{"id":"penlac","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":["Skin irritation"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"trials":[],"_chembl":null,"aliases":["topical Penlac nail lacquer"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"_dailymed":null,"ecosystem":[],"mechanism":{"target":"Deoxyhypusine hydroxylase, Poly [ADP-ribose] polymerase 1"},"_scrapedAt":"2026-03-28T04:02:33.732Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Ciclopirox","title":"Ciclopirox","extract":"Ciclopirox is a medication used for the treatment of moderate onychomycosis of fingernails and toenails, and for the treatment of seborrheic dermatitis."},"references":[],"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Candidiasis of skin","diseaseId":"candidiasis-of-skin","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Onychomycosis due to dermatophyte","diseaseId":"onychomycosis-due-to-dermatophyte","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pityriasis simplex","diseaseId":"pityriasis-simplex","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pityriasis versicolor","diseaseId":"pityriasis-versicolor","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Seborrheic dermatitis","diseaseId":"seborrheic-dermatitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tinea corporis","diseaseId":"tinea-corporis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tinea cruris","diseaseId":"tinea-cruris","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tinea pedis","diseaseId":"tinea-pedis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07024316","phase":"PHASE1, PHASE2","title":"A Study to Investigate the Improvement of Photosensitivity in Terms of Skin Lesions Associated With CEP Following Administration of Oral ATL-001 (Ciclopirox Oral Solution) in Participants Aged >18 Years of Age With CEP","status":"RECRUITING","sponsor":"Atlas Molecular Pharma","startDate":"2026-01-29","conditions":"Congenital Erythropoietic Porphyria (CEP)","enrollment":6},{"nctId":"NCT06971341","phase":"","title":"Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox","status":"NOT_YET_RECRUITING","sponsor":"University of Bologna","startDate":"2025-05-30","conditions":"Onychomycosis of Toenails","enrollment":80},{"nctId":"NCT05647343","phase":"PHASE1","title":"Study to Assess the Safety and Pharmacokinetics of ATL-001 (Ciclopirox Olamine) in Healthy Volunteers","status":"COMPLETED","sponsor":"Atlas Molecular Pharma","startDate":"2023-03-31","conditions":"Adverse Effect of Drugs and Medicaments in Therapeutic Use","enrollment":42},{"nctId":"NCT06485050","phase":"NA","title":"Photodynamic Therapy and Topical Antifungal for Onychomycosis in Patients With Diabetes.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Universidad Complutense de Madrid","startDate":"2024-04-17","conditions":"Dermatologic Disease, Onychomycosis of Toenail, Diabetic Foot","enrollment":10},{"nctId":"NCT05482763","phase":"","title":"Mycosis Culture Collection From Dermatological Isolated","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Rome Tor Vergata","startDate":"2022-07-20","conditions":"Onychomycosis, Resistant Infection, Nail Diseases","enrollment":200},{"nctId":"NCT05809297","phase":"PHASE4","title":"Diode Laser and Photodynamic Therapy Vs. Ciclopirox.","status":"UNKNOWN","sponsor":"Universidad Complutense de Madrid","startDate":"2023-09-01","conditions":"Onychomycosis","enrollment":26},{"nctId":"NCT00804193","phase":"NA","title":"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","status":"COMPLETED","sponsor":"Padagis LLC","startDate":"2004-06","conditions":"Tinea Pedis","enrollment":553},{"nctId":"NCT00802672","phase":"PHASE3","title":"Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis","status":"COMPLETED","sponsor":"Padagis LLC","startDate":"2003-12","conditions":"Tinea Pedis","enrollment":561},{"nctId":"NCT02679911","phase":"PHASE4","title":"Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2015-09","conditions":"Foot Dermatoses","enrollment":20},{"nctId":"NCT02866032","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)","status":"COMPLETED","sponsor":"Moberg Pharma AB","startDate":"2016-09","conditions":"Distal Subungual Onychomycosis","enrollment":452},{"nctId":"NCT02004860","phase":"PHASE3","title":"Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis","status":"COMPLETED","sponsor":"University Hospital, Rouen","startDate":"2014-01","conditions":"Severe Seborrheic Dermatitis","enrollment":120},{"nctId":"NCT02644551","phase":"PHASE2","title":"The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis","status":"UNKNOWN","sponsor":"9305-9954 Quebec Inc","startDate":"2016-11","conditions":"Onychomycosis","enrollment":120},{"nctId":"NCT02961634","phase":"PHASE3","title":"Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis","status":"UNKNOWN","sponsor":"MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA","startDate":"2017-04","conditions":"Onychomycosis","enrollment":46},{"nctId":"NCT00990587","phase":"PHASE1","title":"Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy","status":"COMPLETED","sponsor":"University Health Network, Toronto","startDate":"2009-10","conditions":"Hematologic Malignancy, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia","enrollment":20},{"nctId":"NCT00382330","phase":"NA","title":"Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.","status":"WITHDRAWN","sponsor":"University of Medicine and Dentistry of New Jersey","startDate":"","conditions":"Vulvar Cancer","enrollment":""},{"nctId":"NCT01646580","phase":"PHASE4","title":"Safety Study of Ciclopirox Olamine Cream for Dermatomycoses in Children","status":"TERMINATED","sponsor":"Ferrer Internacional S.A.","startDate":"2008-10","conditions":"Dermatomycoses","enrollment":21},{"nctId":"NCT01139749","phase":"PHASE4","title":"Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea","status":"UNKNOWN","sponsor":"Federal University of São Paulo","startDate":"2011-10","conditions":"Seborrhea, Seborrheic Dermatitis, Quality of Life","enrollment":50},{"nctId":"NCT01419847","phase":"PHASE4","title":"Topical Penlac Nail Lacquer for Onychomycosis in Children","status":"COMPLETED","sponsor":"Rady Children's Hospital, San Diego","startDate":"2002-03","conditions":"Onychomycosis","enrollment":40},{"nctId":"NCT01014637","phase":"PHASE4","title":"Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer in Dermatophytic Onychomycosis","status":"UNKNOWN","sponsor":"Pierre Fabre Dermo Cosmetique","startDate":"2009-08","conditions":"Onychomycosis","enrollment":260},{"nctId":"NCT00127868","phase":"NA","title":"Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)","status":"COMPLETED","sponsor":"Chen, Catherine, M.D.","startDate":"2005-03","conditions":"Tinea Capitis","enrollment":47}],"_emaApprovals":[],"_faersSignals":[{"count":27,"reaction":"FATIGUE"},{"count":27,"reaction":"PAIN"},{"count":25,"reaction":"DRUG INEFFECTIVE"},{"count":22,"reaction":"DYSPNOEA"},{"count":21,"reaction":"ASTHENIA"},{"count":21,"reaction":"DEPRESSION"},{"count":21,"reaction":"NAUSEA"},{"count":20,"reaction":"ARTHRALGIA"},{"count":20,"reaction":"FALL"},{"count":20,"reaction":"PNEUMONIA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":13,"therapeuticAreas":["Dermatology"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"phase_2","status":"active","brandName":"Penlac","genericName":"Penlac","companyName":"9305-9954 Quebec Inc","companyId":"9305-9954-quebec-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1999-12-17T00:00:00.000Z","mah":"VALEANT BERMUDA","brand_name_local":"PENLAC","application_number":"NDA021022"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}