{"id":"inhaled-ambisome","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Nausea"},{"rate":"5-10%","effect":"Vomiting"},{"rate":"5-10%","effect":"Abdominal pain"},{"rate":"5-10%","effect":"Diarrhea"},{"rate":"5-10%","effect":"Headache"},{"rate":"5-10%","effect":"Fatigue"},{"rate":"5-10%","effect":"Rash"},{"rate":"2-5%","effect":"Hypotension"},{"rate":"rare (<1%)","effect":"Anaphylaxis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"This process is known as a 'pore-forming' mechanism, where the drug inserts itself into the cell membrane, disrupting its integrity and leading to cell death. The exact mechanism is not fully understood, but it is thought to involve the formation of pores in the cell membrane, allowing ions and water to flow in and out of the cell, ultimately leading to cell lysis.","oneSentence":"Amphotericin B, the active component of Ambisome, binds to the sterol component of fungal cell membranes, causing cell lysis and death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:48:30.166Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Treatment of invasive aspergillosis, candidemia, and other serious fungal infections"}]},"trialDetails":[{"nctId":"NCT03656081","phase":"PHASE3","title":"Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole","status":"RECRUITING","sponsor":"Poitiers University Hospital","startDate":"2018-12-19","conditions":"Chronic Pulmonary Aspergillosis","enrollment":224},{"nctId":"NCT06137690","phase":"","title":"Factors on Therapeutic Drug Monitoring and Safety of Voriconazole in Critically Ill Elderly Patients","status":"UNKNOWN","sponsor":"People's Hospital of Zhengzhou University","startDate":"2018-07-01","conditions":"Invasive Fungal Infection","enrollment":550},{"nctId":"NCT04004078","phase":"","title":"An Individualized Administration Research of Voriconazole Based on CYP2C19 Gene Polymorphism and TDM","status":"COMPLETED","sponsor":"People's Hospital of Zhengzhou University","startDate":"2018-03-01","conditions":"Invasive Fungal Infection","enrollment":314},{"nctId":"NCT01615809","phase":"PHASE2","title":"Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia","status":"COMPLETED","sponsor":"Fundació Sant Joan de Déu","startDate":"2011-10","conditions":"Invasive Pulmonary Aspergillosis, Lymphoblastic Leukaemia, Myeloblastic Leukaemia","enrollment":32},{"nctId":"NCT01254708","phase":"PHASE2","title":"Safety and Efficacy Study of Inhaled AmBisome for Prevention of Aspergillus Colonization in Lung Transplant Recipients","status":"SUSPENDED","sponsor":"University Health Network, Toronto","startDate":"2012-01","conditions":"Lung Transplant Recipient","enrollment":4},{"nctId":"NCT00177684","phase":"PHASE3","title":"Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)","status":"COMPLETED","sponsor":"University of Pittsburgh","startDate":"2004-09","conditions":"Lung Transplantation, Fungal Infections","enrollment":48},{"nctId":"NCT00235651","phase":"PHASE3","title":"Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients","status":"TERMINATED","sponsor":"University of Pittsburgh","startDate":"2005-10","conditions":"Lung Transplantation, Lung Diseases","enrollment":12}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"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":"inhaled Ambisome®","genericName":"inhaled Ambisome®","companyName":"Poitiers University Hospital","companyId":"poitiers-university-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Amphotericin B, the active component of Ambisome, binds to the sterol component of fungal cell membranes, causing cell lysis and death. Used for Treatment of invasive aspergillosis, candidemia, and other serious fungal infections.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}