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

+ [8]

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

Mitsubishi Tanabe Pharma Factory Ltd.

Tianjin Jinyao Pharmaceutical Co., Ltd.Bausch Health US LLC

+ [2]

Inactive Organization

Alvogen, Inc.

Medicis Pharmaceutical Corp.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (30 Jun 1971),

InflammationPruritus

Regulation-

Login to view timeline

Structure/Sequence

Molecular FormulaC26H32F2O7

InChIKeyWJOHZNCJWYWUJD-IUGZLZTKSA-N

CAS Registry356-12-7

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 Applicable

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

NCT02301494

/ WithdrawnNot ApplicableIIT

Feasibility Study to Determine Effectiveness of 3.75% Topical Imiquimod Cream and Topical Vanos (Fluocinonide) Cream 0.1% in the Treatment of Early Stage Cutaneous T-cell Lymphoma

This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).

Start Date01 Apr 2020

Sponsor / Collaborator

Rochester General Hospital

[+2]

100 Clinical Results associated with Fluocinonide

Login to view more data

100 Translational Medicine associated with Fluocinonide

Login to view more data

100 Patents (Medical) associated with Fluocinonide

Login to view more data

579

Literatures (Medical) associated with Fluocinonide

24 Mar 2025·Journal of Biomolecular Structure and Dynamics

Inhibition of respiratory syncytial virus by Daclatasvir and its derivatives: synthesis of computational derivatives as a new drug development

Article

Author: Afreen, Shagufta ; Mitra, Debanjan ; Das Mohapatra, Pradeep K. ; Abdalla, Mohnad

The most common cause of respiratory tract illness in newborns and young children is the respiratory syncytial virus (RSV). There is no approved vaccination or specific antiviral medication for RSV infections. Here, an attempt has been made to explore the potential of currently marketed drugs as well as their probable derivatives to improve the possibility of developing stronger medications against RSV. From the 100 synthetic drug compounds library, the best drug molecule was identified through drug-likeness properties, toxicity, molecular docking and molecular dynamics simulations. Molecular Mechanics Generalized Born Surface Area (MM-GBSA) was also a method that was applied in this study. Daclatasvir showed the highest binding energy and appeared as the best drug to inhibit matrix protein and a fusion protein of RSV. Based on Daclatasvir, 40 computational derivatives were made. D28, D34 and D40 showed far better results than the actual drug. Changes in lipophilicity character increase the binding energy of derivatives. Molecular dynamic simulations showed their non-deviated, non-fluctuated and stable complex formation with target proteins. The high number of amino acid contacts throughout the trajectory increases the stability and effectiveness of derivatives. The key to producing a novel medicine to eradicate RSV is provided by derivatives. Daclatasvir will be employed as a potential RSV inhibitor up until that point.

01 Feb 2025·Oral Diseases

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

Article

Author: Isola, Gaetano ; Santonocito, Simona ; Alibrandi, Angela ; Verzì, Anna Elisa ; Polizzi, Alessandro ; Tartaglia, Gianluca Martino

ABSTRACTObjectiveTo examine the impact of fluocinonide 0.05% gel formulation for the topical treatment of oral lichen planus (OLP).MethodsThrough an RCT design, 47 patients with OLP were randomly allocated for topical OLP treatment with fluocinonide 0.05% (n = 23) or placebo (n = 24). Patients were examined for OLP symptoms, signs, disease severity, and extension score changes over 6‐month follow‐up.ResultsAfter 6 months, in comparison with placebo, patients treated with fluocinonide experienced a significant reduction of OLP symptoms (p = 0.024), signs (p = 0.014), and OLP extension score (p = 0.028). The two‐way ANOVA estimation models revealed that treatment with fluocinonide determined, at 6 months, a positive significant effect on the reduced OLP signs (p = 0.017), OLP symptoms (p = 0.026), and OLP extension score (p = 0.028). The multivariate regression analysis highlighted that anxiety, stress, and depression were significant predictors of every analyzed OLP outcome (p < 0.05 for each parameter) and that patients who had baseline anxiety, depression, and stress gained more benefits from fluocinonide at 6‐month follow‐up.ConclusionsTopical fluocinonide 0.05% was more efficacious compared to placebo in reducing OLP outcomes at 6‐month follow‐up. Anxiety, depression, and stress were significant predictors of OLP outcomes and positively impacted the treatment with fluocinonide at 6 months.

