MedPath

Lumefantrine

Generic Name
Lumefantrine
Brand Names
Coartem
Drug Type
Small Molecule
Chemical Formula
C30H32Cl3NO
CAS Number
82186-77-4
Unique Ingredient Identifier
F38R0JR742
Background

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

Efficacy, Safety and Tolerability of KLU156 in Adults and Children ≥ 5 kg Body Weight With Uncomplicated P. Falciparum Malaria

Phase 3
Recruiting
Conditions
Uncomplicated Plasmodium Falciparum Malaria
Interventions
First Posted Date
2023-05-06
Last Posted Date
2025-05-16
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
1500
Registration Number
NCT05842954
Locations
🇿🇲

Novartis Investigative Site, Ndola, Zambia

To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria

Phase 2
Recruiting
Conditions
Severe Malaria
Interventions
First Posted Date
2020-12-19
Last Posted Date
2025-03-28
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
252
Registration Number
NCT04675931
Locations
🇺🇬

Novartis Investigative Site, Tororo, Uganda

Effectiveness and Safety of Artesunate-Amodiaquine and Artemether-Lumefantrine for the Treatment of Malaria in Yaounde

Phase 4
Completed
Conditions
Malaria,Falciparum
Interventions
Drug: Artesunate-amodiaquine combination
First Posted Date
2020-09-25
Last Posted Date
2021-04-02
Lead Sponsor
University of Yaounde 1
Target Recruit Count
242
Registration Number
NCT04565184
Locations
🇨🇲

District Medical Center Minkoa Meyos, Yaoundé, Center, Cameroon

Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria

Phase 2
Recruiting
Conditions
Uncomplicated Plasmodium Falciparum Malaria
Interventions
First Posted Date
2020-09-14
Last Posted Date
2024-07-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
295
Registration Number
NCT04546633
Locations
🇲🇱

Novartis Investigative Site, Sotuba, Mali

Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

Phase 2
Completed
Conditions
Malaria
Interventions
First Posted Date
2017-11-07
Last Posted Date
2021-10-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
188
Registration Number
NCT03334747
Locations
🇺🇬

Novartis Investigative Site, Tororo, Uganda

Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Phase 2
Completed
Conditions
Acute Uncomplicated Plasmodium Falciparum Malaria
Interventions
First Posted Date
2017-05-25
Last Posted Date
2022-02-10
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
524
Registration Number
NCT03167242
Locations
🇻🇳

Novartis Investigative Site, Binh Phuoc Province, VNM, Vietnam

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

Phase 1
Completed
Conditions
Malaria
Interventions
Biological: Pfs25M-EPA
Other: AS01
Other: Normal Saline
First Posted Date
2016-10-24
Last Posted Date
2024-12-10
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
301
Registration Number
NCT02942277
Locations
🇲🇱

Bancoumana Malaria Vaccine Center, Bamako, Mali

Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites in Healthy African Adults in Mali

Phase 1
Completed
Conditions
Malaria
Interventions
Biological: PfSPZ Vaccine
Biological: PfSPZ Challenge Material
Other: Normal Saline
Drug: PBS and HSA Diluent
First Posted Date
2015-12-11
Last Posted Date
2021-04-21
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
409
Registration Number
NCT02627456
Locations
🇲🇱

University of Bamako (USTTB/MRTC), Bamako, Mali

Relapses in Plasmodium Ovale and Efficacy of Artemether-lumefantrine for Mixed Species and Non-falciparum Malaria

Not Applicable
Completed
Conditions
Malaria
Interventions
First Posted Date
2015-08-19
Last Posted Date
2017-01-25
Lead Sponsor
Albert Schweitzer Hospital
Target Recruit Count
50
Registration Number
NCT02528279
Locations
🇬🇦

Centre de Recherches Médicales de Lambaréné, Hôpital Albert Schweitzer, Lambaréné, Moyen-Ogooué, Gabon

🇬🇦

Centre de Recherches Médicales de Ngounié, Fougamou, Ngounié, Gabon

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