What it is
Coartem® Baby is the first approved malaria treatment specifically designed for newborns and young infants weighing 2 to 5 kg. It is a dissolvable tablet that can be mixed with breast milk, has a sweet cherry flavour to make administration easier, and delivers precise dosing for the smallest patients.
Why it matters
Malaria is a leading cause of child mortality in Africa, and the youngest infants have always been among the most vulnerable. For decades, no approved medicine existed for babies in this weight range, and clinicians had no choice but to use formulations intended for older children, increasing the risk of dosing errors and toxicity. Coartem® Baby fills this long-standing gap.
The story
Each year, malaria affects more than 250 million people and causes over half a million deaths, the majority among children under five.[1]Since 2003, EDCTP has supported over 20 malaria research projects,[2] advancing simpler and improved therapies for children with severe malaria[3] and for pregnant women.[4]
Between 2020 and 2024, the PAMAfrica consortium[5] conducted the CALINA trial[6] across Burkina Faso, the Democratic Republic of Congo, Kenya, Mali, Nigeria and Zambia. The trial demonstrated the safety and effectiveness of a new artemether-lumefantrine dispersible tablet in neonates and infants weighing less than 5 kg, resulting in therapeutic drug levels in the bloodstream and effective parasite clearance: Coartem® Baby.
This evidence contributed to the market authorisation by Swissmedic in July 2025,[7] the first-ever approval of a malaria treatment for this population. In 2026, Coartem® Baby, developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV), with clinical research co-funded by EDCTP, received WHO prequalification,[8] a key step enabling global health procurers to include it in their programmes and facilitate broader access. This medicine is also known as Riamet® Baby in some countries.
By advancing malaria treatments suitable for the smallest patients, EDCTP helps reduce child mortality and illness, alleviates the long-term burden of malaria on families and communities, and supports Africa's public health priorities.[9]Global Health EDCTP3 continues to drive innovation against malaria, including supporting new formulations to address drug resistance,[10] protect pregnant women,[11] and improve vector-control tools.[12]
Sources:
[2] Malaria – International partnerships against infectious diseases & Malaria treatment – EDCTP
[3] Simplified artesunate regimen found efficacious in treating children with severe malaria – EDCTP
[4] PREGACT: Safety and efficacy of four artemisinin-based combination treatments in African pregnant women with malaria – EDCTP
[7] Swissmedic grants authorisation for a paediatric antimalarial under the MAGHP procedure | Swissmedic
[8] WHO prequalification of Coartem® Baby marks breakthrough in treating malaria in newborns and young infants | Medicines for Malaria Venture
[9] Africa CDC Applauds First-Ever Malaria Treatment for Infants Under 5 kg – Africa CDC
[10] WANECAM-2 consortium reports positive results from phase 2b study of novel treatment for children with malaria
[11] Home – SAFIRE – Safety of Antimalarials in FIRst trimEster
Related links
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Our added value for Europe
EDCTP boosts Europe’s competitiveness by advancing research excellence, innovation, and public–private cooperation in global health. By supporting late-stage development and Africa–Europe partnerships, it bridges the EU innovation gap and creates new market and investment opportunities.
EDCTP strengthens Europe’s health security by tackling climate-sensitive diseases and antimicrobial resistance, enhancing surveillance, and accelerating medical countermeasures. Its rapid crisis responses, from Ebola to COVID-19, show its agility in protecting Europe and global health.
EDCTP drives Europe’s science diplomacy through fair Africa–Europe partnerships that tackle global health challenges. Its equitable governance and ethical research practices strengthen EU credibility and global influence.
EDCTP strengthens Europe’s leadership in digital health by investing in AI, data, and digital technologies while training researchers in fields like bioinformatics and genomic epidemiology.
EDCTP advances the EU’s human rights goals by promoting ethical, inclusive research that addresses unmet medical needs. It ensures innovations reach vulnerable populations while strengthening local scientific and health systems.
Our added value for Africa
EDCTP improves health and prosperity in Africa by funding clinical research, strengthening local capacities, and empowering African scientists. Its investments reduce the burden of infectious diseases, boost productivity, and support sustainable development across the continent.
EDCTP builds Africa’s capacity to detect, prevent, and respond to outbreaks through training, research, and strong partnerships. Its work accelerates vaccine and diagnostic development and reinforces the continent’s health resilience.
EDCTP strengthens Africa’s clinical research ecosystem by investing in skills, infrastructure, and regulatory systems. Initiatives like CTCAN and PACTR connect researchers and regulators, expanding quality trials and fostering local leadership.
EDCTP strengthens Africa-led health partnerships with organisations like Africa CDC and WHO AFRO, aligning research and investment with continental priorities. As an AU–EU Innovation Agenda partner, it builds skills, fosters co-investment, and drives sustainable cooperation.
EDCTP promotes health equity by developing practical solutions for underserved communities, including newborns and children, women, urban poor and rural communities. It funds accessible technologies and digital tools that expand healthcare reach and improve outcomes for those most in need.