Numerous clinical trials spanning Phase 1 through Phase 4 evaluate amodiaquine, primarily targeting Plasmodium falciparum malaria, uncomplicated cases, malaria in pregnancy, and associated anemia. Sponsored by non-profit organizations, international agencies, and academic institutions, these studies range in status from actively recruiting trials on seasonal preventive protocols to completed assessments of combination regimen safety and tolerability.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07322068 | NOT_YET_RECRUITING | Malaria, Falciparum |
Stanford University |
2026-09 | PHASE4 |
| NCT06967519 | RECRUITING | Malaria; Hiv |
Yale University |
2025-12-18 | PHASE4 |
| NCT05951595 | RECRUITING | Uncomplicated Plasmodium Falciparum Malaria |
University of Oxford |
2025-09-11 | PHASE3 |
| NCT06083688 | COMPLETED | Malaria,Falciparum; Anemia in Children |
Liverpool School of Tropical Medicine |
2024-10-14 | PHASE4 |
| NCT04080895 | TERMINATED | Pharmacokinetic; Healthy; Drug Combination |
University of Oxford |
2022-11-01 | PHASE1 |
| NCT05764746 | COMPLETED | Uncomplicated Plasmodium Falciparum Malaria |
Muhimbili University of Health and Allied Sciences |
2023-05-01 | PHASE2; PHASE3 |
| NCT05471544 | UNKNOWN | Malaria |
Malaria Consortium |
2022-07-18 | PHASE3 |
| NCT06182176 | UNKNOWN | Malaria; Soil Transmitted Helminths; Schistosomiasis; Seasonal Malaria Chemoprevention; Mass Drug Administration With Anthelminthic Drugs |
London School of Hygiene and Tropical Medicine |
2024-05-27 | |
| NCT06076213 | COMPLETED | Uncomplicated Plasmodium Falciparum Malaria |
Ministry of Public Health, Democratic Republic of the Congo |
2023-05-01 | PHASE4 |
| NCT05946642 | UNKNOWN | Malaria |
Malaria Consortium |
2023-07-15 | PHASE3 |
| NCT06337253 | UNKNOWN | Malaria,Falciparum; Chemoprevention |
Malaria Consortium |
2024-03-26 | PHASE4 |
| NCT03923725 | COMPLETED | Plasmodium Falciparum Malaria (Uncomplicated) |
University of Oxford |
2020-09-01 | PHASE3 |
| NCT05343312 | COMPLETED | Malaria |
Centro de Investigacao em Saude de Manhica |
2022-03-16 | PHASE4 |
| NCT05979896 | UNKNOWN | Malaria |
Malaria Consortium |
2023-07-28 | PHASE4 |
| NCT06300970 | COMPLETED | Plasmodium Falciparum; Malaria; Uncomplicated Malaria |
Centers for Disease Control and Prevention |
2022-08-09 | PHASE4 |
| NCT05979896 | Recruiting | Malaria |
Malaria Consortium |
2023-07-28 | Phase 4 |
| NCT04816461 | COMPLETED | Malaria; Malaria Prophylaxis; Mass Testing and Treatment |
Institut de Recherche en Sciences de la Sante, Burkina Faso |
2021-07-07 | PHASE4 |
| NCT03939104 | COMPLETED | Plasmodium Falciparum Malaria (Uncomplicated) |
University of Oxford |
2021-06-30 | PHASE3 |
| NCT05550909 | COMPLETED | Malaria,Falciparum |
London School of Hygiene and Tropical Medicine |
2022-10-17 | PHASE2 |
| NCT05354258 | UNKNOWN | Malaria; Soil Transmitted Helminths; Schistosomiasis; Integrated Control; Seasonal Malaria Chemoprevention; Mass Drug Administration With Anthelminthic Drugs |
London School of Hygiene and Tropical Medicine |
2022-06-16 | |
| NCT05323721 | UNKNOWN | Malaria |
Malaria Consortium |
2022-06-01 | PHASE4 |
| NCT05478954 | UNKNOWN | Malaria |
Malaria Consortium |
2022-07-15 | PHASE4 |
| NCT05478954 | Active not recruiting | Malaria |
