{"id":"amphotericin-b-deoxycholate","safety":{"commonSideEffects":[{"rate":"80","effect":"Nephrotoxicity (acute kidney injury)"},{"rate":"80","effect":"Infusion-related reactions (fever, chills, rigors)"},{"rate":"25","effect":"Hypokalemia"},{"rate":"25","effect":"Anemia"},{"rate":"15","effect":"Hypomagnesemia"},{"rate":"null","effect":"Phlebitis at infusion site"}]},"_chembl":{"chemblId":"CHEMBL6067678","moleculeType":null,"molecularWeight":"1338.65"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Amphotericin B is a polyene antibiotic that selectively binds to ergosterol, a sterol unique to fungal cell membranes, rather than cholesterol in human cells. This binding disrupts the lipid bilayer, creating channels that allow leakage of intracellular contents and ultimately leads to fungal cell lysis and death. The deoxycholate formulation is a conventional lipid-associated formulation that improves solubility but is associated with greater nephrotoxicity compared to newer lipid formulations.","oneSentence":"Amphotericin B binds to ergosterol in fungal cell membranes, creating pores that disrupt membrane integrity and cause cell death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:27:13.367Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Systemic fungal infections (invasive aspergillosis, candidiasis, cryptococcosis)"},{"name":"Leishmaniasis"},{"name":"Amphotericin B-responsive fungal infections in immunocompromised patients"}]},"trialDetails":[{"nctId":"NCT06525389","phase":"PHASE3","title":"Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)","status":"NOT_YET_RECRUITING","sponsor":"Duke 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to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis","status":"RECRUITING","sponsor":"Post Graduate Institute of Medical Education and Research, Chandigarh","startDate":"2024-06-03","conditions":"Chronic Pulmonary Aspergillosis, CPA, Aspergilloma","enrollment":196},{"nctId":"NCT04502381","phase":"PHASE2","title":"Combined Inhalational With Intravenous Amphotericin B Versus Intravenous Amphotericin B Alone for Pulmonary Mucormycosis","status":"COMPLETED","sponsor":"Post Graduate Institute of Medical Education and Research, Chandigarh","startDate":"2020-07-01","conditions":"Pulmonary Mucormycosis","enrollment":30},{"nctId":"NCT05642624","phase":"","title":"The PK/PD of Deoxycholic Acid Amphotericin B in Invasive Fungal Infection Patients With Sepsis/Septic Shock","status":"COMPLETED","sponsor":"Southeast University, China","startDate":"2019-02-28","conditions":"Fungal Infection","enrollment":20},{"nctId":"NCT00885703","phase":"PHASE1, PHASE2","title":"High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2010-04-16","conditions":"Cryptococcal Meningitis, HIV Infections","enrollment":168},{"nctId":"NCT04072640","phase":"EARLY_PHASE1","title":"Three Induction Treatments on Cryptococcal Meningitis","status":"UNKNOWN","sponsor":"First Affiliated Hospital of Zhejiang University","startDate":"2021-01-25","conditions":"Cryptococcal Meningitis, HIV/AIDS","enrollment":120},{"nctId":"NCT02283905","phase":"PHASE4","title":"Amphotericin-B and Voriconazole for Pulmonary Blastomycosis","status":"TERMINATED","sponsor":"University of Manitoba","startDate":"2015-06","conditions":"Blastomycosis","enrollment":2},{"nctId":"NCT01945281","phase":"PHASE2","title":"Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-01-15","conditions":"Candidiasis, Invasive","enrollment":51},{"nctId":"NCT00361517","phase":"PHASE3","title":"To Determine Whether Galactomannan Test Will Help to Detect Fungal Infections Early and Hence Start Treatment Early","status":"COMPLETED","sponsor":"Singapore General Hospital","startDate":"2006-06-01","conditions":"Aspergillosis","enrollment":47},{"nctId":"NCT01310738","phase":"PHASE4","title":"Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil","status":"TERMINATED","sponsor":"University of Brasilia","startDate":"2011-02","conditions":"Visceral Leishmaniasis","enrollment":378},{"nctId":"NCT01032187","phase":"PHASE4","title":"Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children","status":"COMPLETED","sponsor":"University of Brasilia","startDate":"2007-10","conditions":"Visceral Leishmaniasis","enrollment":101},{"nctId":"NCT00815516","phase":"PHASE3","title":"Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis","status":"TERMINATED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2013-02","conditions":"Candidiasis","enrollment":30},{"nctId":"NCT01857479","phase":"PHASE2, PHASE3","title":"A Randomized Controlled Trial of Inhaled Amphotericin B for Maintaining Remission in Allergic Bronchopulmonary Aspergillosis","status":"COMPLETED","sponsor":"Post Graduate Institute of Medical Education and Research, Chandigarh","startDate":"2013-05","conditions":"Allergic Bronchopulmonary Aspergillosis","enrollment":21},{"nctId":"NCT02136030","phase":"NA","title":"Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis","status":"UNKNOWN","sponsor":"TTY Biopharm","startDate":"2011-02","conditions":"Cryptococcal Meningitis","enrollment":84},{"nctId":"NCT00002742","phase":"PHASE3","title":"Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer","status":"COMPLETED","sponsor":"Aronex Pharmaceuticals","startDate":"1996-01","conditions":"Chronic Myeloproliferative Disorders, Infection, Leukemia","enrollment":""},{"nctId":"NCT00003031","phase":"PHASE3","title":"Comparison of Voriconazole and Amphotericin B in Treating Patients With Aspergillosis","status":"COMPLETED","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","startDate":"1997-06","conditions":"Infection, Pulmonary Complications","enrollment":212},{"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":"NCT00628719","phase":"PHASE3","title":"Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis","status":"COMPLETED","sponsor":"Banaras Hindu University","startDate":"2008-02","conditions":"Visceral Leishmaniasis","enrollment":400},{"nctId":"NCT00310505","phase":"NA","title":"Amphotericin B Treatment in Visceral Leishmaniasis","status":"COMPLETED","sponsor":"Banaras Hindu University","startDate":"2003-01","conditions":"Visceral Leishmaniasis","enrollment":1500}],"_emaApprovals":[],"_faersSignals":[{"count":71,"reaction":"DRUG INEFFECTIVE"},{"count":20,"reaction":"OFF LABEL USE"},{"count":20,"reaction":"SEPTIC SHOCK"},{"count":18,"reaction":"MULTIPLE ORGAN DYSFUNCTION SYNDROME"},{"count":17,"reaction":"DRUG RESISTANCE"},{"count":14,"reaction":"CONDITION AGGRAVATED"},{"count":14,"reaction":"GEOTRICHUM INFECTION"},{"count":11,"reaction":"IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME"},{"count":9,"reaction":"PNEUMONIA FUNGAL"},{"count":8,"reaction":"DRUG INEFFECTIVE FOR UNAPPROVED INDICATION"}],"_approvalHistory":[],"publicationCount":700,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Fungizone","Anforicin B","Conventional amphotericin B (CAB)","Amphotericin B for injection"],"phase":"marketed","status":"active","brandName":"Amphotericin B Deoxycholate","genericName":"Amphotericin B Deoxycholate","companyName":"Drugs for Neglected Diseases","companyId":"drugs-for-neglected-diseases","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Amphotericin B binds to ergosterol in fungal cell membranes, creating pores that disrupt membrane integrity and cause cell death. Used for Systemic fungal infections (invasive aspergillosis, candidiasis, cryptococcosis), Leishmaniasis, Amphotericin B-responsive fungal infections in immunocompromised patients.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}