Clinical Trials

Numerous clinical trials evaluate artemether, focusing predominantly on the treatment of Plasmodium falciparum malaria, Plasmodium vivax malaria, uncomplicated falciparum infection, and malaria-HIV coinfection. Spanning Phase 1 through Phase 4, these studies encompass completed, recruiting, active not recruiting, and terminated recruitment statuses. Trial sponsors primarily comprise academic institutions, government health agencies, and global research organizations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07533136 NOT_YET_RECRUITING
Uncomplicated P. Vivax Mono-infection
Walter Reed Army Institute of Research (WRAIR)
 2026-05-01
NCT06962319 RECRUITING
Malaria, Pregnancy; Malaria, Antepartum; Malaria (Uncomplicated)
Liverpool School of Tropical Medicine
 2025-09-30 PHASE3
NCT06967519 RECRUITING
Malaria; Hiv
Yale University
 2025-12-18 PHASE4
NCT04704999 RECRUITING
Plasmodium Vivax Malaria
University of Oxford
 2024-07-22 PHASE4
NCT07559370 RECRUITING
Malaria (Plasmodium Falciparum)
Victoria Biomedical Research Institute
 2026-01-20 PHASE2
NCT05757167 ACTIVE_NOT_RECRUITING
Malaria,Falciparum; Malaria in Pregnancy; Malaria in Childbirth; Pregnancy; Neonatal Health; Low Birthweight; Stillbirth; Gestational Age and Weight Conditions; Preterm Birth
Duke University
 2023-11-06 PHASE4
NCT07403643 NOT_YET_RECRUITING
Uncomplicated Malaria
Curtin University
 2026-04 PHASE4
NCT05951595 RECRUITING
Uncomplicated Plasmodium Falciparum Malaria
University of Oxford
 2025-09-11 PHASE3
NCT05788094 RECRUITING
Malaria; Malaria, Vivax; Plasmodium Vivax Malaria
Shoklo Malaria Research Unit
 2023-06-26 PHASE4
NCT04280692 SUSPENDED
Malaria,Falciparum
University of Oxford
 2022-08-22 PHASE1; PHASE2
NCT06347471 COMPLETED
Falciparum; Malaria
Infectious Diseases Research Collaboration, Uganda
 2024-05-28 PHASE4
NCT07527182 COMPLETED
Malaria (Plasmodium Falciparum); Drug Resistance; Artemisinin-resistant; Ethiopia
Didier Menard
 2024-05-01
NCT04080895 TERMINATED
Pharmacokinetic; Healthy; Drug Combination
University of Oxford
 2022-11-01 PHASE1
NCT06294912 COMPLETED
Malaria
Merck Sharp & Dohme LLC
 2024-04-18 PHASE1
NCT05764746 COMPLETED
Uncomplicated Plasmodium Falciparum Malaria
Muhimbili University of Health and Allied Sciences
 2023-05-01 PHASE2; PHASE3
NCT06424002 UNKNOWN
Malaria,Falciparum
Kamuzu University of Health Sciences
 2024-06-01 PHASE4
NCT06970600 COMPLETED
Malaria (Uncomplicated)
Centro de Investigacao em Saude de Manhica
 2024-03-07
NCT06076213 COMPLETED
Uncomplicated Plasmodium Falciparum Malaria
Ministry of Public Health, Democratic Republic of the Congo
 2023-05-01 PHASE4
NCT03923725 COMPLETED
Plasmodium Falciparum Malaria (Uncomplicated)
University of Oxford
 2020-09-01 PHASE3
NCT04708496 UNKNOWN
HIV Coinfection; Malaria
Makerere University
 2021-01-18 PHASE4
NCT04767217 COMPLETED
Uncomplicated Malaria
Jhpiego
 2021-06-14 PHASE4
NCT05343312 COMPLETED
Malaria
Centro de Investigacao em Saude de Manhica
 2022-03-16 PHASE4
NCT06300970 COMPLETED
Plasmodium Falciparum; Malaria; Uncomplicated Malaria
Centers for Disease Control and Prevention
 2022-08-09 PHASE4
NCT04300309 TERMINATED
Plasmodium Falciparum Malaria
Novartis Pharmaceuticals
 2020-12-21 PHASE2; PHASE3
NCT07358767 COMPLETED
Malaria
Noguchi Memorial Institute for Medical Research
 2021-07-01
NCT03939104 COMPLETED
Plasmodium Falciparum Malaria (Uncomplicated)
University of Oxford
 2021-06-30 PHASE3
