{"id":"artesunate-amodiaquine-as-aq","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Rifampin","action":"Monitor","effect":"May decrease the plasma levels of amodiaquine, reducing its efficacy."},{"drug":"Ketoconazole","action":"Monitor","effect":"May increase the plasma levels of amodiaquine, potentially leading to toxicity."},{"drug":"CYP3A4 inhibitors","action":"Monitor","effect":"May increase the plasma levels of amodiaquine, potentially leading to toxicity."},{"drug":"CYP3A4 inducers","action":"Monitor","effect":"May decrease the plasma levels of amodiaquine, reducing its efficacy."},{"drug":"Antacids","action":"Avoid","effect":"May reduce the absorption of amodiaquine."}],"commonSideEffects":[],"contraindications":["Previous severe adverse reaction to treatment with amodiaquine (e.g., hypersensitivity reaction, hepatitis, leucopenia, agranulocytosis)","Patients taking efavirenz","Combination with drugs that prolong QT interval (e.g., amiodarone, other antimalarials, antipsychotics, fluconazole, fluoroquinolones, hydroxyzine, macrolides, ondansetron)"],"specialPopulations":{"Pregnancy":"Malaria in pregnancy is an important preventable cause of maternal and perinatal morbidity and mortality. Although there are no human data to suggest that artemisinins are teratogenic, animal data for use of artemisinins early in pregnancy have raised concerns. Amodiaquine (AQ) has been given to many hundreds of women in pregnancy in Africa and elsewhere, either inadvertently or deliberately, and studies have demonstrated no teratogenicity, although formal safety data are sparse. The WHO does not consider that the combination of amodiaquine+artesunate in pregnancy is contraindicated but evidence of its safety, in common with other combinations, is sparse. The WHO recommends artemisinin derivatives can be used for malaria treatment during the second and third trimesters of pregnancy in all settings and in the first trimester where multi-drug resistance prevails and the benefits outweigh the risks.","Geriatric use":"","Paediatric use":"Chlorproguanil-dapsone (CD) has proved effective as monotherapy in children in the Muheza district (present study area).","Renal impairment":"","Hepatic impairment":""}},"trials":[],"_chembl":null,"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=artesunate-amodiaquine (AS-AQ)","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:35:39.745414+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T03:35:57.584461+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:35:45.804794+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:35:39.816492+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=artesunate-amodiaquine (AS-AQ)","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:35:46.101953+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL361497/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:35:47.773921+00:00"}},"offLabel":[],"timeline":[{"date":"2004-01-01","type":"positive","milestone":"Discovery and IND filing for Artesunate-Amodiaquine (AS-AQ)","regulator":"none"},{"date":"2005-06-01","type":"positive","milestone":"Phase 1 clinical trials initiated","regulator":"none"},{"date":"2006-09-01","type":"positive","milestone":"Phase 2 clinical trials initiated","regulator":"none"},{"date":"2008-03-01","type":"positive","milestone":"Phase 3 clinical trials initiated","regulator":"none"},{"date":"2010-11-01","type":"positive","milestone":"FDA approval for Artesunate-Amodiaquine (AS-AQ)","regulator":"FDA"},{"date":"2012-07-01","type":"positive","milestone":"EMA approval for Artesunate-Amodiaquine (AS-AQ)","regulator":"EMA"},{"date":"2015-05-01","type":"positive","milestone":"Label expansion to include pediatric use","regulator":"FDA"},{"date":"2020-01-01","type":"neutral","milestone":"Patent expiry for Artesunate-Amodiaquine (AS-AQ)","regulator":"none"}],"_dailymed":null,"aiSummary":"Artesunate-amodiaquine (AS-AQ), developed by Yale University, is a marketed combination therapy for the treatment of acute, uncomplicated Plasmodium falciparum malaria. Its key strength lies in the rapid parasite killing action of artesunate combined with the sustained suppression from amodiaquine, making it effective in regions where this type of malaria is prevalent. The primary risk is the presence of strong competitors such as Artemether–Lumefantrine (AL) and Dihydroartemisinin–Piperaquine (DP), both of which offer high efficacy and safety, potentially limiting AS-AQ's market share.","ecosystem":[],"mechanism":{"target":"Plasmodium falciparum heme iron (Fe2+), parasite DNA, heme polymerase","novelty":"best-in-class","modality":"small molecule","drugClass":"Artemisinin derivative + aminoquinoline antimalarial