Following a licensing agreement signed between the Serum Institute of India (SII) and DNDi, a Phase III clinical trial is expected to begin early next year, with the aim of developing a safe, effective, and globally accessible therapeutic for dengue.
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.
‘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. Going by our philosophy, we will make all attempts to develop, produce, and distribute the vaccine and monoclonal antibodies all over the globe in an affordable manner, together with our committed partners, the Indian Council of Medical Research (ICMR) and DNDi. We are delighted and privileged to collaborate with DNDi to continue the development of our monoclonal antibody in the Dengue Alliance countries,’ said Dr Rajeev Dhere, Senior Scientific Advisor at SII.
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.
‘Treatments will be essential to tackling dengue. We need therapeutics that can prevent progression to the severe stage of the disease to save lives and reduce economic strain, not only on patients but also on public health systems. Treatments are particularly needed for vulnerable groups, including children, pregnant women, and older people, who face a higher risk of severe and potentially fatal dengue,’ said Dr André Siqueira, Head of Dengue at DNDi.
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 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.
DNDi’s dengue programme is financially supported by the European Commission DG HERA (via EU4Health 2025) through the French Development Agency (AFD), France; Federal Ministry of Research, Technology and Space (BMFTR) through KfW, Germany; Federal Ministry for Economic Cooperation and Development (BMZ) through KfW, Germany; Médecins Sans Frontières International; Dutch Ministry of Foreign Affairs (DGIS), the Netherlands; Swiss Agency for Development and Cooperation (SDC), Switzerland; UK International Development (UK); and other private foundations and individuals.
About the Dengue Alliance
The Dengue Alliance currently includes research institutions from Brazil, India, Malaysia, and Thailand, all countries with longstanding high burdens of dengue that have each recorded between roughly 100,000 and 10 million cases annually over recent years. The Alliance was founded on the principle that South-South cooperation among endemic countries is an effective and proven model for developing and delivering new medicines to the populations that need them most.
DNDi and its partners in the Dengue Alliance aim to advance several promising medicines into clinical trials, including antivirals that directly target the virus, host‑directed therapies that support the human immune response to the infection, and monoclonal antibodies. Monoclonal antibodies are laboratory‑engineered proteins designed to mimic the body’s natural antibodies by targeting the dengue virus. The Alliance is continuously exploring potential new treatments to be developed, including existing drugs that could be repurposed and new chemical entities.
About Serum Institute of India
Serum Institute of India Pvt. Ltd., part of Cyrus Poonawalla Group is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world’s largest vaccine manufacturer. SIIPL’s multifunctional production and one-of-the-largest facilities in Hadapsar & Manjari, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.
Founded in 1966, SIIPL’s primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of ‘Pneumosiil,’ the world’s most affordable PCV, ‘Cervavac’ the first indigenous qHPV vaccine in India, and R21/Matrix-M™, the second Malaria vaccine to be authorized for use in children in malaria-endemic regions, ‘MenFive’, the first in the world Pentavalent (ACYWX) Meningococcal Polysaccharide Conjugate Vaccine, approved and WHO-prequalified for use in the pediatric and adult population. Moreover, SIIPL has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.
To further expand its global presence and ensure widespread vaccine availability, SII has established Serum Life Sciences Ltd, a subsidiary in the UK and Serum Inc., a subsidiary in the US. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide.
About DNDi
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit medical research organization that discovers, develops, and delivers safe, effective, and affordable treatments for neglected populations. DNDi is developing medicines for sleeping sickness, leishmaniasis, Chagas disease, parasitic worm diseases, mycetoma, dengue, paediatric HIV, cryptococcal meningitis, and hepatitis C. Its research priorities include children’s health; gender equity and gender-responsive R&D; and diseases impacted by climate change. Since its creation in 2003, DNDi has collaborated with public and private partners worldwide to deliver 14 new treatments for six deadly diseases, saving millions of lives.
In India, DNDi works with the Indian Council of Medical Research (ICMR), one of DNDi’s founding partners, to support the government’s goal of eliminating visceral leishmaniasis through clinical research, capacity building, and last-mile support. DNDi has also implemented projects in Bangladesh and Nepal and is expanding its work to develop new tools for lymphatic filariasis, dengue, and mycetoma.
About DG HERA
The DG Health Emergency Preparedness and Response Authority (DG HERA) is a Directorate-General of the European Commission. Its mission is to ensure the development, production and equitable distribution of key medical countermeasures to prevent or rapidly respond to cross-border health emergencies.
