Zydus Secures CDSCO Panel Go-Ahead For Phase III Trial of Empagliflozin-Metoprolol FDC
New Delhi: The Subject Expert Committee (SEC) under the Cardiovascular division of the Central Drugs Standard Control Organisation (CDSCO) has approved the conduct of a Phase III clinical trial proposed by Zydus Healthcare Limited for its fixed-dose combination (FDC) of Empagliflozin 10 mg + Metoprolol Succinate (equivalent to Metoprolol Tartrate 25 mg/50 mg).
The proposal was reviewed during the SEC Cardiovascular meeting held on 10th July 2025 at CDSCO headquarters, New Delhi.
Zydus Healthcare submitted its application in accordance with the earlier SEC recommendation dated 13th February 2025, presenting a revised Phase III clinical trial protocol before the committee. The FDC under consideration consists of:
Empagliflozin 10 mg + Metoprolol Succinate IP 23.75 mg equivalent to Metoprolol Tartrate (ER) 25 mg
Empagliflozin 10 mg + Metoprolol Succinate IP 47.50 mg equivalent to Metoprolol Tartrate (ER) 50 mg
After detailed deliberation, the committee recommended granting permission to conduct the Phase III clinical trial as per the revised protocol submitted by the firm.
Empagliflozin is a sodium-glucose co-transporter-2 (SGLT2) inhibitor, primarily indicated for the management of type 2 diabetes mellitus and heart failure. Metoprolol Succinate, a beta-blocker, is widely used for the treatment of hypertension, angina, and heart failure. The fixed-dose combination aims to offer a simplified therapeutic regimen, potentially improving patient compliance in cardiovascular care.
As per the SEC’s direction, Zydus Healthcare will be required to submit the Phase III clinical trial report to CDSCO for further review after the completion of the study.
The committee’s recommendation was recorded as part of the official proceedings of the SEC Cardiovascular meeting dated 10th July 2025.
