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
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