Zydus Lifesciences has secured permission from the Drugs Controller General of India (DCGI) to begin Phase III clinical trials of its investigational anti-malarial drug Zintrodiazine. This marks a major step forward in the company’s fight against malaria.
Zintrodiazine is described as a novel anti-malarial compound with activity against all current clinical strains of Plasmodium falciparum and Plasmodium vivax, including drug-resistant variants—an increasingly urgent global health concern.
The company will run two multi-centre, randomised, assessor-blind, active-comparator Phase III trials in India, evaluating the drug in patients with uncomplicated malaria caused by either P. falciparum or P. vivax infections. Both studies will assess the efficacy, safety, and tolerability of the oral therapy.
The larger trial will enrol 651 patients with P. falciparum malaria, using PCR-adjusted adequate clinical and parasitological response (ACPR) as the primary endpoint. The second study will involve 390 patients with P. vivax mono-infection, also measuring ACPR as the key efficacy outcome.
Secondary endpoints across both trials include recrudescence, new infections, parasite clearance time, and fever clearance time—key indicators of how quickly and effectively the drug eliminates infection and prevents relapse.
Speaking on the development, Sharvil Patel, Managing Director, Zydus Lifesciences Limited, said, “Our journey of innovation has always been about advancing science to address unmet healthcare needs. Malaria remains a significant health concern affecting people of all ages.
"The approval to begin Phase III trials for Zintrodiazine marks a critical milestone in the fight against malaria. With increasing resistance to current therapies, we are committed to developing an effective treatment to address this challenge.”
