An international research partnership is setting out to address a long-standing gap in global health: children weighing less than 15 kg, broadly corresponding to those under five years of age, are affected by the same parasitic diseases targeted by ivermectin-based control programmes, yet are excluded from receiving the drug because there is currently not enough safety evidence to support its use in this age group.
The IVM-KIDS project aims to address that evidence gap. Bringing together eight institutions across Africa and Europe, the four-year initiative will generate the clinical, pharmacological and regulatory evidence needed to determine whether ivermectin can be safely and effectively extended to treat younger children.
If successful, the project could help pave the way for younger children to be included in ivermectin-based programmes targeting several neglected tropical diseases. Children weighing less than 15 kg are estimated to represent around 20% of the population in endemic regions, making this evidence gap relevant not only to individual treatment, but also to the reach and inclusiveness of large-scale parasite control programmes.
Representatives of the consortium are meeting in Accra, Ghana, to prepare the clinical studies, regulatory work and implementation research that will underpin the project.
Ivermectin is an important tool against parasitic diseases including onchocerciasis, lymphatic filariasis, scabies and soil-transmitted helminth infections. It is also widely used in mass drug administration programmes, in which entire eligible populations are treated to reduce infection and transmission.
Professor Michael Marks of the London School of Hygiene & Tropical Medicine (LSHTM), Principal Investigator of IVM-KIDS, said: “Ivermectin has transformed the control of several parasitic diseases, but the youngest children are still left out because we do not yet have the evidence needed to routinely treat them. IVM-KIDS is designed to address that gap by generating the safety, dosing, efficacy and acceptability data that regulators and policy-makers need.”
Existing evidence has provided encouraging signals. A 2021 systematic review covering more than 1,000 children weighing less than 15 kg who had received oral ivermectin found no serious adverse events and reported that observed adverse events were mild and self-limiting. Since then, several smaller studies have also been conducted which also provide evidence of the safety of ivermectin in this group. However, larger clinical trials are needed to provide strong safety evidence and change global policy. The IVM-KIDS project was established to provide it.
The project will conduct a coordinated programme of clinical research evaluating the safety, pharmacokinetics and efficacy of ivermectin in children weighing between 5 and 15 kg. It will assess both generic ivermectin and a new 3 mg orodispersible formulation developed specifically for use in young children.
Its clinical programme includes research on Trichuris trichiura , an intestinal parasite that causes anaemia, stunting and impaired development, as well as on scabies.
Dr Stella Kepha, Principal Research Scientist at the Kenya Medical Research Institute (KEMRI) and a member of the IVM-KIDS clinical research team, said: “Young children live in the same families and communities affected by these parasitic infections, but current ivermectin programmes cannot include them. Our studies are designed to answer questions needed to change that: whether ivermectin can be used safely in these children and how a child-friendly formulation can work in real-world settings.”
If successful, the implications could extend beyond any single disease. Because ivermectin already plays a role in strategies targeting several neglected tropical diseases, the same paediatric evidence base could potentially help make multiple treatment programmes more inclusive. Current estimates suggest that over 250 million children, mainly in Africa, South-east Asia and the Americas, could ultimately stand to benefit from an expanded indication for ivermectin.
Professor John Amuasi of the Kwame Nkrumah University of Science and Technology (KNUST)/Kumasi Centre for Collaborative Research in Tropical Medicine (KCCR), Scientific Project Leader of IVM-KIDS, said: “Generating evidence in the countries where these diseases are endemic is fundamental. African institutions should not simply be sites where research is implemented; they should help shape the scientific questions, lead the research and determine how the results can be translated into policy and practice. That principle is built into IVM-KIDS.”
The partnership brings together LSHTM in the United Kingdom; KNUST/KCCR in Ghana; KEMRI in Kenya; the Institut National de Recherche Biomédicale (INRB) in the Democratic Republic of the Congo; Laboratorios Liconsa and Fundación Mundo Sano España in Spain; and the Drugs for Neglected Diseases initiative (DNDi) and Swiss Tropical and Public Health Institute (Swiss TPH) in Switzerland.
IVM-KIDS runs from September 2025 to August 2029. The project is supported by the Global Health EDCTP3 Joint Undertaking and its members under the European Union’s Horizon Europe research and innovation programme, and has also received funding from Coefficient Giving.
Randomized controlled/clinical trial
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