NCT05340153 UNKNOWN
Malaria
University of Yaounde 1
 2022-04-11 PHASE4
NCT05605925 UNKNOWN
Malaria
Makerere University
 2022-08-04 PHASE4
NCT05550909 COMPLETED
Malaria,Falciparum
London School of Hygiene and Tropical Medicine
 2022-10-17 PHASE2
NCT04767191 COMPLETED
Uncomplicated Malaria
Jhpiego
 2021-03-15 PHASE4
NCT04695197 COMPLETED
Covid-19; Malaria
Liverpool School of Tropical Medicine
 2021-01-08 PHASE3
NCT04944966 COMPLETED
Malaria
Ifakara Health Institute
 2021-06-02 PHASE2
NCT05605925 Recruiting
Malaria
Makerere University
 2022-08-04 Phase 4
NCT04661579 COMPLETED
Plasmodium Falciparum
PATH
 2020-11-06 PHASE2
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
NCT04241705 UNKNOWN
Malaria
Armauer Hansen Research Institute, Ethiopia
 2020-01-20
NCT04829695 UNKNOWN
Falciparum Malaria
University of Yaounde 1
 2021-04-05 PHASE4
NCT04778813 UNKNOWN
Malaria; Burkina Faso
Centre national de recherche et de formation sur le paludisme
 2021-06-01 PHASE4
NCT05081089 COMPLETED
Malaria,Falciparum
London School of Hygiene and Tropical Medicine
 2021-10-12 PHASE2
NCT03453840 COMPLETED
Uncomplicated Plasmodium Falciparum Malaria
University of California, San Francisco
 2018-02-21 PHASE4
NCT04041973 COMPLETED
Malaria
University of Oxford
 2020-03-11
NCT04708496 Unknown status
HIV Coinfection|Malaria
Makerere University
 2021-01-18 Phase 4
NCT05192265 COMPLETED
Malaria Fever; Plasmodium Falciparum Malaria; Uncomplicated Malaria
University of Ibadan
 2019-05-20 PHASE2; PHASE3
NCT04310085 COMPLETED
Malaria,Falciparum; Parasitemia; Protozoan Infections; Parasitic Disease
Medicines for Malaria Venture
 2020-02-19 PHASE1
NCT04565184 COMPLETED
Malaria,Falciparum
University of Yaounde 1
 2019-05-09 PHASE4
NCT04456634 COMPLETED
Malaria
Medicines for Malaria Venture
 2020-09-10 PHASE1
NCT05070520 COMPLETED
MALARIA
Programme National de Lutte contre le Paludisme, Niger
 2020-09-01 PHASE4
NCT04009343 ACTIVE_NOT_RECRUITING
Uncomplicated Falciparum Malaria
Johns Hopkins Bloomberg School of Public Health
 2019-06-19 PHASE2; PHASE3
NCT04094727 COMPLETED
Malaria
University of California, San Francisco
 2019-10-31 PHASE4
NCT03355664 COMPLETED
Malaria, Falciparum
University of Oxford
 2018-03-19 PHASE3
NCT04264130 COMPLETED
Schistosomiasis Haematobia
Centre de Recherche Médicale de Lambaréné
 2018-07-31 PHASE2
NCT03510481 COMPLETED
Malaria
National Institute of Allergy and Infectious Diseases (NIAID)
 2018-05-14 PHASE1
NCT03452475 COMPLETED
Plasmodium Falciparum
University of Oxford
 2018-03-07 PHASE3
NCT04531072 COMPLETED
Drug Interaction
Fogarty International Center of the National Institute of Health
 2018-09-18 PHASE4
NCT02696954 TERMINATED
Pharmacokinetic; Drug Combination; Healthy
University of Oxford
 2016-11-18 PHASE1; PHASE2
NCT03783299 COMPLETED
Plasmodium Falciparum Malaria
University of California, San Francisco
 2017-11-28 PHASE4
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
NCT03241901 COMPLETED
Malaria,Falciparum
Muhimbili University of Health and Allied Sciences
 2017-07-27 PHASE4
NCT02348788 UNKNOWN
Plasmodium Vivax Malaria Without Complication
Menzies School of Health Research
 2015-01 PHASE3
NCT04897919 COMPLETED
Malaria; Effectiveness
Bandim Health Project
 2015-08-01 PHASE4
NCT02411994 COMPLETED
Malaria
Royal Tropical Institute
 2015-10 PHASE3
NCT05060198 COMPLETED
Malaria,Falciparum
Kenya Medical Research Institute
 2016-06-17
NCT02263950 UNKNOWN
Solid Tumours
LondonPharma Ltd.
