{"id":"naftifine-hydrochloride-cream-2","safety":{"commonSideEffects":[{"rate":null,"effect":"Local irritation (burning, stinging, erythema)"},{"rate":null,"effect":"Pruritus"},{"rate":null,"effect":"Dryness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Naftifine hydrochloride is an allylamine antifungal that works by inhibiting squalene epoxidase, a key enzyme in the ergosterol synthesis pathway of fungi. This inhibition disrupts the integrity of the fungal cell membrane, leading to fungistatic activity (stopping fungal growth). It is applied topically as a cream for dermatophyte and other fungal skin infections.","oneSentence":"Naftifine is a fungistatic agent that inhibits fungal sterol synthesis by blocking squalene epoxidase, disrupting the fungal cell membrane.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:22:40.535Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tinea pedis (athlete's foot)"},{"name":"Tinea cruris (jock itch)"},{"name":"Tinea corporis (ringworm)"},{"name":"Other dermatophyte infections"}]},"trialDetails":[{"nctId":"NCT05363449","phase":"PHASE1","title":"Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis","status":"COMPLETED","sponsor":"Therapeutics, Inc.","startDate":"2022-02-17","conditions":"Tinea Cruris, Tinea Pedis","enrollment":42},{"nctId":"NCT02633813","phase":"PHASE3","title":"BE Study of Naftifine HCL","status":"COMPLETED","sponsor":"Genzum Life Sciences","startDate":"2015-03","conditions":"Tinea Pedis","enrollment":693},{"nctId":"NCT02132260","phase":"PHASE1","title":"Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries, Inc.","startDate":"2013-08","conditions":"Tinea Pedis","enrollment":890},{"nctId":"NCT02227290","phase":"PHASE4","title":"Pediatric Subjects With Tinea Corporis","status":"COMPLETED","sponsor":"Merz North America, Inc.","startDate":"2014-08","conditions":"Tinea Corporis","enrollment":230},{"nctId":"NCT02466867","phase":"PHASE4","title":"An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis","status":"COMPLETED","sponsor":"Merz North America, Inc.","startDate":"2014-01","conditions":"Tinea Corporis","enrollment":27},{"nctId":"NCT01580891","phase":"PHASE1","title":"Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries, Inc.","startDate":"2012-05","conditions":"Tinea Pedis","enrollment":1053}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Naftifine","Naftifine hcl"],"phase":"phase_3","status":"active","brandName":"Naftifine Hydrochloride Cream 2%","genericName":"Naftifine Hydrochloride Cream 2%","companyName":"Sun Pharmaceutical Industries, Inc.","companyId":"sun-pharmaceutical-industries-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Naftifine is a fungistatic agent that inhibits fungal sterol synthesis by blocking squalene epoxidase, disrupting the fungal cell membrane. Used for Tinea pedis (athlete's foot), Tinea cruris (jock itch), Tinea corporis (ringworm).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}