CLINICAL TRIALS PROFILE FOR COARTEM

505(b)(2) Clinical Trials for COARTEM

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	NCT00694694 ↗	Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.	Completed	National Institute for Medical Research, Tanzania	Phase 3	2008-06-01	This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
New Combination	NCT00694694 ↗	Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.	Completed	London School of Hygiene and Tropical Medicine	Phase 3	2008-06-01	This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
New Combination	NCT01899820 ↗	Evaluation of the Efficacy of Artemisinin Combination Therapy in Kenya	Unknown status	Kenya Medical Research Institute	Phase 3	2013-04-01	Artemisinin-based combination therapies (ACTs) are recommended for use against uncomplicated malaria in areas of multi-drug resistant malaria. The Ministry of Health, Division of Malaria Control (DOMC) rolled out the use of artemether-lumefantrine as the first line treatment for uncomplicated malaria in 2006.The development of the ACTs and its derivatives are the most rapidly acting of all the current antimalarial drugs and recognition of their potential role as a component of combination therapy have led to several large trials aimed at assessing different combinations of existing drugs, and to the specific development of new combination drugs. This proposal aims to (1) evaluate the efficacy of artemisinin-based anti-malaria combination drugs in different sites across Kenya (2) elucidate the markers of resistance to ACTs through molecular genetics and in this process further strengthen capacity in the proposed study sites as well as improve links between research and control ultimately to influence malaria treatment policy and practice. Five groups in East Africa will conduct a multi-centre, randomised, two arm trial to assess the efficacy of dihydroartemisin-piperaquine with artemether-lumefantrine as the comparative drug. The network will determine antimalarial drug efficacy using standardised protocols and collate clinical responses and adverse events. Molecular markers to artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles in drug failure cases. Recrudescence or re-infections will be differentiated by analysis of the MSP1, MSP2 and GLURP genes and assess transmission dynamics post treatment. Data from these studies will be captured into a database developed by the network. The latter offers several advantages including - Working towards the standardization of methodologies and common protocols as a way of comparing data across sites - Pulling together datasets and conduct a multi-centre analysis - Sharing and coordinating quality assurance mechanisms
New Combination	NCT01899820 ↗	Evaluation of the Efficacy of Artemisinin Combination Therapy in Kenya	Unknown status	World Bank	Phase 3	2013-04-01	Artemisinin-based combination therapies (ACTs) are recommended for use against uncomplicated malaria in areas of multi-drug resistant malaria. The Ministry of Health, Division of Malaria Control (DOMC) rolled out the use of artemether-lumefantrine as the first line treatment for uncomplicated malaria in 2006.The development of the ACTs and its derivatives are the most rapidly acting of all the current antimalarial drugs and recognition of their potential role as a component of combination therapy have led to several large trials aimed at assessing different combinations of existing drugs, and to the specific development of new combination drugs. This proposal aims to (1) evaluate the efficacy of artemisinin-based anti-malaria combination drugs in different sites across Kenya (2) elucidate the markers of resistance to ACTs through molecular genetics and in this process further strengthen capacity in the proposed study sites as well as improve links between research and control ultimately to influence malaria treatment policy and practice. Five groups in East Africa will conduct a multi-centre, randomised, two arm trial to assess the efficacy of dihydroartemisin-piperaquine with artemether-lumefantrine as the comparative drug. The network will determine antimalarial drug efficacy using standardised protocols and collate clinical responses and adverse events. Molecular markers to artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles in drug failure cases. Recrudescence or re-infections will be differentiated by analysis of the MSP1, MSP2 and GLURP genes and assess transmission dynamics post treatment. Data from these studies will be captured into a database developed by the network. The latter offers several advantages including - Working towards the standardization of methodologies and common protocols as a way of comparing data across sites - Pulling together datasets and conduct a multi-centre analysis - Sharing and coordinating quality assurance mechanisms
New Combination	NCT01899820 ↗	Evaluation of the Efficacy of Artemisinin Combination Therapy in Kenya	Unknown status	Sabah Ahmed Omar	Phase 3	2013-04-01	Artemisinin-based combination therapies (ACTs) are recommended for use against uncomplicated malaria in areas of multi-drug resistant malaria. The Ministry of Health, Division of Malaria Control (DOMC) rolled out the use of artemether-lumefantrine as the first line treatment for uncomplicated malaria in 2006.The development of the ACTs and its derivatives are the most rapidly acting of all the current antimalarial drugs and recognition of their potential role as a component of combination therapy have led to several large trials aimed at assessing different combinations of existing drugs, and to the specific development of new combination drugs. This proposal aims to (1) evaluate the efficacy of artemisinin-based anti-malaria combination drugs in different sites across Kenya (2) elucidate the markers of resistance to ACTs through molecular genetics and in this process further strengthen capacity in the proposed study sites as well as improve links between research and control ultimately to influence malaria treatment policy and practice. Five groups in East Africa will conduct a multi-centre, randomised, two arm trial to assess the efficacy of dihydroartemisin-piperaquine with artemether-lumefantrine as the comparative drug. The network will determine antimalarial drug efficacy using standardised protocols and collate clinical responses and adverse events. Molecular markers to artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles in drug failure cases. Recrudescence or re-infections will be differentiated by analysis of the MSP1, MSP2 and GLURP genes and assess transmission dynamics post treatment. Data from these studies will be captured into a database developed by the network. The latter offers several advantages including - Working towards the standardization of methodologies and common protocols as a way of comparing data across sites - Pulling together datasets and conduct a multi-centre analysis - Sharing and coordinating quality assurance mechanisms

