lumefantrine

Trade name: Coartem

Small moleculeapprovedOrphan Drug ^FDAFast Track ^FDA

Approved

Apr 7, 2009

Lumefantrine is an antimalarial agent used to treat acute uncomplicated malaria. It is administered in combination with artemether for improved efficacy (Coartem tablets). Lumefantrine is a blood schizonticide active against erythrocytic stages of Plasmodium falciparum. The exact mechanism by which lumefantrine exerts its antimalarial effect is unknown. The most common adverse reactions of Coartem in adults are headache, anorexia, dizziness, asthenia, arthralgia and myalgia. — NCATS

Clinical trial activity

183 trials · 205 clinical orgs · 1 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jan 1, 2000 (NCT00140361)

Timeline

2000s

Jan 1, 2002
Novartis — Earliest Phase 3 Sponsor(trial)
Jan 1, 2005
Earliest Phase 1 Sponsor(trial)
Aug 31, 2007
Orphan Drug Designation
Jan 1, 2008
Earliest Phase 2 Sponsor(trial)
Apr 7, 2009
Earliest FDA Approval
Apr 7, 2009
Novartis — NDA Secondary Org
Apr 8, 2009
Novartis — First NDA Organization
Apr 8, 2009
Novartis — NDA Organization

Indications

Approved for

Malaria

Studied for

Mechanism of action

Ferriprotoporphyrin IXINHIBITOR
Ferriprotoporphyrin IX inhibitor

Combination products

coartem
with artemether
Also known as artemether/ lumefantrine

Approval history

approvedPriority reviewFast trackApr 7, 2009

Chemistry & pharmacology

Loading structure…

SMILES

CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1

Mol. weight: 528.95 g/mol
Lipinski Ro5: 2 violation(s)
Rule of 3: No
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Sources

Also known as

(±)-2,7-dichloro-9-((z)-p-chlorobenzylidene)-α-((dibutylamino)methyl)fluorene-4-methanol
(±)-2,7-dichloro-9-((z)-p-chlorobenzylidene)-α-((dibutylamino)methyl)fluorene-4-methanol
2-dibutylamino-1-{2,7-dichloro-9-[1-(4-chloro-phenyl)-meth-(z)-ylidene]-9h-fluoren-4-yl}-ethanol
2-dibutylamino-1-{2,7-dichloro-9-[1-(4-chloro-phenyl)-meth-(z)-ylidene]-9h-fluoren-4-yl}-ethanol
2-dibutylamino-1-[2,7-dichloro-9-(4-chloro-benzylidene)-9h-fluoren-4-yl]-ethanol
2-dibutylamino-1-[2,7-dichloro-9-(4-chloro-benzylidene)-9h-fluoren-4-yl]-ethanol
9h-fluorene-4-methanol, 2,7-dichloro-9-((4-chlorophenyl)methylene)-alpha-((dibutylamino)methyl)-, (z)-
benflumelol
benflumetol
benflumetol
benflumetol
benflumetol
benflumetol, (-)-isomer
benflumetol, (+-)-isomer
benflumetol, (+)-isomer
dl-benflumelol
dl-benflumelol
gnf-pf-1971
gnf-pf-1971
lumefantrine
lumefantrine
lumefantrine
lumefantrine
lumefantrine
lumefantrine
lumefantrine
lumefantrine
lumefantrine
lumefantrine
lumefrantrine

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06967519	Phase 4	Dec 31, 2025	National Institutes of Health (NIH), Yale University
NCT07192900	Phase 1	Oct 31, 2025	Allegheny Health Network, Iovance, Miltenyi Biotec, Inc., University of Pittsburgh
NCT06962319	Phase 3	Sep 30, 2025	Medicines for Malaria Venture, University of Liverpool
NCT06424002	Phase 4	Jun 1, 2024	Boston University, Government of Malawi, Kamuzu University of Health Sciences, Michigan State University
NCT06347471	Phase 4	May 28, 2024	Infectious Disease Institute, Kampala, Uganda, Radboud University, University of London
NCT06294912	Phase 1	Apr 18, 2024	Merck
NCT07235033	Phase 2	Jan 23, 2024	Novartis
NCT05951595	Phase 3	Jan 1, 2024	Mahidol University, University of Oxford
NCT05750628	Phase 2	Dec 26, 2023	Novartis
NCT05842954	Phase 3	Dec 11, 2023	Novartis
NCT05757167	Phase 4	Nov 6, 2023	Duke University, National Institute of Allergy and Infectious Diseases (NIAID)
NCT06076213	Phase 4	May 1, 2023	Centers for Disease Control and Prevention (CDC), Global Health Innovative Technology Fund, Government of the Democratic Republic of the Congo
NCT05567016	Phase 3	Apr 30, 2023	Chan Zuckerberg Initiative, Ifakara Health Institute, National Institute of Allergy and Infectious Diseases (NIAID), Stanford University, University of Basel, University of California, San Francisco
NCT05764746	Phase 2/Phase 3 (Phase 3)	Apr 1, 2023	Muhimbili University, The Swedish Research Council, Uppsala University
NCT06154018	N/A	Mar 18, 2023	University of Ioannina
NCT05550909	Phase 2	Oct 17, 2022	Malaria Research and Training Center, Bamako, Mali, University of London
NCT06300970	Phase 4	Aug 9, 2022	Centers for Disease Control and Prevention (CDC), Government of Liberia
NCT05605925	Phase 4	Aug 4, 2022	Makerere University
NCT05330273	Phase 1	Apr 28, 2022	Medicines for Malaria Venture, Novartis
NCT05340153	Phase 4	Apr 11, 2022	Association Camerounaise pour le Marketing Social (ACMS), Cameroon, Government of Cameroon, Impact Malaria, Cameroon, University of Yaounde

Showing 20 of 183 trials

Page 1 / 10

Organizations

Research & Development (205)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
University of London	Academic/Hospital	24	12	4	2004
Centers for Disease Control and Prevention (CDC)	Government	21	14	3	2000
Novartis	For profit	17	16	4	2001
University of Oxford	Academic/Hospital	16	15	5	2008
Medicines for Malaria Venture	Academic/Hospital	12	4	2	2007
Makerere University	Academic/Hospital	10	5	4	2007
University of California, San Francisco	Academic/Hospital	10	9	3	2004
Karolinska Institute	Academic/Hospital	9	4	1	2002
Mahidol University	Academic/Hospital	9	0	5	2006
Institute of Tropical Medicine, Belgium	Academic/Hospital	8	3	4	2003
United States Agency for International Development	Government	8	0	2	2000
Kenya Medical Research Institute	Academic/Hospital	7	1	4	2007
Radboud University	Academic/Hospital	7	2	4	2009
University of Liverpool	Academic/Hospital	7	4	3	2007
World Health Organization	Government	7	0	3	2002
Centre Muraz	Academic/Hospital	6	3	2	2007
Muhimbili University	Academic/Hospital	6	5	2	2006
National Institutes of Health (NIH)	Government	5	1	2	2012
University of Cape Town	Academic/Hospital	5	3	2	2002
University of Yaounde	Academic/Hospital	5	4	2	2006

205 organizations

Page 1 / 11

Marketing (2)

Organization	Org type	Relationship	Date
Novartis	For profit	NDA2	Apr 7, 2009
Novartis	For profit	NDA	Apr 8, 2009