{"id":"miltefosine-plus-gm-csf","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances (nausea, vomiting, diarrhea)"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL125","moleculeType":"Small molecule","molecularWeight":"407.58"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Miltefosine is an alkylphospholipid that disrupts cell membrane integrity and induces apoptosis in Leishmania parasites. GM-CSF (granulocyte-macrophage colony-stimulating factor) enhances innate and adaptive immune responses by promoting differentiation and activation of macrophages and dendritic cells, which work synergistically to improve parasite clearance and immune memory.","oneSentence":"Miltefosine combined with GM-CSF works by inducing immunogenic cell death and enhancing immune activation to treat leishmaniasis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:21:21.344Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Visceral leishmaniasis (kala-azar)"}]},"trialDetails":[{"nctId":"NCT03023111","phase":"PHASE3","title":"Miltefosine and GM-CSF in Cutaneous Leishmaniasis","status":"COMPLETED","sponsor":"Hospital Universitário Professor Edgard Santos","startDate":"2017-06-30","conditions":"Cutaneous Leishmaniasis","enrollment":300}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Impavido plus GM-CSF"],"phase":"phase_3","status":"active","brandName":"Miltefosine plus GM-CSF","genericName":"Miltefosine plus GM-CSF","companyName":"Hospital Universitário Professor Edgard Santos","companyId":"hospital-universit-rio-professor-edgard-santos","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Miltefosine, a small molecule with an unknown mechanism, is being studied in combination with GM-CSF for the treatment of Cutaneous Leishmaniasis. This combination is being investigated in a randomized and controlled trial, as seen in ClinicalTrials.gov under the study \"Miltefosine and GM-CSF in Cutaneous Leishmaniasis\".","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}