Lumefantrine

Overview

Lumefantrine is an antimalarial agent used to treat acute uncomplicated malaria. It is administered in combination with artemether for improved efficacy. This combination therapy exerts its effects against the erythrocytic stages of Plasmodium spp. and may be used to treat infections caused by P. falciparum and unidentified Plasmodium species, including infections acquired in chloroquine-resistant areas.

Indication

Lumefantrine and artemether combination therapy is indicated for the treatment of acute uncomplicated malaria caused by Plasmodium falciparum, including malaria acquired in chloroquine-resistant areas. May also be used to treat uncomplicated malaria when the Plasmodium species has not been identified. Indicated for use in adults and children greater than 5 kg.

Associated Conditions

Uncomplicated Malaria caused by Plasmodium falciparum

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy, Safety and Tolerability of KLU156 in Adults and Children ≥ 5 kg Body Weight With Uncomplicated P. Falciparum Malaria	2023/05/06	NCT05842954	Phase 3	Active, not recruiting	Novartis Pharmaceuticals
To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria	2020/12/19	NCT04675931	Phase 2	Active, not recruiting	Novartis Pharmaceuticals
Effectiveness and Safety of Artesunate-Amodiaquine and Artemether-Lumefantrine for the Treatment of Malaria in Yaounde	2020/09/25	NCT04565184	Phase 4	Completed	University of Yaounde 1
Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria	2020/09/14	NCT04546633	Phase 2	Recruiting	Novartis Pharmaceuticals
Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa...	2019/05/16	NCT03952650	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.	2017/11/07	NCT03334747	Phase 2	Completed	Novartis Pharmaceuticals
Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria	2017/05/25	NCT03167242	Phase 2	Completed	Novartis Pharmaceuticals
Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali	2016/10/24	NCT02942277	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites in Healthy African Adults in Mali	2015/12/11	NCT02627456	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Relapses in Plasmodium Ovale and Efficacy of Artemether-lumefantrine for Mixed Species and Non-falciparum Malaria	2015/08/19	NCT02528279	Not Applicable	Completed	Albert Schweitzer Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
COARTEM	Novartis Pharmaceuticals Corporation	0078-0568	ORAL	120 mg in 1 1	9/15/2017
COARTEM	Central Texas Community Health Centers	76413-154	ORAL	120 mg in 1 1	3/31/2015

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
RIAMET 20 mg /120 mg artemether/lumefantrine 20 mg/120 mg dispersible tablet blister pack	158523	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	7/9/2010
COARTEM artemether/lumefantrine 20 mg/120 mg tablet blister pack	298287	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	4/13/2018
COARTEM 20 mg /120 mg artemether/lumefantrine 20 mg/120 mg dispersible tablet blister pack	158527	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	7/9/2010
RIAMET artemether/lumefantrine 20 mg/120 mg tablet blister pack	90011	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	7/24/2002

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
RIAMET 20 mg/120 mg COMPRIMIDOS	Novartis Farmaceutica S.A.	63764	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

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