Clinical Trials

Artesunate is evaluated across numerous Phase 1 to Phase 4 clinical trials, examining therapeutic utility in severe and drug-resistant Plasmodium falciparum malaria, viral infections such as COVID-19, and non-communicable conditions including anal high-grade squamous intraepithelial lesions, Friedreich ataxia, idiopathic pulmonary fibrosis, and chronic myeloid leukemia. Sponsored by diverse organizations—including the London School of Hygiene and Tropical Medicine, INSERM, and Pfizer—these studies encompass recruiting, active non-recruiting, and completed statuses to evaluate treatment efficacy across varied disease stages.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07095309 NOT_YET_RECRUITING
Stage II/III Colon Cancer; Bowel Cancer
Metanoic Health Ltd.
2025-08-15 PHASE2
NCT06872112 RECRUITING
Pulmonary Arterial Hypertension (PAH)
Joseph C. Wu
2026-04-01 PHASE1
NCT05988463 RECRUITING
Idiopathic Pulmonary Fibrosis
Joseph C. Wu
2026-08-01 PHASE1
NCT06962319 RECRUITING
Malaria, Pregnancy; Malaria, Antepartum; Malaria (Uncomplicated)
Liverpool School of Tropical Medicine
2025-09-30 PHASE3
NCT07060794 NOT_YET_RECRUITING
Vivax Malaria
Menzies School of Health Research
2026-06 PHASE4
NCT06853184 RECRUITING
CMV Infection
Amivas Inc.
2025-08-01 PHASE2
NCT06967519 RECRUITING
Malaria; Hiv
Yale University
2025-12-18 PHASE4
NCT07470424 NOT_YET_RECRUITING
Malaria
University of Oxford
2026-11-01 PHASE1
NCT07095478 NOT_YET_RECRUITING
CIN 2/3
Metanoic Health Ltd.
2025-08-01 PHASE2
NCT06206564 RECRUITING
Anal High-grade Squamous Intraepithelial Lesion; Anal HSIL; Anal HPV Infection; AIN
Frantz Viral Therapeutics, LLC
2024-01-12 PHASE2
NCT05555862 ACTIVE_NOT_RECRUITING
Anal High Grade Squamous Intraepithelial Lesion; Anal Precancerous Condition; AIN 2/3; HPV Infection; Anal Dysplasia; HPV Disease
Frantz Viral Therapeutics, LLC
2023-02-10 PHASE2
NCT06075264 RECRUITING
Vulvar Diseases; HPV Infection; Vulvar HSIL; Pre-Cancerous Dysplasia; HPV Disease; VIN, Usual Type; VIN 2 of Usual Type; VIN 3 of Usual Type; Vin II; Vin III; VIN Grade 2; VIN Grade 3; High Grade Intraepithelial Neoplasia
Frantz Viral Therapeutics, LLC
2023-12-06 PHASE2
NCT04098744 RECRUITING
CIN 2/3; HPV Infection; Pre-Cancerous Dysplasia; Cervical Dysplasia; HPV Related Disease
Frantz Viral Therapeutics, LLC
2020-09-09 PHASE2
NCT05951595 RECRUITING
Uncomplicated Plasmodium Falciparum Malaria
University of Oxford
2025-09-11 PHASE3
NCT07022743 ACTIVE_NOT_RECRUITING
Chronic Myeloid Leukemia (CML)
Obafemi Awolowo University
2025-07-01 PHASE2
NCT05441410 NOT_YET_RECRUITING
Malaria
University Hospital Tuebingen
2025-06-01 PHASE1; PHASE2
NCT06519994 COMPLETED
Human Immunodeficiency Virus; Human Papillomavirus; Cervical Precancer
UNC Lineberger Comprehensive Cancer Center
2025-01-22 PHASE2
NCT04675931 COMPLETED
Severe Malaria
Novartis Pharmaceuticals
2022-03-07 PHASE2
NCT05750459 COMPLETED
Plasmodium Falciparum Infection
National Institute of Allergy and Infectious Diseases (NIAID)
2023-11-29 PHASE4
NCT06165614 COMPLETED
Cervix Cancer; Cervix Neoplasm; Precancerous Conditions; Cervical Precancer
UNC Lineberger Comprehensive Cancer Center
2024-03-04 PHASE1
NCT06294912 COMPLETED
Malaria
Merck Sharp & Dohme LLC
2024-04-18 PHASE1
NCT05929157 UNKNOWN
Severe Malarial Treatment
