{"id":"liposomal-amphotericin-b-miltefosine","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Nausea"},{"rate":"5-10%","effect":"Vomiting"},{"rate":"5-10%","effect":"Diarrhea"},{"rate":"5-10%","effect":"Abdominal pain"},{"rate":"5-10%","effect":"Fatigue"},{"rate":"5-10%","effect":"Headache"},{"rate":"5-10%","effect":"Rash"},{"rate":"5-10%","effect":"Itching"},{"rate":"5-10%","effect":"Dizziness"},{"rate":"5-10%","effect":"Insomnia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Liposomal amphotericin B works by binding to ergosterol in the fungal cell membrane, causing cell lysis and death. Miltefosine, on the other hand, inhibits the enzyme sphingosine N-acyltransferase, which is involved in the synthesis of sphingolipids, an essential component of fungal cell membranes. This dual mechanism of action makes liposomal amphotericin B + miltefosine a potent antifungal agent.","oneSentence":"Liposomal amphotericin B targets fungal cell membranes, while miltefosine targets fungal cell membranes and inhibits sphingosine N-acyltransferase.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:19:06.197Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Visceral 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":"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":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Impavido","AmBisome"],"phase":"phase_3","status":"active","brandName":"liposomal amphotericin B + miltefosine","genericName":"liposomal amphotericin B + miltefosine","companyName":"Drugs for Neglected Diseases","companyId":"drugs-for-neglected-diseases","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Liposomal amphotericin B targets fungal cell membranes, while miltefosine targets fungal cell membranes and inhibits sphingosine N-acyltransferase. Used for Visceral leishmaniasis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}