Clinical Trials

Amodiaquine hydrochloride has been evaluated across all clinical trial phases in numerous clinical trials, with recruitment statuses ranging from completed and actively recruiting to suspended, terminated, or withdrawn. These studies assess the compound as monotherapy or combination therapy for treating and preventing Plasmodium falciparum malaria, uncomplicated pediatric falciparum malaria, malaria in pregnancy, and associated anemia. Sponsored by academic centers and global health institutes—including the London School of Hygiene and Tropical Medicine, the Malaria Consortium, and the Papua New Guinea Institute of Medical Research—these trials support pediatric and maternal malaria control.

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
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
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
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
NCT01651416 COMPLETED
Malaria; Anaemia
Centre for Global Health Research, Ghana
 2012-07 PHASE4
NCT01231113 COMPLETED
Pregnancy Complicated by Malaria as Antepartum Condition
Kwame Nkrumah University of Science and Technology
 2011-07 PHASE3
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
NCT01152931 COMPLETED
Malaria
University of Lagos, Nigeria
 2010-08 PHASE3
NCT01213433 COMPLETED
Uncomplicated Malaria
Centre Muraz
 2010-10 PHASE4
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
NCT00894660 COMPLETED
Falciparum Malaria
Pfizer
 2009-06 PHASE1
NCT00944840 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
 2008-09 PHASE3
NCT01567423 COMPLETED
Malaria, Falciparum
Epicentre
 2008-04
NCT00297882 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
 2006-07 PHASE3
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
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
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

(data from https://clinicaltrials.gov, updated on 2026-01-07)

Check the Amodiaquine hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a 4-aminoquinoline derivative, amodiaquine binds to free heme within the digestive vacuole of the parasite, preventing its polymerization into non-toxic hemozoin. This accumulation of toxic intracellular heme induces oxidative membrane damage and parasite cell lysis, underlying its therapeutic utility in clinical trials for treating Plasmodium falciparum malaria and preventing malaria-associated anemia.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.