{"id":"naft500-pediatric","safety":{"commonSideEffects":[{"rate":null,"effect":"Local skin irritation"},{"rate":null,"effect":"Burning or stinging at application site"},{"rate":null,"effect":"Erythema"},{"rate":null,"effect":"Pruritus"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Naftifine is an allylamine-class antifungal that disrupts ergosterol biosynthesis in fungal cell membranes by inhibiting the enzyme squalene epoxidase. This leads to accumulation of squalene and depletion of ergosterol, destabilizing the fungal cell membrane and causing fungal cell death. The pediatric formulation (NAFT500) is designed for safe topical use in children.","oneSentence":"NAFT500 is a naftifine hydrochloride topical antifungal that inhibits fungal sterol synthesis by blocking squalene epoxidase.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:56:29.779Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tinea pedis (athlete's foot) in pediatric patients"},{"name":"Tinea cruris (jock itch) in pediatric patients"},{"name":"Tinea corporis (ringworm) in pediatric patients"}]},"trialDetails":[{"nctId":"NCT01712360","phase":"PHASE4","title":"Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis","status":"COMPLETED","sponsor":"Merz North America, Inc.","startDate":"2012-10","conditions":"Tinea Pedis, Tinea Cruris","enrollment":56}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["NAFT500","naftifine","naftifine hydrochloride"],"phase":"marketed","status":"active","brandName":"NAFT500 (pediatric)","genericName":"NAFT500 (pediatric)","companyName":"Merz North America, Inc.","companyId":"merz-north-america-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"NAFT500 is a naftifine hydrochloride topical antifungal that inhibits fungal sterol synthesis by blocking squalene epoxidase. Used for Tinea pedis (athlete's foot) in pediatric patients, Tinea cruris (jock itch) in pediatric patients, Tinea corporis (ringworm) in pediatric patients.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2016-09-08T00:00:00.000Z","mah":"SUN PHARMA CANADA","brand_name_local":"NAFTIFINE HYDROCHLORIDE","application_number":"ANDA205975"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2019-04-10T00:00:00.000Z","mah":"SUN PHARMA CANADA","brand_name_local":"NAFTIFINE HYDROCHLORIDE","application_number":"ANDA208201"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-09-22T00:00:00.000Z","mah":"XIROMED","brand_name_local":"NAFTIFINE HYDROCHLORIDE","application_number":"ANDA210038"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}