{"id":"loceryl-nail-lacquer","safety":{"commonSideEffects":[{"rate":null,"effect":"Nail discoloration or discoloration at application site"},{"rate":null,"effect":"Periungual erythema"},{"rate":null,"effect":"Burning or irritation at application site"},{"rate":null,"effect":"Rash or contact dermatitis"}]},"_chembl":{"chemblId":"CHEMBL489411","moleculeType":"Small molecule","molecularWeight":"317.52"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Amorolfine is a morpholine antifungal that targets the cytochrome P450-dependent enzyme lanosterol 14α-demethylase in the ergosterol synthesis pathway. By inhibiting this enzyme, it causes depletion of ergosterol and accumulation of toxic sterol precursors, leading to fungal cell membrane dysfunction and cell death. This mechanism is effective against dermatophytes, yeasts, and other fungi causing onychomycosis.","oneSentence":"Amorolfine inhibits fungal sterol synthesis by blocking lanosterol demethylase, disrupting the integrity of the fungal cell membrane.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:52:44.886Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Onychomycosis (fungal nail infection) caused by dermatophytes, yeasts, and non-dermatophyte molds"}]},"trialDetails":[{"nctId":"NCT02321098","phase":"PHASE4","title":"Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2014-02","conditions":"Foot Dermatoses","enrollment":50},{"nctId":"NCT02812043","phase":"PHASE4","title":"Comparison Between Long-pulsed Nd:YAG, Amorolfine and Combination Treatment in Treating Non-dermatophyte Onychomycosis","status":"COMPLETED","sponsor":"Mahidol University","startDate":"2016-08","conditions":"Non-dermatophyte Onychomycosis","enrollment":60},{"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":"NCT02705664","phase":"PHASE4","title":"Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2016-01","conditions":"Foot Dermatoses","enrollment":22},{"nctId":"NCT00938925","phase":"NA","title":"Effectiveness of Podiatry Care on Onychomycosis (EPOCAON)","status":"WITHDRAWN","sponsor":"University of Malaga","startDate":"2009-10","conditions":"Onychomycosis","enrollment":""},{"nctId":"NCT03098342","phase":"NA","title":"Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment","status":"UNKNOWN","sponsor":"Chulalongkorn University","startDate":"2017-06-01","conditions":"Onychomycosis of Toenail","enrollment":42},{"nctId":"NCT01851590","phase":"PHASE4","title":"Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis","status":"COMPLETED","sponsor":"Helsinki University Central Hospital","startDate":"2013-10","conditions":"Onychomycosis","enrollment":129},{"nctId":"NCT01929187","phase":"NA","title":"A Randomized Study to Evaluate the Efficacy of Herbal Ingredients Combined With a Carrier System (Phytonail) Compared With Amorolfine 5% Nail Lacquer (Loceryl) in the Treatment of Toenail Onychomycosis","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"2013-02","conditions":"Onycomycosis","enrollment":72},{"nctId":"NCT00459537","phase":"PHASE3","title":"Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis","status":"COMPLETED","sponsor":"Novartis","startDate":"2007-03","conditions":"Onychomycosis","enrollment":1029},{"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}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"PERIPHERAL ARTERY THROMBOSIS"},{"count":1,"reaction":"URINARY TRACT INFECTION"},{"count":1,"reaction":"UROSEPSIS"}],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Loceryl NL"],"phase":"marketed","status":"active","brandName":"Loceryl Nail Lacquer","genericName":"Loceryl Nail Lacquer","companyName":"Galderma R&D","companyId":"galderma-r-d","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Amorolfine inhibits fungal sterol synthesis by blocking lanosterol demethylase, disrupting the integrity of the fungal cell membrane. Used for Onychomycosis (fungal nail infection) caused by dermatophytes, yeasts, and non-dermatophyte molds.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}