Artemether/lumefantrine
First ACT for malaria, developed in China in 1992.
Wikipedia / Wikimedia Commons
Artemether/lumefantrine, often sold as Coartem, is a two-drug combination taken orally to treat malaria caused by *Plasmodium falciparum* when chloroquine is no longer effective. It is not meant for malaria prevention. This was the first artemisinin-based combination therapy (ACT) to become available globally, with the fixed-dose combination Coartem approved by the Chinese FDA in 1998 and by Swissmedic in 1999 after being developed in China under Project 523. It appears on the World Health Organization's List of Essential Medicines.
Common side effects include muscle and joint pain, fever, loss of appetite, and headache. A more serious risk is QT interval prolongation. Though not extensively studied, it seems safe to use during pregnancy, and no dose adjustment is needed for mild to moderate kidney or liver issues. The drug can cause anaphylactic reactions. Frequent side effects (affecting more than 3% of patients) include headache, dizziness, anorexia, sleep disorders, tinnitus, tremor, palpitations, vertigo, gastrointestinal problems, itching, and nasopharyngitis.
Food—especially fat—boosts absorption of both artemether and lumefantrine, so patients should take the tablets with a meal as soon as possible. Because Coartem can prolong the QT interval, combining it with other drugs that do the same may lead to irregular heartbeat and potentially fatal ventricular fibrillation. Using it with halofantrine, another antimalarial, can cause life-threatening QT prolongation. Substances that affect the liver enzyme CYP3A4, including grapefruit juice, can raise or lower blood levels of the drug, leading to either stronger side effects or reduced effectiveness.
In 2001, the first fixed-dose ACT meeting WHO pre-qualification standards for efficacy, safety, and quality was created. Coartem, a fixed-dose combination of fast-acting artemether (which rapidly reduces parasite load) and longer-acting lumefantrine (which clears remaining parasites and lowers the chance of relapse), is approved in over 80 countries, including many in Africa, and by Swissmedic, the European Medicines Agency, and the U.S. FDA. The standard course is six doses over three days.
Coartem is supplied at no profit to developing countries through grants from the Global Fund, the U.S. President's Malaria Initiative, and other donors. Novartis has cut the price by 50% since 2001. The first major redu
- field
- Antimalarial medication
- known_for
- First Artemisinin-based combination therapy (ACT) available worldwide
- first_medical_use
- 1998 (Chinese FDA approval for Coartem)
- developed_in
- China (Project 523)
- trade_name
- Coartem
Lore & Background
Artemether/lumefantrine was developed in China as part of Project 523, with the fixed-dose combination Coartem approved by the Chinese FDA in 1998 and by Swissmedic in 1999. It is a fixed-dose combination of artemether, a fast-acting artemisinin derivative that rapidly reduces parasite biomass, and lumefantrine, a longer-acting antimalarial that eliminates residual parasites and reduces the risk of recrudescence. The standard treatment course consists of six doses administered over three days. In 2001, the first fixed-dose ACT to meet WHO pre-qualification criteria was created, and Coartem is approved in over 80 countries, including by Swissmedic, the European Medicines Agency, and the U.S. Food and Drug Administration. Generic versions have been available since at least the 2010s.
Reader's Guide
Artemether/lumefantrine is significant as the first Artemisinin-based combination therapy (ACT) available worldwide, providing high cure rates even in areas of multi-drug resistance. It is on the World Health Organization's List of Essential Medicines and is widely used in over 80 countries. The medication is provided without profit to developing countries through grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria and the US President's Malaria Initiative. Novartis reduced the price of Coartem by 50% since 2001, with further reductions in 2006 and 2008, increasing access. In 2009, the FDA approved Coartem for adults and children weighing at least five kilograms, and a dispersible formulation for children was launched. The 2025 approval of a lower-dose formulation for infants expands treatment to the youngest patients. Common side effects include muscle and joint pains, fever, loss of appetite, and headache; serious side effects include QT interval prolongation. Food, especially fat, enhances absorption, and interactions with drugs like halofantrine can cause life-threatening QT prolongation.
Did You Know?
- Artemether/lumefantrine was developed in China as part of Project 523.
- It is not available as a generic medication.
- In July 2025, Swissmedic approved a lower-dose formulation for babies weighing under 4.5 kilograms.
- Coartem Dispersible, launched in 2009, disperses quickly in small amounts of water.
Frequently Asked Questions
What is Artemether/lumefantrine?
It is an oral two-drug antimalarial combination, sold under the brand name Coartem, used to treat active falciparum malaria when older agents like chloroquine have lost their effectiveness. It is not intended as a preventive measure.
Where did Artemether/lumefantrine come from?
The drug was created in China during a military research initiative called Project 523. It entered global medical practice in 1992, becoming the first artemisinin-based combination therapy to reach patients around the world.
What role does Artemether/lumefantrine play in malaria treatment?
Artemether rapidly reduces parasite loads while lumefantrine sustains the antimalarial effect over the treatment course. It is specifically indicated for uncomplicated falciparum malaria in areas where chloroquine resistance is a concern.
Why is Artemether/lumefantrine considered a landmark Chinese invention?
It set the global template by being the very first ACT approved for worldwide distribution, showing how pairing an artemisinin derivative with a partner drug can overcome resistance. The WHO lists it as an essential medicine, reflecting its critical standing in public health.
What side effects should patients watch for with Artemether/lumefantrine?
Frequent complaints include muscle and joint aches, fever, diminished appetite, and headaches. A more serious concern is QT interval prolongation, which warrants caution in anyone with pre-existing cardiac rhythm issues.
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