Zydus Lifesciences has received approval from the Drug Controller General of India (DCGI) to initiate two Phase III clinical trials for Zintrodiazine, a novel anti-malarial candidate active against all current clinical strains of Plasmodium falciparum and Plasmodium vivax, including drug-resistant strains. The announcement was made through a press release dated April 25, 2026.

Clinical Trial Details

The company will conduct two multi-centre, randomised, assessor-blind, active-comparator studies to evaluate the efficacy, safety and tolerability of orally administered Zintrodiazine. The first Phase III trial will involve 651 patients with uncomplicated malaria due to P. falciparum, while the second trial will enroll 390 patients with uncomplicated P. vivax malaria. Both trials will use PCR-adjusted adequate clinical and parasitological response (ACPR) as the primary efficacy endpoint.

Secondary endpoints in both trials will include the incidence of recrudescence, new infections, parasite clearance time and fever clearance time.

Strategic Context and Collaboration

Last year, over 1,80,000 people were diagnosed with malaria in India. In 2016, Medicines for Malaria Venture (MMV) and Zydus announced a collaboration to develop a Zintrodiazine-containing drug combination as an effective alternative to current artemisinin-based combination therapies (ACTs), which face increasing resistance threats. The WHO's World Malaria Report 2025 notes that partial resistance to artemisinin derivatives has been confirmed or suspected in at least 8 countries in Africa.

Company Perspective

Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited, stated that the approval marks a critical milestone in the fight against malaria. He emphasized the company's commitment to developing effective treatments to address the challenge of increasing resistance to current therapies. Zydus Lifesciences employs over 29,000 people worldwide, including 1,500 scientists engaged in research and development.

Zydus life science has officially published its notice for the second 100-day investor awareness campaign titled 'Saksham Niveshak' in Financial Express on April 22, 2026. The pharmaceutical company simultaneously communicated this publication to both major stock exchanges, demonstrating compliance with regulatory disclosure requirements.

Official Publication and Exchange Communication

The company published the campaign notice in both English and Gujarati editions of Financial Express on April 22, 2026. Zydus Lifesciences promptly informed the listing departments of BSE Limited and National Stock Exchange of India Limited about this newspaper publication through official correspondence.

Campaign Overview and Timeline

The 'Saksham Niveshak' campaign, launched following directives from the Investor Education and Protection Fund Authority (IEPFA), commenced on April 1, 2026, and will continue until July 9, 2026. This initiative specifically targets shareholders whose dividends have remained unpaid or unclaimed, forming part of IEPFA's broader drive for investor education and facilitation.

Shareholder Action Requirements

The campaign addresses shareholders who need to update their Know Your Customer (KYC) and nomination details or have issues related to unpaid dividends and shares. Shareholders requiring assistance can contact the company's Registrar and Share Transfer Agent, MUFG Intime India Private Limited (formerly Link Intime India Private Limited), located at 5th Floor, 506 to 508, Amarnath Business Centre – I (ABC-I), Besides Gala Business Centre, Off C. G. Road, Ellisbridge, Ahmedabad-380006.

Contact Information and Accessibility

For direct communication, shareholders can reach the company's Nodal Officer at companysecretary@zyduslife.com or contact the Registrar at telephone numbers 079-26465179/86/87 and email ahmedabad@in.mpms.mufg.com . The notice, signed by Dhaval N. Soni, Company Secretary and Compliance Officer (Membership No. FCS7063), is available on the company website at www.zyduslife.com and stock exchange websites at www.nseindia.com and www.bseindia.com .

The bilingual publication approach ensures maximum reach among shareholders across different linguistic backgrounds, emphasizing the company's commitment to inclusive communication and regulatory compliance in preventing shares from being transferred to the IEPF.