Malaria Consortium |
2022-07-15 | Phase 4 |
| NCT05471544 | Active not recruiting | Malaria |
Malaria Consortium |
2022-07-18 | Phase 3 |
| NCT05343312 | Active not recruiting | Malaria |
Centro de Investigacao em Saude de Manhica|United States Agency for International Development (USAID) |
2022-03-16 | Phase 4 |
| NCT04618523 | COMPLETED | Malaria |
Ministry of Public Health, Democratic Republic of the Congo |
2020-10-26 | PHASE4 |
| NCT04829695 | UNKNOWN | Falciparum Malaria |
University of Yaounde 1 |
2021-04-05 | PHASE4 |
| NCT05081089 | COMPLETED | Malaria,Falciparum |
London School of Hygiene and Tropical Medicine |
2021-10-12 | PHASE2 |
| NCT04532931 | COMPLETED | COVID-19 |
Shin Poong Pharmaceutical Co. Ltd. |
2020-09-03 | PHASE2 |
| NCT03640403 | COMPLETED | Malaria,Falciparum; Anemia |
National Institute for Medical Research, Tanzania |
2019-03-26 | PHASE3 |
| NCT03178643 | COMPLETED | Malaria,Falciparum |
Duke University |
2018-01-23 | PHASE4 |
| NCT04565184 | COMPLETED | Malaria,Falciparum |
University of Yaounde 1 |
2019-05-09 | PHASE4 |
| NCT03355664 | COMPLETED | Malaria, Falciparum |
University of Oxford |
2018-03-19 | PHASE3 |
| NCT04002687 | COMPLETED | Malaria |
Medicines for Malaria Venture |
2019-04-04 | PHASE1 |
| NCT04002687 | Completed | Malaria |
Medicines for Malaria Venture|Richmond Pharmacology Limited |
2019-04-04 | Phase 1 |
| NCT02696954 | TERMINATED | Pharmacokinetic; Drug Combination; Healthy |
University of Oxford |
2016-11-18 | PHASE1; PHASE2 |
| NCT04370977 | COMPLETED | Malaria |
Centro de Investigacao em Saude de Manhica |
2018-03-21 | PHASE4 |
| NCT02940756 | COMPLETED | Malaria |
Ministry of Public Health, Democratic Republic of the Congo |
2017-03-15 | PHASE4 |
| NCT02211729 | COMPLETED | Malaria; Respiratory Infections |
London School of Hygiene and Tropical Medicine |
2014-05 | PHASE3 |
| NCT03431714 | COMPLETED | Uncomplicated Falciparum Malaria |
National Institute for Medical Research, Tanzania |
2017-07-14 | PHASE4 |
| NCT03773536 | COMPLETED | Plasmodium Falciparum Malaria |
Professor Anders Björkman |
2017-05-09 | PHASE4 |
| NCT02831023 | COMPLETED | Malaria |
University of California, San Francisco |
2016-07 | PHASE2 |
| NCT02851108 | COMPLETED | Malaria, Falciparum |
Heidelberg University |
2016-10 | PHASE2 |
| NCT02242799 | COMPLETED | Malaria; HIV |
University of Liverpool |
2015-06 | PHASE1 |
| NCT01955382 | COMPLETED | Malaria; Severe Malaria |
National Institute of Allergy and Infectious Diseases (NIAID) |
2013-09 | PHASE2 |
| NCT02741024 | COMPLETED | Malaria |
Medecins Sans Frontieres, Netherlands |
2013-10 | PHASE4 |
| NCT01755559 | COMPLETED | Malaria |
Epicentre |
2013-06 | PHASE4 |
| NCT01697787 | COMPLETED | Malaria |
Centre Muraz |
2012-10 | PHASE4 |
| NCT02637128 | COMPLETED | MALARIA, FALCIPARUM |
Centers for Disease Control and Prevention |
2014-03 | PHASE4 |
| NCT01374581 | COMPLETED | Malaria |
Universiteit Antwerpen |
2012-05 | PHASE3 |
| NCT01845701 | COMPLETED | Malaria |
University of Yaounde 1 |
2010-03 | PHASE3 |
| NCT01967472 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2013-09-16 | |
| NCT00852423 | COMPLETED | Malaria in Pregnancy |
Institute of Tropical Medicine, Belgium |
2010-06 | PHASE3 |
