Drugs / lumefantrine
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lumefantrine

Small molecule

Developed for
malaria · Plasmodium falciparum malaria · Plasmodium vivax malaria · anemia · urinary schistosomiasis
Investigated by
London School of Hygiene and Tropical Medicine · Novartis Pharmaceuticals · Centers for Disease Control and Prevention · Medicines for Malaria Venture · Institute of Tropical Medicine, Belgium · Makerere University
+105 more · University of Oxford · Centre Muraz · European and Developing Countries Clinical Trials Partnership (EDCTP) · University of California, San Francisco · Albert Schweitzer Hospital · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Kamuzu University of Health Sciences · Liverpool School of Tropical Medicine · Manhiça Health Research Centre · Ministry of Health, Malawi · Ministry of Public Health, Democratic Republic of the Congo · Muhimbili University of Health and Allied Sciences · Novartis · Papua New Guinea Institute of Medical Research · Radboud University Medical Center · The University of Western Australia · University of Cape Town · University of Kinshasa · University of Liverpool · Uppsala University · World Health Organization · Yale University · Academic Medical Center - University of Amsterdam · Australian Agency for International Development · Avenue Appia 20 · Bernhard Nocht Institute for Tropical Medicine · Boston University · CH - 1211 Geneva 27 · Cayenne Hospital · Centre for Global Health Research, Ghana · Clinton Health Access Initiative, Nigeria · Curtin University · Dafra Pharma · Department of Health, Philippines · Didier Menard · Disease Control, Department of Health, Myanmar · Division of Malaria Control, Ministry of Health, Nairobi, Kenya · East African Network for Monitoring Antimalarial Treatment · European Union · Evandro Chagas National Institute of Infectious Disease · Foundation for Scientific Research Suriname (SWOS) Paramaribo, Suriname · Fran Aweeka · Fund for Scientific Research, Flanders, Belgium · GlaxoSmithKline · Groupe de Recherche Action en Sante · Health Research Board, Ireland · Infectious Diseases Research Collaboration, Uganda · Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo · Institut de Recherche en Sciences de la Sante, Burkina Faso · Instituto Nacional de Saúde, Mozambique · International Centre of Insect Physiology and Ecology (ICIPE) · Janssen Pharmaceutica N.V., Belgium · Jimma University · Karolinska Institutet · Kenya Medical Research Institute · Kilimanjaro Christian Medical Centre, Tanzania · Kumasi Centre for Collaborative Research (KCCR) · Ludwig-Maximilians - University of Munich · Mahidol Oxford Tropical Medicine Research Unit · Mahidol University · Malawi-Liverpool-Wellcome Trust Clinical Research Programme · Mbarara University of Science and Technology · Medecins Sans Frontieres, Netherlands · Medical Research Council · Medicines for Malaria Venture (MMV), EDCTP, WANECAM · Menzies School of Health Research · Michigan State University · Ministry of Health, Brazil · Ministry of Health, Rwanda · National Department of Health, Papua New Guinea · National Health and Medical Research Council, Australia · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute of Health Research and Development, Ministry of Health Republic of Indonesia · National Malaria Control Program · all 111 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) COARTEM 2009-04-07 fda.gov

