India Pharma Outlook Team | Wednesday, 17 June 2026
The World Health Organization (WHO) has taken a major step toward improving child-focused dengue treatment with the publication of its first-ever Paediatric Drug Optimization Process (PADO) for dengue.
The initiative aims to accelerate the development of safe, effective and age-appropriate dengue therapeutics for children, a group that continues to face a significant burden from the mosquito-borne disease.
The new child-focused dengue treatment roadmap was developed following a WHO-convened PADO meeting held on October 23, 2025.
The report outlines research priorities, investment needs and development strategies to speed up access to dengue protection specifically designed for children. It also sends a clear signal to researchers, pharmaceutical developers, regulators and funding organizations about the most promising candidates for pediatric use.
Dengue has emerged as a growing global public health challenge and is now endemic in more than 100 countries. According to WHO, over 14 million dengue cases and more than 10,000 dengue-related deaths were reported worldwide in 2024, nearly double the figures recorded in 2023.
Children remain among the most affected groups, with younger children facing a higher risk of severe disease, complications and hospitalization. Despite the increasing burden, there are currently no licensed treatments available for dengue fever, leaving supportive care as the primary approach to patient management.
Dr. Daniel Ngamije Madandi, Director of WHO’s Department of Malaria and Neglected Tropical Diseases, emphasized the urgency of the issue, stating that children need access to safe formulations and treatments specifically designed for their needs to reduce severe disease and save lives.
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The PADO for dengue was conducted by WHO in partnership with the Global Accelerator for Paediatric Formulations (GAP-f) network. The process brought together researchers, clinical experts, regulators, donors, product development partnerships and other stakeholders to evaluate the current dengue therapeutics pipeline.
One of the key outcomes of the exercise is the creation of the first-ever PADO priority and watch lists for dengue therapeutics.
Dr. Meg Doherty, Director of Science for Health at WHO, noted that children should be included in dengue therapeutic development from the earliest stages rather than after adult products have already been designed.
Beyond identifying priority candidates, the report also outlines pediatric-specific requirements that contributed to the development of a broader target product profile for both non-severe and severe dengue treatments.
WHO is urging developers to accelerate pediatric investigations of dengue therapies currently being studied in adults during Phase 2 and Phase 3 clinical trials. The organization recommends planning pediatric studies as soon as sufficient adult safety and efficacy data become available.
The report also stresses that future clinical trials should account for factors commonly seen in pediatric dengue cases, including:
Dr. Luis Pizarro, Executive Director of the Drugs for Neglected Diseases initiative (DNDi), said the report will help align the dengue therapeutics community around children's needs by identifying priority candidates, formulation considerations and critical research gaps.
Designed as a practical reference for researchers, product developers, regulators, funders, market-shaping organizations and national health programs, the report reinforces the need to integrate pediatric considerations throughout every stage of dengue drug development.
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