Drugs / Artemether
last change Aug 2026 re-read 9 days ago

Artemether

Small molecule

Developed for
malaria · Plasmodium falciparum malaria · Plasmodium vivax malaria · anemia · cancer · urinary schistosomiasis
Investigated by
London School of Hygiene and Tropical Medicine · Centers for Disease Control and Prevention · Institute of Tropical Medicine, Belgium · Makerere University · University of Oxford · Centre Muraz
+107 more · University of California, San Francisco · Albert Schweitzer Hospital · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · European and Developing Countries Clinical Trials Partnership (EDCTP) · Kamuzu University of Health Sciences · Liverpool School of Tropical Medicine · Manhiça Health Research Centre · Medicines for Malaria Venture · Ministry of Health, Malawi · Ministry of Public Health, Democratic Republic of the Congo · Novartis · Novartis Pharmaceuticals · Papua New Guinea Institute of Medical Research · Proto Pharma Ltd · Radboud University Medical Center · The University of Western Australia · University of Cape Town · University of Kinshasa · University of Liverpool · 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) · LondonPharma Ltd. · 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 · Menzies School of Health Research · Michigan State University · Ministry of Health, Brazil · Ministry of Health, Rwanda · Muhimbili University of Health and Allied Sciences · 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 113 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 58

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
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 1/21 trial
Phase 1/2 NCT02263950 Oct 2014 → Oct 2016 cancer LondonPharma Ltd. Unknown No outcome recorded
Phase 24 trials · 2 missed
Phase 2 NCT05550909 Oct → Dec 2022 Plasmodium falciparum malaria London School of Hygiene and Tropical Medicine Completed Mixed
Phase 2 NCT01614964 Aug 2013 → Jan 2016 Plasmodium falciparum malaria Tulane University Completed Missed primary
Phase 2 NCT01445938 Oct 2011 → Jan 2012 malaria Sanofi Terminated No outcome recorded
Phase 2 NCT01047436 Dec 2009 → Jan 2010 Plasmodium falciparum malaria Proto Pharma Ltd Completed Missed primary
Phase 2/31 trial · 1 met primary
Phase 2/3 NCT04300309 Dec 2020 → Jul 2023 Plasmodium falciparum malaria Novartis Pharmaceuticals Terminated Met primary Stop: Business
Phase 313 trials · 3 met primary · 2 missed
Phase 3 NCT05951595 Sep 2025 → Jul 2026 overdue Plasmodium falciparum malaria University of Oxford Recruiting No outcome recorded
Phase 3 NCT03355664 Mar 2018 → Mar 2020 Plasmodium falciparum malaria University of Oxford Completed Missed primary
Phase 3 NCT02610400 Feb 2016 → Dec 2017 malaria University of California, San Francisco Completed Met primary
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 NCT01258049 Dec 2010 → Aug 2012 Plasmodium falciparum malaria Proto Pharma Ltd Completed Met primary
Phase 3 NCT00393679 Jul 2007 → Dec 2009 malaria Institute of Tropical Medicine, Belgium Completed Mixed
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 Met primary
Phase 425 trials · 1 met primary · 1 missed
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 Mixed
Phase 4 NCT03241901 Jul → Dec 2017 Plasmodium falciparum malaria Muhimbili University of Health and Allied Sciences Completed Missed primary
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 · 1 met primary · 1 missed
— 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 Missed primary
— 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 Met primary
— 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
Comparator or background therapy65 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

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2026-04-24 Novartis Pharmaceuticals Regulatory Novartis malaria treatment Coartem® Baby receives WHO prequalification, paving way for greater access for newborns and young infants novartis.com ↗
Novartis today announced that the World Health Organization (WHO) has prequalified Coartem® (artemether-lumefantrine) Baby, the first and only antimalarial developed specifically for newborns and young infants weighing from 2 to 5 kilograms.
2025-11-12 Novartis Pharmaceuticals Results Novartis Phase III trial for next-generation malaria treatment KLU156 (GanLum) meets primary endpoint, with potential to combat antimalarial resistance novartis.com ↗
The treatment achieved a 97.4% PCR-corrected cure rate using an estimand framework, compared to 94.0% with standard of care.
2025-07-08 Novartis Pharmaceuticals Regulatory Novartis receives approval for first malaria medicine for newborn babies and young infants novartis.com ↗
Novartis today announced Coartem ® (artemether-lumefantrine) Baby has been approved by Swissmedic as the first malaria medicine for newborns and young infants.
2024-04-24 Novartis Pharmaceuticals Results Novartis and Medicines for Malaria Venture announce positive efficacy and safety data for a novel treatment for babies <5 kg with malaria novartis.com ↗
The CALINA trial indicated that the new formulation has good efficacy and safety, and the data have been submitted for regulatory review
2021-09-29 Novartis Pharmaceuticals Results Novartis and Medicines for Malaria Venture report positive results for Phase 2b study of novel ganaplacide/lumefantrine combination in children with malaria novartis.com ↗
In children with acute uncomplicated malaria, response to treatment with ganaplacide/lumefantrine was similar to the rate observed in patients who received artemether-lumefantrine control therapy.

Evidence & citations 21 cited values

Every value below carries the sentence it was read from. 126 sources stand behind the page.

FieldValueCited text
Known as Artemether “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
120

“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 ↗

“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 ↗

“Lumefantrine 480 mg co-formulated with artemether 80 mg administered as single dose to HIV-positive adults receiving lopinavir/ritonavir 400 mg/100 mg twice daily” NCT00619944 ↗

“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 ↗

“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 ↗

Show 110 more sources

Known as .beta.-artemether ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as Artemeter ClinicalTrials.gov intervention name — accepted as the source's own label NCT04877626 ↗
1

NCT02696928 ↗

Known as Artemetero ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as Artemether component of coartem ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as Artemetheri ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as Artemetherum ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as Artesaph ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as arthemether “Coartem® (arthemether+ lumefantrine)” NCT00540410 ↗
Known as ArTiMist “The efficacy of sublingual artemether (ArTiMist) was investigated in two studies.” PMID 26303805 ↗ Aug 2015
Known as Dihydroartemisinin impurity g ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as Falcidol ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as Gvither ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as Larither ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as Malartem ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as NSC-665970 ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as NSC-759820 ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as Paluther ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Known as SM 224 ChEMBL registry synonym — accepted as the source's own label CHEMBL566534 ↗
Modality Small molecule “CoArtem® is an oral, fixed combination of artemether- a derivative of artemisinin” NCT01845701 ↗
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 ↗