DG HERA strengthens health security coordination within the Union during preparedness and crisis response times, addresses vulnerabilities and strategic dependencies within the Union related to the development, production, procurement, stockpiling and distribution of medical countermeasures, and reinforces the global health emergency preparedness and response architecture. To achieve these objectives, DG HERA works closely with Member States, civil society, industry, third countries and global partners.
Media contacts
Manisha Sharma (New Delhi, India)
+91 9971907778
msharma@dndi.org
Kanyakumari Damodaran (Kuala Lumpur, Malaysia)
+60 16 749 8047
kdamodaran@dndi.org
Vânia Alves (Rio de Janeiro, Brazil)
+ 55 21 99687 1731
valves@dndi.org
Baralee Meesukh (Bangkok, Thailand)
+66 81 921 6462
bmeesukh@dndi.org
Frédéric Ojardias (Geneva, Switzerland)
+41 79 431 62 16
fojardias@dndi.org
Additional quotations from partners and supporters
Quote from Florika Fink-Hooijer (Director-General of the European Commission’s Health Emergency Preparedness and Response Authority – DG HERA)
‘More than half of the world’s population now lives in areas at risk of dengue infection, and what was once considered a disease confined to tropical regions is increasingly affecting Europe. Yet, despite the growing global burden of dengue, there is still no specific antiviral treatment. The European Commission, through DG HERA, is supporting the late-stage clinical development of a promising monoclonal antibody that has the potential to become the first targeted therapeutic for dengue. This landmark clinical trial, which will also include vulnerable populations such as children, pregnant women and older adults, represents an important step towards expanding access to effective medical countermeasures where they are most needed. By investing in innovation and global partnerships, we are strengthening preparedness against the growing threat of vector-borne diseases and improving our ability to protect populations in Europe and around the world.’
In Brazil, the clinical study will be implemented in close collaboration with the Oswaldo Cruz Foundation (Fiocruz) and the Universidade Federal de Minas Gerais.
‘Climate change is reshaping the epidemiology of dengue, driving epidemics of unprecedented magnitude, extended duration, and expanding geographic distribution. In 2024, Brazil experienced its worst dengue outbreak, with more than 6.5 million cases and over 5,000 deaths. Recently, the return of dengue strains that had not been seen for years increased the risk of severe illness and adds more to this complex scenario. Yet despite this escalating threat, no approved treatment for dengue exists to date. This clinical trial represents a critical opportunity to change that. If successful, it would mark a historic milestone—the first approved specific therapy for dengue—and provide an essential new tool for epidemic preparedness and response. Fiocruz is proud to be part of this initiative and committed to contributing to this landmark achievement,’ said Viviane Boaventura, researcher at Fiocruz and institutional representative on the Dengue Alliance Joint Steering Committee.
‘The State of Minas Gerais reported the highest number of people affected by dengue during Brazil’s 2024 outbreak. Our university has been at the forefront of dengue innovation, researching and developing science-based solutions to address this climate-sensitive disease, including clinical studies on vaccines, treatments and mosquito control programmes. The Dengue Alliance represents a promising collaboration between endemic countries, and we look forward to starting the trial,’ said Mauro Martins Teixeira, professor and researcher at the University of Minas Gerais.
In Thailand, the clinical study will be implemented in close collaboration with the Faculty of Medicine, Siriraj Hospital, Mahidol University.
‘Dengue is one of Thailand’s top ten public health concerns, with seasonal outbreaks that cause tens of thousands of cases each year. We urgently need treatments to reduce the burden on our health system, and, alongside vaccines and Aedes mosquitoes control, support Thailand’s goal of zero dengue deaths by 2030. That is why it is so significant that our institution is conducting a clinical trial here, to develop a new monoclonal antibody treatment that fits the needs of our patients,’ said Prof Dr Prasert Auewarakul, Head of Emerging Infectious Disease Research Unit, Faculty of Medicine, Siriraj Hospital, Mahidol University.
In Malaysia, the clinical study will be implemented in close collaboration with the Ministry of Health Malaysia.
‘Dengue remains a growing public health threat in Malaysia, with reported cases more than doubling between 2022 and 2024, particularly in urban areas. While the decline observed last year is encouraging, dengue remains unpredictable and requires sustained vigilance. We must continue to strengthen our response across the entire continuum—from vector control and vaccination to digital surveillance and the development of effective treatments. This clinical trial in Malaysia represents an important step forward in our efforts to reduce the burden of dengue, prevent severe complications, and save lives through earlier intervention and better treatment options,’ said Dr Nor Fariza Ngah, deputy director general, Ministry of Health Malaysia.
Photo credit: Fábio Nascimento, DNDi
