Numerous clinical trials spanning Phase 1 to Phase 4 evaluate artemisinin and its derivative combination therapies, primarily targeting Plasmodium falciparum infections, drug-resistant malaria, febrile illness, and associated anaemia. Sponsored by prominent academic and governmental institutions—such as the National Institute of Allergy and Infectious Diseases, the London School of Hygiene and Tropical Medicine, and Duke University—these studies encompass completed, actively recruiting, and withdrawn recruitment statuses. Clinical research investigating exposure-response kinetics in pediatric severe malaria and post-treatment transmission dynamics underlines a broad pipeline dedicated to optimizing antimalarial efficacy and overcoming drug resistance.
| 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 |
| NCT04704999 | RECRUITING | Plasmodium Vivax Malaria |
University of Oxford |
2024-07-22 | 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 |
| 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 | |
| NCT05764746 | COMPLETED | Uncomplicated Plasmodium Falciparum Malaria |
Muhimbili University of Health and Allied Sciences |
2023-05-01 | PHASE2; PHASE3 |
| NCT03923725 | COMPLETED | Plasmodium Falciparum Malaria (Uncomplicated) |
University of Oxford |
2020-09-01 | PHASE3 |
| NCT04767217 | COMPLETED | Uncomplicated Malaria |
Jhpiego |
2021-06-14 | PHASE4 |
| NCT05750459 | Recruiting | Plasmodium Falciparum Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2023-11-29 | Phase 4 |
| NCT05343312 | COMPLETED | Malaria |
Centro de Investigacao em Saude de Manhica |
2022-03-16 | PHASE4 |
| NCT04428385 | COMPLETED | Malaria; Febrile Illness |
Duke University |
2021-03-15 | |
| 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 |
| NCT05829187 | COMPLETED | Uncomplicated Plasmodium Falciparum |
Syamsudin Abdillah,Ph.D, Pharm D |
2022-11-01 | PHASE2 |
| NCT04767191 | COMPLETED | Uncomplicated Malaria |
Jhpiego |
2021-03-15 | PHASE4 |
| NCT04387240 | WITHDRAWN | Covid 19 Positive; Corona Virus Infection |
Princess Nourah Bint Abdulrahman University |
2022-01 | PHASE2 |
| NCT04428307 | COMPLETED | Malaria; Febrile Illness |
Duke University |
2021-01-11 | |
| 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 |
| NCT04778813 | UNKNOWN | Malaria; Burkina Faso |
Centre national de recherche et de formation sur le paludisme |
2021-06-01 | PHASE4 |
| NCT04801017 | UNKNOWN | COVID-19 |
Oncotelic Inc. |
2021-04 | PHASE2 |
| NCT05004753 | COMPLETED | Covid19 |
Mateon Therapeutics |
2020-09-30 | PHASE4 |
| 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 |
| NCT04009343 | ACTIVE_NOT_RECRUITING | Uncomplicated Falciparum Malaria |
Johns Hopkins Bloomberg School of Public Health |
2019-06-19 | PHASE2; PHASE3 |
| NCT04020653 | WITHDRAWN | Malaria |
Neopharma Japan Co., Ltd. |
2019-09-06 | PHASE2 |
| NCT04049916 | COMPLETED | Malaria,Falciparum |
London School of Hygiene and Tropical Medicine |
2019-09-12 | PHASE2; PHASE3 |
| NCT04264130 | COMPLETED | Schistosomiasis Haematobia |
Centre de Recherche Médicale de Lambaréné |
2018-07-31 | PHASE2 |
| NCT02802501 | COMPLETED | Malaria, Vivax |
GlaxoSmithKline |
2018-04-08 | PHASE3 |
| NCT04167566 | COMPLETED | Malaria; Malaria, Asymptomatic Parasitaemia |
Noguchi Memorial Institute for Medical Research |
2017-07-01 | |
| NCT03201770 | COMPLETED | Malaria,Falciparum |
Shin Poong Pharmaceutical Co. Ltd. |
2017-06-22 | PHASE4 |
| NCT02612545 | COMPLETED | Acute Falciparum Malaria |
National Institute of Allergy and Infectious Diseases (NIAID) |
2015-11-20 | PHASE1 |
| NCT02453308 | COMPLETED | Malaria, Falciparum |
University of Oxford |
2015-08 | PHASE2; PHASE3 |
| 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 |
| NCT04897919 | COMPLETED | Malaria; Effectiveness |
Bandim Health Project |
2015-08-01 | PHASE4 |
| NCT01872702 | COMPLETED | Plasmodium Falciparum Malaria |
University of Oxford |
2013-04 | |
| NCT02461186 | WITHDRAWN | Uncomplicated Falciparum Malaria; Artemisinin-resistant |
University of Oxford |
2015-06 | PHASE2; PHASE3 |
| NCT05060198 | COMPLETED | Malaria,Falciparum |
Kenya Medical Research Institute |
2016-06-17 | |
| NCT01054248 | COMPLETED | Malaria |
University of Oxford |
2010-02-16 | PHASE3 |
| NCT02604966 | UNKNOWN | Drug Resistant Malaria Due to Plasmodium Falciparum |
