Zydus Lifesciences Gets CDSCO Panel Nod for Bioavailability Study of Antimalarial Candidate ZY-19489
New Delhi: The Subject Expert Committee (SEC) on Investigational New Drugs under the Central Drugs Standard Control Organisation (CDSCO) has recommended permission for Zydus Lifesciences Limited to conduct a Bioavailability study of its investigational product ZY-19489 tablet 900 mg.
The matter was taken up during the SEC meeting held on September 4, 2025, at CDSCO headquarters in New Delhi.
The company presented its proposal with Protocol No. ZY19489 1003, Version 01 dated June 17, 2025, in line with earlier recommendations made during the 04th/25th SEC (IND) meeting held on May 29, 2025.
ZY-19489 is an antimalarial candidate being developed by Zydus Lifesciences. Designed to tackle the challenge of drug-resistant malaria, the molecule is part of a new generation of therapies aimed at improving treatment outcomes. Malaria remains a pressing health concern in India and worldwide, and novel antimalarial agents are critical to controlling its spread.
Bioavailability studies form an important early step in this process, assessing how well a drug is absorbed and becomes available in the bloodstream. The results provide essential pharmacokinetic data that guide later clinical development.
Zydus Lifesciences Limited, formerly Cadila Healthcare, is among India’s research-driven pharmaceutical companies. The company has built a presence across therapeutic categories and continues to advance a pipeline of novel chemical entities, vaccines, and specialty medicines.
After the detailed deliberation, the committee recommended for the conduct of Bioavailability study as per protocol presented by the firm.