Centre de Recherche Médicale de Lambaréné
2023-09-01 PHASE1; PHASE2
NCT05764746 COMPLETED
Uncomplicated Plasmodium Falciparum Malaria
Muhimbili University of Health and Allied Sciences
2023-05-01 PHASE2; PHASE3
NCT04706130 COMPLETED
Vivax Malaria
University of Maryland, Baltimore
2021-04-15 PHASE4
NCT06076213 COMPLETED
Uncomplicated Plasmodium Falciparum Malaria
Ministry of Public Health, Democratic Republic of the Congo
2023-05-01 PHASE4
NCT06263582 COMPLETED
Cervix Cancer; Cervix Intraepithelial Neoplasia Grade 3; Cervix; Intraepithelial Neoplasia, Grade I; Cervix; Intraepithelial Neoplasia, Grade II
UNC Lineberger Comprehensive Cancer Center
2024-05-29 PHASE1
NCT04921930 COMPLETED
Friedreich Ataxia
Institut National de la Santé Et de la Recherche Médicale, France
2022-05-06 PHASE1; PHASE2
NCT03923725 COMPLETED
Plasmodium Falciparum Malaria (Uncomplicated)
University of Oxford
2020-09-01 PHASE3
NCT04330690 UNKNOWN
COVID-19
Sunnybrook Health Sciences Centre
2020-03-18 PHASE3
NCT04713631 UNKNOWN
Crohn's Disease
Sanjay Gandhi Postgraduate Institute of Medical Sciences
2021-01-21 PHASE2
NCT05343312 COMPLETED
Malaria
Centro de Investigacao em Saude de Manhica
2022-03-16 PHASE4
NCT05929157 Not yet recruiting
Severe Malarial Treatment
Centre de Recherche Médicale de Lambaréné|Institute of Tropical Medicine University of Tuebingen
2023-09-01 Phase 1|Phase 2
NCT06300970 COMPLETED
Plasmodium Falciparum; Malaria; Uncomplicated Malaria
Centers for Disease Control and Prevention
2022-08-09 PHASE4
NCT06472258 COMPLETED
Malaria
RESnTEC, Institute of Research
2023-03-01
NCT05555862 Active not recruiting
Anal High Grade Squamous Intraepithelial Lesion|Anal Precancerous Condition|AIN 2/3|HPV Infection|Anal Dysplasia|HPV Disease
Frantz Viral Therapeutics LLC|Amarex CRO|University of California San Francisco|Anal Dysplasia Clinic MidWest|Laser Surgery Care
2023-02-10 Phase 2
NCT03939104 COMPLETED
Plasmodium Falciparum Malaria (Uncomplicated)
University of Oxford
2021-06-30 PHASE3
NCT02633098 UNKNOWN
Colorectal Cancer; Bowel Cancer
St George's, University of London
2017-04-26 PHASE2
NCT05550909 COMPLETED
Malaria,Falciparum
London School of Hygiene and Tropical Medicine
2022-10-17 PHASE2
NCT05273242 UNKNOWN
COVID-19
Nepal Health Research Council
2021-12-06 PHASE4
NCT04695197 COMPLETED
Covid-19; Malaria
Liverpool School of Tropical Medicine
2021-01-08 PHASE3
NCT03214731 UNKNOWN
Lupus Nephritis
Sun Yat-sen University
2019-01-16 PHASE4
NCT04387240 WITHDRAWN
Covid 19 Positive; Corona Virus Infection
Princess Nourah Bint Abdulrahman University
2022-01 PHASE2
NCT03792516 COMPLETED
Vulvar Dysplasia; HPV-Related Vulvar Intraepithelial Neoplasia; Preinvasive Vulvar Disease; Vulva Intraepithelial Neoplasia; Vulvar Diseases
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2019-04-17 PHASE1
NCT03726593 UNKNOWN
Plasmodium Falciparum Malaria (Drug Resistant)
Armed Forces Research Institute of Medical Sciences, Thailand
2018-10-04 PHASE4
NCT05140278 COMPLETED
Severe Malaria
University of Oxford
2022-07-18 PHASE2
NCT04783051 COMPLETED
Malaria in Pregnancy
University of Kinshasa
2021-05-06 PHASE3
NCT04921930 Recruiting
Friedreich Ataxia
Institut National de la Santé Et de la Recherche Médicale France|Imagine Institute
2022-05-06 Phase 1|Phase 2
NCT04701606 UNKNOWN
Covid19
Shin Poong Pharmaceutical Co. Ltd.