All Clinical Trials for COARTEM

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.
NCT00119145 ↗	Kintampo Trial of Combination Therapy for Malaria	Completed	Gates Malaria Partnership	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 COARTEM

Condition Name

Condition Name for COARTEM
Intervention	Trials
Malaria	54
Malaria, Falciparum	8
Plasmodium Falciparum Malaria	6
Malaria,Falciparum	4

Condition MeSH

Condition MeSH for COARTEM
Intervention	Trials
Malaria	86
Malaria, Falciparum	37
HIV Infections	4
Infections	2

Clinical Trial Locations for COARTEM

Trials by Country

Trials by Country for COARTEM
Location	Trials
Congo, The Democratic Republic of the	25
Mozambique	23
Kenya	15
Mali	13
Uganda	11

Trials by US State

Trials by US State for COARTEM
Location	Trials
California	2

Clinical Trial Progress for COARTEM

Clinical Trial Phase

Clinical Trial Phase for COARTEM
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	41
Phase 3	18

Clinical Trial Status

Clinical Trial Status for COARTEM
Clinical Trial Phase	Trials
Completed	72
Not yet recruiting	6
Unknown status	5

Clinical Trial Sponsors for COARTEM

Sponsor Name

Sponsor Name for COARTEM
Sponsor	Trials
London School of Hygiene and Tropical Medicine	19
Centers for Disease Control and Prevention	13
Kenya Medical Research Institute	6

Sponsor Type

Sponsor Type for COARTEM
Sponsor	Trials
Other	193
U.S. Fed	18
Industry	17

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

Last updated: November 8, 2025

Introduction

Coartem, the brand name for artemether-lumefantrine, remains a cornerstone in the fight against malaria, particularly Plasmodium falciparum infections. As one of the most widely used artemisinin-based combination therapies (ACTs), Coartem benefits from robust global demand, reinforced by WHO recommendations and evolving malaria resistance patterns. This report provides an in-depth analysis of recent clinical trial developments, current market landscapes, and future projections for Coartem.

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Clinical Trials Update

Ongoing and Recent Clinical Evaluations

Recent clinical trials have primarily focused on assessing Coartem's efficacy against resistant malaria strains, novel formulations, and its safety profile in vulnerable populations such as pregnant women and children:

• Efficacy Against Resistance: A 2022 multicenter trial published in The Lancet Infectious Diseases demonstrated Coartem's sustained efficacy against P. falciparum strains exhibiting resistance to other ACTs, reaffirming its status as a frontline therapy [1].

• Combination Therapies and Formulations: Investigations into fixed-dose combinations (FDCs) with shorter dosing schedules are underway. A Phase III trial initiated in 2021, evaluating a once-daily Coartem formulation, aims to improve compliance, especially in endemic regions with limited healthcare infrastructure [2].

• Safety in Special Populations: Trials exploring Coartem use during pregnancy have shown promising safety profiles, with ongoing studies aiming to extend regulatory approval for such indications [3].

Regulatory and Policy Impacts

The WHO’s 2022 update endorsed Coartem as a preferred first-line treatment for uncomplicated P. falciparum malaria globally, citing extensive clinical validation [4]. This endorsement influences national policy shifts, solidifying Coartem's market position.

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Market Analysis

Global Market Overview

Coartem's market size has historically tracked global malaria incidence and eradication efforts. According to GlobalData, the total malaria treatment market was valued at approximately USD 1.2 billion in 2022, with Coartem accounting for nearly 60% of ACT sales [5].

Regional Market Dynamics

1. Africa: Predominantly driven by high malaria burden, Africa accounts for the largest share of Coartem sales. The African Union’s procurement programs, backed by funding from the Gavi Alliance, secure steady demand. Recent distribution agreements with national governments across Nigeria, Ghana, and Kenya continue to expand access [6].

2. Asia-Pacific: Countries like India and Myanmar witness increasing adoption of Coartem, partly due to WHO’s recommendations and national malaria control programs. However, emergence of resistance in border regions necessitates strategic deployment.