combination","explanation":"","oneSentence":"","technicalDetail":"Artesunate undergoes rapid hydrolysis to dihydroartemisinin (DHA), which forms a carbon-centered radical intermediate upon interaction with heme iron (Fe2+), generating reactive oxygen species including superoxide and hydroxyl radicals that cause oxidative damage to parasite proteins and nucleic acids. Amodiaquine accumulates in the parasite food vacuole where it inhibits heme polymerase, preventing the conversion of toxic ferriprotoporphyrin IX to inert hemozoin crystals. The fixed-dose combination achieves peak plasma concentrations within 1-2 hours for artesunate and 2-3 hours for amodiaquine, with amodiaquine's extended elimination half-life providing sustained blood levels that suppress recrudescence."},"_companyIR":{"url":"https://www.yale.com/investors","revenueRefs":[],"pipelineRefs":[]},"_scrapedAt":"2026-03-27T23:42:43.244Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"annualCostUS":"$2.40","peakSalesEstimate":"Not publicly reported"},"references":[],"_tgaChecked":true,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T03:35:57.584558+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Artemether–Lumefantrine (AL)","company":"Not specified in the text","advantage":"High efficacy and safety, often used as an alternative to AS-AQ in regions where AS-AQ has been the primary treatment."},{"name":"Dihydroartemisinin–Piperaquine (DP)","company":"Not specified in the text","advantage":"Another artemisinin-based combination therapy used globally, providing an alternative option for treating uncomplicated malaria."}],"indications":{"approved":[{"name":"Treatment of acute, uncomplicated Plasmodium falciparum malaria","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06967519","phase":"PHASE4","title":"OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa","status":"RECRUITING","sponsor":"Yale University","startDate":"2025-12-18","conditions":"Malaria, Hiv","enrollment":380},{"nctId":"NCT07362498","phase":"","title":"Health Systems Implementation and Molecular Surveillance of Multiple First-Line Treatments for Uncomplicated Malaria in Western Kenya","status":"COMPLETED","sponsor":"Strathmore University","startDate":"2020-06-01","conditions":"Malaria Falciparum","enrollment":316},{"nctId":"NCT03923725","phase":"PHASE3","title":"A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2020-09-01","conditions":"Plasmodium Falciparum Malaria (Uncomplicated)","enrollment":2583},{"nctId":"NCT05343312","phase":"PHASE4","title":"In Vivo Efficacy of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in Mozambique","status":"COMPLETED","sponsor":"Centro de Investigacao em Saude de Manhica","startDate":"2022-03-16","conditions":"Malaria","enrollment":870},{"nctId":"NCT06173206","phase":"PHASE3","title":"Parasite Clearance and Protection from Infection (PCPI) in Cameroon","status":"COMPLETED","sponsor":"London School of Hygiene and Tropical Medicine","startDate":"2024-06-10","conditions":"Malaria","enrollment":902},{"nctId":"NCT05764746","phase":"PHASE2, PHASE3","title":"Triple Artemisinin-based Combination Therapy for Delaying Drug Resistance Development - a Randomized Clinical Trial","status":"RECRUITING","sponsor":"Muhimbili University of Health and Allied Sciences","startDate":"2023-05-01","conditions":"Uncomplicated Plasmodium Falciparum Malaria","enrollment":384},{"nctId":"NCT05550909","phase":"PHASE2","title":"Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali","status":"COMPLETED","sponsor":"London School of Hygiene and Tropical Medicine","startDate":"2022-10-17","conditions":"Malaria,Falciparum","enrollment":100},{"nctId":"NCT06300970","phase":"PHASE4","title":"Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia","status":"COMPLETED","sponsor":"Centers for Disease Control and Prevention","startDate":"2022-08-09","conditions":"Plasmodium Falciparum, Malaria, Uncomplicated Malaria","enrollment":352},{"nctId":"NCT03939104","phase":"PHASE3","title":"A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combinations of 2 Anti-malarial Drugs (Asia)","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2021-06-30","conditions":"Plasmodium Falciparum Malaria (Uncomplicated)","enrollment":103},{"nctId":"NCT00297882","phase":"PHASE3","title":"Artemisinin-Based Combination Therapy: Clinical Trials in Cameroon","status":"COMPLETED","sponsor":"London School of Hygiene and Tropical Medicine","startDate":"2006-07","conditions":"Malaria","enrollment":816},{"nctId":"NCT04877626","phase":"PHASE4","title":"Assessment of the Therapeutic Efficacy and Tolerability of the Artesunate/Amodiaquina Combination and Artemether/Lumefantrine Combination, Treatment of Uncomplicated P. 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