Naftifine

Overview

Naftifine is a synthetic, broad spectrum, antifungal agent and allylamine derivative for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans and Epidermophyton floccosum.

Indication

For the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans and Epidermophyton floccosum.

Associated Conditions

Tinea Corporis
Tinea Cruris
Tinea Pedis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis	2022/05/05	NCT05363449	Phase 1	Completed	Therapeutics, Inc.
Safety and Efficacy of NAFT900 in Children With Tinea Capitis	2016/01/18	NCT02658292	Phase 2	Withdrawn	Merz North America, Inc.
BE Study of Naftifine HCL	2015/12/17	NCT02633813	Phase 3	Completed	Genzum Life Sciences
An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis	2015/06/09	NCT02466867	Phase 4	Completed	Merz North America, Inc.
Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis	2015/01/09	NCT02335255	Phase 1	Completed	Taro Pharmaceuticals USA
Pediatric Subjects With Tinea Corporis	2014/08/28	NCT02227290	Phase 4	Completed	Merz North America, Inc.
Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis	2014/05/07	NCT02132260	Phase 1	Completed	Taro Pharmaceuticals USA
Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris	2013/06/24	NCT01885156	Phase 3	Completed	Merz North America, Inc.
Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis	2012/04/19	NCT01580891	Phase 1	Completed	Taro Pharmaceuticals USA
Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis	2008/09/10	NCT00750139	Phase 3	Completed	Merz North America, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Naftin	Sebela Pharmaceuticals Inc.	54766-772	TOPICAL	2 g in 100 g	12/12/2023
Naftifine Hydrochloride	Sun Pharmaceutical Industries, Inc.	51672-1368	TOPICAL	20 mg in 1 g	5/25/2018
Naftifine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	51672-1368	TOPICAL	20 mg in 1 g	5/25/2018
Naftin	Legacy Pharma USA Inc.	83107-023	TOPICAL	2 g in 100 g	7/30/2025
Naftin	Merz Pharmaceuticals, LLC	0259-4126	TOPICAL	10 mg in 1 g	4/25/2013
Naftifine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	51672-1376	TOPICAL	20 mg in 1 g	2/3/2023
Naftin	Physicians Total Care, Inc.	54868-2240	TOPICAL	10 mg in 1 g	7/1/2010
Naftin	Physicians Total Care, Inc.	54868-2185	TOPICAL	10 mg in 1 g	3/4/2013
NAFTIFINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	0115-1510	TOPICAL	10 mg in 1 g	3/30/2023
Naftifine hydrochloride	Xiromed, LLC	70700-161	TOPICAL	20 mg in 1 g	1/15/2021

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
No HSA approvals found for this drug.

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
EXODERIL CREAM 1%W/W	N/A	Sandoz Hong Kong Limited	N/A	N/A	6/22/2005
ANZUMEI CREAM 1% W/W	N/A	WELLDONE PHARMACEUTICALS LIMITED	N/A	N/A	10/31/2023

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
NAFTIN GEL 1%	allergan herbert skin care division of allergan inc.	02011263	Gel - Topical	1 %	12/31/1993
NAFTIN CRM 1%	allergan herbert skin care division of allergan inc.	02011255	Cream - Topical	1 %	12/31/1993

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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