 2014-10 PHASE1; PHASE2
NCT02528279 COMPLETED
Malaria
Albert Schweitzer Hospital
 2014-10
NCT02242799 COMPLETED
Malaria; HIV
University of Liverpool
 2015-06 PHASE1
NCT01054248 COMPLETED
Malaria
University of Oxford
 2010-02-16 PHASE3
NCT02742285 COMPLETED
Malaria
Thierry Buclin
 2016-05 PHASE4
NCT02600767 COMPLETED
Malaria
Centers for Disease Control and Prevention
 2015-12
NCT02590627 COMPLETED
Malaria
National Institute for Medical Research, Tanzania
 2014-05 PHASE4
NCT02174900 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
 2014-10 PHASE2; PHASE3
NCT01704508 COMPLETED
Malaria
Bandim Health Project
 2012-11 PHASE4
NCT01935882 COMPLETED
Malaria; Asymptomatic Malaria; Plasmodium Falciparum
London School of Hygiene and Tropical Medicine
 2013-09 PHASE2; PHASE3
NCT02325180 COMPLETED
Malaria, Falciparum
London School of Hygiene and Tropical Medicine
 2015-01 PHASE4
NCT02184637 COMPLETED
Malaria, Vivax
GlaxoSmithKline
 2014-07-31 PHASE1
NCT02389374 COMPLETED
Malaria
Menzies School of Health Research
 2014-08 PHASE4
NCT01958905 COMPLETED
Malaria; Severe Acute Malnutrition
Epicentre
 2013-11
NCT02213211 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
 2014-04
NCT02020330 COMPLETED
Plasmodium Falciparum Infection
University of Oxford
 2013-11-25 PHASE3
NCT02001012 COMPLETED
Uncomplicated Knowlesi Malaria
Menzies School of Health Research
 2014-01 PHASE3
NCT01680406 COMPLETED
Plasmodium Vivax Infection
Centers for Disease Control and Prevention
 2012-10 PHASE4
NCT02741024 COMPLETED
Malaria
Medecins Sans Frontieres, Netherlands
 2013-10 PHASE4
NCT01976780 COMPLETED
Malaria
Global Emerging Infections Surveillance and Response System
 2013-06 PHASE4
NCT01755559 COMPLETED
Malaria
Epicentre
 2013-06 PHASE4
NCT02090036 COMPLETED
Plasmodium Falciparum
Muhimbili University of Health and Allied Sciences
 2014-07 PHASE4
NCT01697787 COMPLETED
Malaria
Centre Muraz
 2012-10 PHASE4
NCT01944189 UNKNOWN
Malaria, Falciparum
Makerere University
 2013-09 PHASE4
NCT02223871 COMPLETED
Healthy Subjects
Idorsia Pharmaceuticals Ltd.
 2014-06 PHASE1
NCT02637128 COMPLETED
MALARIA, FALCIPARUM
Centers for Disease Control and Prevention
 2014-03 PHASE4
NCT01619878 COMPLETED
Acute Uncomplicated Falciparum Malaria
Novartis Pharmaceuticals
 2012-10 PHASE2; PHASE3
NCT01374581 COMPLETED
Malaria
Universiteit Antwerpen
 2012-05 PHASE3
NCT01899820 UNKNOWN
Malaria
Sabah Ahmed Omar
 2013-04 PHASE3
NCT01845701 COMPLETED
Malaria
University of Yaounde 1
 2010-03 PHASE3
NCT01150344 COMPLETED
Malaria
Assistance Publique - Hôpitaux de Paris
 2010-07 PHASE4
NCT01916954 COMPLETED
Malaria
University of Oxford
 2013-07 PHASE3
NCT01728961 TERMINATED
HIV Infection; Malaria
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
 2012-02 PHASE4
NCT01967472 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
 2013-09-16
NCT01939886 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
 2013-04 PHASE3
NCT01906788 UNKNOWN
Malaria Transmission
Kilimanjaro Clinical Research Institute
 2013-05 PHASE4
NCT00852423 COMPLETED
Malaria in Pregnancy
Institute of Tropical Medicine, Belgium
 2010-06 PHASE3
NCT01038063 UNKNOWN
Malaria
Liverpool School of Tropical Medicine
 2010-10 PHASE4
NCT02089841 COMPLETED
Plasmodium Falciparum Malaria
Richard Mwaiswelo
 2012-05 PHASE4
NCT01603251 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
 2013-01 PHASE1; PHASE2
