DCGI Approves Zydus' Phase III Trials for Zintrodiazine to Combat Drug-Resistant Malaria
Ahmedabad: Zydus Lifesciences Limited has received approval from the Drugs Controller General of India (DCGI) to initiate Phase III clinical trials of its novel anti-malarial candidate, Zintrodiazine, marking a significant step in addressing drug-resistant malaria.
The company will conduct two multi-centre, randomised, assessor-blind, active-comparator Phase III studies to evaluate the efficacy, safety and tolerability of orally administered Zintrodiazine in patients with uncomplicated malaria caused by Plasmodium falciparum and Plasmodium vivax.
The first trial will enrol 651 patients with P. falciparum malaria, while the second will include 390 patients with P. vivax mono-infection. Both studies will assess efficacy using PCR-adjusted adequate clinical and parasitological response (ACPR) as the primary endpoint. Secondary endpoints include recrudescence rates, new infections, parasite clearance time and fever clearance time.
Zintrodiazine has demonstrated activity against all current clinical strains of malaria parasites, including drug-resistant variants, positioning it as a promising alternative in malaria therapeutics.
Commenting on the development, Managing Director Dr Sharvil Patel stated that the approval represents a critical milestone in combating malaria, especially amid rising resistance to existing therapies. He emphasized the company’s commitment to developing effective treatment options for this persistent global health challenge.
India continues to face a considerable malaria burden, with over 1.8 lakh reported cases in the past year alone. The growing resistance to artemisinin-based combination therapies (ACTs)—currently the frontline treatment—has intensified the need for new drug candidates. According to the WHO World Malaria Report 2025, partial resistance to artemisinin derivatives has already been observed or suspected in multiple African countries.
Zintrodiazine is being developed as part of a combination therapy under a long-standing collaboration between Zydus and Medicines for Malaria Venture (MMV), aimed at delivering an effective alternative to existing treatments.
Zydus Lifesciences, a global innovation-driven healthcare company with over 29,000 employees and 1,500 R&D scientists, continues to focus on developing breakthrough therapies across vaccines, biologics and new chemical entities. Meanwhile, MMV, a not-for-profit partnership, has enabled access to malaria treatments for over 1.48 billion people since 1999, reinforcing global efforts to eliminate the disease.
