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Fluocinolone acetonide

Generic Name
Fluocinolone acetonide
Brand Names
Capex, Derma-Smoothe/FS, Derma-smoothe FS, Dermotic, Flac, Iluvien, Neo-synalar, Otixal, Otovel, Retisert, Synalar, Tri-luma, Yutiq
Drug Type
Small Molecule
Chemical Formula
C24H30F2O6
CAS Number
67-73-2
Unique Ingredient Identifier
0CD5FD6S2M

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

Published: Aug 20, 2025

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]

Continue reading the full research report

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.

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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