NCT00527800 COMPLETED
Malaria; HIV Infections
University of California, San Francisco
 2007-08 PHASE3
NCT01651416 COMPLETED
Malaria; Anaemia
Centre for Global Health Research, Ghana
 2012-07 PHASE4
NCT01575613 COMPLETED
Malaria
Radboud University Medical Center
 2012-04
NCT00885287 COMPLETED
Malaria, Falciparum; HIV Infections
University of Copenhagen
 2009-07 PHASE4
NCT01625871 COMPLETED
Vivax Malaria
University of Khartoum
 2011-09 PHASE3
NCT01258049 COMPLETED
Plasmodium Falciparum Malaria
Proto Pharma Ltd
 2010-12 PHASE3
NCT01256658 COMPLETED
Malaria
Novartis
 2010-11 PHASE4
NCT01599000 COMPLETED
Parasitologically Confirmed; Malarial
Papua New Guinea Institute of Medical Research
 2011-03 PHASE4
NCT01326754 COMPLETED
Malaria, Falciparum
Centers for Disease Control and Prevention
 2011-08
NCT01998295 COMPLETED
Instantaneous Clearance
Muhimbili University of Health and Allied Sciences
 2012-05 PHASE4
NCT01082731 TERMINATED
Malaria
Centers for Disease Control and Prevention
 2010-11 PHASE4
NCT01107145 TERMINATED
Plasmodium Vivax Malaria
Centers for Disease Control and Prevention
 2011-02 PHASE4
NCT00720811 COMPLETED
Malaria; Pneumonia
Mbarara University of Science and Technology
 2009-10
NCT02168569 COMPLETED
Malaria
Centro de Investigacao em Saude de Manhica
 2011-06 PHASE4
NCT01043744 COMPLETED
Malaria; Non-malarial Febrile Illness
Centers for Disease Control and Prevention
 2010-01
NCT00725777 COMPLETED
Acute Non-falciparum Malaria
Albert Schweitzer Hospital
 2008-07
NCT01449045 COMPLETED
Malaria
Cheikh Anta Diop University, Senegal
 2011-07 PHASE3
NCT01459146 UNKNOWN
Malaria; Schistosomiasis; Helminthiasis; Anemia; Change in Sustained Attention
Navrongo Health Research Centre, Ghana
 2010-12 PHASE4
NCT01876966 COMPLETED
HIV
Janssen Pharmaceutica N.V., Belgium
 2011-03 PHASE1
NCT00620438 UNKNOWN
HIV Infections; Tuberculosis
Makerere University
 2008-02 PHASE4
NCT01082705 COMPLETED
P. Falciparum Malaria
Centers for Disease Control and Prevention
 2010-04 PHASE3
NCT01065116 COMPLETED
Malaria
Malaria Consortium, Uganda
 2010-03 PHASE3
NCT00266058 COMPLETED
HIV Infections; Malaria
University of California, San Francisco
 2005-12 PHASE1
NCT01152931 COMPLETED
Malaria
University of Lagos, Nigeria
 2010-08 PHASE3
NCT00808951 COMPLETED
Malaria
Centre Muraz
 2008-12 PHASE4
NCT00677833 COMPLETED
Malaria, Falciparum
Pfizer
 2008-06 PHASE2; PHASE3
NCT00699920 COMPLETED
Malaria
Sanofi
 2008-06 PHASE4
NCT02143934 COMPLETED
Plasmodium Vivax Infection; Plasmodium Vivax Clinical Episode; Plasmodium Falciparum Infection; Plasmodium Falciparum Clinical Episode
Papua New Guinea Institute of Medical Research
 2009-08 PHASE4
NCT00868465 COMPLETED
Uncomplicated Malaria
Radboud University Medical Center
 2009-04
NCT01075945 UNKNOWN
Malaria
University of Khartoum
 2010-02 PHASE4
NCT00869700 COMPLETED
HIV Infections; Malaria
University of Cape Town
 2009-06 PHASE4
NCT01047436 COMPLETED
Falciparum Malaria
Proto Pharma Ltd
 2009-12 PHASE2
NCT01052584 COMPLETED
Malaria
Centers for Disease Control and Prevention
 2009-10
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
NCT04877626 COMPLETED
P. Falciparum Malaria
Universidad Nacional de Colombia
 2008-09 PHASE4
NCT00790881 COMPLETED
Malaria; HIV
University of Cape Town
 2008-10 PHASE4
NCT00495508 COMPLETED
Malaria
Epicentre
 2006-10 PHASE4