National Institute of Malariology, Parasitology and Entomology, Vietnam |
2015-04 | PHASE4 |
| NCT02389439 | COMPLETED | Malaria, Falciparum |
University of Oxford |
2015-03-01 | PHASE2 |
| NCT02590627 | COMPLETED | Malaria |
National Institute for Medical Research, Tanzania |
2014-05 | PHASE4 |
| NCT02298140 | UNKNOWN | Malaria |
Ifakara Health Institute |
2014-11 | |
| NCT01704508 | COMPLETED | Malaria |
Bandim Health Project |
2012-11 | PHASE4 |
| NCT02987270 | COMPLETED | Malaria,Falciparum |
Simon Kariuki |
2013-04 | PHASE3 |
| NCT02325180 | COMPLETED | Malaria, Falciparum |
London School of Hygiene and Tropical Medicine |
2015-01 | PHASE4 |
| NCT02184637 | COMPLETED | Malaria, Vivax |
GlaxoSmithKline |
2014-07-31 | PHASE1 |
| NCT02073149 | COMPLETED | Anaemia |
London School of Hygiene and Tropical Medicine |
2014-06 | PHASE2; PHASE3 |
| NCT01976780 | COMPLETED | Malaria |
Global Emerging Infections Surveillance and Response System |
2013-06 | PHASE4 |
| NCT01755559 | COMPLETED | Malaria |
Epicentre |
2013-06 | PHASE4 |
| NCT01930331 | COMPLETED | Plasmodium Falciparum; Malaria, Falciparum |
Ifakara Health Institute |
2014-01-07 | PHASE4 |
| 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 |
| 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 |
| NCT00764036 | COMPLETED | Metastatic Breast Cancer; Locally Advanced Breast Cancer |
Heidelberg University |
2008-10 | PHASE1 |
| NCT00852423 | COMPLETED | Malaria in Pregnancy |
Institute of Tropical Medicine, Belgium |
2010-06 | PHASE3 |
| NCT01906788 | UNKNOWN | Malaria Transmission |
Kilimanjaro Clinical Research Institute |
2013-05 | PHASE4 |
| NCT02974348 | COMPLETED | Drug Resistant Malaria Due to Plasmodium Falciparum |
University of Bamenda |
2013-01 | PHASE3 |
| NCT00527800 | COMPLETED | Malaria; HIV Infections |
University of California, San Francisco |
2007-08 | PHASE3 |
| NCT01775592 | COMPLETED | Plasmodium Falciparum |
National Institute of Malariology, Parasitology and Entomology, Vietnam |
2012-09 | PHASE4 |
| 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 | |
| NCT01190371 | UNKNOWN | Malaria |
KEMRI-Wellcome Trust Collaborative Research Program |
2011-04 | PHASE4 |
| NCT01459146 | UNKNOWN | Malaria; Schistosomiasis; Helminthiasis; Anemia; Change in Sustained Attention |
Navrongo Health Research Centre, Ghana |
2010-12 | PHASE4 |
| NCT01043796 | COMPLETED | Malaria |
Centers for Disease Control and Prevention |
2010-05 | PHASE3 |
| NCT01082705 | COMPLETED | P. Falciparum Malaria |
Centers for Disease Control and Prevention |
2010-04 | PHASE3 |
| NCT01165372 | COMPLETED | Malaria |
Oxford University Clinical Research Unit, Vietnam |
2010-08 | PHASE2 |
| NCT01391403 | COMPLETED | Schizophrenia |
Beijing HuiLongGuan Hospital |
2008-09 | PHASE3 |
| NCT00868465 | COMPLETED | Uncomplicated Malaria |
Radboud University Medical Center |
2009-04 | |
| NCT00753506 | COMPLETED | Schizophrenia; Schizoaffective Disorder |
Sheppard Pratt Health System |
2008-08 | |
| NCT01075945 | UNKNOWN | Malaria |
University of Khartoum |
2010-02 | PHASE4 |
| NCT00393679 | COMPLETED | Fever; Malaria |
Institute of Tropical Medicine, Belgium |
2007-07 | PHASE3 |
| NCT00639873 | COMPLETED | Malaria |
Medical University of Vienna |
2008-06 | |
| NCT00902811 | UNKNOWN | Uncomplicated Falciparum Malaria |
Medecins Sans Frontieres, Netherlands |
2008-12 | PHASE4 |
| NCT00722150 | COMPLETED | Falciparum Malaria |
Armed Forces Research Institute of Medical Sciences, Thailand |
2008-07 | |
| NCT00297882 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2006-07 | PHASE3 |
| NCT00452907 | COMPLETED | Malaria |
Sanofi |
2005-07 | PHASE4 |
| NCT00336388 | COMPLETED | Malaria |
Centers for Disease Control and Prevention |
2006-07 | |
| NCT00373607 | COMPLETED | Malaria |
Institute of Tropical Medicine, Belgium |
2003-07 | PHASE3 |
| NCT00479206 | COMPLETED | Malaria, Falciparum |
Medical University of Vienna |
2006-10 | |
| NCT00301015 | COMPLETED | Uncomplicated Plasmodium Falciparum Malaria |
Karolinska University Hospital |
2006-03 | PHASE4 |
| NCT00336375 | COMPLETED | Malaria |
Karolinska University Hospital |
2006-06 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2026-04-16)
Check the
Artemisinin
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.