01 % | 12/31/1968 |
RETISERT | bausch & lomb inc | 02306980 | Implant - Intravitreal | 0.59 MG | 9/13/2012 |
FLUODERM ONT 0.01% | 00716804 | Ointment - Topical | .1 MG / G | 12/31/1979 | |
OTIXAL | medexus pharmaceuticals inc. | 02459655 | Solution - Otic | 0.025 % / W/V | 5/8/2017 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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