{"id":"miltefosine-and-paromomycin","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances (nausea, vomiting, diarrhea)"},{"rate":null,"effect":"Nephrotoxicity"},{"rate":null,"effect":"Ototoxicity"},{"rate":null,"effect":"Hepatotoxicity"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Miltefosine is an alkylphospholipid that accumulates in parasite cells and disrupts membrane integrity and mitochondrial function. Paromomycin is an aminoglycoside antibiotic that inhibits bacterial-like protein synthesis in Leishmania ribosomes. The combination targets multiple pathways to enhance antiparasitic efficacy.","oneSentence":"Miltefosine disrupts parasite cell membranes while paromomycin inhibits protein synthesis, together providing synergistic activity against Leishmania parasites.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:51:20.930Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Visceral leishmaniasis"},{"name":"Cutaneous leishmaniasis"}]},"trialDetails":[{"nctId":"NCT03129646","phase":"PHASE3","title":"Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa","status":"COMPLETED","sponsor":"Drugs for Neglected Diseases","startDate":"2018-01-24","conditions":"Visceral Leishmaniasis","enrollment":439},{"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":"NCT03829917","phase":"PHASE2, PHASE3","title":"Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis","status":"COMPLETED","sponsor":"Fundacion Nacional de Dermatologia","startDate":"2019-02-01","conditions":"Cutaneous Leishmaniasis, American","enrollment":120},{"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":"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":199,"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":"Miltefosine and Paromomycin","genericName":"Miltefosine and Paromomycin","companyName":"Drugs for Neglected Diseases","companyId":"drugs-for-neglected-diseases","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Miltefosine disrupts parasite cell membranes while paromomycin inhibits protein synthesis, together providing synergistic activity against Leishmania parasites. Used for Visceral leishmaniasis, Cutaneous leishmaniasis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}