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.

Background

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Safety and Efficacy of NAFT900 in Children With Tinea Capitis	2016/01/18	NCT02658292	Phase 2	Withdrawn	Merz North America, Inc.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	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
Naftin	Sebela Pharmaceuticals Inc.	54766-770	TOPICAL	10 mg in 1 g	12/21/2018

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
Naftifine Hydrochloride Ointment	唐山红星药业有限责任公司	国药准字H19980172	化学药品	软膏剂	9/20/2020
Naftifine Hydrochloride Cream	福州基石医药科技有限公司	国药准字H19980056	化学药品	乳膏剂	5/14/2020
Naftifine Hydrochloride Solution	唐山红星药业有限责任公司	国药准字H19980173	化学药品	溶液剂	9/20/2020

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.

Related News

No news found

AI-Powered Research

Premium Access