Serum Institute of India ties up with DNDi for Phase III trial of dengue therapy

3 min readPuneJul 9, 2026 07:28 PM IST

Under the agreement, SII will supply the study drug for the overseas trial and oversee its refrigerated transport to clinical trial sites. (File image)

Pune-based Serum Institute of India (SII) has signed a licensing agreement with the non-profit medical research organisation Drugs for Neglected Diseases initiative (DNDi) to conduct Phase III clinical trials and facilitate future access to an SII-developed monoclonal antibody therapy for dengue, formerly known as VIS513.

The agreement paves the way for a Phase III trial, led by DNDi, to begin in the first quarter of 2027 across Malaysia, Thailand and Brazil. Around 1,000 participants will be enrolled at trial sites in the three countries. In India, the therapy is already undergoing a Phase III trial at over 25 centres.

Monoclonal antibodies are laboratory-engineered proteins designed to neutralise viruses. Under the agreement, SII will supply the study drug for the overseas trial and oversee its refrigerated transport to clinical trial sites.

Dr Rajeev Dhere, Senior Scientific Advisor at SII, said the company was committed to developing both preventive and therapeutic interventions against dengue.

“We are working on both preventive and therapeutic applications to protect populations in dengue-endemic areas. In keeping with our philosophy, we will strive to develop, produce and distribute the vaccine and monoclonal antibodies globally in an affordable manner, together with our partners, the Indian Council of Medical Research (ICMR) and DNDi,” he said.

The international trial will be funded by the European Commission’s Directorate-General for Health Emergency Preparedness and Response Authority (DG HERA) in partnership with the French Development Agency (AFD).

Despite the rapid spread of dengue and increasingly frequent outbreaks, there is no specific treatment for the disease. Management remains supportive, relying on close monitoring and intravenous fluids for severe cases, which often places heavy pressure on health systems during outbreaks.

Story continues below this ad

“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 the economic burden on patients and public health systems. They are particularly needed for vulnerable groups, including children, pregnant women and older people,” said Dr André Siqueira, Head of Dengue at DNDi, in a statement.

Dengue is among the world’s fastest-growing mosquito-borne viral diseases. While current control efforts focus largely on curbing transmission by Aedes mosquitoes, DNDi and its partners in the Dengue Alliance are advancing multiple treatment candidates, including antivirals, host-directed therapies and monoclonal antibodies, through clinical development.