Zydus Gets Nod for Phase III Clinical Trials of Zintrodiazine in India

Zydus Lifesciences Limited has received approval to begin Phase III clinical trials of Zintrodiazine for treating malaria in India, marking a key step in its push to develop new therapies against the disease.

The company said the Zintrodiazine trials will focus on patients with uncomplicated infections caused by Plasmodium falciparum and Plasmodium vivax.

Both studies will be multi-center, randomized, assessor-blind, and use active comparators to evaluate the drug’s efficacy, safety, and tolerability when taken orally.

The first Phase III trial will enroll 651 patients with P. falciparum malaria. The second will include 390 patients with P. vivax mono-infection. In both trials, the primary goal is to measure effectiveness using PCR-adjusted adequate clinical and parasitological response (ACPR). Researchers will also track secondary outcomes such as recrudescence, new infections, parasite clearance time, and fever resolution.

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Speaking on the development, Sharvil Patel 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."

India continues to report a high burden of malaria, with over 180,000 cases recorded last year. Zydus has been working with Medicines for Malaria Venture since 2016 to develop a Zintrodiazine-based combination therapy.

Rising resistance to artemisinin-based treatments remains a global concern. According to the World Health Organization, resistance has been confirmed or suspected in multiple African countries. The Zintrodiazine trials aim to deliver an effective alternative to current frontline therapies.