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.
NCT00119145 ↗	Kintampo Trial of Combination Therapy for Malaria	Completed	London School of Hygiene and Tropical Medicine	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.
NCT00153491 ↗	Adherence to Lumefantrine-Artemether	Completed	Ifakara Health Research and Development Centre		2002-08-01	This is a study of how well caregivers of children with malaria adhere to the recommended regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group receiving directly observed treatment in hospital or to a group treated at home by the routine caregiver (typically, patient's mother). Clinical/parasitologic, hematologic, pharmacologic and qualitative parameters were monitored over a 28-day follow-up period and are used to evaluate drug adherence.

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
Infection	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

COARTEM Market Analysis and Financial Projection

Last updated: February 6, 2026

What is the current status of clinical trials for Coartem?

Coartem (artemether-lumefantrine) has completed most phases of clinical evaluation for its approved indications, primarily malaria treatment. Its initial approval was granted in 2009 by the U.S. FDA and the European Medicines Agency (EMA). Recent updates show no ongoing or newly initiated phase III trials in major markets. However, some studies remain ongoing or in post-marketing surveillance, especially in endemic regions for resistance monitoring.

Clinical trial summary:

• Phase III completion: Achieved in 2008 across multiple endemic countries.
• Post-marketing surveillance: Ongoing in Africa and Southeast Asia, focusing on resistance patterns.
• New indications: Trials investigating Coartem for uncomplicated Plasmodium falciparum malaria with varying resistance profiles continue in Africa and Asia.

Notable recent trials:

• Efficacy in multi-drug resistant malaria: Phase IV studies in India and Ghana showed sustained efficacy with a safety profile consistent with earlier trials.
• Combination therapies: Trials exploring Coartem in combination with other antimalarials for resistant strains are underway in Southeast Asia.

How does the market for Coartem look today?

The global antimalarial market, primarily driven by artemisinin-based combination therapies (ACTs), dominated by Coartem, was valued at approximately $2.8 billion in 2022. The market's growth rate is estimated at 3.5% annually, driven by malaria endemic zones and a rise in resistant strains necessitating new formulations and broader distribution.

Market distribution:

• Regional dominance: Africa accounts for more than 55% of sales, followed by Southeast Asia at 25%, and Latin America at 10%.
• Key markets: Sub-Saharan Africa, India, and Southeast Asia.

Market dynamics:

• Pricing: Coartem pricing varies—from $0.50 per treatment course in endemic regions to over $10 in developed countries.
• Generic options: Increasing availability of generics has pressured brand pricing, but Coartem retains a leadership position due to brand recognition and proven efficacy.

What are the market projections for Coartem in the coming years?

Market forecasts project steady growth to approximately $3.7 billion by 2030, reflecting increased malaria control programs and resistance-driven demand for effective therapies.

Drivers:

• Resistant strains: Emergence of artemisinin resistance in Southeast Asia prompts demand for new formulations and combination therapies, potentially expanding Coartem's market share if adapted.
• Global health initiatives: WHO and global donors increase funding for malaria eradication, bolstering distribution channels.
• Innovation pipelines: Development of fixed-dose combinations and pediatric formulations expand market applicability.

Risks:

• Pricing pressures: Competition from generics and price-sensitive markets may limit revenue growth.
• Regulatory hurdles: Changes in approval standards or patent issues could impact market access.
• Resistance development: Widespread resistance may reduce efficacy, forcing reliance on newer therapies.

What strategic opportunities exist for Coartem?

• Formulation advancements: Developing long-acting or injectable formulations could improve compliance and efficacy.
• Expansion into new indications: Trials for malaria prophylaxis and non-malarial uses could diversify revenue streams.
• Partnerships: Collaborations with governments and NGOs may facilitate wider distribution, especially in underserved areas.

What are the competitive considerations?

Coartem faces competition from generics and new ACTs like artesunate-mefloquine and dihydroartemisinin-piperaquine. Its market share remains protected by established efficacy, but price competition and resistance issues threaten its dominance.

Key Takeaways

• Coartem completed major clinical trials over a decade ago; ongoing post-marketing studies focus on resistance.
• The global malaria treatment market, dominated by Coartem, is valued at nearly $3 billion, growing annually.
• Resistance and funding dynamics shape future market opportunities.
• Innovative formulations and new use cases present growth avenues.
• Competition primarily comes from generics and emerging ACTs, pressuring pricing and market share.

FAQs

Q1: Are there any new formulations of Coartem in development?
Yes. Research includes long-acting injectable forms and pediatric dispersible tablets aimed at improving adherence and expanding use cases.

Q2: How is resistance affecting Coartem's efficacy?
Reports of artemisinin resistance in Southeast Asia threaten efficacy, prompting research into combination therapies and new formulations to counter resistance.

Q3: What is the impact of generics on Coartem's market?
Generics have increased price competition, reducing market share in some regions but Coartem maintains leadership through proven efficacy and brand recognition.

Q4: Are there ongoing clinical trials for new indications?
Limited trials are exploring Coartem's use for malaria prophylaxis and in combination with other drugs to address resistant strains.

Q5: How vulnerable is Coartem to patent expiration?
Patent protections in some markets either have expired or are expiring soon, leading to increased generic competition but not immediately affecting current distribution, especially in low-income regions.

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References

1. WHO Malaria Report 2022
2. MarketWatch: "Global Antimalarial Market Size, Share & Trends 2023-2030" (marketdata)
3. ClinicalTrials.gov: Coartem-related studies (accessed Jan 2023)