Drugs / Artesunate
Artesunate
also known as
Arsumax · ART · .alpha.-artesunic acid · Argesun · ARS · Artesunate amivas · Artesunate for Injection · artesunato · +11 more
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
2
3
2
5
7
13
14
15
7
4
5
4
6
2
3
5
4
2
5
8
5
3
4
3
8
2
1
20002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
Also used as a comparator or background therapy in 60 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 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 1/23 trials | ||||||
| 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 28 trials | ||||||
| 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 | No outcome recorded |
| 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 2/32 trials | ||||||
| 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 319 trials | ||||||
| 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 | NCT06173206 Comparator | Jun → 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 | No outcome recorded |
| Phase 3 | NCT00403260 Comparator | Jan 2007 → Oct 2008 | Plasmodium falciparum malaria | Medicines for Malaria Venture | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT00373607 Comparator | Jul 2003 → Jul 2005 | malaria | Institute of Tropical Medicine, Belgium | Completed | No outcome recorded |
| Phase 417 trials | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
| Phase not applicable7 trials | ||||||
| — | 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 | No outcome recorded |
| — | 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 |
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 207 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | artésunate | “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 2009201“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 ↗ “a three-day course of either chloroquine (Ethiopia) or artesunate-amodiaquine (Madagascar)” NCT06923592 ↗ “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 “artesunate plus amodiaquine (ASAQ) and artemether-lumefantrine (AL)” PMID 21838909 ↗ Aug 2011 “Efficacy and safety of fixed-dose artesunate-amodiaquine vs.” PMID 25436614 ↗ Dec 2014 “3 days of artesunate sulfadoxine/pyrimethamine on days 0-2” NCT02592408 ↗ “Pyronaridine-Artesunate(180/60mg) tablet for 3days.” NCT05084911 ↗ “one 25mg artesunate and 67.5mg amodiaquine tablet” NCT05343312 ↗ “Artesunate-mefloquine for 3 days” NCT02453308 ↗ “Artesunate monotherapy (AS)” NCT06166498 ↗ “plus intravenous Artesunate” NCT01641289 ↗ |
| 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 20171“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 | AS (Guilin Pharmaceuticals) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06173206 ↗ |
| 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 ↗ |