Trials 61 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT05330273 Apr → Nov 2022 malaria Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT05236530 Mar → Oct 2022 malaria Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT05084651 Nov 2021 → May 2022 malaria Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02242799 Jun 2015 → Sep 2016 HIV infectious disease, malaria University of Liverpool Completed No outcome recorded
Phase 1 NCT02184637 Jul 2014 → Apr 2015 Plasmodium vivax malaria GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01876966 Mar → Jul 2011 HIV infectious disease Janssen Pharmaceutica N.V., Belgium Completed No outcome recorded
Phase 1 NCT00697892 Jul 2005 → Dec 2008 HIV infectious disease, malaria Fran Aweeka Completed No outcome recorded
Phase 24 trials
Phase 2 NCT05550909 Oct → Dec 2022 Plasmodium falciparum malaria London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 2 NCT04546633 Feb 2021 → Aug 2024 Plasmodium falciparum malaria Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT03167242 Aug 2017 → Jun 2021 Plasmodium falciparum malaria Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT01614964 Aug 2013 → Jan 2016 Plasmodium falciparum malaria Tulane University Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT05764746 May 2023 → Dec 2024 Plasmodium falciparum malaria Muhimbili University of Health and Allied Sciences Unknown No outcome recorded
Phase 2/3 NCT04300309 Dec 2020 → Jul 2023 Plasmodium falciparum malaria Novartis Pharmaceuticals Terminated No outcome recorded
Phase 313 trials
Phase 3 NCT05951595 Sep 2025 → Jul 2026 overdue Plasmodium falciparum malaria University of Oxford Recruiting No outcome recorded
Phase 3 NCT05842954 Mar 2024 → Jun 2025 Plasmodium falciparum malaria Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT03355664 Mar 2018 → Mar 2020 Plasmodium falciparum malaria University of Oxford Completed No outcome recorded
Phase 3 NCT02610400 Feb 2016 → Dec 2017 malaria University of California, San Francisco Completed No outcome recorded
Phase 3 NCT01939886 Apr → Nov 2013 malaria London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 3 NCT01374581 May 2012 → Jun 2014 malaria University of Antwerp Completed No outcome recorded
Phase 3 NCT01625871 Sep 2011 → Sep 2012 Plasmodium vivax malaria University of Khartoum Completed No outcome recorded
Phase 3 NCT00393679 Jul 2007 → Dec 2009 malaria Institute of Tropical Medicine, Belgium Completed No outcome recorded
Phase 3 NCT00484900 May 2006 → May 2007 Plasmodium falciparum malaria Dafra Pharma Completed No outcome recorded
Phase 3 NCT00123552 Nov 2004 → Jun 2006 malaria University of California, San Francisco Completed No outcome recorded
Phase 425 trials
Phase 4 NCT07713602 Jun 2027 → May 2028 expected malaria Novartis Pharmaceuticals Not yet recruiting No outcome recorded
Phase 4 NCT07403643 Apr → Dec 2026 expected malaria Curtin University Not yet recruiting No outcome recorded
Phase 4 NCT06967519 Dec 2025 → Dec 2027 expected HIV infectious disease, malaria Yale University Recruiting No outcome recorded
Phase 4 NCT06424002 Jun → Dec 2024 Plasmodium falciparum malaria Kamuzu University of Health Sciences Unknown No outcome recorded
Phase 4 NCT05788094 Jun 2023 → Feb 2026 overdue Plasmodium vivax malaria Shoklo Malaria Research Unit Recruiting 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 NCT05070520 Sep 2020 Plasmodium falciparum malaria National Malaria Control Program, Niger Completed No outcome recorded
Phase 4 NCT03453840 Feb 2018 → Aug 2021 Plasmodium falciparum malaria University of California, San Francisco Completed No outcome recorded
Phase 4 NCT03241901 Jul → Dec 2017 Plasmodium falciparum malaria Muhimbili University of Health and Allied Sciences 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 not applicable10 trials
NCT07527182 May 2024 → Oct 2025 Plasmodium falciparum malaria Didier Menard Completed No outcome recorded
NCT06970600 Mar → Oct 2024 Plasmodium falciparum malaria Manhiça Health Research Centre Completed No outcome recorded
NCT05540470 Sep 2022 → Mar 2025 Plasmodium vivax malaria Cayenne Hospital Completed No outcome recorded
NCT02600767 Dec 2015 → May 2016 malaria Centers for Disease Control and Prevention Completed No outcome recorded
NCT01575613 Apr → Nov 2012 malaria Radboud University Medical Center Completed No outcome recorded
NCT01326754 Aug 2011 → Jun 2012 Plasmodium falciparum malaria Centers for Disease Control and Prevention Completed No outcome recorded
