Zydus Lifesciences has received permission from the Drug Controller General of India (DCGI) to start Phase III clinical trials for its anti-malarial drug candidate, Zintrodiazine, as per an exchange filing dated April 25, 2026.
The studies will be conducted in India and will include patients with uncomplicated malaria caused by Plasmodium falciparum and Plasmodium vivax.
The approval allows the company to move the drug into late-stage testing, where outcomes are studied in a larger and more diverse patient group.
The clinical programme includes 2 separate trials. One will involve 651 patients diagnosed with P. falciparum malaria. The second will enrol 390 patients with P. vivax mono-infection.
Both trials are structured as multi-centre, randomised and assessor-blind studies. An active comparator will be used to assess how the drug performs against existing treatments.
The main endpoint in both studies is PCR-adjusted adequate clinical and parasitological response (ACPR). Additional measures include recurrence of infection, new infections, parasite clearance time and fever clearance time.
Zintrodiazine is being developed as part of a combination therapy for addressing gaps in current malaria treatment. Artemisinin-based therapies, which are widely used, are showing reduced effectiveness in some regions.
According to the World Health Organization, partial resistance to artemisinin derivatives has been identified or suspected in at least 8 countries in Africa.
The drug candidate is part of a collaboration between Zydus Lifesciences and the Medicines for Malaria Venture, which began in 2016. The objective has been to develop an alternative to existing therapies, particularly for resistant strains.
In India, more than 180,000 malaria cases were reported in a recent year, indicating a continued disease burden.
As of April 27, 2026, at 11:17 am, Zydus Lifesciences Ltd share price was trading at ₹949.05, up 2.33% from the previous closing price.
The planned studies are expected to generate key clinical data on treatment outcomes. These findings will shape the drug’s progress towards potential regulatory approval.
Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. This does not constitute a personal recommendation/investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions.
Investments in the securities market are subject to market risks, read all the related documents carefully before investing.
Published on: Apr 27, 2026, 1:14 PM IST
Team Angel One
We're Live on WhatsApp! Join our channel for market insights & updates
Get the link to download the App
