Zydus gets DCGI nod for Phase III trials of anti-malarial Zintrodiazine

Zydus Lifesciences Ltd has received approval from the Drugs Controller General of India (DCGI) to initiate two Phase III clinical trials for Zintrodiazine, a novel anti-malarial candidate. This compound is effective against all current clinical strains of Plasmodium falciparum and Plasmodium vivax, including drug-resistant varieties. The first multi-centre, randomized trial will enroll 651 patients with uncomplicated P. falciparum malaria, while the second will involve 390 patients with uncomplicated P. vivax mono-infection. Both trials will primarily evaluate the efficacy of orally administered Zintrodiazine based on PCR-adjusted adequate clinical and parasitological response (ACPR). This development is a significant step in addressing the growing challenge of antimalarial drug resistance, particularly against artemisinin-based combination therapies, and stems from a 2016 collaboration with Medicines for Malaria Venture (MMV).