Delving into the Latest Updates on Fluocinonide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Fluocinonide (JP17/USP/INN), Fluocinonide Cream, Fluocinonide Gream

+ [10]

Target

GR

Action

agonists

Mechanism

GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesCongenital Disorders+ [5]

Active Indication

Alopecia AreataDermatitisImpetigo+ [12]

Inactive Indication

Inflammation

Originator Organization

County Line Pharmaceuticals LLC

Active Organization

Tianjin Jinyao Pharmaceutical Co., Ltd.Tanabe Pharma Factory Co., Ltd.

Mayinglong Pharmaceutical Group Co., Ltd.

+ [2]

Inactive Organization

Medicis Pharmaceutical Corp.

Alvogen, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (30 Jun 1971),

InflammationPruritus

Regulation-

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Structure/Sequence

Molecular FormulaC26H32F2O7

InChIKeyWJOHZNCJWYWUJD-IUGZLZTKSA-N

CAS Registry356-12-7

The goal of this randomized clinical trial is to find out whether giving an intravenous lidocaine + dexmedetomidine combination (LIDEX) during laparoscopic bariatric surgery can lower post-operative pain, inflammation, and oxidative stress in adults with obesity.
The main questions it aims to answer are:
* Pain control: Does LIDEX reduce pain 24 hours after surgery, as measured with the International Pain Outcomes Questionnaire (IPOQ)?
* Biomarkers: Does LIDEX lower blood levels of key inflammatory cytokines-interleukin-1 beta (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10)-and oxidative-stress markers-malondialdehyde (MDA), the reduced/oxidized glutathione ratio (GSH/GSSG), superoxide dismutase (SOD), and catalase-compared with the individual drugs or saline placebo?
Researchers will compare four groups: lidocaine alone, dexmedetomidine alone, LIDEX, and placebo (saline solution, a look-alike substance that contains no drug) to learn which approach works best.
Participants will:
* Receive an intravenous infusion of their assigned study drug(s) during surgery.
* Provide three small blood samples (before surgery, immediately after, and three hours after).
* Complete a short pain questionnaire (IPOQ) 24 hours after surgery.

Start Date06 Oct 2025

Sponsor / Collaborator

Instituto Mexicano del Seguro Social

NCT06504160

/ RecruitingPhase 1/2IIT

Safety and Efficacy of Topical Bacteriotherapy for Atopic Dermatitis Using Staphylococcus Hominis A9

This is a Phase 1b, randomized, placebo/vehicle-controlled, double-blinded, multi-center trial. It is designed to assess the safety and efficacy of S. hominis A9 (ShA9) topical application as a treatment for atopic dermatitis (AD). The trial will enroll adults and adolescents with atopic dermatitis who are culture positive for S. aureus colonization.
The primary safety objective of this study is to compare the safety profile of ShA9 to placebo (vehicle) over 14 weeks of application, which includes an initial two-week period of co-treatment with topical corticosteroids (TCS). The primary efficacy objective of this study is to assess the ability of ShA9, compared to placebo (vehicle), to prolong the period of atopic dermatitis control over 12 weeks after conclusion of an initial two-week period of co-treatment with TCS.

Start Date10 Apr 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+2]

NCT06135805

/ CompletedNot ApplicableIIT

Impact of the Efficacy of Fluocinonide 0.05% Oral Gel in the Treatment of Oral Lichen Planus

A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of Fluocinonide 0,05% and determinate the statistical significance of the outcome variables. Oral cavity lichen is a chronic inflammatory condition affecting the mucosa of the oral cavity , which significantly reduces the quality of life of affected individuals.

Start Date20 Aug 2023

Sponsor / Collaborator

University of Catania

100 Clinical Results associated with Fluocinonide

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100 Translational Medicine associated with Fluocinonide

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100 Patents (Medical) associated with Fluocinonide

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414

Literatures (Medical) associated with Fluocinonide

01 Oct 2025·ORAL DISEASES

Comment on “Impact of Topical Fluocinonide on Oral Lichen Planus Evolution: Randomized Controlled Clinical Trial”

Letter

Author: Jin, Jianqiu

03 Aug 2025·Expert Opinion On Drug Safety

Central serous chorioretinopathy secondary to drugs: a real-world pharmacovigilance study of the FDA adverse event reporting system (FAERS)

Article

Author: Zhang, Chunyan ; Huang, Lin ; Huang, Jing ; Zhang, Xiaohong ; Ren, Xiaolei

BACKGROUND:

The objective of this study was to evaluate the reporting associations between Central serous chorioretinopathy (CSCR) and many available drugs using FAERS.

RESEARCH DESIGN AND METHODS:

FAERS reports from 2004 to 2023 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify CSCR cases. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (CIs) for the reporting associations between available drugs and CSCR were calculated. A reporting association was considered statistically significant when the lower limit of the 95% CI was > 1.0.

RESULTS:

There were 1002 reports of 110 drugs with suspected drug-associated CSCR based on the 'primary suspects' role code in the FAERS database found to have statistically significant signals. Among the top 20 ROR drugs, the most frequently reported drugs were dermatological drugs (ATC:D, 210 cases, 64.41%), followed by antitumor agents and immunological agents (ATC:L,77 cases, 23.62%), Systemic Hormonal Preparations, Excl. Sex hormones and Insulins (ATC:H, 19 cases, 5.80%) and sensory organ drugs (ATC:S, 9 cases, 2.76%). The top 3 drugs associated with CSCR were Prednisolone (144 cases, 44.17%), Fluticasone (29 cases, 8.90%), and Methylprednisolone (27 cases, 8.28%).

