Drugs / Artemether-lumefantrine
Artemether-lumefantrine
also known as
Coartem · Coartem(R) · A-L · ALN · AM-LM · Artemether-lumefantrin · Artemether-lumefantrine, COA566 · COA566 · +4 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | COARTEM | — | 2009-04-07 | fda.gov ↗ |
Trials 41 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04080895 | Nov 2022 → Apr 2025 | — | University of Oxford | Terminated | No outcome recorded |
| Phase 1 | NCT04456634 | Sep → Nov 2020 | malaria | Medicines for Malaria Venture | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02696954 | Nov 2016 → Mar 2019 | — | University of Oxford | Terminated | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05081089 | Oct → Dec 2021 | Plasmodium falciparum malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 2 | NCT04944966 | Jun 2021 → Sep 2022 | malaria | Ifakara Health Institute | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT01619878 | Oct 2012 → Jul 2014 | Plasmodium falciparum malaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/3 | NCT00677833 | Jun 2008 → Sep 2010 | Plasmodium falciparum malaria | Pfizer | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00386763 | Aug 2006 → Mar 2007 | Plasmodium falciparum malaria | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00344006 | Jun 2006 → Aug 2007 | Plasmodium falciparum malaria | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 423 trials | ||||||
| Phase 4 | NCT05757167 | Nov 2023 → Dec 2026 expected | Plasmodium falciparum malaria, fetal growth restriction, pregnancy disorder with abortive outcome | Duke University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06076213 | May 2023 → Sep 2024 | Plasmodium falciparum malaria | Ministry of Public Health, Democratic Republic of the Congo | Completed | No outcome recorded |
| Phase 4 | NCT04778813 | Jun → Dec 2021 | malaria | Centre national de recherche et de formation sur le paludisme | Unknown | No outcome recorded |
| Phase 4 | NCT04708496 | Jan 2021 → Jan 2024 | coinfection, malaria | Makerere University | Unknown | No outcome recorded |
| Phase 4 | NCT04094727 | Oct 2019 → Jun 2020 | malaria | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT04531072 | Sep 2018 → May 2019 | — | Fogarty International Center of the National Institute of Health | Completed | No outcome recorded |
| Phase 4 | NCT02389374 | Aug 2014 → Mar 2015 | malaria | Menzies School of Health Research | Completed | No outcome recorded |
| Phase 4 | NCT02637128 | Mar → Jul 2014 | Plasmodium falciparum malaria | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| Phase 4 | NCT01755559 | Jun 2013 → Nov 2014 | malaria | Epicentre | Completed | No outcome recorded |
| Phase 4 | NCT01680406 | Oct 2012 → Dec 2014 | Plasmodium vivax malaria | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| Phase 4 | NCT02089841 | May 2012 → Aug 2013 | Plasmodium falciparum malaria | Richard Mwaiswelo | Completed | No outcome recorded |
| Phase 4 | NCT01107145 | Feb 2011 → Jan 2012 | Plasmodium vivax malaria | Centers for Disease Control and Prevention | Terminated | No outcome recorded |
| Phase 4 | NCT01459146 | Dec 2010 → Oct 2011 | anemia, malaria, schistosomiasis | Navrongo Health Research Centre, Ghana | Unknown | No outcome recorded |
| Phase 4 | NCT01256658 | Nov 2010 → Jul 2012 | malaria | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT01084213 | Jun 2010 → Jul 2012 | anemia, malaria, pregnancy disorder | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01075945 | Feb → Apr 2010 | malaria | University of Khartoum | Unknown | No outcome recorded |
| Phase 4 | NCT00808951 | Dec 2008 → Oct 2010 | malaria | Centre Muraz | Completed | No outcome recorded |
| Phase 4 | NCT01017770 | Sep 2008 → Jan 2010 | Plasmodium falciparum malaria | Centre Muraz | Completed | No outcome recorded |
| Phase 4 | NCT00454961 | Apr 2007 → ? | malaria | Karolinska University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00426439 | Dec 2006 → Nov 2008 | Plasmodium falciparum malaria | Bandim Health Project | Completed | No outcome recorded |
| Phase 4 | NCT00336375 | Jun → Jul 2006 | malaria | Karolinska University Hospital | 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 | NCT00386750 | Jun → Nov 2005 | Plasmodium falciparum malaria | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase not applicable9 trials | ||||||
| — | NCT04041973 | Mar 2020 → Mar 2021 | malaria | University of Oxford | Completed | No outcome recorded |
| — | NCT02528279 | Oct 2014 → Oct 2016 | malaria | Albert Schweitzer Hospital | Completed | No outcome recorded |
| — | NCT02213211 | Apr 2014 → Mar 2015 | malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| — | NCT01958905 | Nov 2013 → Mar 2015 | malaria, protein-energy malnutrition | Epicentre | Completed | No outcome recorded |