2021-03-29 PHASE2; PHASE3
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
NCT03093129 UNKNOWN
Colorectal Cancer
The 108 Military Central Hospital
2018-01-08 PHASE2
NCT03100045 COMPLETED
HPV-Related Anal Intraepithelial Neoplasia; AIN2/3; Artesunate; Alternative Treatment; Anal Dysplasia; Precancerous Conditions; Human Papilloma Virus
Johns Hopkins University
2017-04-20 PHASE1
NCT04532931 COMPLETED
COVID-19
Shin Poong Pharmaceutical Co. Ltd.
2020-09-03 PHASE2
NCT04475107 COMPLETED
COVID-19
Shin Poong Pharmaceutical Co. Ltd.
2020-07-09 PHASE2
NCT03893097 COMPLETED
Schistosoma Haematobium; Schistosoma Mansoni
Institute of Tropical Medicine, Belgium
2019-10-14 PHASE3
NCT03640403 COMPLETED
Malaria,Falciparum; Anemia
National Institute for Medical Research, Tanzania
2019-03-26 PHASE3
NCT05192265 COMPLETED
Malaria Fever; Plasmodium Falciparum Malaria; Uncomplicated Malaria
University of Ibadan
2019-05-20 PHASE2; PHASE3
NCT04374019 TERMINATED
COVID; Sars-CoV2
Susanne Arnold
2020-05-01 PHASE2
NCT04565184 COMPLETED
Malaria,Falciparum
University of Yaounde 1
2019-05-09 PHASE4
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
NCT03814616 UNKNOWN
Malaria,Falciparum
Shin Poong Pharmaceutical Co. Ltd.
2018-10-03 PHASE2
NCT03201770 COMPLETED
Malaria,Falciparum
Shin Poong Pharmaceutical Co. Ltd.
2017-06-22 PHASE4
NCT02663700 COMPLETED
Plasmodium Falciparum Infection
National Institute of Allergy and Infectious Diseases (NIAID)
2016-04-07 PHASE1
NCT02612545 COMPLETED
Acute Falciparum Malaria
National Institute of Allergy and Infectious Diseases (NIAID)
2015-11-20 PHASE1
NCT04370977 COMPLETED
Malaria
Centro de Investigacao em Saude de Manhica
2018-03-21 PHASE4
NCT02354534 COMPLETED
Cervical Intraepithelial Neoplasia Grade 2/3; High-risk HPV (Any Strain)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2015-02 PHASE1
NCT02996695 COMPLETED
Plasmodium Falciparum Infection
National Institute of Allergy and Infectious Diseases (NIAID)
2017-04-06 PHASE1
NCT02940756 COMPLETED
Malaria
Ministry of Public Health, Democratic Republic of the Congo
2017-03-15 PHASE4
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
NCT02411994 COMPLETED
Malaria
Royal Tropical Institute
2015-10 PHASE3
NCT01640587 TERMINATED
P. Falciparum Malaria
University of Oxford
2013-11
NCT02304289 TERMINATED
Hepatocellular Carcinoma
University Hospital, Ghent
2014-11 PHASE1
NCT02851108 COMPLETED
Malaria, Falciparum
Heidelberg University
2016-10 PHASE2
NCT02242799 COMPLETED
Malaria; HIV
University of Liverpool
2015-06 PHASE1
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
NCT02653898 UNKNOWN
Malaria; Parasitic Diseases
Armed Forces Research Institute of Medical Sciences, Thailand
2016-01 PHASE4
NCT02389439 COMPLETED
Malaria, Falciparum
University of Oxford
2015-03-01 PHASE2
NCT02353026 COMPLETED
Solid Tumors
Georgetown University
2015-01 PHASE1
NCT02297477 UNKNOWN
Malaria
Armed Forces Research Institute of Medical Sciences, Thailand
2014-12 PHASE4
NCT02084602 COMPLETED
Malaria, Falciparum
Instituto Nacional de Salud. Peru
2014-06-18 PHASE4
NCT02052323 COMPLETED
Malaria
Armed Forces Research Institute of Medical Sciences, Thailand
2013-10 PHASE4
NCT02492178 COMPLETED
Malaria
University of Oxford
2015-07 PHASE2
NCT01955382 COMPLETED
Malaria; Severe Malaria
National Institute of Allergy and Infectious Diseases (NIAID)
2013-09 PHASE2
NCT02092766 COMPLETED
Anaemia
University of Oxford
2014-06 PHASE4
NCT01662700 UNKNOWN
Acute Uncomplicated Malaria With P.Vivax Infection
Mahidol University
2012-10 PHASE4
NCT01708876 COMPLETED
Uncomplicated Plasmodium Knowlesi Malaria
Menzies School of Health Research
2012-10 PHASE3
NCT01976780 COMPLETED
Malaria
Global Emerging Infections Surveillance and Response System
2013-06 PHASE4
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
NCT01350856 COMPLETED
Falciparum Malaria
University of Oxford
2011-05 PHASE4
NCT01845701 COMPLETED
Malaria
University of Yaounde 1
2010-03 PHASE3
NCT02563704 COMPLETED
Malaria
University of Yaounde 1
2013-09 PHASE3
NCT01707199 COMPLETED
Uncomplicated P. Falciparum Malaria
University of Oxford
2012-10
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
NCT01868438 COMPLETED
Malaria
Medicines for Malaria Venture
2013-05 PHASE1
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
NCT02974348 COMPLETED
Drug Resistant Malaria Due to Plasmodium Falciparum
University of Bamenda
2013-01 PHASE3
NCT01805232 UNKNOWN
Malaria
University of Khartoum
2013-03 PHASE4
NCT01319448 COMPLETED
Malaria; Sickle Cell Crisis
London School of Hygiene and Tropical Medicine
2011-09 PHASE1; PHASE2
NCT01144702 COMPLETED
Falciparum Malaria
Oswaldo Cruz Foundation
2010-11 PHASE2; PHASE3
NCT01231113 COMPLETED
Pregnancy Complicated by Malaria as Antepartum Condition
Kwame Nkrumah University of Science and Technology
2011-07 PHASE3
NCT01374126 COMPLETED
Falciparum Malaria
Medical University of Vienna
2011-07 PHASE2
NCT01552330 COMPLETED
Healthy
University of Oxford
2012-05 PHASE1
NCT01074905 COMPLETED
Vivax Malaria
University of Oxford
2010-05 PHASE3
NCT01523002 COMPLETED
Malaria
Medicines for Malaria Venture
2012-01 PHASE1
NCT01326754 COMPLETED
Malaria, Falciparum
Centers for Disease Control and Prevention
2011-08
NCT01288820 COMPLETED
Vivax Malaria
University of Oxford
2011-01 PHASE3
NCT01107145 TERMINATED
Plasmodium Vivax Malaria
Centers for Disease Control and Prevention
2011-02 PHASE4
NCT02168569 COMPLETED
Malaria
Centro de Investigacao em Saude de Manhica
2011-06 PHASE4
NCT01082731 TERMINATED
Malaria
Centers for Disease Control and Prevention
2010-11 PHASE4
NCT01190371 UNKNOWN
Malaria
KEMRI-Wellcome Trust Collaborative Research Program
2011-04 PHASE4
NCT01407887 COMPLETED
Uncomplicated Falciparum Malaria
Heidelberg University
2011-08 PHASE2
NCT01165372 COMPLETED
Malaria
Oxford University Clinical Research Unit, Vietnam
2010-08 PHASE2
NCT01213433 COMPLETED
Uncomplicated Malaria
Centre Muraz
2010-10 PHASE4
NCT00988507 TERMINATED
Plasmodium Falciparum Infection
Sanofi
2009-10 PHASE2
NCT01152931 COMPLETED
Malaria
University of Lagos, Nigeria
2010-08 PHASE3
NCT04368910 TERMINATED
Malaria
Medicines for Malaria Venture
2007-09-06 PHASE3
NCT00936767 WITHDRAWN
Uncomplicated Falciparum Malaria
University of Oxford
2010-10 PHASE2; PHASE3
NCT00808951 COMPLETED
Malaria
Centre Muraz
2008-12 PHASE4
NCT01082718 WITHDRAWN
Malaria; Pregnancy
Centers for Disease Control and Prevention
2010-03 PHASE2; PHASE3
NCT01156389 COMPLETED
Malaria
Medicines for Malaria Venture
2010-07 PHASE1
NCT00699920 COMPLETED
Malaria
Sanofi
2008-06 PHASE4
NCT00285662 COMPLETED
Malaria; Anemia
Papua New Guinea Institute of Medical Research
2006-06
NCT00284687 COMPLETED
Cytomegalovirus Infections
Hadassah Medical Organization
2006-07 PHASE3
NCT00682578 COMPLETED
Uncomplicated Falciparum Malaria; Vivax Malaria
University of Oxford
2007-07 PHASE3
NCT01017770 COMPLETED
Uncomplicated P. Falciparum Malaria in Children
Centre Muraz
2008-09 PHASE4
NCT01054651 COMPLETED
Schistosoma Mansoni
Kenya Medical Research Institute
2009-10 PHASE3
NCT00393679 COMPLETED
Fever; Malaria
Institute of Tropical Medicine, Belgium
2007-07 PHASE3
NCT00493363 COMPLETED
Falciparum Malaria
University of Oxford
2007-06
NCT00639873 COMPLETED
Malaria
Medical University of Vienna
2008-06
NCT04877626 COMPLETED
P. Falciparum Malaria
Universidad Nacional de Colombia
2008-09 PHASE4
NCT00722150 COMPLETED
Falciparum Malaria
Armed Forces Research Institute of Medical Sciences, Thailand
2008-07
NCT00379821 COMPLETED
Plasmodium Falciparum Infection
National Institute of Allergy and Infectious Diseases (NIAID)
2007-02 PHASE3
NCT00894374 COMPLETED
Falciparum Malaria
Pfizer
2009-06 PHASE1
NCT00701961 COMPLETED
Plasmodium Falciparum Malaria
Institute of Tropical Medicine, Belgium
2008-10 PHASE2; PHASE3
NCT00875030 COMPLETED
Healthy Volunteers
Pfizer
2009-06 PHASE4
NCT00164255 COMPLETED
Malaria
Centers for Disease Control and Prevention
2003-01 PHASE4
NCT01567423 COMPLETED
Malaria, Falciparum
Epicentre
2008-04
NCT00297882 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
2006-07 PHASE3
NCT00231452 COMPLETED
Malaria
Hospital Clinic of Barcelona
2005-09
NCT00540410 COMPLETED
Malaria
Sanofi
2007-09 PHASE4
NCT00432367 COMPLETED
Malaria; Anaemia; Pregnancy
London School of Hygiene and Tropical Medicine
2007-02 PHASE3
NCT00694694 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
2008-06 PHASE3
NCT00697892 COMPLETED
HIV Infections; Malaria
Fran Aweeka
2005-07 PHASE1
NCT00444106 COMPLETED
Malaria; Falciparum
Novartis
2007-05 PHASE4
NCT00563914 COMPLETED
Malaria
Sanofi
2007-10 PHASE1; PHASE2
NCT00538382 COMPLETED
Malaria
NICHD Global Network for Women's and Children's Health
2007-05 PHASE1
NCT00403260 COMPLETED
Falciparum Malaria
Medicines for Malaria Venture
2007-01 PHASE3
NCT00541385 COMPLETED
Malaria
Medicines for Malaria Venture
2007-10 PHASE3
NCT00509015 COMPLETED
Malaria, Falciparum
Radboud University Medical Center
2008-02
NCT00682630 COMPLETED
Malaria
Medicines for Malaria Venture
2007-09 PHASE1
NCT00522132 COMPLETED
Malaria
Medicines for Malaria Venture
2007-09 PHASE2
NCT00550160 COMPLETED
Malaria
Kwame Nkrumah University of Science and Technology
2007-04 PHASE4
NCT01659281 COMPLETED
Plasmodium Falciparum Malaria
Armed Forces Research Institute of Medical Sciences, Thailand
2007-09
NCT00440999 COMPLETED
Malaria
Medicines for Malaria Venture
2007-03 PHASE3
NCT00422084 COMPLETED
Malaria
Medicines for Malaria Venture
2007-01 PHASE3
NCT00140361 COMPLETED
Malaria (Uncomplicated)
Centers for Disease Control and Prevention
2000-01 PHASE4
NCT00459615 COMPLETED
Falciparum Malaria; Uncomplicated Malaria
U.S. Army Office of the Surgeon General
2007-04 PHASE2
NCT00460369 COMPLETED
Uncomplicated Malaria
Institut de Recherche pour le Developpement
2007-04
NCT00298610 COMPLETED
Malaria
U.S. Army Medical Research and Development Command
2006-03 PHASE2
NCT00510159 COMPLETED
Schistosoma Haematobium
Dafra Pharma
2007-08 PHASE2; PHASE3
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
NCT00356005 COMPLETED
Uncomplicated Falciparum Malaria
Medical University of Vienna
2006-08 PHASE2
NCT00344006 COMPLETED
Malaria, Falciparum
GlaxoSmithKline
2006-06 PHASE3
NCT00331708 TERMINATED
Malaria
Professor Karen I Barnes
2006-04
NCT00452907 COMPLETED
Malaria
Sanofi
2005-07 PHASE4
NCT00371735 COMPLETED
Malaria, Falciparum
GlaxoSmithKline
2006-04 PHASE3
NCT00292942 COMPLETED
Malaria; Malaria, Cerebral
U.S. Army Medical Research and Development Command
2006-06-12 PHASE1
NCT00119132 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
2005-06 PHASE2; PHASE3
NCT00386503 COMPLETED
Malaria
Sanofi
2006-06 PHASE1
NCT00331136 COMPLETED
Uncomplicated Plasmodium Falciparum Malaria
Medicines for Malaria Venture
2006-06 PHASE2
NCT00123552 COMPLETED
Malaria
University of California, San Francisco
2004-11 PHASE3
NCT00111163 COMPLETED
Malaria; Anemia
Centers for Disease Control and Prevention
2004-03
NCT01594931 COMPLETED
Plasmodium Falciparum Malaria
Medicines for Malaria Venture
2005-07 PHASE2
NCT00386750 TERMINATED
Malaria; Falciparum
Novartis Pharmaceuticals
2005-06 PHASE4
NCT00164359 COMPLETED
Malaria, Falciparum
Centers for Disease Control and Prevention
2005-04 PHASE4
NCT00164710 COMPLETED
Malaria, Falciparum
Centers for Disease Control and Prevention
2005-04 PHASE4
NCT03768908 COMPLETED
Plasmodium Falciparum Malaria
Professor Anders Björkman
2005-01-05 PHASE4
NCT00299208 COMPLETED