| NCT01023399 | COMPLETED | Malaria |
Sanofi |
2009-11 | PHASE4 |
| NCT01378286 | COMPLETED | Malaria |
Sanofi |
2012-01 | PHASE3 |
| NCT01634945 | COMPLETED | Anemia |
Swiss Federal Institute of Technology |
2012-04 | |
| NCT01319448 | COMPLETED | Malaria; Sickle Cell Crisis |
London School of Hygiene and Tropical Medicine |
2011-09 | PHASE1; PHASE2 |
| NCT01231113 | COMPLETED | Pregnancy Complicated by Malaria as Antepartum Condition |
Kwame Nkrumah University of Science and Technology |
2011-07 | PHASE3 |
| NCT01651416 | COMPLETED | Malaria; Anaemia |
Centre for Global Health Research, Ghana |
2012-07 | PHASE4 |
| NCT01326754 | COMPLETED | Malaria, Falciparum |
Centers for Disease Control and Prevention |
2011-08 | |
| NCT01288820 | COMPLETED | Vivax Malaria |
University of Oxford |
2011-01 | PHASE3 |
| NCT02168569 | COMPLETED | Malaria |
Centro de Investigacao em Saude de Manhica |
2011-06 | PHASE4 |
| NCT00712374 | UNKNOWN | Malaria |
London School of Hygiene and Tropical Medicine |
2008-09 | PHASE4 |
| NCT01407887 | COMPLETED | Uncomplicated Falciparum Malaria |
Heidelberg University |
2011-08 | PHASE2 |
| NCT01328990 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2011-04 | PHASE1; PHASE2 |
| NCT01213433 | COMPLETED | Uncomplicated Malaria |
Centre Muraz |
2010-10 | PHASE4 |
| NCT01152931 | COMPLETED | Malaria |
University of Lagos, Nigeria |
2010-08 | PHASE3 |
| NCT00808951 | COMPLETED | Malaria |
Centre Muraz |
2008-12 | PHASE4 |
| NCT00285662 | COMPLETED | Malaria; Anemia |
Papua New Guinea Institute of Medical Research |
2006-06 | |
| NCT01017770 | COMPLETED | Uncomplicated P. Falciparum Malaria in Children |
Centre Muraz |
2008-09 | PHASE4 |
| NCT00393679 | COMPLETED | Fever; Malaria |
Institute of Tropical Medicine, Belgium |
2007-07 | PHASE3 |
| NCT00944840 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2008-09 | PHASE3 |
| NCT00894660 | COMPLETED | Falciparum Malaria |
Pfizer |
2009-06 | PHASE1 |
| NCT00297882 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2006-07 | PHASE3 |
| NCT01567423 | COMPLETED | Malaria, Falciparum |
Epicentre |
2008-04 | |
| NCT00540410 | COMPLETED | Malaria |
Sanofi |
2007-09 | PHASE4 |
| NCT00432367 | COMPLETED | Malaria; Anaemia; Pregnancy |
London School of Hygiene and Tropical Medicine |
2007-02 | PHASE3 |
| NCT00697892 | COMPLETED | HIV Infections; Malaria |
Fran Aweeka |
2005-07 | PHASE1 |
| NCT00563914 | COMPLETED | Malaria |
Sanofi |
2007-10 | PHASE1; PHASE2 |
| NCT00852371 | COMPLETED | Malaria; Intermittent Preventive Treatment |
London School of Hygiene and Tropical Medicine |
2008-02 | PHASE3 |
| NCT00550160 | COMPLETED | Malaria |
Kwame Nkrumah University of Science and Technology |
2007-04 | PHASE4 |
| NCT00561899 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2007-08 | PHASE2; PHASE3 |
| NCT00529620 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2007-09 | PHASE3 |
| NCT00460369 | COMPLETED | Uncomplicated Malaria |
Institut de Recherche pour le Developpement |
2007-04 | |
| NCT00146731 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2004-01 | PHASE3 |
| NCT00425763 | COMPLETED | Malaria |
Centers for Disease Control and Prevention |
2007-05 | PHASE4 |
| NCT00323622 | COMPLETED | Malaria |
GlaxoSmithKline |
2005-04 | PHASE2 |
