Dengue is the most important vector-borne viral infection in humans, with a record 14 million cases reported in 2024. It is caused by an Aedes mosquito-transmitted flavivirus with four serotypes. Dengue can cause an acute illness characterised by fever with headache, myalgia, and rash. This early non-severe febrile phase can, in turn, progress to late severe disease with vascular leak, bleeding, and shock. In some cases, this can result in further complications, including multi-organ failure and death. Patient groups at higher risk of severe dengue outcomes overlap with those for whom live-attenuated vaccines are contraindicated, unlicensed, or lack efficacy data, underscoring the need for safe and effective dengue therapeutics to reduce symptom severity, progression to severe dengue, and development of organ failure. While there are no licensed treatments for dengue fever at present, several drug candidates (small molecules and monoclonal antibodies) are now in phase 2 trials for dengue treatment. The WHO has therefore developed target product profiles (TPPs) for treatments for non-severe and severe dengue to support the ongoing clinical development of dengue therapeutics approaching Phase 3 pivotal trials.
WHO are seeking feedback on these TPPs from industry, product development partnerships, regulatory agencies, funders, procurement agencies, the scientific community, and healthcare workers involved in the care and delivery of interventions to dengue patients.
The TPPs and Public Consultation Comments Form may be downloaded from the links below:
- Target Product Profile (Feedback form)
- Draft Target Product Profile
Completed comment forms and questions can be submitted to the Veterinary Public Health, Vector Control and Environment Unit at VVE@who.int.
The TPP Expert Development Group will consider proposed revisions arising from the public consultation before they are finalised. The final versions of these TPPs will be made publicly available on the WHO website once they have been approved for publication.