The Serum Institute of India (SII) and the non-profit medical research organization Drugs for Neglected Diseases initiative (DNDi) have signed a licensing agreement covering clinical testing and future access for an SII-developed monoclonal antibody treatment (formerly known as VIS513) against dengue.
With this agreement finalized, a Phase III clinical trial led by DNDi is expected to begin in the first quarter of 2027 across Malaysia, Thailand, and Brazil, all home to leading public health institutions that are members of the Dengue Alliance, a global partnership of dengue-endemic countries working to develop effective and accessible treatments. 1,000 participants are expected to join the study across the three countries.
Monoclonal antibodies are currently among the most advanced dengue treatment candidates. SII has developed and optimized the current formulation of its treatment and conducted pre-clinical studies and Phase I and II clinical trials that delivered promising safety and efficacy results. It is currently leading a pivotal Phase III clinical trial in India. For the Phase III trial conducted by DNDi in Malaysia, Thailand and Brazil, SII will supply study medicines and manage their refrigerated transportation to clinical trial sites.
Dr Rajeev Dhere, Senior Scientific Advisor at SII, stated: “Serum Institute of India is committed to go all out in controlling dengue. We are working on both preventive and therapeutic applications to protect populations in dengue-endemic areas.”
Led by DNDi, the trial in Malaysia, Thailand, and Brazil will be conducted with financial support from the European Commission’s Directorate-General for Health Emergency Preparedness and Response Authority (DG HERA) in partnership with the French Development Agency (AFD). Last November, DG HERA announced it will invest EUR 20 million to advance the development of two new dengue medicines.
Despite dengue’s rapid global spread and increasingly frequent outbreaks, there is still no specific treatment. Patient management remains purely symptomatic, requiring intensive care—including close monitoring and administration of intravenous fluids—that can lead to health systems becoming quickly overwhelmed during outbreaks.
Dr André Siqueira, Head of Dengue at DNDi, emphasized: “Treatments will be essential to tackling dengue. We need therapeutics that can prevent progression to severe disease to save lives and reduce economic strain.”
Children under 15 years of age are at higher risk of developing severe dengue. Pregnant women with dengue face increased risk of maternal mortality and pregnancy loss.
Dengue is one of the fastest-growing mosquito-borne viral infections, with 5.6 billion people at risk. The disease was once limited to tropical countries. Fuelled by climate change and globalization, dengue is expanding to many other parts of the world, including Europe.
Current efforts to control dengue focus mainly on reducing the transmission by Aedes mosquitoes that carry the virus, and on deploying vaccines developed in recent years. However, vaccine coverage remains low, and their effectiveness varies depending on prior exposure and virus serotype. Treatments are therefore an essential addition to the arsenal of health tools required to tackle the disease.
The partnership between SII and DNDi reflects a shared commitment to equitable access through provisions designed to meet public health needs. In low- and middle-income countries (LMICs), the product will be made available at the lowest sustainable price needed to support access while preserving reliable supply. In Europe, the product will be offered on an affordable basis in agreement with relevant authorities to ensure timely and equitable access while supporting long-term sustainability. The partnership will prioritize supply through the public sector in all countries.
The clinical study will be implemented in close collaboration with Dengue Alliance partners: the Oswaldo Cruz Foundation (Fiocruz) and the Universidade Federal de Minas Gerais in Brazil; the Faculty of Medicine, Siriraj Hospital, Mahidol University in Thailand; and the Ministry of Health in Malaysia.
Florika Fink-Hooijer, Director-General of DG HERA, noted: “More than half of the world’s population now lives in areas at risk of dengue infection. Despite the growing global burden of dengue, there is still no specific antiviral treatment.”
In Brazil, Viviane Boaventura, a researcher at Fiocruz, said: “Climate change is reshaping the epidemiology of dengue, driving epidemics of unprecedented magnitude. In 2024, Brazil experienced its worst dengue outbreak.” In Thailand, Prof Dr Prasert Auewarakul, Head of the Emerging Infectious Disease Research Unit at Mahidol University, said dengue is “one of Thailand’s top ten public health concerns, with seasonal outbreaks causing tens of thousands of cases.” And in Malaysia, Dr Nor Fariza Ngah, deputy director general of the Ministry of Health, said dengue “remains a growing public health threat in Malaysia, with reported cases more than doubling between 2022 and 2024.”
Source Organization: Drugs for Neglected Diseases initiative (DNDi)
Publication Date: 8-Jul-2026
Funding: European Commission DG HERA (via EU4Health 2025) through the French Development Agency (AFD); German Federal Ministry of Research, Technology and Space (BMFTR) and Federal Ministry for Economic Cooperation and Development (BMZ), both via KfW; Médecins Sans Frontières International; Dutch Ministry of Foreign Affairs (DGIS); Swiss Agency for Development and Cooperation (SDC); UK International Development; other private foundations and individuals.
Source: EurekAlert