Zydus Lifesciences Limited (“Zydus”), a leading innovation-driven global lifesciences company, has received regulatory approval from the Drugs Controller General of India (DCGI) to commence two Phase III clinical trials for Zintrodiazine. This novel compound targets uncomplicated malaria caused by Plasmodium falciparum and Plasmodium vivax, including clinical strains that have developed resistance to existing therapies.
The Phase III program consists of multi-centre, randomised, assessor-blind, active-comparator studies. The first trial will enroll 651 patients with P. falciparum malaria to evaluate efficacy through PCR-adjusted adequate clinical and parasitological response (ACPR). The second trial, involving 390 patients, focuses on P. vivax mono-infection. A key priority is tracking recrudescence, which refers to the re-emergence of symptoms and parasites if the initial treatment fails to completely eradicate the infection. Researchers willalso document the occurrence of any entirely new infections during the follow-up period. Additionally, the studies will measure the drug’s speed of action by recording the exact parasite clearance time and fever clearance time, ensuring the treatment provides rapid relief to patients.
“The approval to begin Phase III trials for Zintrodiazinemarks a critical milestone in the fight against malaria,” stated Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited. “With increasing resistance to current therapies, we are committed to developing an effective treatment to address this challenge”.
This development follows a decade-long collaboration initiated in 2016 between Zydus and Medicines for Malaria Venture (MMV). The partnership aims to provide a powerful alternative to artemisinin-based combination therapies (ACTs), which are currently facing global threats from drug resistance. According to the WHO’s World Malaria Report 2025, partial resistance to artemisinin derivatives has been confirmed or suspected in at least eight African countries.
With over 180,000 malaria diagnoses in India last year alone, Zintrodiazine represents a vital step toward securing the next generation of front-line antimalarial treatments.
Written by: Pragna Biswas
Graphics by – Pramit Hazra
