You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 26, 2024

CLINICAL TRIALS PROFILE FOR ARTESUNATE


✉ Email this page to a colleague

« Back to Dashboard


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.
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.
>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.
NCT00118807 ↗ Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children Completed London School of Hygiene and Tropical Medicine 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 102
Malaria, Falciparum 17
Falciparum Malaria 12
Plasmodium Falciparum Malaria 10
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Artesunate
Intervention Trials
Malaria 191
Malaria, Falciparum 83
Malaria, Vivax 15
Neoplasms 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Artesunate

Trials by Country

Trials by Country for Artesunate
Location Trials
Mozambique 28
Burkina Faso 23
Congo, The Democratic Republic of the 23
Thailand 22
Kenya 18
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Artesunate
Location Trials
Maryland 6
Kentucky 2
Ohio 2
California 2
Texas 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Artesunate

Clinical Trial Phase

Clinical Trial Phase for Artesunate
Clinical Trial Phase Trials
Phase 4 61
Phase 3 50
Phase 2/Phase 3 12
[disabled in preview] 67
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Artesunate
Clinical Trial Phase Trials
Completed 161
Not yet recruiting 15
Recruiting 15
[disabled in preview] 27
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Artesunate

Sponsor Name

Sponsor Name for Artesunate
Sponsor Trials
London School of Hygiene and Tropical Medicine 26
University of Oxford 24
Medicines for Malaria Venture 17
[disabled in preview] 45
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Artesunate
Sponsor Trials
Other 478
Industry 52
U.S. Fed 36
[disabled in preview] 15
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.