Last update 21 Nov 2024

Luliconazole

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Luconac Solution, Luliconazole (JAN/USAN/INN), Lulifin

+ [12]

Target

fungal CYP51A1

Mechanism

fungal CYP51A1 inhibitors(Fungal CYP51A1 inhibitors)

Therapeutic Areas

Infectious DiseasesSkin and Musculoskeletal Diseases

Active Indication

Tinea ManusOnychomycosisCandidiasis, Cutaneous+ [7]

Inactive Indication

Candidiasis, Chronic Mucocutaneous

Originator Organization

Nihon Nohyaku Co., Ltd.

Active Organization

Sato Pharmaceutical Co., Ltd.

Hainan Hailing Chemipharma Corp. Ltd.Bausch Health US LLC

+ [6]

Inactive Organization

Topica Pharmaceuticals, Inc.

Janus Pharmaceuticals, Inc.

Drug Highest PhaseApproved

First Approval Date

JP (11 Apr 2005),

CandidiasisTinea VersicolorTinea

Regulation-

Structure

Molecular FormulaC14H9Cl2N3S2

InChIKeyYTAOBBFIOAEMLL-REQDGWNSSA-N

CAS Registry187164-19-8

Clinical Trials associated with Luliconazole

IRCT20240711062393N1 / RecruitingPhase 1IIT

Efficacy Evaluation of Loaded Nanostructured Lipid Carriers (NLC) with Luliconazole in Treatment-Resistant Dermatophytosis

Start Date10 Aug 2024

Sponsor / Collaborator

Mazandaran University of Medical Sciences

CTRI/2024/03/063613 / RecruitingPhase 4

A Comparative study to evaluate the efficacy and safety of topical Luliconazole versus topical Ciclopirox olamine among patients with Tinea corporis/cruris - NIL

Start Date16 Mar 2024

Sponsor / Collaborator

Pradeep & Co.

CTRI/2023/01/049161 / Active, not recruitingPhase 3IIT

A randomized study to evaluate and compare the efficacy of emollient versus topical luliconazole in the maintenance of remission of recurrent dermatophytosis after adequate systemic treatment.

Start Date26 Jan 2023

Sponsor / Collaborator-

100 Clinical Results associated with Luliconazole

100 Translational Medicine associated with Luliconazole

100 Patents (Medical) associated with Luliconazole

199

Literatures (Medical) associated with Luliconazole

01 Nov 2024·Current Drug Research Reviews

Assessing the Efficacy of Berberine Hydrochloride-loaded Transethosomal Gel System in Treating Dermatophytosis Caused by Trichophyton rubrum in ex-vivo, in-vitro and in-vivo Models

Article

Author: Tiwari, Varsha ; Singh, Sunil ; Sharma, Ajay ; Tiwari, Abhishek ; Mishra, Koushlesh Kumar ; Kaur, Chanchal Deep

Background:Dermatophytosis is the most common dermatological disorder worldwide. Many drugs are available in the market for the treatment of dermatophytosis, but they have had limited success due to the stratum corneum barrier, antifungal resistance, drug permeation, drug retention in skin layers, etc. Thus, there is a constant need for new topical compounds that are effective against dermatophytosis. Berberine-hydrochloride is an attractive candidate to become an antifungal drug, and by using nanotechnology, it achieves deeper penetration in skin layers with enhanced permeability through the stratum corneum.Methods:In this study, we developed an oleic acid-containing berberine-hydrochloride-loaded transethosomal gel for effective treatment of dermatophytosis by Trichophyton rubrum. Berberine- hydrochloride-loaded transethosomal gels were fabricated using the hot homogenization method, followed by the incorporation of transethosomes into the gel-based system using carbopol 934. Transethosomal gel was characterized by physicochemical properties, in vitro drug release, ex-vivo permeation studies, CLSM visualization, antifungal activity, histopathological evaluation, and dermatokinetic study.Results:Berberine-hydrochloride-loaded transethosomes seemed to be spherical and found in a range between 200-300 nm. Berberine-hydrochloride-loaded transethosomal gel formulation also exhibited controlled ex-vivo permeation of berberine-hydrochloride over 24 hr through excised rat skin, and CLSM confirmed deeper penetration into skin layers. The in vivo study revealed that transethosomal gel had a healing effect on the skin of Wistar rats infected with Trichophyton rubrum and was better than luliconazole cream. The histopathological evaluation confirmed its safety, and the dermatokinetic study showed transethosomal gel superiority over marketed cream.Conclusion:Therefore, the incorporation of berberine hydrochloride-loaded transethosomal nanosystems into the gel has the potential to enhance antifungal activity and permeation through transdermal drug delivery.

