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Last Updated: December 11, 2024

CLINICAL TRIALS PROFILE FOR ARTESUNATE


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505(b)(2) Clinical Trials for Artesunate

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.
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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Artesunate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00111163 ↗ Intermittent Preventive Treatment With Antimalarials in Kenyan Infants Completed Bill and Melinda Gates Foundation N/A 2004-03-01 The purpose of the study is to see whether antimalarial drugs administered at the time of routine infant vaccinations prevents malaria and anemia in the first year of life.
NCT00111163 ↗ Intermittent Preventive Treatment With Antimalarials in Kenyan Infants Completed Kenya Medical Research Institute N/A 2004-03-01 The purpose of the study is to see whether antimalarial drugs administered at the time of routine infant vaccinations prevents malaria and anemia in the first year of life.
NCT00111163 ↗ Intermittent Preventive Treatment With Antimalarials in Kenyan Infants Completed Centers for Disease Control and Prevention N/A 2004-03-01 The purpose of the study is to see whether antimalarial drugs administered at the time of routine infant vaccinations prevents malaria and anemia in the first year of life.
NCT00118807 ↗ Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children Completed Medical Research Council Phase 3 2003-08-01 The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
NCT00118807 ↗ Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children Completed National Malaria Control Programme, The Gambia Phase 3 2003-08-01 The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Artesunate

Condition Name

Condition Name for Artesunate
Intervention Trials
Malaria 104
Malaria, Falciparum 17
Falciparum Malaria 12
Plasmodium Falciparum Malaria 10
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Condition MeSH

Condition MeSH for Artesunate
Intervention Trials
Malaria 194
Malaria, Falciparum 84
Malaria, Vivax 15
Carcinoma in Situ 4
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Clinical Trial Locations for Artesunate

Trials by Country

Trials by Country for Artesunate
Location Trials
Congo, The Democratic Republic of the 31
Mozambique 28
Burkina Faso 23
Thailand 22
Kenya 19
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Trials by US State

Trials by US State for Artesunate
Location Trials
Maryland 6
Ohio 3
California 3
Kentucky 2
Texas 1
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Clinical Trial Progress for Artesunate

Clinical Trial Phase

Clinical Trial Phase for Artesunate
Clinical Trial Phase Trials
Phase 4 62
Phase 3 52
Phase 2/Phase 3 12
[disabled in preview] 44
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Clinical Trial Status

Clinical Trial Status for Artesunate
Clinical Trial Phase Trials
Completed 161
Not yet recruiting 18
Recruiting 17
[disabled in preview] 22
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Clinical Trial Sponsors for Artesunate

Sponsor Name

Sponsor Name for Artesunate
Sponsor Trials
London School of Hygiene and Tropical Medicine 28
University of Oxford 24
Medicines for Malaria Venture 17
[disabled in preview] 33
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Sponsor Type

Sponsor Type for Artesunate
Sponsor Trials
Other 485
Industry 54
U.S. Fed 37
[disabled in preview] 15
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