lumefantrine

also known as Benflumelol · Benflumetol · CPG-56695 · Dl-benflumelol · GNF-PF-1971 · lumefantrina · Lumefantrine component of coartem · lumefantrine-SDF · +1 more

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
+104 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 · 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 · 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 · 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 · National Malaria Control Program, Niger · all 110 on the full record

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 60

today

US approved 2009

200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
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 · 1 met primary · 1 missed
Phase 2	NCT05550909	Oct → Dec 2022	Plasmodium falciparum malaria	London School of Hygiene and Tropical Medicine	Completed	Mixed
Phase 2	NCT04546633	Feb 2021 → Aug 2024	Plasmodium falciparum malaria	Novartis Pharmaceuticals	Completed	Met primary
Phase 2	NCT03167242	Aug 2017 → Jun 2021	Plasmodium falciparum malaria	Novartis Pharmaceuticals	Completed	Mixed
Phase 2	NCT01614964	Aug 2013 → Jan 2016	Plasmodium falciparum malaria	Tulane University	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	NCT05842954	Mar 2024 → Jun 2025	Plasmodium falciparum malaria	Novartis Pharmaceuticals	Completed	Met primary
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	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 3	NCT00406146	Oct 2004 → Dec 2006	malaria	University of Ghana Medical School	Unknown	No outcome recorded
Phase 3	NCT00118794	Sep 2004 → Jun 2005	malaria	London School of Hygiene and Tropical Medicine	Completed	Missed primary
Phase 3	NCT00709969	Jul 2002 → Feb 2003	Plasmodium falciparum malaria	Novartis	Completed	No outcome recorded

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 4	NCT02742285	May → Jul 2016	malaria	Thierry Buclin	Completed	No outcome recorded
Phase 4	NCT01697787	Oct 2012 → Sep 2014	Plasmodium falciparum malaria	Centre Muraz	Completed	No outcome recorded
Phase 4	NCT01651416	Jul → Dec 2012	anemia, malaria	Centre for Global Health Research, Ghana	Completed	No outcome recorded
Phase 4	NCT01599000	Mar 2011 → Jul 2012	malaria	Papua New Guinea Institute of Medical Research	Completed	No outcome recorded
Phase 4	NCT01038063	Oct 2010 → Sep 2013	malaria	Liverpool School of Tropical Medicine	Unknown	No outcome recorded
Phase 4	NCT00869700	Jun 2009 → Feb 2010	HIV infectious disease, malaria	University of Cape Town	Completed	No outcome recorded
Phase 4	NCT00902811	Dec 2008 → Oct 2009	Plasmodium falciparum malaria	Medecins Sans Frontieres, Netherlands	Unknown	No outcome recorded
Phase 4	NCT00790881	Oct 2008 → Aug 2009	HIV infectious disease, malaria	University of Cape Town	Completed	No outcome recorded
Phase 4	NCT00619944	Feb → Dec 2008	HIV infectious disease	Makerere University	Completed	No outcome recorded
Phase 4	NCT00620438	Feb 2008 → Jul 2011	HIV infectious disease, tuberculosis	Makerere University	Unknown	No outcome recorded
Phase 4	NCT00444106	May 2007 → Nov 2008	Plasmodium falciparum malaria	Novartis	Completed	Met primary
Phase 4	NCT00374205	Sep 2006 → Oct 2007	Plasmodium falciparum malaria	Bernhard Nocht Institute for Tropical Medicine	Terminated	No outcome recorded
Phase 4	NCT00164710	Apr → Sep 2005	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	NCT00451139	—	malaria	Jimma University	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 therapy66 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 1/2	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 2	NCT07559370 Comparator	Jan 2026 → Jun 2027 expected	Plasmodium falciparum malaria	Victoria Biomedical Research Institute	Recruiting	No outcome recorded
Phase 2	NCT07811882 Comparator	Oct 2025 → Jun 2026	Plasmodium falciparum malaria	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT07235033 Comparator	Jan 2024 → Mar 2025	Plasmodium falciparum malaria	Novartis Pharmaceuticals	Completed	Met primary
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	Met primary
Phase 2	NCT04020653 Background	Sep 2019 → May 2020	malaria	Neopharma Japan Co., Ltd.	Withdrawn	No outcome recorded
Phase 2	NCT03199755 Comparator	Aug → Dec 2018	malaria	Worcester Polytechnic Institute	Withdrawn	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	NCT02696928 Background	Apr 2016 → Oct 2017	Plasmodium vivax malaria	Heidelberg University	Withdrawn	No outcome recorded
Phase 2	NCT01445938 Comparator	Oct 2011 → Jan 2012	malaria	Sanofi	Terminated	No outcome recorded
Phase 2/3	NCT05764746 Comparator	May 2023 → Dec 2024	Plasmodium falciparum malaria	Muhimbili University of Health and Allied Sciences	Completed	No outcome recorded
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 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	Missed primary
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 3	NCT02348788 Comparator	Jan 2015 → Dec 2017	Plasmodium vivax malaria	Menzies School of Health Research	Unknown	No outcome recorded
Phase 3	NCT01899820 Comparator	Apr 2013 → Jun 2014	malaria	Sabah Ahmed Omar	Unknown	No outcome recorded
Phase 3	NCT02974348 Comparator	Jan → May 2013	Plasmodium falciparum malaria	University of Bamenda	Completed	No outcome recorded
Phase 3	NCT01152931 Comparator	Aug → Nov 2010	malaria	University of Lagos, Nigeria	Completed	No outcome recorded
Phase 3	NCT01082705 Comparator	Apr 2010 → Jun 2011	Plasmodium falciparum malaria	Centers for Disease Control and Prevention	Completed	No outcome recorded
Phase 3	NCT01845701 Comparator	Mar 2010 → Apr 2014	malaria	University of Yaounde 1	Completed	Met primary
Phase 3	NCT01054248 Comparator	Feb 2010 → Sep 2016	malaria	University of Oxford	Completed	No outcome recorded
Phase 3	NCT00694694 Comparator	Jun → Dec 2008	malaria	London School of Hygiene and Tropical Medicine	Completed	Missed primary
Phase 3	NCT00541385 Comparator	Oct 2007 → Sep 2008	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 4	NCT04704999 Comparator	Jul 2024 → Oct 2027 expected	Plasmodium vivax malaria	University of Oxford	Recruiting	No outcome recorded
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 4	NCT04829695 Comparator	Apr → Dec 2021	Plasmodium falciparum malaria	University of Yaounde 1	Unknown	No outcome recorded
Phase 4	NCT04767191 Comparator	Mar 2021 → Dec 2022	malaria	Jhpiego	Completed	No outcome recorded
Phase 4	NCT04565184 Comparator	May 2019 → Nov 2020	Plasmodium falciparum malaria	University of Yaounde 1	Completed	No outcome recorded
Phase 4	NCT04370977 Comparator	Mar → Sep 2018	malaria	Manhiça Health Research Centre	Completed	No outcome recorded
Phase 4	NCT02325180 Comparator	Jan → Jun 2015	Plasmodium falciparum malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 4	NCT02741024 Comparator	Oct 2013 → Dec 2014	malaria	Medecins Sans Frontieres, Netherlands	Completed	No outcome recorded
Phase 4	NCT01704508 Comparator	Nov 2012 → Oct 2015	Plasmodium falciparum malaria	Bandim Health Project	Completed	No outcome recorded
Phase 4	NCT01998295 Comparator	May → Jun 2012	—	Muhimbili University of Health and Allied Sciences	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	NCT01082731 Comparator	Nov 2010 → Jan 2012	malaria	Centers for Disease Control and Prevention	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT04877626 Comparator	Sep 2008 → Oct 2009	Plasmodium falciparum malaria	National University of Colombia	Completed	No outcome recorded
Phase 4	NCT00699920 Comparator	Jun 2008 → Jun 2010	malaria	Sanofi	Completed	Met primary
Phase 4	NCT00540410 Comparator	Sep 2007 → Feb 2009	Plasmodium falciparum malaria	Sanofi	Completed	No outcome recorded
Phase 4	NCT00529867 Comparator	May → Dec 2007	Plasmodium falciparum malaria	Dafra Pharma	Completed	No outcome recorded
Phase 4	NCT00495508 Comparator	Oct 2006 → Jun 2009	Plasmodium falciparum malaria	Epicentre	Completed	No outcome recorded
Phase 4	NCT00452907 Comparator	Jul 2005 → Jun 2007	malaria	Sanofi	Completed	No outcome recorded
Phase 4	NCT03768908 Comparator	Jan → Jul 2005	Plasmodium falciparum malaria	Professor Anders Björkman	Completed	No outcome recorded
—	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 Stop: Enrollment
—	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
—	NCT01567423 Comparator	Apr 2008 → Apr 2009	Plasmodium falciparum malaria	Epicentre	Completed	No outcome recorded
—	NCT00460369 Comparator	Apr → Nov 2007	malaria	Research Institute for Development	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 7

