CLINICAL TRIALS PROFILE FOR ARTEMETHER; LUMEFANTRINE

505(b)(2) Clinical Trials for Artemether; Lumefantrine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00203801 ↗	Combination Antimalarials in Uncomplicated Malaria	Completed	Global Fund	N/A	2002-01-01	The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.
New Combination	NCT00203801 ↗	Combination Antimalarials in Uncomplicated Malaria	Completed	Medical Research Council, South Africa	N/A	2002-01-01	The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.
New Combination	NCT00203801 ↗	Combination Antimalarials in Uncomplicated Malaria	Completed	World Health Organization	N/A	2002-01-01	The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.
New Combination	NCT00203801 ↗	Combination Antimalarials in Uncomplicated Malaria	Completed	University of Cape Town	N/A	2002-01-01	The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.

All Clinical Trials for Artemether; Lumefantrine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00118794 ↗	Lapdap and Coartemether for Uncomplicated Malaria	Completed	Medical Research Council	Phase 3	2004-09-01	Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.
NCT00118794 ↗	Lapdap and Coartemether for Uncomplicated Malaria	Completed	National Malaria Control Programme, The Gambia	Phase 3	2004-09-01	Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.
NCT00118794 ↗	Lapdap and Coartemether for Uncomplicated Malaria	Completed	London School of Hygiene and Tropical Medicine	Phase 3	2004-09-01	Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.
NCT00119145 ↗	Kintampo Trial of Combination Therapy for Malaria	Completed	Kintampo Health Research Centre, Ghana	Phase 4	2005-06-01	Case management is one of the key strategies for malaria control in most endemic countries. Plasmodium falciparum malaria is becoming resistant to commonly used and cheap antimalarial drugs such as chloroquine, amodiaquine, and sulfadoxine-pyrimethamine (SP). Thus the safety and efficacy of new anti-malarial drugs need to be tested in sites with well-characterised malariometric indices in order to make appropriate treatment policies. Artemisinin-based combination chemotherapies have been documented to consistently produce faster relief of clinical symptoms and parasite clearance in uncomplicated falciparum malaria than any other currently used antimalarial drugs. So far, artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AR-LM) are the only two registered fixed-dose artemisinin combination chemotherapies produced at industrial scale, with good manufacturing practices and already used in Africa. Several African countries, including Ghana, are therefore introducing either AS-AQ or AR-LM as first-line antimalarials or evaluating the case for such a change. Clearly, a direct comparison of both the safety and efficacy profiles of the two combinations under different epidemiological conditions is urgently needed to guide informed decisions on the most appropriate antimalarial first-line treatment regimen. This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination therapy, artemether-lumefantrine, and artesunate-lapdap in an open-labelled, randomised, non-inferiority drug trial. The study results will inform future decisions on first- and second-line treatments for uncomplicated P. falciparum malaria with respect to efficacy and safety in Ghana.

Clinical Trial Conditions for Artemether; Lumefantrine

Condition Name

Condition Name for Artemether; Lumefantrine
Intervention	Trials
Malaria	96
Malaria, Falciparum	14
Malaria,Falciparum	11
Plasmodium Falciparum Malaria	9

Condition MeSH

Condition MeSH for Artemether; Lumefantrine
Intervention	Trials
Malaria	165
Malaria, Falciparum	66
HIV Infections	9
Malaria, Vivax	7

Clinical Trial Locations for Artemether; Lumefantrine

Trials by Country

Trials by Country for Artemether; Lumefantrine
Location	Trials
Tanzania	28
Congo, The Democratic Republic of the	27
Kenya	25
Mozambique	22
Burkina Faso	17

Trials by US State

Trials by US State for Artemether; Lumefantrine
Location	Trials
California	2
Maryland	1

Clinical Trial Progress for Artemether; Lumefantrine

Clinical Trial Phase

Clinical Trial Phase for Artemether; Lumefantrine
Clinical Trial Phase	Trials
Phase 4	75
Phase 3	41
Phase 2/Phase 3	12

Clinical Trial Status

Clinical Trial Status for Artemether; Lumefantrine
Clinical Trial Phase	Trials
Completed	124
Not yet recruiting	15
Unknown status	14

Clinical Trial Sponsors for Artemether; Lumefantrine

Sponsor Name

Sponsor Name for Artemether; Lumefantrine
Sponsor	Trials
London School of Hygiene and Tropical Medicine	26
Centers for Disease Control and Prevention	20
University of Oxford	18

Sponsor Type

Sponsor Type for Artemether; Lumefantrine
Sponsor	Trials
Other	419
Industry	34
U.S. Fed	31

Artemether-Lumefantrine: Clinical Trials, Market Analysis, and Projections

Introduction

Artemether-lumefantrine, a combination of the artemisinin derivative artemether and the antimalarial lumefantrine, is a cornerstone in the treatment of uncomplicated Plasmodium falciparum malaria. This article delves into recent clinical trials, market analysis, and future projections for this crucial antimalarial drug.

Clinical Trials Update

Efficacy and Safety in Tanzania

A recent single-arm clinical trial conducted in Tanzania in 2022 assessed the efficacy and safety of artemether-lumefantrine for treating uncomplicated P. falciparum malaria. The study involved 352 participants across four sentinel sites, with a standard 6-dose, 3-day regimen. The results showed high efficacy in three regions, but the PCR-corrected efficacy in Pwani fell below the WHO-defined 90% threshold, highlighting the need for diversified antimalarial strategies[1].