NCT00725777 Jul 2008 → Dec 2011 malaria Albert Schweitzer Hospital Completed No outcome recorded
NCT00157833 Jul 2004 → Aug 2005 Plasmodium falciparum malaria, Plasmodium vivax malaria Menzies School of Health Research Completed No outcome recorded
NCT00229775 Jul 2003 → Jul 2008 malaria Centers for Disease Control and Prevention Completed No outcome recorded
NCT00304980 Mar 2003 → Apr 2005 Plasmodium falciparum malaria Institute of Tropical Medicine, Belgium Terminated No outcome recorded
Also used as a comparator or background therapy in 63 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT06294912 Background Apr 2024 → Jan 2025 malaria Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT04310085 Background Feb → Dec 2020 Plasmodium falciparum malaria, parasitemia Medicines for Malaria Venture Completed No outcome recorded
Phase 1 NCT03510481 Background May 2018 → Nov 2019 malaria National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT02223871 Background Jun → Jul 2014 Idorsia Pharmaceuticals Ltd. Completed No outcome recorded
Phase 1 NCT00266058 Comparator Dec 2005 → Nov 2010 HIV infectious disease, malaria University of California, San Francisco Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT04280692 Background Aug 2022 → Dec 2025 Plasmodium falciparum malaria University of Oxford Suspended No outcome recorded
Phase 1/2 NCT01603251 Comparator Jan → Apr 2013 malaria London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 29 trials
Phase 2 NCT07559370 Comparator Jan 2026 → Jun 2027 expected Plasmodium falciparum malaria Victoria Biomedical Research Institute Recruiting No outcome recorded
Phase 2 NCT07235033 Comparator Jan 2024 → Mar 2025 Plasmodium falciparum malaria Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT04675931 Background Mar 2022 → Jul 2025 Plasmodium falciparum malaria Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT04661579 Background Nov 2020 → Jun 2022 Plasmodium falciparum malaria PATH Completed No outcome recorded
Phase 2 NCT04020653 Background Sep 2019 → May 2020 malaria Neopharma Japan Co., Ltd. Withdrawn No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT04009343 Comparator Jun 2019 → Aug 2020 overdue Plasmodium falciparum malaria Johns Hopkins Bloomberg School of Public Health Active not recruiting 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 NCT01935882 Comparator Sep 2013 → Jul 2015 Plasmodium falciparum malaria London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 315 trials
Phase 3 NCT06962319 Comparator Sep 2025 → Aug 2028 expected malaria Liverpool School of Tropical Medicine Recruiting No outcome recorded
Phase 3 NCT06516042 Comparator Aug 2024 → Jan 2025 overdue Plasmodium falciparum malaria PATH Active not recruiting No outcome recorded
Phase 3 NCT04695197 Comparator Jan 2021 → Nov 2022 COVID-19, malaria Liverpool School of Tropical Medicine Completed No outcome recorded
Phase 3 NCT03923725 Comparator Sep 2020 → Mar 2024 Plasmodium falciparum malaria University of Oxford Completed No outcome recorded
Phase 3 NCT03452475 Comparator Mar 2018 → Jun 2019 Plasmodium falciparum malaria University of Oxford Completed No outcome recorded
Phase 422 trials
Phase 4 NCT06347471 Comparator May 2024 → Nov 2025 Plasmodium falciparum malaria Infectious Diseases Research Collaboration, Uganda 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 NCT05605925 Background Aug → Dec 2022 malaria Makerere University Unknown No outcome recorded
Phase 4 NCT05340153 Comparator Apr → Dec 2022 malaria University of Yaounde 1 Unknown No outcome recorded
Phase 4 NCT05343312 Comparator Mar 2022 → Sep 2023 Plasmodium falciparum malaria Manhiça Health Research Centre Completed No outcome recorded
Phase not applicable7 trials
NCT07533136 Comparator May 2026 → Oct 2028 expected Plasmodium vivax malaria Walter Reed Army Institute of Research (WRAIR) Not yet recruiting No outcome recorded
NCT03813108 Background Apr 2019 → Feb 2021 Plasmodium falciparum malaria Radboud University Medical Center Terminated No outcome recorded
NCT01967472 Comparator Sep → Dec 2013 malaria London School of Hygiene and Tropical Medicine Completed No outcome recorded
NCT00720811 Comparator Oct 2009 → Jan 2012 malaria, pneumonia Mbarara University of Science and Technology Completed No outcome recorded
NCT00868465 Comparator Apr 2009 → May 2010 malaria Radboud University Medical Center Completed No outcome recorded