01 Sep 2024·The Journal of Dermatology

Impact of new antifungal medications on onychomycosis prescriptions and costs in Japan: A nationwide claims database study

Article

Author: Sato, Daisuke ; Yoshimura, Kensuke ; Sakamaki, Kentaro ; Togawa, Yaei ; Miyachi, Hideaki

AbstractOnychomycosis, a fungal nail infection, is a common dermatological condition in Japan, with a prevalence of approximately 5%–10%. Despite the introduction of new antifungal medications and updated treatment guidelines published in 2019, data on real‐world prescription trends and the associated medical costs are limited. This study aimed to investigate the prescription patterns and medical costs of topical and oral antifungal medications for onychomycosis in Japan from fiscal years 2014 to 2021 using the National Database of Health Insurance Claims and Specific Health Checkups of Japan Open Data. We analyzed the annual prescription volumes and medical costs of four antifungal medications: efinaconazole, luliconazole, fosravuconazole, and terbinafine. The prescription volume of efinaconazole, a topical medication launched in 2014, rapidly increased and dominated the market share. Fosravuconazole, an oral medication introduced in 2018, showed an increasing trend, coinciding with a decline in efinaconazole prescriptions. Terbinafine, a well‐established oral medication, experienced a substantial decrease in prescription volume. The sex‐ and age‐adjusted prescription volume per 100 000 population was higher among older adults, particularly for efinaconazole. The total medical costs for onychomycosis treatment more than doubled in fiscal year 2015 compared with that for 2014, mainly driven by efinaconazole prescriptions, and exceeded 30 billion Japanese yen in fiscal years 2019–2021. The costs slightly decreased in fiscal years 2020 and 2021, possibly due to the introduction of fosravuconazole. The predominance of topical prescriptions, especially in older adults, raises concerns regarding adherence to the Japanese guidelines that recommend oral antifungals as the first‐line treatment for onychomycosis. The substantial increase in medical costs also highlights the economic burden of onychomycosis and the need for cost‐effective treatment strategies. This study provides valuable insights into the real‐world prescription trends and medical costs of onychomycosis treatment in Japan, suggesting an opportunity to assess potential gaps between guideline recommendations and clinical practice.

01 Sep 2024·Naunyn-Schmiedeberg's Archives of Pharmacology

Polymeric micelle gel with luliconazole: in vivo efficacy against cutaneous candidiasis in Wistar rats

Article

Author: Narang, Raj Kumar ; Singh, Gurmeet

The objective of this research was focused on the design and development of luliconazole-loaded polymeric micelle hydrogel (LUL-PM-CHG) using quality by design (QbD) principle to improve the penetration and retention of LUL in the skin. The optimization of the formulation involved the utilization of a Box-Behnken design with three factors and three levels. The impact of specific formulation variables, namely the ratio of poloxamer P123 and F127, sonication time, and the quantity of drug, was investigated in terms of particle size, micellar incorporation efficiency, and polydispersity index. The LUL-loaded P123/F127 mixed micelles involved the thin film hydration method for thin preparation. The characteristics of optimized formulation include a particle size of 226 ± 8.52 nm, a polydispersity index (PDI) of 0.153 ± 0.002, a zeta potential (ZP) of 30.15 ± 2.32 mV, and a micellar incorporation efficiency (MIE) of 88.38 ± 3.84%. In vitro release studies indicated a sustained release of LUL-PM-CHG for a duration of up to 8 h. The MIC, GI₅₀, and GI₉₀ of different formulations on Candida albicans were determined using both the microtiter broth dilution method and the plate method and showed that LUL-PM-CHG exhibited the highest antifungal activity compared to the other formulations, with MIC values of 3.25 ± 0.19 ng/mL, GI₅₀ values of 37.11 ± 2.89, and GI₉₀ values of 94.98 ± 3.41 The study also measured the % of inhibition activity and the generation of intracellular reactive oxygen species (ROS) using flow cytometry. LUL-PM-CHG showed the highest percentage of inhibition (75.5%) and ROS production (MFI-140951), indicating its enhanced activity compared to LUL-CHG and LUL. Fungal infection was induced in Wistar rats using immunosuppressant's treatment followed by exposure to C. albicans. Finally, in vivo fungal scaling and histopathological studies indicated a reduction in fungal infection in Wistar rat skin after treatment. The obtained results suggested that LUL-PM can serve as a promising formulation to enhance luliconazole antifungal activity and increase patient compliance.

