Luliconazole

Overview

Luliconazole is a topical antifungal agent that acts by unknown mechanisms but is postulated to involve altering the synthesis of fungi cell membranes. It was approved by the FDA (USA) in November 2013 and is marketed under the brand name Luzu. Luliconazole is also approved in Japan.

Indication

Luliconazole is indicated for the treatment of interdigital tinea pedis, tinea cruris, or tinea corporis infections caused by Trichophyton rubrum and Epidermophyton floccosum.

Associated Conditions

Tinea infections of the feet caused by Epidermophyton floccosum
Tinea infections of the feet caused by Trichophyton rubrum

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis	2016/05/11	NCT02767947	Phase 4	Completed	Bausch Health Americas, Inc.
Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris	2016/05/10	NCT02767271	Phase 4	Completed	Bausch Health Americas, Inc.
Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris	2015/03/20	NCT02394340	Phase 4	Completed	Bausch & Lomb Incorporated
Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis	2011/09/12	NCT01431820	Phase 2	Completed	Topica Pharmaceuticals
Topical Antifungal Treatment for Tinea Pedis	2011/07/19	NCT01396811	Phase 3	Completed	Medicis Global Service Corporation
Topical Antifungal Treatment for Tinea Pedis	2011/07/19	NCT01396785	Phase 3	Completed	Medicis Global Service Corporation
Topical Antifungal Treatment for Tinea Cruris	2011/04/27	NCT01342315	Phase 3	Completed	Medicis Global Service Corporation
Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis	2010/01/07	NCT01044381	Phase 1	Completed	Topica Pharmaceuticals
Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)	2009/03/26	NCT00869336	Phase 2	Completed	Tinea Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Luzu	Bausch Health US, LLC	99207-850	TOPICAL	10 mg in 1 g	4/1/2020
LULICONAZOLE	Oceanside Pharmaceuticals	68682-850	TOPICAL	10 mg in 1 g	4/30/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
LUCONAC EXTERNAL SOLUTION FOR NAILS 5% w/w	Sato Pharmaceutical Co., Ltd. Kazusa Akademia Factory	SIN16428P	SOLUTION	5% w/w	2/14/2022

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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