| — | NCT01043744 | Jan 2010 → Dec 2011 | malaria | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| — | NCT00878007 | Jan 2010 → Apr 2012 | anemia, malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| — | NCT01052584 | Oct 2009 → Jan 2010 | malaria | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| — | NCT00127998 | Jul 2005 → ? | malaria | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| — | NCT00203801 | Jan 2002 → Jul 2005 | malaria | University of Cape Town | Completed | No outcome recorded |
Also used as a comparator or background therapy in 35 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02942277 Background | Oct 2016 → Jul 2020 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT01103830 Comparator | Feb → Aug 2010 | Plasmodium falciparum malaria | sigma-tau i.f.r. S.p.A. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03952650 Background | May 2019 → Feb 2021 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT05750628 Comparator | Jan 2024 → Jun 2026 overdue | Plasmodium falciparum malaria | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT04546633 Comparator | Feb 2021 → Aug 2024 | Plasmodium falciparum malaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03334747 Comparator | Nov 2017 → Nov 2019 | malaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03167242 Comparator | Aug 2017 → Jun 2021 | Plasmodium falciparum malaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05192265 Comparator | May 2019 → Dec 2020 | Plasmodium falciparum malaria | University of Ibadan | Completed | No outcome recorded |
| Phase 2/3 | NCT02174900 Comparator | Oct 2014 → Dec 2015 | Plasmodium falciparum malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT05842954 Comparator | Mar 2024 → Jun 2025 | Plasmodium falciparum malaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03939104 Comparator | Jun 2021 → Jan 2023 | Plasmodium falciparum malaria | University of Oxford | Completed | No outcome recorded |
| Phase 3 | NCT02411994 Comparator | Oct 2015 → Aug 2017 | malaria | Royal Tropical Institute | Completed | No outcome recorded |
| Phase 3 | NCT02001012 Comparator | Jan 2014 → Jan 2015 | — | Menzies School of Health Research | Completed | No outcome recorded |
| Phase 3 | NCT02020330 Comparator | Nov 2013 → Feb 2015 | Plasmodium falciparum malaria | University of Oxford | Completed | No outcome recorded |
| Phase 3 | NCT01916954 Comparator | Jul 2013 → Mar 2014 | Plasmodium falciparum malaria | University of Oxford | Completed | No outcome recorded |
| Phase 3 | NCT01449045 Comparator | Jul → Dec 2011 | malaria | Cheikh Anta Diop University, Senegal | Completed | No outcome recorded |
| Phase 3 | NCT00852423 Comparator | Jun 2010 → Oct 2013 | Plasmodium falciparum malaria | Institute of Tropical Medicine, Belgium | Completed | No outcome recorded |
| Phase 3 | NCT00527800 Comparator | Aug 2007 → Mar 2013 | HIV infectious disease, malaria | University of California, San Francisco | Completed | No outcome recorded |
| Phase 3 | NCT00422084 Comparator | Jan 2007 → Apr 2008 | malaria | Medicines for Malaria Venture | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT04704999 Background | Jul 2024 → Oct 2027 expected | Plasmodium vivax malaria | University of Oxford | Recruiting | No outcome recorded |
| Phase 4 | NCT04767217 Comparator | Jun 2021 → Dec 2023 | malaria | Jhpiego | Completed | No outcome recorded |
| Phase 4 | NCT03783299 Background | Nov 2017 → Nov 2018 | Plasmodium falciparum malaria | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT04897919 Comparator | Aug 2015 → Oct 2017 | malaria | Bandim Health Project | Completed | No outcome recorded |
| Phase 4 | NCT02590627 Comparator | May 2014 → Dec 2015 | malaria | National Institute for Medical Research, Tanzania | 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 | NCT01906788 Comparator | May → Oct 2013 | malaria | Kilimanjaro Clinical Research Institute | Unknown | No outcome recorded |
| Phase 4 | NCT01350856 Comparator | May 2011 → Apr 2014 | Plasmodium falciparum malaria | University of Oxford | Completed | No outcome recorded |
| Phase 4 | NCT02143934 Comparator | Aug 2009 → May 2010 | Plasmodium falciparum malaria, Plasmodium vivax malaria | Papua New Guinea Institute of Medical Research | Completed | No outcome recorded |
| Phase 4 | NCT00885287 Comparator | Jul 2009 → Oct 2012 | HIV infectious disease, Plasmodium falciparum malaria | University of Copenhagen | Completed | No outcome recorded |
| Phase 4 | NCT00540202 Comparator | Sep 2007 → Apr 2008 | malaria | Makerere University | Unknown | 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 applicable3 trials | ||||||
| — | NCT07358767 Comparator | Jul 2021 → Mar 2023 | malaria | Noguchi Memorial Institute for Medical Research | Completed | No outcome recorded |
| — | NCT05060198 Comparator | Jun 2016 → Mar 2017 | Plasmodium falciparum malaria | Kenya Medical Research Institute | Completed | No outcome recorded |