Press releases naming this drug 2 releases

DateIssuerRelease
2022-11-23 Novartis Pharmaceuticals Novartis and Medicines for Malaria Venture announce decision to move to Phase 3 study for novel ganaplacide/lumefantrine-SDF combination in adults and children with malaria novartis.com
2021-09-29 Novartis Pharmaceuticals Novartis and Medicines for Malaria Venture report positive results for Phase 2b study of novel ganaplacide/lumefantrine combination in children with malaria novartis.com

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 125 sources stand behind the page.

FieldValueCited text
Known as lumefantrine “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
122

“RACD involved rapid diagnostic testing and treatment with artemether-lumefantrine and single-dose primaquine, rfMDA involved presumptive treatment with artemether-lumefantrine,...” PMID 32334702 Apr 2020

“Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes and receive presumptive treatment with artemether/lumefantrine...” NCT03813108

“Our aim was to compare the safety and efficacy of dihydroartemisinin-piperaquine with that of artemether-lumefantrine in patients with uncomplicated malaria caused by...” PMID 17336652 Mar 2007

“Participants that provide consent to participate in the TDA and are deemed eligible for treatment will receive a course of dihydroartemisinin-piperaquine (DP) if male, and...” NCT06516042

“Patients will be treated with single dose SP (25 mg/kg of the sulfadoxine component in a single dose) plus CQ (25 mg/kg over three days) or artemether + lumefantrine (twice...” NCT00229775

“Coartem®: artemether 20 mg - lumefantrine 120 mg co-formulated tabs (Coartem®, Novartis) given as six twice-daily doses over three days, according to weight-groups.” NCT00902811

“Augmented 4 day regimen of artemether lumefantrine 2 doses per day for 4 days. Each dose consists of 5 tablets (20/120 mg of artemether/lumefantrine per tablet).” NCT01054248

“Artemether 80 mg + lumefantrine 480 mg was administered twice a day for 3 days with a standard meal or drink rich in fat within 30 min of dosing, as per label.” NCT07235033

“KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF)” NCT05842954

“artemether 20 mg / lumefantrine 120 mg co-formulated tablets given as six twice-daily doses over three days” NCT01567423

“Artemether-lumefantrine (20/120 mg) as a fixed dose combination twice daily for 3 days according to weight” NCT03355664

“A blister of 24 tablets of Artemether 20 mg + lumefantrine 120 mg of generic medication” NCT05540470

“80 mg of oral artemether and 480 mg of oral lumefantrine twice daily for 3 days” PMID 28916443 Sep 2017

“a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients” NCT04546633

“A single Coartem tablet contains 20 mg artemether and 120 mg lumefantrine.” NCT03199755

“artemether-lumefantrine for repeated treatment of uncomplicated malaria in” PMID 25436614 Dec 2014

“one tablet (20mg artemether and 120mg lumefantrine)” NCT05343312

“Artemether 20 mg and lumefantrine 120 mg” NCT04020653

“Artemether-lumefantrine for 3 days” NCT02453308

“Artemether: LumefantrineNCT07713602

LumefantrineNCT04675931

NCT00619944

NCT01651416

NCT02325180

NCT01876966

NCT05550909

NCT05951595

NCT00140361

NCT02600767

NCT02168569

NCT00123552

NCT05340153

NCT00694694

NCT05070520

NCT04264130

NCT07403643

NCT00406146

NCT01445938

NCT00444106

NCT00869700

NCT00118794

NCT07527182

NCT00297882

NCT00868465

NCT06347471

NCT01935882

NCT01998295

NCT06300970

NCT04300309

NCT00725777

NCT00620438

NCT04370977

NCT01845701

NCT04009343

NCT06970600

NCT06967519

NCT00540410

NCT03452475

NCT00495508

NCT04565184

NCT00164710

NCT00790881

NCT01967472

NCT00697892

NCT05084651

NCT03510481

NCT02940756

NCT01603251

NCT04310085

NCT00452907

NCT01599000

NCT04695197

NCT02742285

NCT05764746

NCT01899820

NCT03241901

NCT00460369

NCT06424002

NCT00393679

NCT03923725

NCT00374205

NCT06962319

NCT00304980

NCT03768908

NCT05605925

NCT00709969

NCT04829695

NCT01374581

NCT01082731

NCT00529867

NCT02242799

NCT07533136

NCT04618523

NCT01152931

NCT02741024

NCT04767191

NCT02348788

NCT01625871

NCT02974348

NCT05330273

NCT01704508

NCT00720811

NCT01939886

NCT03167242

NCT07559370

NCT02223871

NCT01038063

NCT00541385

NCT04280692

NCT05788094

NCT04661579

NCT01697787

NCT02184637

NCT03453840

NCT02696928

NCT00266058

NCT01575613

NCT00451139

NCT05236530

NCT01082705

NCT06294912

NCT01326754

Known as Benflumelol ChEMBL registry synonym — accepted as the source's own label CHEMBL38827
Known as Benflumetol ChEMBL registry synonym — accepted as the source's own label CHEMBL38827
Known as CPG-56695 ChEMBL registry synonym — accepted as the source's own label CHEMBL38827
Known as Dl-benflumelol ChEMBL registry synonym — accepted as the source's own label CHEMBL38827
Known as GNF-PF-1971 ChEMBL registry synonym — accepted as the source's own label CHEMBL38827
Known as lumefantrina ClinicalTrials.gov intervention name — accepted as the source's own label NCT04877626
Known as Lumefantrine component of coartem ChEMBL registry synonym — accepted as the source's own label CHEMBL38827
Known as lumefantrine-SDF “KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF)” NCT05842954
Known as Lumefantrinum ChEMBL registry synonym — accepted as the source's own label CHEMBL38827
Modality Small molecule “Lumefantrine is a synthetic compound” NCT00620438
Route Oral “Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days, dosage dependent on body weight.” NCT00444106