CLINICAL TRIALS PROFILE FOR LULICONAZOLE

All Clinical Trials for Luliconazole

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00869336 ↗	Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)	Completed	Tinea Pharmaceuticals	Phase 2	2009-03-01	To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or 28 days to achieve "complete clearance" at 2 weeks post treatment.
NCT01044381 ↗	Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis	Completed	Topica Pharmaceuticals	Phase 1/Phase 2	2010-12-01	To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting in adults with distal subungual onychomycosis of the toenails.
NCT01431820 ↗	Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis	Completed	Topica Pharmaceuticals	Phase 2/Phase 3	2012-05-01	The purpose of this study is to determine the safety and efficacy of a topical antifungal formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of the toenails.
NCT02394340 ↗	Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris	Completed	Bausch Health Americas, Inc.	Phase 4	2015-02-03	This is an open-label, maximal use study to evaluate whether luliconazole in plasma acts as an inhibitor of cytochrome P2C19 (CYP2C19) as measured by circulating levels of omeprazole before and after treatment with a maximum dose of luliconazole cream 1% in participants with moderate to severe tinea pedis and tinea cruris.
NCT02394340 ↗	Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris	Completed	Valeant Pharmaceuticals International, Inc.	Phase 4	2015-02-03	This is an open-label, maximal use study to evaluate whether luliconazole in plasma acts as an inhibitor of cytochrome P2C19 (CYP2C19) as measured by circulating levels of omeprazole before and after treatment with a maximum dose of luliconazole cream 1% in participants with moderate to severe tinea pedis and tinea cruris.
NCT02394340 ↗	Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris	Completed	Bausch & Lomb Incorporated	Phase 4	2015-02-03	This is an open-label, maximal use study to evaluate whether luliconazole in plasma acts as an inhibitor of cytochrome P2C19 (CYP2C19) as measured by circulating levels of omeprazole before and after treatment with a maximum dose of luliconazole cream 1% in participants with moderate to severe tinea pedis and tinea cruris.

Clinical Trial Conditions for Luliconazole

Condition Name

Condition Name for Luliconazole
Intervention	Trials
Tinea Pedis	3
Tinea Corporis	2
Tinea Cruris	2
Onychomycosis of Toenail	1

Condition MeSH

Condition MeSH for Luliconazole
Intervention	Trials
Tinea	5
Onychomycosis	3
Tinea Pedis	3
Tinea cruris	2

Clinical Trial Locations for Luliconazole

Trials by Country

Trials by Country for Luliconazole
Location	Trials
United States	25
Dominican Republic	3
Honduras	3

Trials by US State

Trials by US State for Luliconazole
Location	Trials
Texas	4
Oregon	2
Minnesota	2
Virginia	1
Utah	1

Clinical Trial Progress for Luliconazole

Clinical Trial Phase

Clinical Trial Phase for Luliconazole
Clinical Trial Phase	Trials
Phase 4	4
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Luliconazole
Clinical Trial Phase	Trials
Completed	7
Recruiting	1

Clinical Trial Sponsors for Luliconazole

Sponsor Name

Sponsor Name for Luliconazole
Sponsor	Trials
Bausch Health Americas, Inc.	4
Valeant Pharmaceuticals International, Inc.	3
Topica Pharmaceuticals	2

Sponsor Type

Sponsor Type for Luliconazole
Sponsor	Trials
Industry	13

Luliconazole: Clinical Trials, Market Analysis, and Projections

Introduction to Luliconazole

Luliconazole is an imidazole antifungal agent with a dual mechanism of action, exhibiting both antimycotic and fungicidal activities against dermatophytes. It inhibits ergosterol biosynthesis and reduces protease production by Trichophyton species, making it an effective treatment for various fungal infections such as tinea pedis, tinea cruris, and tinea corporis[1][5].

Clinical Trials Overview

Phase 2 and Phase 3 Trials

The clinical development program for luliconazole cream, 1%, included extensive Phase 2 and Phase 3 trials. The program involved two Phase 3 clinical trials for tinea pedis and one Phase 3 trial for tinea cruris. These trials were crucial in demonstrating the safety and efficacy of luliconazole for the proposed indications. Additional studies included a Phase 2 dose-ranging study, a maximal use pharmacokinetic (PK) study, a thorough QT study, and several dermal safety studies[1].

Pediatric Studies

A significant aspect of the clinical trials was the inclusion of pediatric patients. A single well-controlled clinical study was conducted to evaluate the safety and efficacy of luliconazole cream, 1%, in the treatment of tinea corporis in subjects aged 2 years and older. This study provided sufficient evidence of safety and efficacy in pediatric patients, supporting the expansion of the drug's indications to include younger populations[5].

