U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Approvals and Databases
  5. Drug Trials Snapshots: ARTESUNATE
  1. Drug Approvals and Databases

Drug Trials Snapshots: ARTESUNATE

The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the ARTESUNATE Package Insert for complete information.

ARTESUNATE for injection
Amivas LLC
Approval date: May 26, 2020


What is the drug for?

ARTESUNATE is a drug used for initial treatment of severe malaria in children and adults. Treatment of severe malaria with artesunate should always be followed by a complete treatment course of an appropriate antimalarial drug.

Malaria is a serious infectious disease that is spread by mosquitos infected by a parasite.

How is this drug used?

ARTESUNATE is an injection given directly into the vein by a healthcare professional. First three doses are given during the first 24 hours of treatment (at 0, 12 and 24 hours) followed by once daily administration until patient is able to take oral antimalarial therapy.

What are the benefits of this drug?

The number of patients treated with ARTESUNATE who died in the hospital (called in-hospital mortality rate) was lower than the number who died in the control group treated with quinine (a drug approved for the treatment of acute malaria). The in-hospital mortality rate was 13% for ARTESUNATE-treated patients versus 21% for quinine-treated patients.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: ARTESUNATE worked similarly in males and females.
  • Race: Not reported.
  • Age: ARTESUNATE worked similarly in all tested age groups. The number of patients older than 65 years was limited; therefore, difference between patients younger and older than 65 years of age could not be determined.

What are the possible side effects?

ARTESUNATE may cause serious side effects including hemolytic anemia (a condition in which red blood cells are destroyed), and severe allergic reactions.

The most common side effects of ARTESUNATE are kidney failure requiring dialysis, hemoglobinuria (the presence of hemoglobin in urine) and jaundice.

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in males and females.
  • Race: Not reported.
  • Age: The occurrence of side effects was similar in all tested age groups. The number of patients older than 65 years was limited; therefore, differences between patients younger and older than 65 years of age could not be determined.


Who participated in the trials?

The FDA approved ARTESUNATE based primarily on evidence from a clinical trial (Trial 1) of 1461 hospitalized patients with severe malaria. The trial was conducted at 10 sites in Myanmar, Bangladesh, India, and Indonesia.

The FDA also considered data from one large trial conducted from 2005-2010 in nine African countries in 5,425 hospitalized pediatric patients with severe malaria (Trial 2) and a smaller trial conducted from 2007-2008 in Gabon and Malawi. (Trial 3)

Figure 1 summarizes how many males and females were enrolled in Trial 1.

Figure 1. Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trial. In total, 386 women (77%) and 1075 men (74%) participated in the clinical trial.

FDA Review

Figure 2 summarizes the percentage of patients by race.

Figure 2. Demographics by Race

Not collected

FDA Review

Figure 3 summarizes the percentage of patients by age.

Figure 3. Demographics by Age

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total,  202 (14%) were 2 – 15 years, 1221 (83%) were 15-65 years and 38 were 65 years and older (3%).

FDA Review

Figure 4 summarizes the percentage of patients by ethnicity.

Figure 4. Demographics by Ethnicity

Not collected

How were the trials designed?

One trial was used to evaluate both, safety and benefits of ARTESUNATE. Trial enrolled patients with severe malaria who needed hospitalization because of their condition. Patients received at random either ARTESUNATE or a medicine used to treat malaria (quinine). Patients and the health care providers knew which treatment was being given.

The benefit of ARTESUNATE in comparison to quinine was evaluated by comparing the number of patients who died while in the hospital (in-hospital mortality).

The benefit of ARTESUNATE was supported by the data from Trial 2 in which pediatric patients younger than 15 years of age with severe malaria were randomly assigned treatment with ARTESUNATE or quinine.


CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.


Back to Drug Trials Snapshots


Back to Top