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
NCT00619944 COMPLETED
HIV Infections
Makerere University
 2008-02 PHASE4
NCT00697892 COMPLETED
HIV Infections; Malaria
Fran Aweeka
 2005-07 PHASE1
NCT00694694 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
 2008-06 PHASE3
NCT00444106 COMPLETED
Malaria; Falciparum
Novartis
 2007-05 PHASE4
NCT00426439 COMPLETED
Malaria, Falciparum
Bandim Health Project
 2006-12 PHASE4
NCT00229775 COMPLETED
Malaria
Centers for Disease Control and Prevention
 2003-07
NCT00422084 COMPLETED
Malaria
Medicines for Malaria Venture
 2007-01 PHASE3
NCT00140361 COMPLETED
Malaria (Uncomplicated)
Centers for Disease Control and Prevention
 2000-01 PHASE4
NCT00529867 COMPLETED
Malaria, Falciparum
Dafra Pharma
 2007-05 PHASE4
NCT00460369 COMPLETED
Uncomplicated Malaria
Institut de Recherche pour le Developpement
 2007-04
NCT00344006 COMPLETED
Malaria, Falciparum
GlaxoSmithKline
 2006-06 PHASE3
NCT00123552 COMPLETED
Malaria
University of California, San Francisco
 2004-11 PHASE3
NCT00386750 TERMINATED
Malaria; Falciparum
Novartis Pharmaceuticals
 2005-06 PHASE4
NCT00164710 COMPLETED
Malaria, Falciparum
Centers for Disease Control and Prevention
 2005-04 PHASE4
NCT00233337 COMPLETED
Acute Uncomplicated P. Falciparum Malaria
Novartis Pharmaceuticals
 2001-05 PHASE4
NCT03768908 COMPLETED
Plasmodium Falciparum Malaria
Professor Anders Björkman
 2005-01-05 PHASE4
NCT00203801 COMPLETED
Malaria
University of Cape Town
 2002-01
NCT03764527 COMPLETED
Plasmodium Falciparum Malaria
Professor Anders Björkman
 2002-11-01 PHASE4
NCT00709969 COMPLETED
Plasmodium Falciparum Malaria
Novartis
 2002-07 PHASE3
NCT00336375 COMPLETED
Malaria
Karolinska University Hospital
 2006-06 PHASE4
NCT00386763 COMPLETED
Malaria; Falciparum
Novartis
 2006-08 PHASE3
NCT00118794 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
 2004-09 PHASE3
NCT00127998 COMPLETED
Malaria
Centers for Disease Control and Prevention
 2005-07
NCT00484900 COMPLETED
Plasmodium Falciparum Malaria
Dafra Pharma
 2006-05 PHASE3
NCT00316329 COMPLETED
Malaria
Sanofi
 2006-03 PHASE3
NCT00119145 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
 2005-06 PHASE4
NCT00451139 COMPLETED
Malaria
Jimma University
 PHASE4
NCT00304980 TERMINATED
Plasmodium Falciparum Malaria
Institute of Tropical Medicine, Belgium
 2003-03
NCT00540202 UNKNOWN
Uncomplicated Malaria
Makerere University
 2007-09 PHASE4
NCT00374205 TERMINATED
Malaria, Falciparum
Bernhard Nocht Institute for Tropical Medicine
 2006-09 PHASE4
NCT00454961 COMPLETED
Malaria
Karolinska University Hospital
 2007-04 PHASE4
NCT00406146 UNKNOWN
Uncomplicated Malaria
University of Ghana Medical School
 2004-10 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-04-16)

Check the Artemether (SM-224) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Artemether undergoes heme-mediated cleavage of its endoperoxide bridge to generate toxic reactive oxygen species and alkylating free radicals that disrupt essential parasitic cytosolic components and cellular membrane integrity. This potent oxidative stress induces rapid cell death and parasite clearance, providing the biochemical basis for its evaluated clinical efficacy in treating Plasmodium falciparum and Plasmodium vivax malaria infections.

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>).

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