{"id":"liposomal-amphotericin-b-with-miltefosine","safety":{"commonSideEffects":[{"rate":null,"effect":"Nephrotoxicity"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Electrolyte abnormalities"},{"rate":null,"effect":"Gastrointestinal disturbances"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Amphotericin B binds to ergosterol in fungal cell membranes, causing leakage and cell death; the liposomal formulation reduces toxicity to human cells. Miltefosine is an alkylphospholipid that inhibits phosphatidylcholine synthesis and disrupts cell membrane integrity in both fungi and parasites. The combination leverages synergistic mechanisms to improve efficacy against resistant organisms.","oneSentence":"Liposomal amphotericin B disrupts fungal cell membranes while miltefosine inhibits phosphatidylcholine synthesis, together providing enhanced antifungal and antiparasitic activity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:19:06.177Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Visceral leishmaniasis"},{"name":"Fungal infections (investigational combination)"}]},"trialDetails":[{"nctId":"NCT04799236","phase":"PHASE3","title":"Treatment of Mucosal Bolivian Leishmaniasis","status":"RECRUITING","sponsor":"Fundacion Nacional de Dermatologia","startDate":"2021-04-01","conditions":"Mucosal Leishmaniasis","enrollment":120},{"nctId":"NCT02366884","phase":"PHASE2","title":"Clinical Evaluation of a New Form of Cancer Therapy (Atavistic Chemotherapy) Based on the Principles of Atavistic Metamorphosis (2011)","status":"UNKNOWN","sponsor":"Dr. Frank Arguello Cancer Clinic","startDate":"2011-07-26","conditions":"Neoplasms","enrollment":250},{"nctId":"NCT03399955","phase":"PHASE2","title":"Short Course Regimens for Treatment of PKDL (Sudan)","status":"UNKNOWN","sponsor":"Drugs for Neglected Diseases","startDate":"2018-05-09","conditions":"PKDL - Post-Kala-Azar Dermal Leishmanioid","enrollment":110},{"nctId":"NCT02011958","phase":"PHASE3","title":"Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.","status":"COMPLETED","sponsor":"Drugs for Neglected Diseases","startDate":"2014-07","conditions":"Visceral Leishmaniasis","enrollment":59},{"nctId":"NCT01067443","phase":"PHASE2","title":"Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa","status":"COMPLETED","sponsor":"Drugs for Neglected Diseases","startDate":"2010-03","conditions":"Primary Visceral Leishmaniasis","enrollment":151},{"nctId":"NCT01122771","phase":"PHASE3","title":"Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh","status":"COMPLETED","sponsor":"Drugs for Neglected Diseases","startDate":"2010-05","conditions":"Visceral Leishmaniasis","enrollment":602},{"nctId":"NCT00523965","phase":"PHASE3","title":"Combination Therapy in Indian Visceral Leishmaniasis","status":"COMPLETED","sponsor":"Banaras Hindu University","startDate":"2007-09","conditions":"Leishmaniasis, Visceral","enrollment":624},{"nctId":"NCT00696969","phase":"PHASE3","title":"Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis","status":"COMPLETED","sponsor":"Drugs for Neglected Diseases","startDate":"2008-06","conditions":"Visceral Leishmaniasis","enrollment":634},{"nctId":"NCT00370825","phase":"PHASE2","title":"Combination Chemotherapy for the Treatment of Indian Kala-Azar","status":"COMPLETED","sponsor":"Banaras Hindu University","startDate":"2006-09","conditions":"Visceral Leishmaniasis","enrollment":200}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":184,"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":"Liposomal Amphotericin B with Miltefosine","genericName":"Liposomal Amphotericin B with Miltefosine","companyName":"Banaras Hindu University","companyId":"banaras-hindu-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Liposomal amphotericin B disrupts fungal cell membranes while miltefosine inhibits phosphatidylcholine synthesis, together providing enhanced antifungal and antiparasitic activity. Used for Visceral leishmaniasis, Fungal infections (investigational combination).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}