The World Health Organization has published its first-ever Paediatric Drug Optimization Process for dengue, marking an important step toward developing dengue treatments specifically designed for children. The new report identifies research priorities, development needs, and investment gaps to accelerate the availability of safe, appropriate, and child-friendly dengue therapeutics.
The guidance is based on discussions from a WHO-convened meeting held in October 2025 and was developed in partnership with the Global Accelerator for Paediatric Formulations network. It brought together researchers, clinicians, regulators, donors, product developers, and other stakeholders to review the dengue treatment pipeline and agree on priorities for children.
Dengue is a growing global public health threat and is now endemic in more than 100 countries. In 2024, more than 14 million dengue cases and over 10,000 dengue-related deaths were reported, nearly double the number recorded in 2023. Children are heavily affected by the disease, and young children face higher risks of severe illness and complications.
Despite the growing burden of dengue, there are currently no licensed treatments for dengue fever. Supportive care remains the main approach to clinical management. WHO officials stressed that children must be considered from the earliest stages of dengue treatment development rather than being added later after products are designed for adults.
The report identifies the first priority and watch lists for paediatric dengue therapeutics. A novel monoclonal antibody for dengue treatment in children has been placed on the priority list for the next three to five years because it is already at a more advanced stage of development, including evaluation in children from five years of age. Four additional candidates have been placed on the watch list for continued monitoring over the medium to longer term.
The report also outlines paediatric-specific considerations for future dengue treatments, including formulation design, trial planning, and clinical suitability for children. It calls for paediatric studies to be planned early once sufficient adult data are available, especially for therapeutics already being evaluated in adult Phase 2 and Phase 3 trials.
WHO emphasises that paediatric dengue research must reflect the real clinical conditions affecting children in dengue-endemic settings. Trial designs should account for differences in disease presentation as well as relevant health factors such as malnutrition, obesity, and other comorbidities that may influence treatment outcomes.
The Drugs for Neglected Diseases initiative welcomed the report, noting that it can help align researchers, developers, and funders around children’s needs. By identifying priority candidates, formulation requirements, and research gaps, the report provides practical direction for improving dengue treatment development for children.
The report is intended as a reference for researchers, product developers, funders, regulators, market-shaping organisations, and national health programmes. Its central message is that child-focused considerations must be integrated into every stage of dengue therapeutic development to ensure future treatments are safe, usable, acceptable, and accessible for children living in dengue-endemic areas.
