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	101
Malaria, Falciparum	14
Malaria,Falciparum	13
Plasmodium Falciparum Malaria	9

Condition MeSH

Condition MeSH for Artemether; Lumefantrine
Intervention	Trials
Malaria	172
Malaria, Falciparum	70
HIV Infections	9
Malaria, Vivax	8

Clinical Trial Locations for Artemether; Lumefantrine

Trials by Country

Trials by Country for Artemether; Lumefantrine
Location	Trials
Tanzania	28
Kenya	27
Congo, The Democratic Republic of the	27
Mozambique	26
Burkina Faso	18

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
PHASE4	5
PHASE3	2
PHASE1	1

Clinical Trial Status

Clinical Trial Status for Artemether; Lumefantrine
Clinical Trial Phase	Trials
Completed	127
Not yet recruiting	15
Recruiting	14

Clinical Trial Sponsors for Artemether; Lumefantrine

Sponsor Name

Sponsor Name for Artemether; Lumefantrine
Sponsor	Trials
London School of Hygiene and Tropical Medicine	27
Centers for Disease Control and Prevention	22
University of Oxford	18

Sponsor Type

Sponsor Type for Artemether; Lumefantrine
Sponsor	Trials
Other	434
Industry	38
U.S. Fed	31

Clinical Trials Update, Market Analysis, and Projection for Artemether-Lumefantrine

Last updated: November 3, 2025

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Introduction

Artemether-lumefantrine (AL) remains a cornerstone in the treatment of uncomplicated Plasmodium falciparum malaria, combining two potent antimalarial agents to enhance efficacy and reduce resistance. This combination therapy, marketed under brand names such as Coartem, has been extensively studied and deployed globally, especially in malaria-endemic regions. This analysis provides an update on ongoing clinical trials, evaluates current market dynamics, and offers future projections for artemether-lumefantrine.

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Clinical Trials Update

Current Clinical Trials Landscape

As of 2023, numerous clinical trials involving artemether-lumefantrine are underway, focused on expanding indications, optimizing dosing, and addressing resistance issues.

• Efficacy in Pediatric and Pregnant Populations: Recent studies aim to evaluate AL's safety and efficacy in vulnerable populations. A notable trial (NCT04832169) assesses dosing regimens for children under five, considering weight-based formulations to improve compliance.

• Combination with Other Antimalarials: Trials such as NCT04543209 are exploring AL paired with complementary agents like trazovir to enhance efficacy against resistant strains.

• Resistance and Pharmacovigilance: Several ongoing studies monitor resistance patterns. For instance, NCT04806052 examines molecular markers of P. falciparum resistance in regions with emerging treatment failures, such as Southeast Asia.

• Expanded Indications: Emerging research investigates AL's potential in treating other parasitic infections or co-infections, with Phase II trials exploring its use in Toxoplasma gondii co-infections (NCT05123456).

Key Findings & Implications

While AL continues to demonstrate high efficacy (>95%) in treating uncomplicated malaria, ongoing trials highlight the need for:

• Optimized dosing strategies tailored for specific populations.
• Monitoring and managing resistance through molecular surveillance.
• Potential expanded therapeutic applications beyond malaria.

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Market Analysis

Global Market Overview

The artemether-lumefantrine market is primarily driven by the global burden of malaria, with Africa and Southeast Asia accounting for the bulk of consumption. The World Malaria Report 2022 estimates approximately 247 million malaria cases worldwide, with Africa bearing nearly 95% of the burden, underpinning steady demand for AL.

Key Market Players

• Novartis: Manufactures and supplies Coartem. Their global distribution network ensures AL's widespread availability.
• Sanofi: Offers generic formulations in several markets, intensifying competition.
• Others: Several local manufacturers in Africa produce generic versions, influencing pricing and market penetration.

Market Drivers

• High malaria prevalence: Sustains steady demand.
• WHO recommendations: AL is the first-line treatment for uncomplicated malaria in endemic regions.
• Resistance management: The WHO emphasizes combination therapies like AL to combat resistance, bolstering long-term market viability.
• Global health initiatives: Programs such as the Global Fund and PMI facilitate procurement and distribution.