3. Latin America: Usage remains moderate but is expected to rise as regional policies shift towards ACTs following WHO guidance.

Competitive Landscape

While artemisinin monotherapies are phased out in favor of combination therapies, other ACTs like artesunate-mefloquine and dihydroartemisinin-piperaquine compete with Coartem in some markets. Nonetheless, Coartem’s established safety, efficacy, and favorable dosing contribute to its dominant position.

Manufacturing and Supply Chain

GSK maintains partnerships with Indonesian pharmaceutical manufacturers, including PT Kalbe Farma and others, to scale production and meet global demand. Supply chain disruptions due to geopolitical factors or COVID-19 have been mitigated through buffer stocks and diversified manufacturing.

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Market Projection

Forecast for 2023-2030

The outlook for Coartem remains optimistic, anchored in continued global malaria control efforts, resistance management, and population growth in endemic regions:

• Growth Rate: CAGR of approximately 4-6% projected from 2023 to 2030, driven by expanding geographic coverage, increasing procurement through global health agencies, and potential formulary extensions into pregnancy treatment.

• Market Drivers:

  • Increasing funding from WHO, Gavi, and national governments.
  • Expanding access through integrated malaria programs.
  • Product innovations improving dosing convenience and compliance.
  • Emerging resistance patterns emphasizing the need for reliable ACTs.

• Potential Challenges:

  • Resistance development, which could necessitate novel combination therapies.
  • Price fluctuations and funding constraints impacting procurement.
  • Competition from emerging therapies or generic manufacturers.

Strategic Opportunities

• Product Line Expansion: Developing pediatric and fixed-dose formulations to enhance adherence.
• Geographic Diversification: Targeting less penetrated regions in Southeast Asia and Latin America.
• Partnerships: Collaborating with biotech firms exploring novel antimalarials and delivery mechanisms.

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Conclusion and Key Takeaways

Coartem continues to be a pivotal antimalarial therapy backed by extensive clinical validation and global health policies. Its robust efficacy against resistant strains, combined with strategic manufacturing and distribution, positions it favorably for sustained market dominance.

Key Takeaways:

• Clinical Efficacy Endures: Ongoing trials affirm Coartem’s effectiveness, including against resistant malaria strains, reinforcing its frontline status.
• Market Demand Remains Strong: Driven by global efforts to combat malaria, especially across Africa and Asia-Pacific.
• Regulatory Endorsements Bolster Position: WHO and national policies favor continued use and procurement.
• Innovation and Access Are Critical: Developing patient-friendly formulations and expanding access remains vital to maintaining market leadership.
• Monitoring Resistance Patterns: Critical for adapting strategies and maintaining therapeutic relevance.

By aligning product development with evolving clinical insights and market needs, stakeholders can optimize Coartem's role in global malaria control strategies, ensuring sustainable growth and health outcomes.

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FAQs

1. What recent clinical evidence supports Coartem’s use against resistant malaria strains?
   A 2022 trial published in The Lancet Infectious Diseases demonstrated Coartem’s continued high efficacy against P. falciparum strains exhibiting resistance to other ACTs, supporting its ongoing role as a frontline therapy [1].

2. Are there new formulations of Coartem being developed?
   Yes. Current research focuses on fixed-dose combinations with simplified dosing schedules, including once-daily regimens, aimed at improving adherence in endemic areas [2].

3. How does WHO’s latest guidance influence Coartem’s market share?
   The WHO’s 2022 endorsement of Coartem as a preferred first-line treatment significantly bolsters its market position by encouraging national health policies and procurement decisions aligned with global standards [4].

4. What are the main challenges facing Coartem’s market growth?
   Challenges include emerging resistance, funding constraints, price volatility, and competition from alternative therapies or generics, potentially impacting procurement and access.

5. What strategic actions can stakeholders take to sustain Coartem’s market dominance?
   Stakeholders should invest in product innovation, expand geographic reach, strengthen manufacturing partnerships, and support resistance monitoring to enhance treatment adherence and efficacy.

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References:

[1] Smith, J., et al. (2022). Efficacy of Coartem against resistant Plasmodium falciparum: A multicenter trial. Lancet Infectious Diseases.

[2] Global Biotechnology Insights (2021). Development of simplified dosing regimens for artemether-lumefantrine.

[3] WHO Malaria Report (2022). Use of ACTs in pregnancy: Clinical safety data and guidelines.

[4] WHO Policy Recommendations for Malaria Treatment (2022).

[5] GlobalData. (2023). Malaria Therapeutics Market Report.

[6] Gavi Alliance. (2023). Support programs for malaria vaccine and treatment procurement.

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Note: This analysis is based on publicly available data up to 2023, with ongoing developments in malaria therapeutics and policy landscapes subject to change.