{"id":"terbinafine-tablets","safety":{"commonSideEffects":[{"rate":"2-3%","effect":"Headache"},{"rate":"3-6%","effect":"Gastrointestinal disturbance (nausea, diarrhea, dyspepsia)"},{"rate":"1-3%","effect":"Rash"},{"rate":"0.5-2%","effect":"Taste disturbance"},{"rate":"1-3%","effect":"Hepatotoxicity (elevated liver enzymes)"},{"rate":"<1%","effect":"Neutropenia"}]},"_chembl":null,"_dailymed":{"setId":"bf020c17-578f-74c4-e053-2995a90a9e7d","title":"TERBINAFINE HYDROCHLORIDE (TERBINAFINE TABLETS 250 MG) TABLET [NUCARE PHARMACEUTICALS,INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Terbinafine is a fungistatic and fungicidal agent that selectively inhibits the enzyme squalene epoxidase in the fungal sterol synthesis pathway. By blocking ergosterol production, an essential component of fungal cell membranes, the drug causes membrane instability and cell death. This mechanism is particularly effective against dermatophytes and other fungi causing superficial infections.","oneSentence":"Terbinafine inhibits fungal squalene epoxidase, disrupting ergosterol synthesis and causing fungal cell membrane collapse.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T03:50:02.634Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Onychomycosis (fungal nail infection)"},{"name":"Tinea pedis (athlete's foot)"},{"name":"Tinea corporis (ringworm)"},{"name":"Tinea cruris (jock itch)"}]},"trialDetails":[{"nctId":"NCT07046988","phase":"","title":"Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis","status":"RECRUITING","sponsor":"Shandong University","startDate":"2021-06-15","conditions":"Tinea Capitis","enrollment":60},{"nctId":"NCT00833586","phase":"PHASE1","title":"Terbinafine HCl 250 mg Tablet Under Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2002-01","conditions":"Healthy","enrollment":28},{"nctId":"NCT05049525","phase":"PHASE2","title":"Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease","status":"TERMINATED","sponsor":"Montreal Heart Institute","startDate":"2022-02-22","conditions":"Crohn's Disease, Inflammatory Bowel Diseases","enrollment":16},{"nctId":"NCT00647647","phase":"PHASE1","title":"Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® Tablets 250 mg","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Inc","startDate":"2004-02","conditions":"Healthy","enrollment":36},{"nctId":"NCT00648713","phase":"PHASE1","title":"Fed Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® 250 mg","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Inc","startDate":"2004-02","conditions":"Healthy","enrollment":36},{"nctId":"NCT05119712","phase":"EARLY_PHASE1","title":"Terbinafine Treatment of Axial Spondyloarthropathy","status":"WITHDRAWN","sponsor":"Oregon Health and Science University","startDate":"2021-03-09","conditions":"Ankylosing Spondylitis, Axial Spondyloarthritis, Psoriatic Spondylitis","enrollment":""},{"nctId":"NCT05881980","phase":"PHASE2, PHASE3","title":"Efficacy and Safety of Terbinafine and Itraconazole","status":"UNKNOWN","sponsor":"Dhaka Medical College","startDate":"2023-05","conditions":"Tinea Corporis, Tinea Cruris, Tinea Faciei","enrollment":150},{"nctId":"NCT00833664","phase":"PHASE1","title":"Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2002-01","conditions":"Healthy","enrollment":22},{"nctId":"NCT05578950","phase":"PHASE1","title":"Comparative Study Between Pulse Therapy With Oral Itraconazole Versus Continuous Oral Terbinafine Therapy for Treatment of Onychomycosis","status":"COMPLETED","sponsor":"Combined Military Hospital Abbottabad","startDate":"2022-03-01","conditions":"Onychomycosis","enrollment":100},{"nctId":"NCT05128916","phase":"PHASE3","title":"Efficacy of Intralesional PRP in Treatment of Onychomycosis","status":"UNKNOWN","sponsor":"Sohag University","startDate":"2021-12-01","conditions":"Platelet Rich Plasma","enrollment":75},{"nctId":"NCT00602342","phase":"NA","title":"Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Roxane Laboratories","startDate":"2004-03","conditions":"Onychomycosis","enrollment":30},{"nctId":"NCT00602251","phase":"NA","title":"Bioequivalency Study of Terbinafine Tablets Under Fed Conditions","status":"COMPLETED","sponsor":"Roxane Laboratories","startDate":"2004-03","conditions":"Onychomycosis","enrollment":30},{"nctId":"NCT02019446","phase":"NA","title":"Laser Treatment for Onychomycosis in Diabetes","status":"UNKNOWN","sponsor":"BCDiabetes.Ca","startDate":"2018-07","conditions":"Diabetes Mellitus, Type 2, Onychomycosis","enrollment":60},{"nctId":"NCT01790165","phase":"PHASE2","title":"TDT 067 Open Label Multi-Dose Onychomycosis Study","status":"COMPLETED","sponsor":"Celtic Pharma Development Services","startDate":"2009-12","conditions":"Onychomycosis","enrollment":27},{"nctId":"NCT01286701","phase":"PHASE1","title":"Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2002-01","conditions":"Healthy","enrollment":18},{"nctId":"NCT01286688","phase":"PHASE1","title":"Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fasting Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2002-01","conditions":"Fasting","enrollment":36},{"nctId":"NCT00691184","phase":"PHASE1","title":"Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis","status":"COMPLETED","sponsor":"NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)","startDate":"2005-02","conditions":"Onychomycosis/Onycholysis and Tinea Pedis","enrollment":56}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":14,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Lamisil","Terbinafine 250"],"phase":"marketed","status":"active","brandName":"Terbinafine Tablets","genericName":"Terbinafine Tablets","companyName":"Oregon Health and Science University","companyId":"oregon-health-and-science-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Terbinafine Tablets are a small molecule that inhibits the enzyme squalene monooxygenase. They are used to treat conditions such as onychomycosis, tinea capitis, and athlete's foot.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}