| — | NCT00513500 Comparator | Jun 2007 → Feb 2009 | malaria, pneumonia | Boston University | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-24 | Novartis Pharmaceuticals | Novartis malaria treatment Coartem® Baby receives WHO prequalification, paving way for greater access for newborns and young infants novartis.com ↗ |
| 2015-07-16 | Novartis Pharmaceuticals | Novartis malaria treatment Coartem® 80/480mg receives WHO prequalification, enabling greater access for patients novartis.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 80 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Artemether/lumefantrine | “This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination therapy (AS-AQ), Artemether-lumefantrine (Coartem), and Artesunate-lapdap) in a drug...” NCT00119145 ↗66“Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used...” NCT02942277 ↗ “Artesunate 2 mg/kg/day for 3 days followed by a full course of either artemether-lumefantrine or DHA-piperaquine or artesunate-mefloquine or artesunate-amodiaquine” NCT01350856 ↗ “Children (with or without clinical malaria symptoms) found to be RDT-positive will be treated with artemether-lumefantrine according to national guidelines.” NCT00878007 ↗ “Patients will receive the study drug combination artemether-lumefantrine (Coartem®) orally as a 6 dose regimen for three consecutive days.” NCT02528279 ↗ “Artemether-lumefantrine dispersible tablets (Coartem™, Novartis pharma) twice daily according to body weights.” NCT05192265 ↗ “treated if positive for malaria with artemether-lumefantrine (AL).” PMID 26258474 ↗ Aug 2015 “Artemether-lumefantrine will be given twice daily over 3 days.” NCT04704999 ↗ “standard 6-dose regimen of artemether-lumefantrine (AL).” PMID 31964380 ↗ Jan 2020 “Artemether-lumefantrine (AL)” NCT05060198 ↗ |
| Known as | A-L | “Artemether-lumefantrine (A-L) is a common and widely available ACT” NCT02001012 ↗ |
| Known as | ALN | “artemether-lumefantrine (ALN)” NCT04767217 ↗ |
| Known as | AM-LM | “A WHO standard protocol was used to assess efficacy of the combinations artesunate-amodiaquine (AS-AQ Winthrop®), dihydroartemisinin-piperaquine (DHA-PPQ, Eurartesim®) and...” PMID 29370844 ↗ Jan 2018 |
| Known as | Artemether-lumefantrin | “Artemether-lumefantrin (AL)” NCT04778813 ↗ |
| Known as | Artemether-lumefantrine, COA566 | “Artemether-lumefantrine, COA566” NCT01619878 ↗ |
| Known as | COA566 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01256658 ↗ |
| Known as | Coartem | “to several different antimalarial drugs and drug combinations: chloroquine (CQ), sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in combination with...” NCT00127998 ↗16“A WHO standard protocol was used to assess efficacy of the combinations artesunate-amodiaquine (AS-AQ Winthrop®), dihydroartemisinin-piperaquine (DHA-PPQ, Eurartesim®) and...” PMID 29370844 ↗ Jan 2018 “This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination therapy (AS-AQ), Artemether-lumefantrine (Coartem), and Artesunate-lapdap) in a drug...” NCT00119145 ↗ “Increased systemic exposures of artemether and dihydroartemisinin in infants under 5 kg with uncomplicated Plasmodium falciparum malaria treated with artemether-lumefantrine (Coartem®).” PMID 25886021 ↗ Apr 2015 “Artemether-lumefantrine (Coartem; Novartis) administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine at a dosage of:” NCT01043744 ↗ “A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)” NCT01256658 ↗ “artemether- lumefantrine (Coartem or AL) was adopted as first line therapy in Ethiopia in 2004.” NCT01680406 ↗ “artemether- lumefantrine (Coartem or AL) was adopted as first line therapy in Ethiopia in 2004” NCT01052584 ↗ |
| Known as | Coartem(R) | “Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used...” NCT02942277 ↗1“Three day treatment with artemether-lumefantrine (Coartem(R)” NCT00852423 ↗ |
| Known as | Coartem-D | “Dispersible formulation of artemether-lumefantrine (Coartem-D™; 20mg artemether/120mg lumefantrine per tablet, Novartis, Switzerland) administered twice a day for 3 days...” NCT02637128 ↗ |
| Known as | Malherbal | “* Maytenus senegalensis (Malherbal) has a very long history of safe medicinal use in Africa in adult as well as infants and children.” NCT04944966 ↗ |
| Known as | Maytenus senegalensis | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04944966 ↗ |
| Known as | Riamet | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01103830 ↗ |
| Modality | Traditional medicine (herbal / TCM) | “The herbal medicine (Maytenus senegalensis) has been scientifically investigated for acute toxicity in vitro and antiplasmodial activity both in vitro and in vivo where it...” NCT04944966 ↗ |
| Route | Oral | “The World Health Organization recommends oral artemisinin-based combination therapy (ACT) for treating uncomplicated malaria.” PMID 33289099 ↗ Dec 2020 |