News (Medical) associated with Luliconazole

10 Sep 2015

·www.bioportfolio.com

Onychomycosis (Tinea Unguium) - Pipeline Review, H2 2015

Recently added to the BioPortfolio report store, Onychomycosis (Tinea Unguium) - Pipeline Review, H2 2015 is a new report from Global Markets Direct published on 2015-07-30. This 68-page report is available in PDF from $2000. Onychomycosis (Tinea Unguium) - Pipeline Review, H2 2015 Summary Global Markets Direct’s, ‘Onychomycosis (Tinea Unguium) - Pipeline Review, H2 2015’, provides an overview of the Onychomycosis (Tinea Unguium)’s therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Onychomycosis (Tinea Unguium), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Onychomycosis (Tinea Unguium) and special features on late-stage and discontinued projects. Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct’s team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope - The report provides a snapshot of the global therapeutic landscape of Onychomycosis (Tinea Unguium) - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Onychomycosis (Tinea Unguium) and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Onychomycosis (Tinea Unguium) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Onychomycosis (Tinea Unguium) pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Reasons to buy - Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage … Table of Contents Table of Contents 2 List of Tables 5 List of Figures 6 Introduction 7 Global Markets Direct Report Coverage 7 Onychomycosis (Tinea Unguium) Overview 8 Therapeutics Development 9 Pipeline Products for Onychomycosis (Tinea Unguium) - Overview 9 Pipeline Products for Onychomycosis (Tinea Unguium) - Comparative Analysis 10 Onychomycosis (Tinea Unguium) - Therapeutics under Development by Companies 11 Onychomycosis (Tinea Unguium) - Pipeline Products Glance 12 Clinical Stage Products 12 Early Stage Products 13 Unknown Stage Products 14 Onychomycosis (Tinea Unguium) - Products under Development by Companies 15 Onychomycosis (Tinea Unguium) - Companies Involved in Therapeutics Development 16 Anacor Pharmaceuticals, Inc. 16 Eisai Co., Ltd. 17 Helix BioMedix, Inc. 18 Hexima Limited 19 Meiji Seika Pharma Co., Ltd. 20 Moberg Pharma AB 21 NAL Pharmaceuticals Ltd. 22 Nihon Nohyaku Co., Ltd. 23 Novabiotics Limited 24 Nuvo Research Inc. 25 Viamet Pharmaceuticals, Inc. 26 Onychomycosis (Tinea Unguium) - Therapeutics Assessment 27 Assessment by Monotherapy Products 27 Assessment by Target 28 Assessment by Mechanism of Action 30 Assessment by Route of Administration 32 Assessment by Molecule Type 34 Drug Profiles 36 AN-2718 - Drug Profile 36 Product Description 36 Mechanism of Action 36 R&D Progress 36 E-1224 - Drug Profile 37 Product Description 37 Mechanism of Action 37 R&D Progress 37 ELS-160 - Drug Profile 39 Product Description 39 Mechanism of Action 39 R&D Progress 39 HB-1275 - Drug Profile 40 Product Description 40 Mechanism of Action 40 R&D Progress 40 HXP-124 - Drug Profile 41 Product Description 41 Mechanism of Action 41 R&D Progress 41 luliconazole - Drug Profile 42 Product Description 42 Mechanism of Action 42 R&D Progress 42 ME-1111 - Drug Profile 45 Product Description 45 Mechanism of Action 45 R&D Progress 45 NAL-3216 - Drug Profile 46 Product Description 46 Mechanism of Action 46 R&D Progress 46 NP-213 - Drug Profile 47 Product Description 47 Mechanism of Action 47 R&D Progress 47 terbinafine - Drug Profile 49 Product Description 49 Mechanism of Action 49 R&D Progress 49 terbinafine - Drug Profile 50 Product Description 50 Mechanism of Action 50 R&D Progress 50 VT-1161 - Drug Profile 51 Product Description 51 Mechanism of Action 51 R&D Progress 51 Onychomycosis (Tinea Unguium) - Recent Pipeline Updates 53 Onychomycosis (Tinea Unguium) - Dormant Projects 58 Onychomycosis (Tinea Unguium) - Discontinued Products 61 Onychomycosis (Tinea Unguium) - Product Development Milestones 62 Featured News & Press Releases 62 Mar 26, 2015: Moberg Pharma Announces Grant of EU Patent for MOB-015 Related to Topical… For more information open Onychomycosis (Tinea Unguium) - Pipeline Review, H2 2015. SKU: GMDHC6868IDB