Supervised vs. Unsupervised Administration

Another study compared the efficacy and safety of artemether-lumefantrine under supervised and unsupervised administration in children under 5 years old in rural Tanzania. Despite lower lumefantrine concentrations in the unsupervised group, the drug remained highly efficacious and well-tolerated, indicating its robust performance even in less controlled settings[3].

Triple Therapy with Amodiaquine

A large randomized controlled trial evaluated the efficacy of artemether-lumefantrine alone versus artemether-lumefantrine plus amodiaquine in treating uncomplicated falciparum malaria. The addition of amodiaquine was found to be well-tolerated and effective, potentially reducing the risk of recrudescence, especially in areas with high artemisinin resistance[4].

Market Analysis

Global Market Size and Share

The global artemisinin combination therapy (ACT) market, dominated by artemether-lumefantrine, was valued at USD 597.2 million in 2023. Artemether-lumefantrine accounted for 37.1% of the market share, driven by its superior effectiveness and safety in treating uncomplicated malaria. The WHO's strong recommendation and its widespread adoption in national malaria control strategies further boost its market presence[5].

Regional Market Dynamics

The North American market holds the largest revenue share, primarily due to the increasing number of imported malaria cases and the growing awareness among healthcare providers about the efficacy of ACTs. Other regions, such as Europe, Asia Pacific, and Middle East and Africa, also contribute significantly to the market, driven by the ongoing need to combat malaria and drug resistance[5].

Market Drivers and Restraints

Key drivers of the artemether-lumefantrine market include the rising incidence of malaria, the increasing resistance of malaria parasites to traditional monotherapies, and the drug's ability to rapidly reduce parasitic load and lower the risk of resistance development. However, factors such as the potential for side effects (like vomiting and mild bradycardia when combined with amodiaquine) and the need for continuous monitoring of efficacy in different regions can act as restraints[4][5].

Projections and Future Outlook

Market Growth

The global ACT market is projected to grow at a CAGR of 8.2% from 2024 to 2030, driven by the increasing demand for effective antimalarial treatments. Artemether-lumefantrine is expected to continue its dominance due to its established efficacy and safety profile[5].

Emerging Trends

The market is likely to see increased adoption of other ACT combinations, such as pyronaridine-artesunate, driven by the need to tackle drug resistance. Additionally, advancements in pharmacokinetics and the development of new formulations could further enhance the therapeutic lifetime of these drugs[5].

Public Health Implications

As global travel and immigration increase, the incidence of malaria in non-endemic regions is expected to rise, further driving the demand for ACTs. Public health initiatives and awareness campaigns will play a crucial role in ensuring the continued efficacy and accessibility of artemether-lumefantrine and other ACTs[5].

Safety and Tolerability

Artemether-lumefantrine has been consistently shown to be well-tolerated and safe, even in repeated treatments and unsupervised administration. However, side effects such as vomiting and mild bradycardia, especially when combined with other drugs like amodiaquine, need to be monitored[3][4].

Conclusion

Artemether-lumefantrine remains a vital component in the fight against uncomplicated falciparum malaria, supported by robust clinical trials and a strong market presence. As the global health community continues to battle malaria and drug resistance, the efficacy, safety, and market dynamics of this drug will be crucial.

Key Takeaways

• High Efficacy: Artemether-lumefantrine has shown high efficacy in treating uncomplicated P. falciparum malaria, even in unsupervised settings.
• Market Dominance: It dominates the ACT market with a 37.1% share, driven by its effectiveness and safety.
• Regional Variations: Efficacy can vary by region, highlighting the need for diversified antimalarial strategies.
• Future Growth: The market is projected to grow at a CAGR of 8.2% from 2024 to 2030.
• Public Health: Increasing global travel and immigration will drive the demand for ACTs in non-endemic regions.

FAQs

What is the current efficacy of artemether-lumefantrine in treating uncomplicated falciparum malaria?

Artemether-lumefantrine has shown high efficacy, with PCR-corrected cure rates ranging from 89.9% to 98.9% in different regions, although it fell below the WHO-defined 90% threshold in one region[1].

How does the addition of amodiaquine affect the efficacy of artemether-lumefantrine?

The addition of amodiaquine to artemether-lumefantrine was found to be well-tolerated and effective, potentially reducing the risk of recrudescence, especially in areas with high artemisinin resistance[4].

What are the main drivers of the artemether-lumefantrine market?

The main drivers include the rising incidence of malaria, increasing resistance to traditional monotherapies, and the drug's ability to rapidly reduce parasitic load and lower the risk of resistance development[5].

What are the projected market growth and trends for artemether-lumefantrine?

The global ACT market, including artemether-lumefantrine, is projected to grow at a CAGR of 8.2% from 2024 to 2030, with emerging trends including the adoption of other ACT combinations and advancements in pharmacokinetics[5].

How safe and tolerable is artemether-lumefantrine?

Artemether-lumefantrine has been shown to be well-tolerated and safe, even in repeated treatments and unsupervised administration, although side effects like vomiting and mild bradycardia need to be monitored[3][4].

Sources

1. Efficacy and safety of artemether-lumefantrine against uncomplicated falciparum malaria infection in Tanzania, 2022, a single arm clinical trial. PubMed.
2. Global Coartem Artemether Lumefantrine Market Report 2024. Cognitivemarketresearch.
3. Efficacy and Effectiveness of Artemether-Lumefantrine after Initial and Repeated Treatment. Oxford University Press.
4. Triple therapy with artemether–lumefantrine plus amodiaquine for uncomplicated falciparum malaria. The Lancet.
5. Artemisinin Combination Therapy Market Size Report, 2030. Grand View Research.

Last updated: 2025-01-03