[Translation] A multicenter, randomized, double-blind, positive-drug parallel controlled clinical trial of fenticonazole nitrate vaginal soft capsules in the treatment of vulvovaginal candidiasis

评价硝酸芬替康唑阴道软胶囊治疗外阴阴道假丝酵母菌病的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of fenticonazole nitrate vaginal soft capsules in the treatment of vulvovaginal candidiasis.

Start Date-

Sponsor / Collaborator-

CTR20170167

/ RecruitingPhase 3

硝酸芬替康唑栓治疗外阴阴道假丝酵母菌病多中心、随机、剂量、疗程探索临床研究

[Translation] A multicenter, randomized, dose- and course-exploratory clinical study of fenticonazole nitrate suppositories in the treatment of vulvovaginal candidiasis

评价硝酸芬替康唑栓治疗外阴阴道假丝酵母菌病的有效性和安全性

[Translation]

To evaluate the efficacy and safety of fenticonazole nitrate suppositories in the treatment of vulvovaginal candidiasis

Start Date09 Aug 2016

Sponsor / Collaborator

Shandong Teruilin Medicine Technology Development Co., Ltd.

CTR20130309

/ Active, not recruitingPhase 2

评价硝酸芬替康唑栓的有效性和安全性的多中心、随机、盲法、阳性药物平行对照II期临床试验

[Translation] A multicenter, randomized, blinded, positive drug parallel controlled phase II clinical trial to evaluate the efficacy and safety of fenticonazole nitrate suppositories

评价硝酸芬替康唑栓治疗外阴阴道念珠菌病的有效性和安全性，探索硝酸芬替康唑栓治疗外阴阴道念珠菌病的临床使用剂量。

[Translation]

To evaluate the efficacy and safety of fenticonazole nitrate suppositories in the treatment of vulvovaginal candidiasis and to explore the clinical dosage of fenticonazole nitrate suppositories in the treatment of vulvovaginal candidiasis.

Start Date05 Aug 2014

Sponsor / Collaborator

Beijing Meidi Kangxin Pharmaceutical Technology Co.,Ltd.

100 Clinical Results associated with Fenticonazole Nitrate

100 Translational Medicine associated with Fenticonazole Nitrate

100 Patents (Medical) associated with Fenticonazole Nitrate

174

Literatures (Medical) associated with Fenticonazole Nitrate

04 Mar 2025·Microbiology Spectrum

Antifungal susceptibility testing and determination of local epidemiological cut-off values for Candida species isolated from women with vulvovaginal candidiasis

Article

Author: Resoulai, Esmeralda ; Meletiadis, Joseph ; Kanioura, Lamprini ; Siopi, Maria ; Antonopoulou, Stavroula ; Kroustali, Vasiliki

ABSTRACT The lack of clinical breakpoints and epidemiological cut-off values (ECOFFs) for antifungals prescribed for vulvovaginal candidiasis (VVC) make interpretation of antifungal susceptibility data difficult. This leads to empirical prescribing, poor clinical management and emergence of resistance. The in vitro susceptibilities of 152 Candida albicans , 105 Candida parapsilosis , 31 Nakaseomyces glabratus, and 8 Pichia kudriavzevii VVC isolates against eight antifungals, were determined according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST) E.Def 7.4. The minimum inhibitory concentration (MIC) distributions were analyzed and local ECOFFs were determined visually and statistically. The in vitro activity of azoles was correlated with fluconazole susceptibility and clinical data were evaluated. The MICs of various azoles showed a significant correlation with the MICs of fluconazole and fluconazole non-wild type (WT) isolates had significantly higher MICs for other azoles. The estimated local ECOFFs for C. albicans were 0.016 mg/L (ketoconazole, clotrimazole), 0.06 mg/L (miconazole, econazole, itraconazole), 1 mg/L (fenticonazole), and 3,200 mg/L (boric acid). For C. parapsilosis , local ECOFFs were 0.06 mg/L (ketoconazole, clotrimazole, itraconazole), 1 mg/L (miconazole, econazole), 2 mg/L (fenticonazole), and 3,200 mg/L (boric acid). For N. glabratus , they were 1 mg/L (ketoconazole, clotrimazole, miconazole, itraconazole), 2 mg/L (econazole, fenticonazole), and 12,800 mg/L (boric acid). Non-WT isolates were detected for azoles in N. glabratus (10%–35%), C. albicans (5%–16%), and C. parapsilosis (≤ 3%). All isolates were WT for boric acid. Local ECOFFs were established for three major Candida species causing VVC, guiding the identification of non-WT isolates potentially associated with treatment failure. IMPORTANCE The interpretation of in vitro susceptibility data of Candida isolates from women with vulvovaginal candidiasis (VVC) is challenging due to the lack of clinical breakpoints (CBPs) and epidemiological cut-off values (ECOFFs) for drugs used in VVC. In the present study, local ECOFFs were established for three major Candida species causing VVC, guiding the identification of non-wild type isolates potentially associated with treatment failure. This paper provides the framework for developing ECOFFs and ultimately CBPs that would help guide antifungal therapy of VVC.