| NCT00119132 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2005-06 | PHASE2; PHASE3 |
| NCT00386503 | COMPLETED | Malaria |
Sanofi |
2006-06 | PHASE1 |
| NCT00123552 | COMPLETED | Malaria |
University of California, San Francisco |
2004-11 | PHASE3 |
| NCT00142246 | COMPLETED | Malaria, Falciparum |
London School of Hygiene and Tropical Medicine |
2005-01 | PHASE3 |
| NCT00111163 | COMPLETED | Malaria; Anemia |
Centers for Disease Control and Prevention |
2004-03 | |
| NCT00164710 | COMPLETED | Malaria, Falciparum |
Centers for Disease Control and Prevention |
2005-04 | PHASE4 |
| NCT00164359 | COMPLETED | Malaria, Falciparum |
Centers for Disease Control and Prevention |
2005-04 | PHASE4 |
| NCT03768908 | COMPLETED | Plasmodium Falciparum Malaria |
Professor Anders Björkman |
2005-01-05 | PHASE4 |
| NCT00137514 | COMPLETED | Malaria, Falciparum |
Bandim Health Project |
2001-03 | PHASE4 |
| NCT03764527 | COMPLETED | Plasmodium Falciparum Malaria |
Professor Anders Björkman |
2002-11-01 | PHASE4 |
| NCT00465257 | SUSPENDED | Malaria |
Karolinska University Hospital |
2007-05 | PHASE4 |
| NCT00374205 | TERMINATED | Malaria, Falciparum |
Bernhard Nocht Institute for Tropical Medicine |
2006-09 | PHASE4 |
| NCT00158548 | COMPLETED | Malaria; Falciparum Malaria; Vivax Malaria |
London School of Hygiene and Tropical Medicine |
2001-06 | PHASE3 |
| NCT00545935 | COMPLETED | Malaria |
Heidelberg University |
2007-07 | PHASE2 |
| NCT00131703 | COMPLETED | Malaria; Pregnancy |
London School of Hygiene and Tropical Medicine |
2003-03 | PHASE3 |
| NCT00132548 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2004-06 | PHASE3 |
| NCT00157885 | COMPLETED | Malaria, Falciparum; Malaria, Vivax |
Menzies School of Health Research |
2005-07 | |
| NCT00406146 | UNKNOWN | Uncomplicated Malaria |
University of Ghana Medical School |
2004-10 | PHASE3 |
| NCT00261222 | COMPLETED | Malaria |
Heidelberg University |
2005-09 | PHASE2 |
| NCT00127998 | COMPLETED | Malaria |
Centers for Disease Control and Prevention |
2005-07 | |
| NCT00378625 | COMPLETED | Malaria,Falciparum; Malaria; Antimalarials |
Centro Internacional de Entrenamiento e Investigaciones Médicas |
2000-04 | PHASE3 |
| NCT00118807 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2003-08 | PHASE3 |
| NCT00316329 | COMPLETED | Malaria |
Sanofi |
2006-03 | PHASE3 |
| NCT00146783 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2004-06 | PHASE2; PHASE3 |
| NCT00119145 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2005-06 | PHASE4 |
| NCT00461578 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2005-04 | |
| NCT00238017 | UNKNOWN | Malaria |
Charite University, Berlin, Germany |
2005-10 | PHASE4 |
| NCT00376155 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2006-05 | PHASE4 |
| NCT01204411 | WITHDRAWN | Malaria, Falciparum; Malnutrition; Child |
Epicentre |
PHASE4 | |
| NCT00445796 | COMPLETED | Malaria |
Sanofi |
2005-06 | PHASE4 |
| NCT00354380 | COMPLETED | Malaria |
Heidelberg University |
2006-09 | PHASE2 |
| NCT00146718 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2003-08 | PHASE2; PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-01-07)
Check the
Amodiaquine
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.