Onychomycosis Trials

Topica Pharmaceuticals has been advancing a 10% luliconazole solution for the treatment of onychomycosis. Based on positive Phase 2 results, the company is preparing to enter Phase 3 development. The Phase 2 study demonstrated the safety and efficacy of the 10% solution and identified the optimal dosing regimen for future studies[4].

Market Analysis

Current Market Size and Growth

The global luliconazole market has been experiencing significant growth. As of 2023, the market size was valued at USD 0.21 billion and is projected to reach USD 0.35 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 5.84% during the forecast period[2].

Key Drivers

The growth of the luliconazole market is driven by several factors, including an increasing elderly population and technological advancements. The elderly are more susceptible to fungal infections, and advancements in antifungal treatments have improved the efficacy and safety of luliconazole[2].

Market Segmentation

The luliconazole market is segmented based on type (15gm, 30gm), application (online pharmacy, offline pharmacy), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the market dynamics and identifying key growth areas[3].

Market Projections

Future Growth

The luliconazole cream market is expected to continue its upward trend from 2023 to 2031. The market is poised for significant and noteworthy development, driven by positive market dynamics and sustained expansion. The thorough analysis of market segments, including drivers, restraints, opportunities, and challenges, indicates robust growth rates in the foreseeable future[3].

Key Players

The market is dominated by several key players, including Zydus (India), NIHON NOHYAKU CO., LTD. (Japan), Brinton Pharmaceuticals Ltd (U.S.), Hainan Hailing (China), and Sun Pharmaceutical Industries Ltd (India). These companies are instrumental in driving innovation and expansion in the luliconazole market[2].

Regulatory Background

FDA Approvals and Recommendations

Luliconazole cream, 1%, has undergone rigorous regulatory scrutiny. The FDA has approved the drug for the treatment of tinea pedis, tinea cruris, and tinea corporis in adults and pediatric patients aged 2 years and older. The regulatory process included several meetings and submissions, including Pre-IND, End-of-Phase 2, and Pre-NDA meetings, as well as Special Protocol Assessments[1][5].

Postmarket Requirements

The FDA has recommended postmarket risk evaluation and mitigation strategies, including in vivo drug interaction trials to evaluate the inhibition potential of luliconazole for CYP2C19 and CYP3A4. These trials have been completed or waived, ensuring the continued safety and efficacy of the drug[5].

Key Takeaways

• Clinical Trials: Luliconazole has undergone extensive clinical trials, including Phase 2 and Phase 3 studies, demonstrating its safety and efficacy for various fungal infections.
• Pediatric Use: The drug has been approved for use in pediatric patients aged 2 years and older, expanding its indications.
• Market Growth: The global luliconazole market is projected to grow from USD 0.21 billion in 2023 to USD 0.35 billion by 2032, with a CAGR of 5.84%.
• Key Drivers: The market is driven by an increasing elderly population and technological advancements.
• Regulatory Compliance: Luliconazole has met rigorous FDA regulatory requirements, ensuring its safety and efficacy.

FAQs

What is the expected market size of luliconazole by 2032?

The global luliconazole market size is expected to reach USD 0.35 billion by 2032[2].

What is the CAGR of the luliconazole market from 2023 to 2032?

The luliconazole market is expected to exhibit a CAGR of 5.84% from 2023 to 2032[2].

Which companies are the key players in the luliconazole market?

Key players include Zydus (India), NIHON NOHYAKU CO., LTD. (Japan), Brinton Pharmaceuticals Ltd (U.S.), Hainan Hailing (China), and Sun Pharmaceutical Industries Ltd (India)[2].

What are the primary indications for luliconazole?

Luliconazole is primarily indicated for the treatment of tinea pedis, tinea cruris, and tinea corporis[1][5].

Is luliconazole approved for pediatric use?

Yes, luliconazole cream, 1%, is approved for use in pediatric patients aged 2 years and older[5].

Sources

1. FDA Document: "204153Orig1s000 - accessdata.fda.gov"
2. Business Research Insights: "Luliconazole Market Forecast To 2032"
3. Market Research Intellect: "Global Luliconazole Cream Market Size, Scope And Forecast Report"
4. Biospace: "Topica Pharmaceuticals Announces 10% Luliconazole Program Ready for Phase 3 Development for Onychomycosis"
5. FDA Document: "Application Type Efficacy Supplement - FDA"