{"id":"am-fdc","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Medecins Sans Frontieres, Netherlands","category":"company"}],"phase":"marketed","safety":{},"trials":[],"aliases":["Far-Manguinhos, Brazil"],"company":"Medecins Sans Frontieres, Netherlands","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=AM(FDC)","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T04:28:06.972524+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T04:28:13.835008+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AM(FDC)","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T04:28:14.624550+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2074718/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T04:28:15.597794+00:00"}},"allNames":["am(fdc)"],"offLabel":[],"synonyms":[],"timeline":[],"approvals":[],"ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"am(fdc) is a small molecule that likely interacts with specific receptors, enzymes, or other biological molecules to produce its therapeutic effect, but the exact mechanism of action is unknown."},"commercial":{},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=am%28fdc%29","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=am(fdc)","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-31T10:21:22.225791","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T04:28:17.639893+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"am(fdc)","indications":{"approved":[{"name":"Epilepsy","diseaseId":"epilepsy","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03226275","phase":"PHASE1","title":"Bioequivalence Trial of Concor AM® vs Bisoprolol and Amlodipine in Chinese Participants","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2017-08-09","conditions":["Healthy"],"enrollment":32,"completionDate":"2017-09-09"},{"nctId":"NCT01977794","phase":"PHASE3","title":"Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2014-03","conditions":["Hypertension"],"enrollment":200,"completionDate":"2015-03"},{"nctId":"NCT00902811","phase":"PHASE4","title":"Effectiveness of Artemisinin Combination Regimens in Falciparum Malaria","status":"UNKNOWN","sponsor":"Medecins Sans Frontieres, Netherlands","startDate":"2008-12","conditions":["Uncomplicated Falciparum Malaria"],"enrollment":600,"completionDate":"2009-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"chemblId":"CHEMBL2074718"},"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Medecins Sans Frontieres, Netherlands","relationship":"Original Developer"}],"publicationCount":146,"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"originalDeveloper":"Medecins Sans Frontieres, Netherlands","recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","brandName":"AM(FDC)","companyName":"Medecins Sans Frontieres, Netherlands","companyId":"medecins-sans-frontieres-netherlands","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T04:28:17.639893+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}