01 Dec 2024·International Journal of Pharmaceutics

Development and biopharmaceutical evaluation of aqueous micelle based corticosteroid formulations for topical treatment of oral lichen planus

Article

Author: Kalia, Yogeshvar N ; Suter, Valerie G.A. ; Suter, Valerie G A ; Tyagi, Vasundhara ; Kalia, Yogeshvar N. ; Lapteva, Maria ; Kandekar, Somnath

The dearth of approved products to treat oral lichen planus (OLP) compels off-label use of dermatological corticosteroid formulations not optimized for indications in the oral cavity. The aims of this study were to develop aqueous micelle based formulations of triamcinolone acetonide (TA) and fluocinonide (FLU), using D-tocopheryl polyethylene glycol succinate, and to investigate corticosteroid delivery to the epithelium-lamina propria junction region - the anatomical target for OLP treatment - in comparison to that from marketed products. Total mucosal deposition of TA after application of Kenacort® A Orabase® (0.1 % TA) and micellar hydrogel (0.1 %) was 242.1 ± 68.5 and 5936.7 ± 1269.6 ng/cm², respectively. For FLU, deposition after application of Novoter (0.05 % FLU) and micellar hydrogel (0.05 %) was 617.1 ± 126.5 and 2580.0 ± 285.5 ng/cm², respectively. A buccal biodistribution study showed that application of micelle hydrogels under occlusion for 30 min delivered 117.0 ± 15.6 ng/cm² and 225.6 ± 36.7 ng/cm², of TA and FLU, respectively, to the epithelium-lamina propria junction region. In contrast, the amounts deposited after applying Kenacort® A Orabase® and Novoter, were < LOQ. The results demonstrated that TPGS-based micelles improved mucosal bioavailability of TA and FLU in the epithelium-lamina propria junction region and might serve to improve topical OLP therapy.

100 Deals associated with Fluocinonide

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D00325	Fluocinonide	C05AA11 D07AC08	DB01047

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Alopecia Areata	Japan	Mitsubishi Tanabe Pharma Factory Ltd.	01 May 2020
Dermatitis	Japan	Mitsubishi Tanabe Pharma Factory Ltd.	01 May 2020
Impetigo	Japan	Mitsubishi Tanabe Pharma Factory Ltd.	01 May 2020
Prurigo	Japan	Mitsubishi Tanabe Pharma Factory Ltd.	01 May 2020
Vitiligo	Japan	Mitsubishi Tanabe Pharma Factory 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	Mayinglong Pharmaceutical Group Co., Ltd.	01 Jan 1981
Dermatitis, Seborrheic	China	Tianjin Jinyao Pharmaceutical 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	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981
Neurodermatitis	China	Mayinglong Pharmaceutical Group Co., Ltd.	01 Jan 1981
Pruritus	China	Mayinglong Pharmaceutical Group Co., Ltd.	01 Jan 1981
Pruritus	China	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981
Psoriasis	China	Mayinglong Pharmaceutical Group Co., Ltd.	01 Jan 1981
Psoriasis	China	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Phase 3	China	Ocumension Suzhou Biotech Co., Ltd.	30 Jan 2022
Dermatitis, Atopic	Phase 1	United States	Medicis Pharmaceutical Corp.	01 Feb 2012
Pruritus	Phase 1	United States	Alvogen, Inc.	30 Jun 1971

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

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)	xjhiolvgrs(wtmyvjwbde) = fcdumvllgg gyxshqpump (dukyapjlrq, zyhzfwqwdz - ehgzldzpfn) View more	-	12 Nov 2019
NCT01802580 (CTgov)	Early Phase 1	Psoriasis	40	fluocinonide 0.05% ointment (Standard of Care, no Internet Survey)	xjhiolvgrs(wtmyvjwbde) = thqvoschle gyxshqpump (dukyapjlrq, nsjsxctzen - xzilekvred) View more	-	12 Nov 2019
NCT01422408 (CTgov)	Phase 2	vaginal mucosa dry \| Dyspareunia \| Invasive Mammary Carcinoma	34	Management of Therapy Complications+Fluocinonide Cream	roiwmwgvvh(fjjdpwqljp) = hvjsbhnksf gatnczglly (ztxibwgwso, yogjmagcmq - wackkpqinr) View more	-	09 Aug 2017
NCT00819507 (CTgov)	Phase 4	Dermatitis, Atopic	25	Fluocinonide	flhauedpkn(bxalklrbtv) = pokhxbcbgl wnzwlsriyz (nwvziupsmg, lkhzlltqxh - srdfkcdvhc) View more	-	11 Jul 2017
NCT01469767 (CTgov)	Phase 2	Pruritus \| Dermatitis, Atopic	10	Fluocinonide cream	(bfakruvlcg) = uhkfwegiaf olkopfyjur (kafbqrgwcy, hidisglsby - ozeuteqbvy) View more	-	01 May 2017