01 Dec 2024·Antonie van Leeuwenhoek

Species distribution and antifungal susceptibility profiles of yeasts isolated from onychomycosis: a cross-sectional study with insights into emerging species

Article

Author: Kharazi, Mahboobeh ; Motamedi, Marjan ; Jabrodini, Ahmad ; Rezaei Arab, Maryam ; Shariat, Sahar ; Zomorodian, Kamiar ; Shabanzadeh, Shafigheh ; Ghasemi, Farnia ; Yazdanpanah, Somayeh

Candida onychomycosis is a common fungal infection affecting the nails, primarily caused by Candida (C.) species. Regarding the increasing trend of Candida onychomycosis and the antifungal resistant phenomenon in recent years, this study aims to evaluate the epidemiological characteristics of Candida onychomycosis, the distribution of emerging species, and the antifungal susceptibility profiles of isolates. Onychomycosis caused by yeast species was confirmed through direct examination and culture of nail scraping among all individuals suspected to have onychomycosis and referred to a medical mycology laboratory between June 2019 and March 2022. Species of yeast isolates were identified using the multiplex PCR and PCR-RFLP methods. The antifungal susceptibility of isolates to common antifungal agents and imidazole drugs was evaluated according to the M-27-A3 CLSI protocol. Among 101 yeast strains isolated from onychomycosis, Candida parapsilosis complex (50.49%) was the most common species, followed by C. albicans (20.79%) and C. tropicalis (10.89%). Rare species of yeasts such as C. guilliermondii and Saccharomyces cerevisiae were also identified by molecular methods. Results obtained from antifungal susceptibility testing showed significant differences in MIC values of isoconazole, fenticonazole, and sertaconazole among different species. Overall, a fluconazole-resistant rate of 3% was found among Candida species. Moreover, there was a statistically significant difference in MICs of fenticonazole and clotrimazole between the two most prevalent causative species, C. parapsilosis complex and C. albicans. Correct identification of the causative agents of onychomycosis and performing susceptibility testing could be helpful in choosing the most appropriate antifungal therapy.

01 Oct 2024·Journal of Biological Chemistry

Development of a high throughput cytochrome P450 ligand-binding assay

Article

Author: Scott, Emily E. ; Frydendall, Elyse K ; Frydendall, Elyse ; Scott, Emily E

Human cytochrome P450 enzymes are membrane-embedded monooxygenases responsible for xenobiotic metabolism, steroidogenesis, fatty acid metabolism, and vitamin metabolism. Their active sites can accommodate diverse small molecules and understanding these interactions is key to decoding enzymatic functionality and designing drugs. The most common method for characterizing small molecule binding is quantifying absorbance changes that typically occur when ligands enter the active site near the heme iron. Traditionally, such titrations are monitored by a spectrophotometer, requiring significant manual time, protein, and increasing solvents. This assay was adapted for semi-automated high throughput screening, increasing throughput 50-fold while requiring less protein and keeping solvent concentrations constant. This 384-well assay was validated for both type I and II shifts typically observed for substrates and heme-coordinating inhibitors, respectively. This assay was used to screen a library of ∼100 diverse imidazole-containing compounds which can coordinate with the heme iron if compatible with the overall active site. Three human cytochrome P450 enzymes were screened: drug-metabolizing CYP2A6 and CYP2D6 and sterol-metabolizing CYP8B1. Each bound different sets of imidazole compounds with varying K_d values, providing a unique binding fingerprint. As a final validation, the K_d values were used to generate pharmacophores to compare to experimental X-ray structures. Applications for the high-throughput assay include the following: 1) facilitating generation of pharmacophores for enzymes where structures are not available, 2) screening to identify ligands for P450 orphans, 3) screening for inhibitors of P450s drug targets, 4) screening potential new drugs to avoid and/or control P450 metabolism, and 5) efficient validation of computational ligand binding predictions.

100 Deals associated with Fenticonazole Nitrate

External Link

KEGG	Wiki	ATC	Drug Bank
D02583	Fenticonazole Nitrate	D01AC12 G01AF12	DB13434

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Mycoses	-	-	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Candidiasis, Vulvovaginal	Phase 3	China	Shandong Teruilin Medicine Technology Development Co., Ltd.	09 Aug 2016
Tinea Pedis	Phase 2	China	Kaifeng Pharmaceutical (Group) Co., Ltd.	12 Apr 2019
Dermatomycoses	Phase 1	China	Nanjing Haina Pharmaceutical Technology Co Ltd.	17 Aug 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis