Artesunate

also known as Arsumax · ART · .alpha.-artesunic acid · Argesun · ARS · Artesunate amivas · Artesunate for Injection · artesunato · +10 more

Small molecule

Developed for: malaria · Plasmodium falciparum malaria · COVID-19 · cervical intraepithelial neoplasia grade 2/3 · Plasmodium vivax malaria · human papilloma virus infection · anemia · precancerous condition
+23 more
· anal canal carcinoma in situ · cytomegalovirus infection · Schistosoma mansoni infectious disease · anogenital human papillomavirus infection · anus disorder · breast cancer · cancer · chronic myeloid leukemia · colorectal carcinoma · Friedreich ataxia · hepatocellular carcinoma · idiopathic pulmonary fibrosis · intraepithelial neoplasia · lupus nephritis · malignant colon neoplasm · pulmonary arterial hypertension · squamous cell intraepithelial neoplasia · urinary schistosomiasis · vulvar intraepithelial neoplasia · colorectal cancer · Crohn disease · parasitemia · vulvar disease
Investigated by: London School of Hygiene and Tropical Medicine · World Health Organization · Centers for Disease Control and Prevention · University of Oxford · Sanofi · Medicines for Malaria Venture
+200 more
· Frantz Viral Therapeutics, LLC · Institute of Tropical Medicine, Belgium · Shin Poong Pharmaceutical Co. Ltd. · Armed Forces Research Institute of Medical Sciences, Thailand · Kenya Medical Research Institute · Bill and Melinda Gates Foundation · Dafra Pharma · Medical Research Council, South Africa · Medical University of Vienna · National Institute of Allergy and Infectious Diseases (NIAID) · U.S. Army Medical Research and Development Command · Centre Muraz · GlaxoSmithKline · Global Fund · Heidelberg University · International Centre for Diarrhoeal Disease Research, Bangladesh · Kinshasa School of Public Health · Liverpool School of Tropical Medicine · Mahidol University · Malaria Research and Training Center, Bamako, Mali · National Institute for Medical Research, Tanzania · Shin Poong Pharmaceuticals · UNC Lineberger Comprehensive Cancer Center · University of Cape Town · University of Kinshasa · University of Yaounde 1 · Wellcome Trust · Albert Schweitzer Hospital · Anal Dysplasia Clinic MidWest · Cheikh Anta Diop University, Senegal · Clinical Research Malaysia · Department for International Development, United Kingdom · Epicentre · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · European and Developing Countries Clinical Trials Partnership (EDCTP) · Global Emerging Infections Surveillance and Response System · HealthNet TPO · Institut Pasteur · Institut de Recherche pour le Developpement, Senegal · Joseph C. Wu · Kintampo Health Research Centre, Ghana · Kwame Nkrumah University of Science and Technology · Laser Surgery Care · Makerere University · Medecins Sans Frontieres, Spain · Medical Research Council Unit, The Gambia · Mepha Ltd. · Metanoic Health Ltd. · Military Infectious Diseases Research Program (MIDRP) · Ministry of Health, Senegal · Ministry of Public Health, Democratic Republic of the Congo · National Cancer Institute (NCI) · National Malaria Control Program · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · University of California, San Francisco · University of North Carolina · Uppsala University · Walter Reed Army Institute of Research (WRAIR) · AbbVie · Academic Medical Center - University of Amsterdam · Amarex CRO · Amarex Clinical Research · Amivas Inc. · Anticancer Fund, Belgium · Apotex Inc. · Arch Biopartners Inc. · Armauer Hansen Research Institute, Ethiopia · Association Camerounaise pour le Marketing Social (ACMS), Cameroon · Biotechnology Center (BTC), University of Yaounde I, Cameroon · Center for International Health and Development · Centre Mère et Enfant de la Fondation Chantal Biya · Centres for Disease Control and Prevention, Kenya. · Charite University, Berlin, Germany · Communities · all 206 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	EU (EMA)	Artesunate Amivas	—	2021-11-22	europa.eu ↗
Approved	US (FDA)	ARTESUNATE	—	2020-05-26	fda.gov ↗

Trials 143 · started per year

today

US approved 2020

EU approved 2021

20002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 117 trials
Phase 1	NCT05988463	Jan → Nov 2027 expected	idiopathic pulmonary fibrosis	Joseph C. Wu	Recruiting	No outcome recorded
Phase 1	NCT07470424	Jun 2026 → Jun 2027 expected	malaria	University of Oxford	Not yet recruiting	No outcome recorded
Phase 1	NCT06872112	Apr 2026 → Jan 2029 expected	pulmonary arterial hypertension	Joseph C. Wu	Recruiting	No outcome recorded
Phase 1	NCT06263582	May → Aug 2024	cervical cancer, cervical intraepithelial neoplasia grade 2/3	UNC Lineberger Comprehensive Cancer Center	Completed	No outcome recorded
Phase 1	NCT06165614	Mar 2024 → Jan 2025	cervical cancer, cervical intraepithelial neoplasia grade 2/3, precancerous condition	UNC Lineberger Comprehensive Cancer Center	Completed	No outcome recorded
Phase 1	NCT03792516	Apr 2019 → Aug 2022	vulvar intraepithelial neoplasia	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Completed	No outcome recorded
Phase 1	NCT03100045	Apr 2017 → Oct 2021	anus disorder, human papilloma virus infection, intraepithelial neoplasia	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT02242799	Jun 2015 → Sep 2016	HIV infectious disease, malaria	University of Liverpool	Completed	No outcome recorded
Phase 1	NCT02354534	Feb 2015 → Jul 2018	cervical intraepithelial neoplasia grade 2/3	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Completed	No outcome recorded
Phase 1	NCT02353026	Jan → Dec 2015	cancer	Georgetown University	Completed	No outcome recorded
Phase 1	NCT02304289	Nov 2014 → Dec 2016	hepatocellular carcinoma	University Hospital, Ghent	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT01552330	May → Oct 2012	—	University of Oxford	Completed	No outcome recorded
Phase 1	NCT00764036	Oct 2008 → Nov 2013	breast cancer	Heidelberg University	Completed	No outcome recorded
Phase 1	NCT00538382	May 2007 → Nov 2008	malaria	NICHD Global Network for Women's and Children's Health	Completed	No outcome recorded
Phase 1	NCT00292942	Jun 2006 → Jan 2007	cerebral malaria	U.S. Army Medical Research and Development Command	Completed	No outcome recorded
Phase 1	NCT00386503	Jun → Dec 2006	malaria	Sanofi	Completed	No outcome recorded
Phase 1	NCT00292929	? → Oct 2006	cerebral malaria	U.S. Army Medical Research and Development Command	Completed	No outcome recorded

Phase 1/22 trials
Phase 1/2	NCT04921930	May 2022 → Apr 2024	Friedreich ataxia	French National Institute of Health and Medical Research	Completed	No outcome recorded
Phase 1/2	NCT01319448	Sep 2011 → Apr 2013	malaria, sickle cell disease	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 232 trials · 3 met primary
Phase 2	NCT07095309	Aug 2025 → Aug 2032 expected	malignant colon neoplasm	Metanoic Health Ltd.	Not yet recruiting	No outcome recorded
Phase 2	NCT06853184	Aug 2025 → May 2028 expected	cytomegalovirus infection	Amivas Inc.	Recruiting	No outcome recorded
Phase 2	NCT07095478	Aug 2025 → Jun 2027 expected	cervical intraepithelial neoplasia grade 2/3	Metanoic Health Ltd.	Not yet recruiting	No outcome recorded
Phase 2	NCT07022743	Jul 2025 → Jul 2026 overdue	chronic myeloid leukemia	Obafemi Awolowo University	Active not recruiting	No outcome recorded
Phase 2	NCT06519994	Jan 2025 → Apr 2026	HIV infectious disease, human papilloma virus infection, precancerous condition	UNC Lineberger Comprehensive Cancer Center	Completed	No outcome recorded
Phase 2	NCT06206564	Jan 2024 → Dec 2026 expected	anal canal carcinoma in situ, anogenital human papillomavirus infection, squamous cell intraepithelial neoplasia	Frantz Viral Therapeutics, LLC	Recruiting	No outcome recorded
Phase 2	NCT05555862	Feb 2023 → Dec 2026 expected	anal canal carcinoma in situ, human papilloma virus infection	Frantz Viral Therapeutics, LLC	Active not recruiting	No outcome recorded
Phase 2	NCT05550909	Oct → Dec 2022	Plasmodium falciparum malaria	London School of Hygiene and Tropical Medicine	Completed	Mixed
Phase 2	NCT05140278	Jul 2022	malaria	University of Oxford	Completed	No outcome recorded
Phase 2	NCT04098744	Sep 2020 → Jul 2026 overdue	cervical intraepithelial neoplasia grade 2/3, human papilloma virus infection, precancerous condition	Frantz Viral Therapeutics, LLC	Recruiting	No outcome recorded
Phase 2	NCT04532931	Sep 2020 → Aug 2021	COVID-19	Shin Poong Pharmaceutical Co. Ltd.	Completed	No outcome recorded
Phase 2	NCT04475107	Jul 2020 → Mar 2021	COVID-19	Shin Poong Pharmaceutical Co. Ltd.	Completed	No outcome recorded
Phase 2	NCT04502342	Jun → Aug 2020	COVID-19	Institute for Research and Development of Medicinal and Food Plants of Guinea	Unknown	No outcome recorded
Phase 2	NCT04374019	May → Dec 2020	COVID-19	Susanne Arnold	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT03814616	Oct 2018 → Oct 2019	Plasmodium falciparum malaria	Shin Poong Pharmaceutical Co. Ltd.	Unknown	No outcome recorded
Phase 2	NCT02633098	Apr 2017 → Dec 2022	colorectal carcinoma	St George's, University of London	Unknown	No outcome recorded
Phase 2	NCT02492178	Jul → Oct 2015	Plasmodium falciparum malaria	University of Oxford	Completed	No outcome recorded
Phase 2	NCT01374126	Jul 2011 → Nov 2012	Plasmodium falciparum malaria	Medical University of Vienna	Completed	No outcome recorded
Phase 2	NCT01165372	Aug 2010 → May 2011	malaria	Oxford University Clinical Research Unit, Vietnam	Completed	No outcome recorded
Phase 2	NCT00988507	Oct 2009 → Nov 2010	Plasmodium falciparum malaria	Sanofi	Terminated	Met primary Stop: Business
Phase 2	NCT00522132	Sep 2007 → Jun 2008	malaria	Medicines for Malaria Venture	Completed	Met primary
Phase 2	NCT00459615	Apr → Dec 2007	Plasmodium falciparum malaria	U.S. Army Office of the Surgeon General	Completed	No outcome recorded
Phase 2	NCT00354380	Sep → Nov 2006	malaria	Heidelberg University	Completed	No outcome recorded
Phase 2	NCT00356005	Aug 2006 → Aug 2007	Plasmodium falciparum malaria	Medical University of Vienna	Completed	No outcome recorded
Phase 2	NCT00331136	Jun → Dec 2006	Plasmodium falciparum malaria	Medicines for Malaria Venture	Completed	No outcome recorded
Phase 2	NCT00298610	Mar 2006 → Oct 2007	malaria	U.S. Army Medical Research and Development Command	Completed	No outcome recorded
Phase 2	NCT00243737	Oct 2005 → Apr 2006	malaria	Albert Schweitzer Hospital	Completed	No outcome recorded
Phase 2	NCT01594931	Jul 2005 → Mar 2006	Plasmodium falciparum malaria	Medicines for Malaria Venture	Completed	No outcome recorded
Phase 2	NCT00486694	Mar → Aug 2004	Plasmodium vivax malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 2	NCT00519467	Jun 2003 → Feb 2005	Plasmodium falciparum malaria	GlaxoSmithKline	Completed	Met primary
Phase 2	NCT00959517	Jul 2001 → Jun 2005	Plasmodium falciparum malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 2	NCT00299208	? → Jul 2005	Plasmodium falciparum malaria	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase 2/37 trials · 3 met primary
Phase 2/3	NCT05764746	May 2023 → Dec 2024	Plasmodium falciparum malaria	Muhimbili University of Health and Allied Sciences	Completed	No outcome recorded
Phase 2/3	NCT04701606	Mar 2021 → Apr 2022	COVID-19	Shin Poong Pharmaceutical Co. Ltd.	Unknown	No outcome recorded
Phase 2/3	NCT04049916	Sep 2019 → Jan 2020	Plasmodium falciparum malaria	London School of Hygiene and Tropical Medicine	Completed	Met primary
Phase 2/3	NCT01144702	Nov 2010 → Apr 2013	Plasmodium falciparum malaria	Oswaldo Cruz Foundation	Completed	No outcome recorded
Phase 2/3	NCT00510159	Aug → Oct 2007	urinary schistosomiasis	Dafra Pharma	Completed	No outcome recorded
Phase 2/3	NCT00119132	Jun 2005 → Dec 2006	malaria	London School of Hygiene and Tropical Medicine	Completed	Met primary
Phase 2/3	NCT00132561	Jun 2002 → Dec 2003	malaria	London School of Hygiene and Tropical Medicine	Completed	Met primary
Phase 330 trials · 8 met primary · 5 missed
Phase 3	NCT06962319	Sep 2025 → Aug 2028 expected	malaria	Liverpool School of Tropical Medicine	Recruiting	No outcome recorded
Phase 3	NCT06923592	May 2025 → Apr 2027 expected	Plasmodium falciparum malaria, Plasmodium vivax malaria	London School of Hygiene and Tropical Medicine	Recruiting	No outcome recorded
Phase 3	NCT05084911	Oct 2021 → Mar 2023	COVID-19	Shin Poong Pharmaceutical Co. Ltd.	Completed	No outcome recorded
Phase 3	NCT04695197	Jan 2021 → Nov 2022	COVID-19, malaria	Liverpool School of Tropical Medicine	Completed	Missed primary
Phase 3	NCT04330690	Mar 2020 → Mar 2024	COVID-19	Sunnybrook Health Sciences Centre	Unknown	Missed primary
Phase 3	NCT03893097	Oct 2019 → Mar 2021	Schistosoma mansoni infectious disease	Institute of Tropical Medicine, Belgium	Completed	Mixed
Phase 3	NCT01374581	May 2012 → Jun 2014	malaria	University of Antwerp	Completed	No outcome recorded
Phase 3	NCT01378286	Jan 2012 → Jun 2013	malaria	Sanofi	Completed	Met primary
Phase 3	NCT01845701	Mar 2010 → Apr 2014	malaria	University of Yaounde 1	Completed	Met primary
Phase 3	NCT01054248	Feb 2010 → Sep 2016	malaria	University of Oxford	Completed	No outcome recorded
Phase 3	NCT01054651	Oct → Dec 2009	Schistosoma mansoni infectious disease	Kenya Medical Research Institute	Completed	Missed primary
Phase 3	NCT00694694	Jun → Dec 2008	malaria	London School of Hygiene and Tropical Medicine	Completed	Missed primary
Phase 3	NCT00541385	Oct 2007 → Sep 2008	malaria	Medicines for Malaria Venture	Completed	Met primary
Phase 3	NCT04368910	Sep 2007 → Oct 2010	malaria	Medicines for Malaria Venture	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00393679	Jul 2007 → Dec 2009	malaria	Institute of Tropical Medicine, Belgium	Completed	Mixed
Phase 3	NCT00432367	Feb 2007 → Feb 2009	anemia, malaria, pregnancy disorder	London School of Hygiene and Tropical Medicine	Completed	Met primary
Phase 3	NCT00379821	Feb 2007 → Aug 2009	Plasmodium falciparum malaria	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 3	NCT00284687	Jul 2006 → Mar 2010	cytomegalovirus infection	Hadassah Medical Organization	Completed	No outcome recorded
Phase 3	NCT00344006	Jun 2006 → Aug 2007	Plasmodium falciparum malaria	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT00484900	May 2006 → May 2007	Plasmodium falciparum malaria	Dafra Pharma	Completed	No outcome recorded
Phase 3	NCT00371735	Apr 2006 → May 2007	Plasmodium falciparum malaria	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00316329	Mar 2006 → ?	Plasmodium falciparum malaria	Sanofi	Completed	Met primary
Phase 3	NCT00123552	Nov 2004 → Jun 2006	malaria	University of California, San Francisco	Completed	Met primary
Phase 3	NCT00406146	Oct 2004 → Dec 2006	malaria	University of Ghana Medical School	Unknown	No outcome recorded
Phase 3	NCT00132548	Jun → Dec 2004	malaria	London School of Hygiene and Tropical Medicine	Completed	Met primary
Phase 3	NCT00146731	Jan 2004 → Sep 2007	malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 3	NCT00118807	Aug 2003 → Feb 2004	Plasmodium falciparum malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 3	NCT00158548	Jun 2001 → Dec 2004	Plasmodium falciparum malaria, Plasmodium vivax malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 3	NCT00289250	May → Dec 2001	Plasmodium falciparum malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 3	NCT00378625	Apr 2000 → Mar 2006	Plasmodium falciparum malaria	International Center for Training and Medical Research	Completed	No outcome recorded

Phase 436 trials · 1 met primary
Phase 4	NCT06967519	Dec 2025 → Dec 2027 expected	HIV infectious disease, malaria	Yale University	Recruiting	No outcome recorded
Phase 4	NCT05750459	Nov 2023 → Apr 2025	Plasmodium falciparum malaria	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 4	NCT05273242	Dec 2021 → Dec 2022	COVID-19	Nepal Health Research Council	Unknown	No outcome recorded
Phase 4	NCT04829695	Apr → Dec 2021	Plasmodium falciparum malaria	University of Yaounde 1	Unknown	No outcome recorded
Phase 4	NCT04618523	Oct 2020 → Feb 2022	malaria	Ministry of Public Health, Democratic Republic of the Congo	Completed	No outcome recorded
Phase 4	NCT04565184	May 2019 → Nov 2020	Plasmodium falciparum malaria	University of Yaounde 1	Completed	No outcome recorded
Phase 4	NCT03214731	Jan 2019 → Sep 2022	lupus nephritis	Sun Yat-sen University	Unknown	No outcome recorded
Phase 4	NCT03726593	Oct 2018 → Aug 2022	Plasmodium falciparum malaria	Armed Forces Research Institute of Medical Sciences, Thailand	Unknown	No outcome recorded
Phase 4	NCT03773536	May → Sep 2017	Plasmodium falciparum malaria	Professor Anders Björkman	Completed	No outcome recorded
Phase 4	NCT02940756	Mar 2017 → Jan 2018	malaria	Ministry of Public Health, Democratic Republic of the Congo	Completed	No outcome recorded
Phase 4	NCT02604966	Apr 2015 → Sep 2016	Plasmodium falciparum malaria	National Institute of Malariology, Parasitology and Entomology, Vietnam	Unknown	No outcome recorded
Phase 4	NCT02084602	Jun 2014 → Nov 2015	Plasmodium falciparum malaria	National Institute of Health of Peru	Completed	No outcome recorded
Phase 4	NCT02092766	Jun 2014 → Apr 2015	anemia	University of Oxford	Completed	No outcome recorded
Phase 4	NCT02052323	Oct 2013 → Oct 2015	Plasmodium falciparum malaria	Armed Forces Research Institute of Medical Sciences, Thailand	Completed	No outcome recorded
Phase 4	NCT01805232	Mar → May 2013	malaria	University of Khartoum	Unknown	No outcome recorded
Phase 4	NCT01697787	Oct 2012 → Sep 2014	Plasmodium falciparum malaria	Centre Muraz	Completed	No outcome recorded
Phase 4	NCT01662700	Oct 2012 → Dec 2014	Plasmodium vivax malaria	Mahidol University	Unknown	No outcome recorded
Phase 4	NCT01190371	Apr → Nov 2011	malaria	KEMRI-Wellcome Trust Collaborative Research Program	Unknown	No outcome recorded
Phase 4	NCT01082731	Nov 2010 → Jan 2012	malaria	Centers for Disease Control and Prevention	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01023399	Nov 2009 → Oct 2013	malaria	Sanofi	Completed	No outcome recorded
Phase 4	NCT00875030	Jun 2009	—	Pfizer	Completed	No outcome recorded
Phase 4	NCT00902811	Dec 2008 → Oct 2009	Plasmodium falciparum malaria	Medecins Sans Frontieres, Netherlands	Unknown	No outcome recorded
Phase 4	NCT00699920	Jun 2008 → Jun 2010	malaria	Sanofi	Completed	Met primary
Phase 4	NCT00978172	Dec 2007 → Mar 2009	malaria	Mepha Ltd.	Completed	No outcome recorded
Phase 4	NCT00540410	Sep 2007 → Feb 2009	Plasmodium falciparum malaria	Sanofi	Completed	No outcome recorded
Phase 4	NCT00425763	May → Aug 2007	malaria	Centers for Disease Control and Prevention	Completed	No outcome recorded
Phase 4	NCT00465257	May 2007 → ?	malaria	Karolinska University Hospital	Suspended	No outcome recorded
Phase 4	NCT00550160	Apr 2007 → May 2008	malaria	Kwame Nkrumah University of Science and Technology	Completed	No outcome recorded
Phase 4	NCT00238017	Oct → Dec 2005	malaria	Charite University, Berlin, Germany	Unknown	No outcome recorded
Phase 4	NCT00452907	Jul 2005 → Jun 2007	malaria	Sanofi	Completed	No outcome recorded
Phase 4	NCT00119145	Jun 2005 → May 2006	malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 4	NCT00445796	Jun 2005 → ?	malaria	Sanofi	Completed	No outcome recorded
Phase 4	NCT00164710	Apr → Sep 2005	Plasmodium falciparum malaria	Centers for Disease Control and Prevention	Completed	No outcome recorded
Phase 4	NCT00164255	Jan 2003 → Jun 2009	Plasmodium falciparum malaria	Centers for Disease Control and Prevention	Completed	No outcome recorded
Phase 4	NCT00140361	Jan 2000 → Jan 2008	malaria	Centers for Disease Control and Prevention	Completed	No outcome recorded
Phase 4	NCT01204411	—	Plasmodium falciparum malaria, protein-energy malnutrition	Epicentre	Withdrawn	No outcome recorded

Phase not applicable19 trials · 2 met primary · 2 missed
—	NCT06472258	Mar → Jun 2023	malaria	RESnTEC, Institute of Research	Completed	No outcome recorded
—	NCT04301531	Mar 2020 → Nov 2021	malaria	Noguchi Memorial Institute for Medical Research	Completed	No outcome recorded
—	NCT01707199	Oct 2012 → Jan 2014	Plasmodium falciparum malaria	University of Oxford	Completed	No outcome recorded
—	NCT01326754	Aug 2011 → Jun 2012	Plasmodium falciparum malaria	Centers for Disease Control and Prevention	Completed	No outcome recorded
—	NCT00722150	Jul 2008 → Aug 2009	Plasmodium falciparum malaria	Armed Forces Research Institute of Medical Sciences, Thailand	Completed	No outcome recorded
—	NCT00639873	Jun 2008 → Nov 2009	malaria	Medical University of Vienna	Completed	No outcome recorded
—	NCT01567423	Apr 2008 → Apr 2009	Plasmodium falciparum malaria	Epicentre	Completed	No outcome recorded
—	NCT00493363	Jun 2007 → Dec 2009	Plasmodium falciparum malaria	University of Oxford	Completed	No outcome recorded
—	NCT00479206	Oct 2006 → Feb 2007	Plasmodium falciparum malaria	Medical University of Vienna	Completed	No outcome recorded
—	NCT00331708	Apr 2006 → Jul 2007	malaria	Professor Karen I Barnes	Terminated	No outcome recorded
—	NCT00231452	Sep 2005 → Mar 2009	malaria	Hospital Clinic of Barcelona	Completed	Missed primary
—	NCT00157885	Jul → Dec 2005	Plasmodium falciparum malaria, Plasmodium vivax malaria	Menzies School of Health Research	Completed	No outcome recorded
—	NCT00127998	Jul 2005 → ?	malaria	Centers for Disease Control and Prevention	Completed	No outcome recorded
—	NCT00461578	Apr 2005 → Oct 2006	malaria	London School of Hygiene and Tropical Medicine	Completed	Missed primary
—	NCT00111163	Mar 2004 → Mar 2006	anemia, malaria	Centers for Disease Control and Prevention	Completed	Mixed
—	NCT00203814	Jan 2004 → Mar 2005	Plasmodium falciparum malaria	University of Cape Town	Completed	Met primary
—	NCT00287300	Sep 2003 → Aug 2005	malaria	University of North Carolina	Completed	No outcome recorded
—	NCT00203736	Jan → Oct 2003	malaria	University of Cape Town	Completed	Met primary
—	NCT00203801	Jan 2002 → Jul 2005	malaria	University of Cape Town	Completed	No outcome recorded

Comparator or background therapy59 trials
Phase 1	NCT06294912 Background	Apr 2024 → Jan 2025	malaria	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT02996695 Background	Apr 2017 → Jun 2018	Plasmodium falciparum malaria	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT02663700 Background	Apr 2016 → Dec 2018	Plasmodium falciparum malaria	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT01868438 Comparator	May → Oct 2013	malaria	Medicines for Malaria Venture	Completed	No outcome recorded
Phase 1/2	NCT05441410 Background	Jun 2025 → Jun 2026 overdue	malaria	University Hospital Tuebingen	Not yet recruiting	No outcome recorded
Phase 1/2	NCT05929157 Comparator	Sep 2023 → Dec 2024	malaria	Centre de Recherche Médicale de Lambaréné	Unknown	No outcome recorded
Phase 1/2	NCT00563914 Background	Oct 2007 → Nov 2008	malaria	Sanofi	Completed	No outcome recorded
Phase 2	NCT06075264 Comparator	Dec 2023 → Dec 2026 expected	human papilloma virus infection, intraepithelial neoplasia, vulvar disease	Frantz Viral Therapeutics, LLC	Recruiting	No outcome recorded
Phase 2	NCT04675931 Comparator	Mar 2022 → Jul 2025	Plasmodium falciparum malaria	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT04713631 Comparator	Jan 2021 → Dec 2023	Crohn disease	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Unknown	No outcome recorded
Phase 2	NCT04264130 Comparator	Jul 2018 → Dec 2019	urinary schistosomiasis	Centre de Recherche Médicale de Lambaréné	Completed	No outcome recorded
Phase 2	NCT03093129 Comparator	Jan 2018 → Dec 2021	colorectal cancer	The 108 Military Central Hospital	Unknown	No outcome recorded
Phase 2	NCT01955382 Background	Sep 2013 → Jul 2015	Plasmodium falciparum malaria	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 2	NCT01407887 Comparator	Aug 2011	Plasmodium falciparum malaria	Heidelberg University	Completed	No outcome recorded
Phase 2	NCT00545935 Comparator	Jul → Oct 2007	malaria	Heidelberg University	Completed	No outcome recorded
Phase 2/3	NCT02453308 Comparator	Aug 2015 → Mar 2018	Plasmodium falciparum malaria	University of Oxford	Completed	No outcome recorded
Phase 2/3	NCT00936767 Comparator	Oct 2010	Plasmodium falciparum malaria	University of Oxford	Withdrawn	No outcome recorded
Phase 3	NCT05951595 Comparator	Sep 2025 → Jul 2026 overdue	Plasmodium falciparum malaria	University of Oxford	Recruiting	No outcome recorded
Phase 3	NCT06166498 Comparator	Jul → Dec 2024	malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 3	NCT03939104 Comparator	Jun 2021 → Jan 2023	Plasmodium falciparum malaria	University of Oxford	Completed	No outcome recorded
Phase 3	NCT03923725 Comparator	Sep 2020 → Mar 2024	Plasmodium falciparum malaria	University of Oxford	Completed	No outcome recorded
Phase 3	NCT02563704 Comparator	Sep 2013 → Mar 2014	malaria	University of Yaounde 1	Completed	No outcome recorded
Phase 3	NCT01939886 Comparator	Apr → Nov 2013	malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 3	NCT02974348 Comparator	Jan → May 2013	Plasmodium falciparum malaria	University of Bamenda	Completed	No outcome recorded
Phase 3	NCT01708876 Comparator	Oct 2012 → Dec 2014	—	Menzies School of Health Research	Completed	No outcome recorded
Phase 3	NCT01231113 Comparator	Jul 2011 → Dec 2012	Plasmodium falciparum malaria	Kwame Nkrumah University of Science and Technology	Completed	No outcome recorded
Phase 3	NCT01288820 Comparator	Jan 2011 → Apr 2012	Plasmodium vivax malaria	University of Oxford	Completed	No outcome recorded
Phase 3	NCT01152931 Comparator	Aug → Nov 2010	malaria	University of Lagos, Nigeria	Completed	No outcome recorded
Phase 3	NCT01074905 Comparator	May 2010 → Oct 2012	Plasmodium vivax malaria	University of Oxford	Completed	No outcome recorded
Phase 3	NCT00682578 Comparator	Jul 2007 → Feb 2010	Plasmodium falciparum malaria, Plasmodium vivax malaria	University of Oxford	Completed	Met primary
Phase 3	NCT00403260 Comparator	Jan 2007 → Oct 2008	Plasmodium falciparum malaria	Medicines for Malaria Venture	Completed	Met primary
Phase 3	NCT00297882 Comparator	Jul 2006 → Apr 2009	malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 3	NCT00646126 Comparator	Aug 2005 → ?	Plasmodium falciparum malaria, parasitemia	Tropical Medicine Research Institute	Completed	No outcome recorded
Phase 3	NCT00330902 Comparator	Jan → Nov 2004	malaria	London School of Hygiene and Tropical Medicine	Completed	Missed primary
Phase 3	NCT00373607 Comparator	Jul 2003 → Jul 2005	malaria	Institute of Tropical Medicine, Belgium	Completed	No outcome recorded
Phase 4	NCT06300970 Comparator	Aug 2022 → Aug 2023	Plasmodium falciparum malaria	Centers for Disease Control and Prevention	Completed	No outcome recorded
Phase 4	NCT05343312 Comparator	Mar 2022 → Sep 2023	Plasmodium falciparum malaria	Manhiça Health Research Centre	Completed	No outcome recorded
Phase 4	NCT04706130 Background	Apr 2021 → Oct 2024	Plasmodium vivax malaria	University of Maryland, Baltimore	Completed	Met primary
Phase 4	NCT04370977 Comparator	Mar → Sep 2018	malaria	Manhiça Health Research Centre	Completed	No outcome recorded
Phase 4	NCT02653898 Comparator	Jan → Aug 2016	malaria	Armed Forces Research Institute of Medical Sciences, Thailand	Unknown	No outcome recorded
Phase 4	NCT02592408 Comparator	Nov 2015 → May 2016	malaria	Menzies School of Health Research	Completed	No outcome recorded
Phase 4	NCT02297477 Comparator	Dec 2014 → Dec 2015	Plasmodium falciparum malaria	Armed Forces Research Institute of Medical Sciences, Thailand	Unknown	No outcome recorded
Phase 4	NCT02741024 Comparator	Oct 2013 → Dec 2014	malaria	Medecins Sans Frontieres, Netherlands	Completed	No outcome recorded
Phase 4	NCT01976780 Comparator	Jun 2013 → Dec 2014	Plasmodium falciparum malaria	Global Emerging Infections Surveillance and Response System	Completed	No outcome recorded
Phase 4	NCT02168569 Comparator	Jun 2011 → Jan 2012	Plasmodium falciparum malaria	Manhiça Health Research Centre	Completed	No outcome recorded
Phase 4	NCT01350856 Comparator	May 2011 → Apr 2014	Plasmodium falciparum malaria	University of Oxford	Completed	No outcome recorded
Phase 4	NCT04877626 Comparator	Sep 2008 → Oct 2009	Plasmodium falciparum malaria	National University of Colombia	Completed	No outcome recorded
Phase 4	NCT00444106 Comparator	May 2007 → Nov 2008	Plasmodium falciparum malaria	Novartis	Completed	Met primary
Phase 4	NCT00374205 Comparator	Sep 2006 → Oct 2007	Plasmodium falciparum malaria	Bernhard Nocht Institute for Tropical Medicine	Terminated	No outcome recorded
Phase 4	NCT00164359 Background	Apr → Sep 2005	Plasmodium falciparum malaria	Centers for Disease Control and Prevention	Completed	No outcome recorded
Phase 4	NCT03768908 Comparator	Jan → Jul 2005	Plasmodium falciparum malaria	Professor Anders Björkman	Completed	No outcome recorded
Phase 4	NCT03764527 Comparator	Nov 2002 → Feb 2003	Plasmodium falciparum malaria	Professor Anders Björkman	Completed	No outcome recorded
—	NCT01640587 Comparator	Nov 2013 → Mar 2017	Plasmodium falciparum malaria	University of Oxford	Terminated	No outcome recorded
—	NCT01967472 Comparator	Sep → Dec 2013	malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
—	NCT01641289 Comparator	Jul 2012 → Sep 2014	malaria	University of Oxford	Completed	Met primary
—	NCT00509015 Comparator	Feb → Aug 2008	Plasmodium falciparum malaria	Radboud University Medical Center	Completed	No outcome recorded
—	NCT01659281 Comparator	Sep 2007 → May 2008	Plasmodium falciparum malaria	Armed Forces Research Institute of Medical Sciences, Thailand	Completed	No outcome recorded
—	NCT00460369 Comparator	Apr → Nov 2007	malaria	Research Institute for Development	Completed	No outcome recorded
—	NCT00285662 Comparator	Jun 2006 → May 2010	anemia, malaria	Papua New Guinea Institute of Medical Research	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 7

Date	Issuer	Release
2023-07-06	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Regulatory Fosun Pharma Receives WHO Prequalification for Its Second-generation Artesunate for Injection Argesun® fosunpharma.com ↗ The second-generation artesunate for injection Argesun® independently developed by Fosun Pharma (600196.SH;02196.HK) was approved by WHO Prequalification1(WHO PQ) on 27 June 2023, which can enhance the accessibility of innovative antimalarial drugs and ultimately contribute to saving more lives.
2023-04-05	Amivas Inc.	Regulatory AMIVAS IRELAND LTD. RECEIVES MHRA AUTHORISATION FOR UK amivas.com ↗ AMIVAS Ireland Ltd., specialists in treatments for rare and neglected tropical diseases, including severe malaria, announced today the Medicines & Healthcare Products Regulatory Agency (MHRA) has authorised the Company to commercialize its lead product, Artesunate Amivas (artesunate), in the U.K.
2014-01-20	Shin Poong Pharmaceutical Co. Ltd.	Results EMA에서 승인받은 국내신약16호 Pyramax® 3상 임상시험 보고서 shinpoong.co.kr ↗ 그 결과, 치료율 측면에서, 피라맥스(Pyramax ® )정이 99.2%, Meflooquine + Artesunate이 97.8%(PCR corrected, at Day 28)를 보여, 피라맥스(Pyramax ® )정이 기존 치료제 복합요법(Artemisinin 계열의 약물과 타 말라리아 치료제의 병용치료요법)과 비교하여 동등이상의 효과가 있음을 입증 하였다.
2013-06-03	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Regulatory WHO Approves New Doses of Severe Malaria Treatment from Fosun Pharma fosunpharma.com ↗ The official website of World Health Organization published on Thursday May 23rd 2013 the pre-qualification of two new strengths of Artesun from Guilin Pharma, Fosun Pharma’s subsidiary.
2012-05-25	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Regulatory Fosun Pharma – Another Artesunate Combination passed PQ Certification fosunpharma.com ↗ On May 24, 2012, WHO Prequalification Program published in its website to add the Co-blister of artesunate tablet (50mg) + sulfadoxine/pyrimethamine tablet (500mg/25mg) produced by Guilin Pharmaceutical Co., Ltd. into its prequalified list.
2010-11-08	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Regulatory Artesunate Injection from Guilin Pharma Passed WHO-PO Attestation fosunpharma.com ↗ On Nov. 5th, WHO official website has listed Artesunate injection (Artesun) of Guilin Pharma on the PO drug list.
2010-11-07	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Results New Malaria Drug Proves Effective in Study of African Children fosunpharma.com ↗ Following artesunate treatment 8.5% (230/2712) of the patients died compared with 10.9% (297/2713) following quinine, an odds ratio stratified for study site of 0.75 (95%CI 0.63 to 0.90), and a relative reduction of 22.5% (95% CI 8.1 to 36.9%, p=0.0022).

All press releases naming this drug 10 releases

Date	Issuer	Release
2023-10-17	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Easier, Faster and Safer! Fosun Pharma's Self-developed Argesun® Brings a New Era in Severe Malaria Treatment fosunpharma.com ↗
2023-07-06	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Fosun Pharma Receives WHO Prequalification for Its Second-generation Artesunate for Injection Argesun® fosunpharma.com ↗
2023-04-05	Amivas Inc.	AMIVAS IRELAND LTD. RECEIVES MHRA AUTHORISATION FOR UK amivas.com ↗
2015-02-06	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Fosun Pharma’s Artesunate for Injection is Added to the Honours List of the French Medical Journal Prescrire fosunpharma.com ↗
2014-01-20	Shin Poong Pharmaceutical Co. Ltd.	EMA에서 승인받은 국내신약16호 Pyramax® 3상 임상시험 보고서 shinpoong.co.kr ↗
2013-10-31	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Guilin Pharma Announces Partnership with Idis for Controlled Access to Injectable Artesunate fosunpharma.com ↗
2013-06-03	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	WHO Approves New Doses of Severe Malaria Treatment from Fosun Pharma fosunpharma.com ↗
2012-05-25	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Fosun Pharma – Another Artesunate Combination passed PQ Certification fosunpharma.com ↗
2010-11-08	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Artesunate Injection from Guilin Pharma Passed WHO-PO Attestation fosunpharma.com ↗
2010-11-07	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	New Malaria Drug Proves Effective in Study of African Children fosunpharma.com ↗

Evidence & citations 22 cited values

Every value below carries the sentence it was read from. 206 sources stand behind the page.

Field	Value	Cited text
Known as	artésunate	“If the enzyme activity is normal and no other contra-indication for treatment are found, the participants will be treated with 14 days of primaquine 0.25mg/kg/day OR 7 days of...” NCT06923592 ↗ 201 “Patients with uncomplicated falciparum malaria and over six months of age were recruited in Cameroon, Mali, Rwanda and Sudan. 1,384 patients were randomly assigned to receive...” PMID 19366448 ↗ Apr 2009 “Patients received Cospherunate (50 mg Artésunate/125 mg Amodiaquine) at the rate of 2 tablets orally twice daily for 6 days and Azythromycine 250 mg orally at the rate of 2...” NCT04502342 ↗ “Following the recommendation of the WHO, Ghana changed its malaria treatment guidelines adopting artesunate and amodiaquine as first line for the treatment of uncomplicated...” NCT04301531 ↗ “We will assess the efficacy of a three day course of amodiaquine plus three days of artesunate (AQ3/AS3) for the treatment of symptomatic, uncomplicated P. falciparum infections.” NCT00425763 ↗ “Artesunate-mefloquine fixed dose combination (artesunate 25mg/mefloquine hydrochloride 55mg, or artesunate 100mg/mefloquine hydrochloride 220mg), according to age-group.” NCT00902811 ↗ “Artesunate 25mg / amodiaquine 67.5mg: 1 tab/day for 3 days in children 5 to 8.9 kg Artesunate 50mg / amodiaquine 135mg: 1 tab/day for 3 days in children 9 to 17.9 kg” NCT01567423 ↗ “A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Participants With Idiopathic Pulmonary Fibrosis (SAFE-IPF)” NCT05988463 ↗ “Artesunate, 2.4 mg/kg or 3 mg/kg, by intravenous administration of reconstituted solution” NCT04675931 ↗ “Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)” NCT00540410 ↗ “Ferroquine (SSR97193) Plus Artesunate, versus Amodiaquine Plus Artesunate” PMID 28722611 ↗ Jul 2017 Show 191 more sources
Known as	.alpha.-artesunic acid	ChEMBL registry synonym — accepted as the source's own label CHEMBL361497 ↗
Known as	Argesun	“Argesun 60mg (1 step parenteral artesunate)” NCT05140278 ↗
Known as	ARS	“The purpose of this study were firstly to characterize the population pharmacokinetics of artesunate (ARS) and its active metabolite dihydroartemisinin (DHA) in patients with...” PMID 25248945 ↗ Sep 2014
Known as	Arsumax	“Monthly chemoprophylaxis with SP (Fansidar® 500/25 mg) plus Artesunate (AS, Arsumax® 50 mg) or placebo (provided by Roche and Sanofi-Aventis) was administered according to the...” NCT00231452 ↗ 1 “artesunate (Arsumax, Sanofi, France: 4mg/kg, day1,2,3)” NCT00509015 ↗
Known as	ART	“The antimalarial drug artesunate (ART) is a promising candidate for cancer treatment as it displays anticancer effects in various models.” PMID 28439738 ↗ Apr 2017 1 “Artesunate (ART) is a water soluble semisynthetic artemisinin with improved pharmacokinetic properties.” NCT02304289 ↗
Known as	Artesunate amivas	ChEMBL registry synonym — accepted as the source's own label CHEMBL361497 ↗
Known as	Artesunate for Injection	“Artesunate for Injection” NCT00459615 ↗
Known as	artesunato	ClinicalTrials.gov intervention name — accepted as the source's own label NCT04877626 ↗
Known as	Artesunatum	ChEMBL registry synonym — accepted as the source's own label CHEMBL361497 ↗
Known as	Artesunic acid	ChEMBL registry synonym — accepted as the source's own label CHEMBL361497 ↗
Known as	Dihydroqinghaosu hemisuccinate	ChEMBL registry synonym — accepted as the source's own label CHEMBL361497 ↗
Known as	LJPC-0118	ChEMBL registry synonym — accepted as the source's own label CHEMBL361497 ↗
Known as	NSC-712571	ChEMBL registry synonym — accepted as the source's own label CHEMBL361497 ↗
Known as	Plasmotrin	ChEMBL registry synonym — accepted as the source's own label CHEMBL361497 ↗
Known as	Qinghaozhi	ChEMBL registry synonym — accepted as the source's own label CHEMBL361497 ↗
Known as	Saphnate	ChEMBL registry synonym — accepted as the source's own label CHEMBL361497 ↗
Known as	SODIUM ARESUNATE	ChEMBL registry synonym — accepted as the source's own label CHEMBL361497 ↗
Known as	Zysunate	ChEMBL registry synonym — accepted as the source's own label CHEMBL361497 ↗
Action	Inhibit	“Artesunate has been shown to suppress tumor necrosis factor-α expression” NCT04713631 ↗
Modality	Small molecule	“Artesunate is a water-soluble hemisuccinate derivative of artemisinin.” NCT01845701 ↗
Route	Oral	“oral therapy with artesunate could be a beneficial option” NCT00284687 ↗