Plasmodium Falciparum Malaria
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE2
NCT00203801 COMPLETED
Malaria
University of Cape Town
2002-01
NCT00373607 COMPLETED
Malaria
Institute of Tropical Medicine, Belgium
2003-07 PHASE3
NCT00959517 COMPLETED
Uncomplicated Falciparum Malaria
London School of Hygiene and Tropical Medicine
2001-07 PHASE2
NCT00519467 COMPLETED
Malaria
GlaxoSmithKline
2003-06 PHASE2
NCT03764527 COMPLETED
Plasmodium Falciparum Malaria
Professor Anders Björkman
2002-11-01 PHASE4
NCT00378625 COMPLETED
Malaria,Falciparum; Malaria; Antimalarials
Centro Internacional de Entrenamiento e Investigaciones Médicas
2000-04 PHASE3
NCT00484900 COMPLETED
Plasmodium Falciparum Malaria
Dafra Pharma
2006-05 PHASE3
NCT00646126 COMPLETED
Plasmodium Falciparum; Asymptomatic Parataemia; Sub Patent Parasitaemia
Tropical Medicine Research Institute
2005-08 PHASE3
NCT00118807 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
2003-08 PHASE3
NCT00287300 COMPLETED
Malaria
University of North Carolina
2003-09
NCT00316329 COMPLETED
Malaria
Sanofi
2006-03 PHASE3
NCT00132561 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
2002-06 PHASE2; PHASE3
NCT00479206 COMPLETED
Malaria, Falciparum
Medical University of Vienna
2006-10
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
NCT00330902 COMPLETED
Plasmodium Infections
London School of Hygiene and Tropical Medicine
2004-01 PHASE3
NCT00978172 COMPLETED
Malaria
Mepha Ltd.
2007-12 PHASE4
NCT01204411 WITHDRAWN
Malaria, Falciparum; Malnutrition; Child
Epicentre
PHASE4
NCT00445796 COMPLETED
Malaria
Sanofi
2005-06 PHASE4
NCT00354380 COMPLETED
Malaria
Heidelberg University
2006-09 PHASE2
NCT00289250 COMPLETED
Asymptomatic P.Falciparum Malaria
London School of Hygiene and Tropical Medicine
2001-05 PHASE3
NCT00465257 SUSPENDED
Malaria
Karolinska University Hospital
2007-05 PHASE4
NCT00203736 COMPLETED
Malaria
University of Cape Town
2003-01
NCT00243737 COMPLETED
Malaria
Albert Schweitzer Hospital
2005-10 PHASE2
NCT00374205 TERMINATED
Malaria, Falciparum
Bernhard Nocht Institute for Tropical Medicine
2006-09 PHASE4
NCT00203814 COMPLETED
Malaria
University of Cape Town
2004-01
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
NCT00132548 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
2004-06 PHASE3
NCT00292929 COMPLETED
Malaria; Malaria, Cerebral
U.S. Army Medical Research and Development Command
PHASE1
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
NCT00486694 COMPLETED
Malaria, Vivax
London School of Hygiene and Tropical Medicine
2004-03 PHASE2
NCT00127998 COMPLETED
Malaria
Centers for Disease Control and Prevention
2005-07

(data from https://clinicaltrials.gov, updated on 2025-07-31)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Artesunate potently inhibits exported protein 1 (EXP1) and modulates STAT3 signal transduction pathways, thereby impairing essential metabolic transport mechanisms and triggering selective apoptosis in targeted pathogenic and neoplastic cells. This targeted cellular toxicity directly underlies its therapeutic efficacy in reducing parasite burdens and inhibiting abnormal cell proliferation, supporting its clinical application and investigation for severe malaria, human papillomavirus-associated anal dysplasia, and various malignancies.

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.