CONCLUSIONS:

This is the first real-world study using FAERS database to investigate drug-induced CSCR. Clinicians and pharmacist must keep in mind CSCR is a serious ocular complication associated with glucocorticoids, tyrosine kinase receptor inhibitor, and other drugs that can cause CSCR.

01 Jun 2025·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Trends in Medicare Part D spending on topical steroids from 2012 to 2021: Increasing costs of generic topical steroids and potential savings

Article

Author: Kamal, Kanika ; Manjaly, Priya ; Ly, Sophia ; Mostaghimi, Arash

BACKGROUND:

Increasing prescription drug costs are a major concern in health care. The literature lacks an up-to-date assessment of US expenditures on topical steroids, one of the most prescribed medications in dermatology.

OBJECTIVE:

To characterize trends in Medicare spending and costs per unit of topical steroids and to model potential savings from substitution of the cheapest steroid within each potency class.

METHODS:

This is a retrospective analysis of Medicare Part D Public Use Files, which provides prescription drug expenditure data between 2012 and 2021.

RESULTS:

Between 2012 and 2021, Medicare Part D spent $5.7 billion on topical steroids, with generics accounting for 98.3%. While there has been a steady decline since 2015, total annual spending has overall increased by 35.6%, from $322.2 million in 2012 to $437 million in 2021. Inflation-adjusted costs per unit increased for most generic topical steroids, while the rate of change declined with increasing market competition. Medicare had potential savings of $2.4 billion if prescriptions were substituted for the cheapest steroid within each potency class.

LIMITATIONS:

The data set represented only 70% to 77% of beneficiaries with Part D plans, excluded manufacturer rebates, and aggregated all drug strengths. We also excluded drugs with proprietary vehicles.

CONCLUSION:

Medicare expenditures on topical steroids have increased in the past decade, primarily driven by rising generic drug costs.

100 Deals associated with Fluocinonide

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External Link

KEGG	Wiki	ATC	Drug Bank
D00325	Fluocinonide	C05AA11 D07AC08	DB01047

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Alopecia Areata	Japan	Tanabe Pharma Factory Co., Ltd.	01 May 2020
Dermatitis	Japan	Tanabe Pharma Factory Co., Ltd.	01 May 2020
Impetigo	Japan	Tanabe Pharma Factory Co., Ltd.	01 May 2020
Prurigo	Japan	Tanabe Pharma Factory Co., Ltd.	01 May 2020
Vitiligo	Japan	Tanabe Pharma Factory Co., Ltd.	01 May 2020
Skin Diseases	United States	Bausch Health US LLC	02 Mar 2006
Plaque psoriasis	United States	Bausch Health US LLC	11 Feb 2005
Dermatitis, Atopic	China	Mayinglong Pharmaceutical Group Co., Ltd.	01 Jan 1981
Dermatitis, Contact	China	Mayinglong Pharmaceutical Group Co., Ltd.	01 Jan 1981
Dermatitis, Contact	China	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981
Dermatitis, Seborrheic	China	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981
Dermatitis, Seborrheic	China	Mayinglong Pharmaceutical Group Co., Ltd.	01 Jan 1981
Eczema	China	Mayinglong Pharmaceutical Group Co., Ltd.	01 Jan 1981
Eczema	China	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981
Neurodermatitis	China	Mayinglong Pharmaceutical Group Co., Ltd.	01 Jan 1981
Neurodermatitis	China	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981
Psoriasis	China	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981
Psoriasis	China	Mayinglong Pharmaceutical Group Co., Ltd.	01 Jan 1981
Inflammation	United States	Alvogen, Inc.	30 Jun 1971
Pruritus	United States	Alvogen, Inc.	30 Jun 1971

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Phase 3	China	Ocumension Therapeutics (Suzhou) co., Ltd.	30 Jan 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01802580 (CTgov)	Early Phase 1	Psoriasis	40	Internet Survey+fluocinonide 0.05% ointment (Intervention - Internet Reminder Survey)	jwoxfpgirj(yrxggogtid) = ilzoisyyvf arjkilbqht (spgskbclgu, feioifuifp - omlcqtmlum) View more	-	12 Nov 2019
NCT01802580 (CTgov)	Early Phase 1	Psoriasis	40	fluocinonide 0.05% ointment (Standard of Care, no Internet Survey)	jwoxfpgirj(yrxggogtid) = zaxdokyqyw arjkilbqht (spgskbclgu, hphcbbfvkz - vjhhjrrcmn) View more	-	12 Nov 2019
NCT01422408 (CTgov)	Phase 2	vaginal mucosa dry \| Breast Cancer \| Dyspareunia	34	Management of Therapy Complications+Fluocinonide Cream	ikmeteugwh(utqezcgbil) = hkhzronhkz rjegilillg (rrqakygvzs, wlpmgosxbz - xxemjziywh) View more	-	09 Aug 2017
NCT00819507 (CTgov)	Phase 4	Dermatitis, Atopic	25	Fluocinonide	bpbcoabreo(eustyklsgt) = doidsggajm gaxrrkzcms (utvmhmgwuk, 7.9) View more	-	11 Jul 2017
NCT01469767 (CTgov)	Phase 2	Pruritus \| Dermatitis, Atopic	10	Fluocinonide cream	umuzhsadsu(qvccrngecj) = qeoscsbfdm dthdtoauwg (aelfsiplad, vprzhwviou - bebulzrihq) View more	-	01 May 2017
AAO2015	Not Applicable	Diabetic macular oedema	44	Fluocinolone Acetate Intravitreal Implant (Illuvien)	tgnkwajmix(wmanepgjeu) = No report of endophthalmitis in our cohort of patients jovzhkuvtj (oyfijcdwos ) View more	Positive	16 Nov 2015