CLINICAL TRIALS PROFILE FOR ARTESUNATE

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	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	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 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.

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

Condition MeSH

Condition MeSH for artesunate
Intervention	Trials
Malaria	194
Malaria, Falciparum	84
Malaria, Vivax	15
Carcinoma in Situ	4

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

Trials by US State

+

−

Trials by US State for artesunate
Location	Trials
Maryland	6
California	3
Ohio	3
Kentucky	2
Florida	1

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

Clinical Trial Status

Clinical Trial Status for artesunate
Clinical Trial Phase	Trials
Completed	161
Not yet recruiting	18
Recruiting	17

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
Centers for Disease Control and Prevention	17

Sponsor Type

Sponsor Type for artesunate
Sponsor	Trials
Other	485
Industry	54
U.S. Fed	37

Clinical Trials, Market Analysis, and Projections for Artesunate

Introduction to Artesunate

Artesunate is a derivative of artemisinin, a compound extracted from the plant Artemisia annua. It is widely used in the treatment of malaria, particularly for severe cases. Here, we will delve into the current clinical trials, market analysis, and future projections for this crucial antimalarial drug.

Current Clinical Trials

SAFIRE Consortium Trial

A significant ongoing clinical trial is the SAFIRE (Safety of Antimalarials in the First Trimester) consortium's Phase 3 clinical trial. This trial, supported by the Global Health EDCTP3 Joint Undertaking and other international partners, aims to evaluate the efficacy, safety, and tolerability of antimalarial drugs, including artesunate, in women during their first trimester of pregnancy. This is the first-ever Phase 3 clinical trial to include pregnant women in this critical stage, addressing a long-standing gap in clinical research[1].

Cipargamin Trial

Another relevant trial is the study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of intravenous cipargamin in participants with moderately severe and severe malaria. While this trial focuses on cipargamin, it highlights the ongoing need for effective treatments against malaria and the potential risks associated with artemisinin resistance. Artesunate remains a standard of care for severe malaria, but trials like these seek to develop alternative treatments to mitigate resistance[4].

Efficacy and Safety of Artesunate

Clinical Evidence

Artesunate has been proven to be highly efficacious in treating severe malaria. FDA-approved trials have shown that artesunate significantly reduces in-hospital mortality rates compared to quinine. For example, in a trial involving 1461 hospitalized patients, the in-hospital mortality rate was 13% for artesunate-treated patients versus 21% for quinine-treated patients[3].

Safety Profile

While artesunate is effective, it also comes with potential side effects. Common adverse reactions include hemolytic anemia, kidney failure requiring dialysis, and severe allergic reactions. However, the overall safety profile of intravenous artesunate is generally favorable when compared to other treatments like quinine[3].

Market Analysis

Market Size and Growth

The global artesunate market is projected to grow significantly over the next few years. By 2032, the market is expected to reach USD 1.2 billion, growing at a Compound Annual Growth Rate (CAGR) of 4.23%. This growth is driven by increasing demand for effective malaria treatments, particularly in regions where malaria is endemic[2].

Segmentation

The artesunate market can be segmented by application (malaria treatment, schistosomiasis treatment, and other parasitic diseases), formulation (injectable, oral tablets, inhalation), distribution channel (hospital pharmacies, retail pharmacies, online pharmacies), and end user (hospitals, clinics, homecare). The injectable formulation is particularly important for severe malaria cases, where rapid treatment is crucial[2].

Regional Analysis

The market is geographically segmented into North America, Europe, South America, Asia Pacific, and the Middle East and Africa. The Asia Pacific and African regions are expected to drive significant growth due to the high prevalence of malaria in these areas[2].

Future Projections

Addressing Artemisinin Resistance

One of the key challenges facing the use of artesunate is the emergence of artemisinin resistance in certain regions. To mitigate this, ongoing research and clinical trials are focused on developing new treatments and ensuring the continued efficacy of existing ones. The SAFIRE trial and other studies aim to provide robust evidence for the safe use of antimalarials, including artesunate, in various patient populations[1][4].

Expanding Treatment Options

Future projections include the expansion of treatment options for malaria, particularly for vulnerable populations such as pregnant women. The SAFIRE trial's findings will be crucial in informing policy and guidelines for malaria treatment in early pregnancy, ensuring that women have optimal treatment options available[1].

Market Expansion

The artesunate market is expected to expand as global health initiatives continue to prioritize malaria eradication. Increased funding and support from international organizations will drive research and development, leading to more effective and safe treatments. The market growth will also be influenced by the increasing awareness and demand for antimalarial drugs in endemic regions[2].

Key Takeaways

• Clinical Trials: Ongoing trials like the SAFIRE consortium's Phase 3 trial are addressing critical gaps in the use of antimalarials in pregnant women.
• Efficacy and Safety: Artesunate has been proven to be highly effective in treating severe malaria, though it comes with potential side effects.
• Market Analysis: The global artesunate market is projected to grow significantly, driven by demand in malaria-endemic regions.
• Future Projections: Addressing artemisinin resistance and expanding treatment options, particularly for vulnerable populations, will be key areas of focus.

FAQs

What is the primary use of artesunate?

Artesunate is primarily used for the treatment of severe malaria, particularly in cases requiring hospitalization.

What are the potential side effects of artesunate?

Common side effects include hemolytic anemia, kidney failure requiring dialysis, and severe allergic reactions.

What is the significance of the SAFIRE trial?

The SAFIRE trial is the first-ever Phase 3 clinical trial to evaluate the efficacy and safety of antimalarials in women during their first trimester of pregnancy, addressing a critical gap in clinical research.

How is the artesunate market expected to grow?

The global artesunate market is projected to reach USD 1.2 billion by 2032, growing at a CAGR of 4.23%.

What are the challenges facing the use of artesunate?

One of the main challenges is the emergence of artemisinin resistance in certain regions, which necessitates ongoing research and development of new treatments.

Sources

1. Africa-Europe partnership to launch historic Phase 3 clinical trial in early pregnancy... - MMV.
2. Artesunate Market Size, Share, Growth Report 2032 - Market Research Future.
3. Drug Trials Snapshots: ARTESUNATE - FDA - FDA.
4. To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants with Severe Malaria - ClinicalTrials.gov.