Date	Issuer	Release
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 ↗ Novartis today announced positive results from KALUMA, a Phase III study for new malaria treatment KLU156 (ganaplacide/lumefantrine, or GanLum).
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
2022-10-25	Novartis Pharmaceuticals	Regulatory Novartis maintains growth momentum and confirms FY’22 Group guidance novartis.com ↗ FDA granted Fast Track Designation and Orphan Drug Designation for ganaplacide and lumefantrine (combination), which is being co-developed with Medicines for Malaria Venture, for acute, uncomplicated malaria
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 ↗ The ganaplacide/lumefantrine solid dispersion formulation combination met the primary objective in Part B of the study in children with acute uncomplicated malaria.
2011-11-22	Sanaria Inc.	Results Quantitative assessment of Plasmodium falciparum sexual development reveals potent transmission- blocking activity by methylene blue sanaria.com ↗ These studies reveal activity of the first-line antimalarial dihydroartemisinin and the partner drugs lumefantrine and pyronaridine against early gametocyte stages, along with moderate inhibition of mature gametocyte transmission to Anopheles mosquitoes.

All press releases naming this drug 8 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 ↗
2025-11-12	Novartis Pharmaceuticals	Novartis Phase III trial for next-generation malaria treatment KLU156 (GanLum) meets primary endpoint, with potential to combat antimalarial resistance novartis.com ↗
2025-07-08	Novartis Pharmaceuticals	Novartis receives approval for first malaria medicine for newborn babies and young infants novartis.com ↗
2024-04-24	Novartis Pharmaceuticals	Novartis and Medicines for Malaria Venture announce positive efficacy and safety data for a novel treatment for babies <5 kg with malaria novartis.com ↗
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 ↗
2022-10-25	Novartis Pharmaceuticals	Novartis maintains growth momentum and confirms FY’22 Group guidance 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 ↗
2011-11-22	Sanaria Inc.	Quantitative assessment of Plasmodium falciparum sexual development reveals potent transmission- blocking activity by methylene blue sanaria.com ↗

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 127 sources stand behind the page.

Field	Value	Cited 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 124 “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 ↗ Show 114 more sources
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 ↗