{"id":"ambisome-miltefosine","safety":{"commonSideEffects":[{"rate":null,"effect":"Nephrotoxicity"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Electrolyte abnormalities"},{"rate":null,"effect":"Hepatotoxicity"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Amphotericin B binds to ergosterol in fungal and parasitic cell membranes, causing membrane disruption and cell death. Miltefosine is an alkylphospholipid that inhibits phosphatidylcholine synthesis and induces apoptosis in Leishmania parasites. The combination leverages two distinct mechanisms to enhance efficacy against visceral leishmaniasis and other neglected tropical diseases.","oneSentence":"Ambisome (liposomal amphotericin B) disrupts fungal cell membranes while miltefosine inhibits phosphatidylcholine synthesis, together providing synergistic antileishmanial and antifungal activity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:44:29.121Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Visceral leishmaniasis (kala-azar)"},{"name":"Cutaneous leishmaniasis"}]},"trialDetails":[{"nctId":"NCT07463040","phase":"PHASE3","title":"Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL)","status":"NOT_YET_RECRUITING","sponsor":"Institute of Tropical Medicine, Belgium","startDate":"2027-01-01","conditions":"Cutaneous Leihmaniasis","enrollment":900},{"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":"NCT06040489","phase":"PHASE2, PHASE3","title":"Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly","status":"RECRUITING","sponsor":"University of Brasilia","startDate":"2022-06-22","conditions":"Leishmaniasis; Brazilian, Leishmaniasis, Mucocutaneous","enrollment":100},{"nctId":"NCT05493059","phase":"","title":"Study of Cases of Cutaneous Leishmaniasis Treated With Miltefosine in French Guiana, Retrospective Study","status":"UNKNOWN","sponsor":"Centre Hospitalier de Cayenne","startDate":"2022-08-08","conditions":"Cutaneous Leishmaniases, Treatment Adherence, Primary Health Care","enrollment":20},{"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":"NCT00371995","phase":"PHASE2","title":"Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar","status":"COMPLETED","sponsor":"Banaras Hindu University","startDate":"2007-10","conditions":"Visceral Leishmaniasis","enrollment":150},{"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":3,"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":"Ambisome + Miltefosine","genericName":"Ambisome + Miltefosine","companyName":"Drugs for Neglected Diseases","companyId":"drugs-for-neglected-diseases","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ambisome (liposomal amphotericin B) disrupts fungal cell membranes while miltefosine inhibits phosphatidylcholine synthesis, together providing synergistic antileishmanial and antifungal activity. Used for Visceral leishmaniasis (kala-azar), Cutaneous leishmaniasis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}