A new baby-friendly dispersible anti-malarial is born

3 out of 4 deaths from malaria occur in children under age five.  Malaria affects even the tiniest infants.  Malaria is also known to influence neurocognitive development in young infants and affects a child’s health long after infancy.  Malaria is also a cause of infant mortality. 

A drug formulation, Coartem® (artemether-lumefantrine) Baby, also known as Riatem Baby, is newly approved as a treatment for infants as of July 2025. The pharmaceutical is dispersible meaning it can be dissolved in another liquid, including breastmilk.

The two compounds that comprise Coartem were developed in China in the 1970s, following the isolation of artemether from artmesinin (naturally found in wormwood).

Novartis acquired the rights to the compounds and created the brand name Coartem in 1999.   By 2004 the World Health Organization approved the dual formulation as the first fixed-dosed artemisinin.  However, use in infants was still uncharted.

“Launched on 6 December 2007, 'Make medicines child size' is a five-year global campaign spearheaded by the World Health Organization (WHO) [1]. The aim is to raise awareness and accelerate action to address the need for improved availability and access to safe and effective child-specific medicines for all children under the age of 15.” 

By 2009 researchers were testing the dispersible Coartem tablet to see if it was not inferior to the crushed tablets already being used.  It was not inferior.

The next step was to address the bitter flavor of the antimalarials.  A study in Tanzanian schoolchildren compared an oral suspensions of strawberry, orange and cherry. The clear winner was cherry.

Next was a phase III clinical trial testing Coartem in infants under and over 28 days and weighing more than 5 kg (NCT04300309) with uncomplicated facliparum malaria.  

The results of this trial were that the pharmacokinetic endpoints of the trial were met.  In other words, the medicine worked.

Eight countries Burkina Faso, Cote d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda accounted for 47 percent of malaria in 2023.  These eight countries are now expected to approve the new medicine for use in their countries. 

Sources

https://www.idse.net/Parasitology/Article/07-25/First-Malaria-Medicine-for-Newborns-Young-Infants-Approved/77677

https://www.novartis.com/news/media-releases/novartis-receives-approval-first-malaria-medicine-newborn-babies-and-young-infants

Abdulla S, Sagara I. Dispersible formulation of artemether/lumefantrine: specifically developed for infants and young children. Malar J. 2009 Oct 12;8 Suppl 1(Suppl 1):S7. doi: 10.1186/1475-2875-8-S1-S7. PMID: 19818174; PMCID: PMC2760242.

https://www.nature.com/articles/s41598-025-94800-w

https://malariajournal.biomedcentral.com/articles/10.1186/1475-2875-8-S1-S7