Tanzania has become the first country in the world to grant regulatory approval for arpraziquantel – the first-ever treatment developed specifically for preschool-aged children affected by schistosomiasis. 

This achievement, supported through the Access and Delivery Partnership (ADP) in close collaboration with the Government of Tanzania, marks a major milestone in the fight against the disease and paves the way for a pilot rollout in three districts later this year, offering a long-awaited solution for young children who have been excluded from treatment efforts.

Schistosomiasis is a neglected tropical disease that affects over 250 million people globally, including an estimated 30 million preschool-aged children (24–59 months old) in sub-Saharan Africa. It is caused by parasitic worms and spreads through contact with contaminated water. If left untreated, it can lead to long-term organ damage, malnutrition and impaired cognitive development, trapping communities in a cycle of poverty and poor health.

Despite being highly vulnerable to the disease, preschool-aged children have historically been excluded from mass treatment campaigns due to a lack of an age-appropriate formulation of the World Health Organization (WHO)-recommended treatment, praziquantel. Arpraziquantel is a new, child-friendly version of the medicine designed to be safe, effective and easy for young children to swallow. It was developed by the Pediatric Praziquantel Consortium under the leadership of Merck KGaA, Darmstadt, Germany, with support from the Global Health Innovative Technology (GHIT) Fund and the European and Developing Countries Clinical Trials Partnership (EDCTP). Arpraziquantel received a positive scientific opinion from the European Medicines Agency in December 2023 and was added to the WHO list of prequalified medicines in May 2024. 

Regulatory approval plays a critical role in ensuring that new health technologies are safe, effective and meet rigorous quality standards before they can be introduced into national health systems. It is also an essential gateway for timely access – especially in low- and middle-income countries where regulatory capacity may be limited.

In Tanzania, ADP helped accelerate the approval process for arpraziquantel by the Tanzania Medicines & Medical Devices Authority by providing technical assistance and facilitating the use of the WHO Stringent Regulatory Authority Collaborative Registration Procedure. This allowed the national authority to rely on assessments conducted by trusted regulators, in this case the European Medicines Agency, significantly reducing approval timelines and enabling faster access to this life-saving medicine. 

The United Nations Development Programme (UNDP) leads ADP, in partnership with WHO, the Special Programme for Research and Training in Tropical Diseases (TDR) and PATH. The project is funded by the Government of Japan. 

Tanzania joins other ‘first-wave’ countries in rolling out arpraziquantel, including Côte d'Ivoire, Ghana, Kenya, Senegal and Uganda. The first administration of arpraziquantel was carried out in Uganda in March 2025, as part of the Pediatric Praziquantel Consortium's ADOPT programme, led by Swiss TPH and Unlimit Health.  ADP, the Pediatric Praziquantel Consortium and others are supporting these first wave countries on introduction with product supplied by Merck KGaA, Darmstadt, Germany. 

As part of an end-to-end package of support, ADP is working with partners to strengthen the capacity of national regulatory authorities, enhance regional regulatory systems harmonization, conduct baseline disease mapping, promote community engagement and support national consultations, ensuring that life-saving health technologies reach populations safely and without delay.

In Tanzania, the work is being implemented through the National Institute for Medical Research through the "Strengthening Capacity for Delivery and Uptake of Paediatric Praziquantel Formulation for Schistosomiasis" project. 

The upcoming pilot initiative in Tanzania, expected to launch in the fourth quarter of this year, will reach more than 25,000 preschool-aged children in the district councils of Itilima, Sengerema, and Kigoma over an 18-month period. The experience gained from Tanzania and other ‘first-wave’ countries, combined with the evidence generated, will help inform national strategies and guide future scale-up across the continent.

Tanzania’s leadership in introducing arpraziquantel offers a powerful example of what is possible when science, partnerships and political will align to protect the most vulnerable and build a healthier, more resilient future for all.