Japan-headquartered Takeda Pharmaceutical Company will bring its dengue vaccine Qdenga to India through an exclusive distribution agreement with Ltd. This is the country’s first approved dengue vaccine, and is expected to be available in the first half of 2027, the company said.
The multinational’s subsidiary Takeda Biopharmaceuticals India Pvt Ltd and Dr Reddy’s have formalized a distribution agreement under which the latter will promote and distribute Qdenga in the private market for pediatric and adult vaccination in India. The vaccine had received regulatory approval from India’s Central Drugs Standard Control Organization (CDSCO) in July 2026 for individuals in the 4-60 years age-group.
Qdenga (TAK-003) is a live-attenuated tetravalent dengue vaccine, built on a DENV-2 backbone with structural proteins from DENV-1, DENV-3, and DENV-4, enabling broad immune coverage across all four dengue serotypes, the company said. It is given as a two-dose regimen, three months apart.
“While inclusion in India’s public immunization program remains an important long-term ambition, private-market availability through Dr Reddy’s will provide a pathway for eligible individuals to access the vaccine once it becomes available,” the company said.
Dengue is an evolving public-health challenge in India, with reported cases increasing 11-fold over the past two decades, the company said. “According to a nationwide dengue surveillance study conducted by the Virus Research and Diagnostic Laboratory of the Indian Council of Medical Research, all four dengue virus serotypes (DENV-1 to DENV-4) are co-circulating across multiple regions in India, with 1 in 14, patients being infected with multiple dengue serotypes concurrently,” it added.
Mahender Nayak, Takeda’s Head of Intercontinental Markets, International Business Unit, welcomed a recent Parliamentary Committee on Health’s recommendation to consider dengue vaccine for the Universal Immunization Program. “This reflects the growing recognition of dengue as a significant public health challenge,” he added.
MV Ramana, Dr Reddy’s Chief Executive Officer (Global Generics), added, “As the second-largest vaccine player in India, we believe the introduction of India’s first approved dengue vaccine is an important development for the country’s healthcare landscape.”
Global trials
The dengue vaccine TAK-003 has been studied in more than 60,000 participants in global clinical programs across eight dengue-endemic countries (Brazil, Colombia, Panama, the Dominican Republic and Nicaragua, Philippines, Thailand and Sri Lanka), the company said. The seven-year pivotal Phase 3 TIDES (Tetravalent Immunization against Dengue Efficacy Study, DEN-301) trial, which was Takeda’s largest interventional clinical study to date, was designed in accordance with WHO guidance for second-generation dengue vaccines, it added. “Overall efficacy was seen across all four dengue virus serotypes through seven years, highlighting the durability of the vaccine’s safety and efficacy profile across diverse populations worldwide,” the company said.