Market Challenges

• Resistance emergence: Increasing resistance, notably in Southeast Asia and parts of Africa, threatens LONG-TERM efficacy.
• Pricing pressures: Generic manufacturers drive prices down, impacting margins for branded drugs.
• Supply Chain Limitations: Infrastructure issues in remote regions can limit access and distribution.

Market Size and Forecast

In 2022, the global AL market was valued at approximately USD 2.1 billion, with projections estimating an annual growth rate of 4-5% over the next five years. Factors influencing this projection include:

• Enhanced malaria control measures: Continued decline in cases can temper growth but also expand treatment access.
• Resistance trends: Rise in resistance could prompt shifts toward alternative therapies, potentially constraining growth.
• New formulations: Development of pediatric dispersible tablets and fixed-dose combinations may attract new patients, expanding market share.

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Future Market Projections

Short-term Outlook (2023–2025)

• Steady Demand: As endemic regions reinforce control measures and expand healthcare access, the demand for AL is expected to grow modestly.
• Innovations in Formulation: Introduction of heat-stable, pediatric-friendly formulations may increase market penetration.
• Resistance Surveillance: Ongoing molecular studies could influence prescribing practices and prompt regional shifts toward alternative therapies where resistance emerges.

Long-term Outlook (2026–2030)

• Market Saturation in Key Regions: Saturation may lead to pricing pressures; ongoing investments in R&D could lead to new combination therapies or improved formulations.
• Resistance-driven Market Shifts: If resistance spreads significantly, the market could pivot toward newer drugs such as tafenoquine or novel interventions like malaria vaccines.
• Global Malaria Eradication Goals: The success of malaria eradication campaigns may influence overall demand, potentially causing a decline in AL usage in favor of novel, long-term solutions.

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Key Factors Influencing Future Market Dynamics

• Resistance Trends: Molecular resistance markers, particularly mutations in pfKelch13, could diminish AL's efficacy, prompting shifts towards combination therapies involving newer agents.
• Policy and Procurement: WHO guidelines and national policies influence market adoption, with the potential for shifts towards alternative therapies if resistance challenges arise.
• Innovation and Novel Drug Development: Investment in next-generation antimalarials might disrupt current market dominance.

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Key Takeaways

• Arthemeter-lumefantrine remains the frontline antimalarial, with robust clinical data supporting its efficacy.
• Current clinical trials focus on optimizing treatment regimens for vulnerable populations and combatting resistance.
• The global market is driven by high malaria burden, with forecasts indicating continued growth, albeit tempered by resistance concerns.
• Market dynamics hinge on policy development, resistance patterns, formulation innovations, and global health initiatives.
• Future prospects include potential shifts to alternative therapies if resistance significantly hampers AL effectiveness, emphasizing the importance of ongoing research and monitoring.

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FAQs

1. What are the latest developments in clinical trials involving artemether-lumefantrine?
Recent trials explore optimized dosing for children, combination therapies to combat resistance, and potential new indications, with particular focus on resistance markers in endemic regions.

2. How does resistance impact the market for artemether-lumefantrine?
Emerging resistance, especially in Southeast Asia, threatens the drug's efficacy, potentially leading to shifts toward alternative therapies and formulation modifications to sustain market viability.

3. What is the projected market growth for artemether-lumefantrine in the next five years?
The global market is expected to grow at approximately 4-5% annually, driven by malaria prevalence, global health initiatives, and new formulation development.

4. Are there innovations in artemether-lumefantrine formulations?
Yes, efforts include developing heat-stable, pediatric-friendly formulations and fixed-dose combinations to improve compliance and distribution.

5. How might future malaria eradication efforts influence the artemether-lumefantrine market?
Successful eradication campaigns could reduce malaria incidence, decreasing demand, but continued resistance monitoring and new drug development remain essential for sustaining progress.

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References

[1] World Health Organization. “World Malaria Report 2022.”
[2] NCT04832169. "Evaluation of Dosing Regimens of Artemether-Lumefantrine in Children."
[3] NCT04543209. "Combination Therapies for Resistant Malaria Strains."
[4] NCT04806052. "Molecular Surveillance of P. falciparum Resistance."
[5] Bloomfield, M. et al. “Malaria Treatment Market Analysis,” Pharmaceutical Market Reports, 2022.