Ciclopirox

Overview

Ciclopirox olamine (used in preparations called Batrafen, Loprox, Mycoster, Penlac and Stieprox) is a synthetic antifungal agent for topical dermatologic treatment of superficial mycoses. In particular, the agent is especially effective in treating Tinea versicolor.

Indication

Used as a topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum.

Associated Conditions

Fungal skin infection
Pityriasis versicolor
Seborrheic dermatitis of the scalp
Tinea Corporis
Tinea Cruris
Tinea Pedis
Vulvovaginal Candidiasis
Cutaneous candidiasis
Mild Onychomycosis
Moderate Onychomycosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Diode Laser and Photodynamic Therapy Vs. Ciclopirox.	2023/04/12	NCT05809297	Phase 4	Not yet recruiting	Universidad Complutense de Madrid
Study to Assess the Safety and Pharmacokinetics of ATL-001 (Ciclopirox Olamine) in Healthy Volunteers	2022/12/12	NCT05647343	Phase 1	Completed	Atlas Molecular Pharma
Mycosis Culture Collection From Dermatological Isolated	2022/08/01	NCT05482763	N/A	Active, not recruiting	University of Rome Tor Vergata
Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis	2016/11/11	NCT02961634	Phase 3	UNKNOWN	MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA
Study to Evaluate the Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)	2016/08/15	NCT02866032	Phase 3	Completed	Moberg Pharma AB
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer	2016/02/11	NCT02679911	Phase 4	Completed	Galderma R&D
The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis	2016/01/01	NCT02644551	Phase 2	UNKNOWN	9305-9954 Quebec Inc
Safety Study of Ciclopirox Olamine Cream for Dermatomycoses in Children	2012/07/20	NCT01646580	Phase 4	Terminated	Ferrer Internacional S.A.
Topical Penlac Nail Lacquer for Onychomycosis in Children	2011/08/18	NCT01419847	Phase 4	Completed	Rady Children's Hospital, San Diego
Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis	2008/12/08	NCT00804193	Not Applicable	Completed	Padagis LLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ciclodan	Medimetriks Pharmaceuticals, Inc.	43538-500	TOPICAL	2.28 g in 1 mL	12/21/2020
Ciclopirox	Akorn	50383-419	TOPICAL	71.3 mg in 1 mL	5/26/2022
Loprox	Bausch Health US, LLC	99207-010	TOPICAL	10 mg in 0.96 mL	5/1/2019
Ciclopirox	A-S Medication Solutions	50090-6562	TOPICAL	80 mg in 1 mL	10/23/2019
Ciclopirox	Teligent Pharma, Inc.	52565-032	TOPICAL	10 mg in 0.96 mL	9/9/2019
Ciclopirox	Padagis Israel Pharmaceuticals Ltd	45802-141	TOPICAL	80 mg in 1 mL	6/7/2017
ciclopirox	Glenmark Pharmaceuticals Inc., USA	68462-455	TOPICAL	7.7 mg in 1 g	1/13/2017
Ciclopirox	Taro Pharmaceuticals U.S.A., Inc.	51672-1351	TOPICAL	10 mg in 0.96 mL	12/2/2015
Ciclopirox	Bryant Ranch Prepack	72162-2076	TOPICAL	80 mg in 1 mL	8/17/2023
Ciclopirox	Taro Pharmaceuticals U.S.A., Inc.	51672-5302	TOPICAL	80 mg in 1 mL	12/4/2019

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
REJUVENAIL ANTI-FUNGAL NAIL LACQUER ciclopirox 80mg/g solution bottle	197723	A Menarini Australia Pty Ltd	Medicine	A	5/22/2012

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PMS-CICLOPIROX	Pharmascience Inc	02413574	Solution - Topical	8 % / W/W	10/22/2013
CICLOPIROX TOPICAL SOLUTION	Sterimax Inc	02410346	Solution - Topical	8 % / W/W	9/16/2013
TARO-CICLOPIROX	Taro Pharmaceuticals Inc	02353288	Solution - Topical	8 % / W/W	10/25/2011
APO-CICLOPIROX	Apotex Inc	02298953	Solution - Topical	8 % / W/W	4/18/2008

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ONY-TEC 80 mg/g BARNIZ DE UÑAS MEDICAMENTOSO	Almirall S.A.	72143	BARNIZ DE UÑAS MEDICAMENTOSO	Medicamento Sujeto A Prescripción Médica	Commercialized
KITONAIL 80 MG/G BARNIZ DE UÑAS MEDICAMENTOSO	Polichem, S.A.	77129	BARNIZ DE UÑAS MEDICAMENTOSO	Sin Receta	Not Commercialized
CICLOPIROX ISDIN 80 MG/G BARNIZ DE UÑAS MEDICAMENTOSO	Isdin S.A.	77178	BARNIZ DE UÑAS MEDICAMENTOSO	Medicamento Sujeto A Prescripción Médica	Commercialized
CICLOCUTAN 80 MG/G BARNIZ DE UÑAS MEDICAMENTOSO	Mibe Pharma Espana S.L.	84137	BARNIZ DE UÑAS MEDICAMENTOSO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
DEXULAC 80 MG/G BARNIZ DE UÑAS MEDICAMENTOSO	Laboratorio Reig Jofre, S.A.	84423	BARNIZ DE UÑAS MEDICAMENTOSO	Medicamento Sujeto A Prescripción Médica	Commercialized
CICLOCHEM UÑAS 80mg/g BARNIZ DE UÑAS MEDICAMENTOSO	Galenicum Derma S.L.U.	61719	BARNIZ DE UÑAS MEDICAMENTOSO	Medicamento Sujeto A Prescripción Médica	Commercialized
CICLONIC 80 MG/G BARNIZ DE UÑAS MEDICAMENTOSO	Galenicum Derma S.L.U.	84430	BARNIZ DE UÑAS MEDICAMENTOSO	Medicamento Sujeto A Prescripción Médica	Commercialized
MICLAST 80 mg/g BARNIZ DE UÑAS MEDICAMENTOSO	Pierre Fabre Iberica S.A.	74682	BARNIZ DE UÑAS MEDICAMENTOSO	Medicamento Sujeto A Prescripción Médica	Commercialized
CICLOPIROX SERRA 80 MG/G BARNIZ DE UÑAS MEDICAMENTOSO	Laboratorios Serra Pamies S.A.	77305	BARNIZ DE UÑAS MEDICAMENTOSO	Medicamento Sujeto A Prescripción Médica	Commercialized

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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