First in Class

100 Deals associated with Luliconazole

External Link

KEGG	Wiki	ATC	Drug Bank
D01980	Luliconazole	D01AC18	DB08933

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Tinea Manus	US	Bausch Health US LLC	20 Feb 2018
Onychomycosis	JP	Sato Pharmaceutical Co., Ltd.	22 Jan 2016
Candidiasis, Cutaneous	CN	Hainan Hailing Chemipharma Corp. Ltd.	27 Jun 2012
Mycoses	KR	Dream Pharma Corp.	01 Feb 2010
Tinea corporis	JP	Nihon Nohyaku Co., Ltd.	31 Jul 2005
tinea cruris	JP	Nihon Nohyaku Co., Ltd.	31 Jul 2005
Tinea Pedis	JP	Nihon Nohyaku Co., Ltd.	31 Jul 2005
Candidiasis	JP	Sun Pharma Japan Ltd.	11 Apr 2005
Tinea	JP	Sun Pharma Japan Ltd.	11 Apr 2005
Tinea Versicolor	JP	Sun Pharma Japan Ltd.	11 Apr 2005

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Tinea corporis	Preclinical	SV	Topica Pharmaceuticals, Inc.	01 May 2011
Tinea corporis	Preclinical	BZ	Topica Pharmaceuticals, Inc.	01 May 2011
Tinea corporis	Preclinical	HN	Topica Pharmaceuticals, Inc.	01 May 2011
Tinea corporis	Preclinical	PR	Topica Pharmaceuticals, Inc.	01 May 2011
tinea cruris	Preclinical	PR	Topica Pharmaceuticals, Inc.	01 May 2011
tinea cruris	Preclinical	BZ	Topica Pharmaceuticals, Inc.	01 May 2011
Tinea Pedis	Preclinical	PR	Topica Pharmaceuticals, Inc.	01 May 2011
Tinea Pedis	Preclinical	SV	Topica Pharmaceuticals, Inc.	01 May 2011
Tinea Pedis	Preclinical	BZ	Topica Pharmaceuticals, Inc.	01 May 2011
Tinea Pedis	Preclinical	HN	Topica Pharmaceuticals, Inc.	01 May 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02767947 (CTgov)	Phase 4	Tinea corporis	75	Luliconazole Cream 1% (Luliconazole Cream 1%)	mucotxlvhs(uawridtsns) = pfbwgvydnc eqdxyokxfz (vfnsbuxfrk, duiljeeonq - ckfzrnyzla) View more	-	27 Nov 2019
				Vehicle Cream (Vehicle Cream)	mucotxlvhs(uawridtsns) = pximxqpwiv eqdxyokxfz (vfnsbuxfrk, lncpfmdydb - gynpsrwvzi) View more
NCT02767271 (CTgov)	Phase 4	tinea cruris \| Tinea Pedis	30	Luliconazole Cream 1% (Tinea Pedis)	(gignmebwwa) = huqxsiqyln gvhinclmyf (jlnzuvcfmp, jintpcalrd - bazlbjqnzl) View more	-	27 Nov 2019
				Luliconazole Cream 1% (Tinea Cruris)	rlpwcmzbhe(jkqtvrfbyk) = vowrsjuxaq yuhbsmoxio (oausucvgfa, shzfvqwvnt - ppovxonwbx) View more
NCT02394340 (CTgov)	Phase 4	tinea cruris \| Tinea Pedis	20	Omeprazole 40 mg+Luliconazole Cream 1%	bbsybszvbj(kmmhikbmgl) = xxyyxnbwrx uxylpxlpqq (ohgfnyjtmk, aqtiuuquxo - sgnhgewqrk) View more	-	27 Nov 2019

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