{"id":"ciclopirox-olamine-oral","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances (nausea, diarrhea)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Elevated liver enzymes"},{"rate":null,"effect":"Abdominal pain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ciclopirox olamine chelates polyvalent cations (iron and aluminum) that are essential cofactors for fungal cytochrome P450 enzymes, thereby inhibiting critical metabolic pathways. This mechanism disrupts fungal cell membrane and cell wall synthesis, leading to fungistatic and fungicidal activity against a wide range of dermatophytes, yeasts, and other fungi. The oral formulation extends systemic antifungal activity beyond topical application.","oneSentence":"Ciclopirox olamine is a broad-spectrum antifungal agent that inhibits fungal cytochrome P450 enzymes and disrupts fungal cell membrane integrity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:05:52.091Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Onychomycosis (fungal nail infection)"},{"name":"Systemic fungal infections"}]},"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":"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":"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":"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":"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":"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":[],"_approvalHistory":[],"publicationCount":145,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Ciclopirox Olamine Oral","genericName":"Ciclopirox Olamine Oral","companyName":"Atlas Molecular Pharma","companyId":"atlas-molecular-pharma","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ciclopirox olamine is a broad-spectrum antifungal agent that inhibits fungal cytochrome P450 enzymes and disrupts fungal cell membrane integrity. Used for Onychomycosis (fungal nail infection), Systemic fungal infections.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}