Zydus Gets SEC Nod to Begin Phase IV Trial of Dydrogesterone ER for Habitual Miscarriage
New Delhi: The Subject Expert Committee (SEC) under the Reproductive division of the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Zydus Healthcare Ltd to conduct a Phase IV clinical trial of Dydrogesterone Extended Release (ER) Tablets 20 mg for the indication of habitual miscarriage.
The recommendation was made during the 6th SEC (Reproductive) meeting held on 19th June 2025 at CDSCO Headquarters, New Delhi. Zydus submitted the proposal under Protocol No. C2B05785, Version 01, dated 6th May 2025.
The firm had earlier been instructed by CDSCO—vide letter dated 24th January 2025 and based on SEC’s recommendation dated 5th November 2024—to submit Phase IV protocols for both habitual miscarriage and threatened miscarriage.
At the June 2025 meeting, the firm presented the protocol specifically for habitual miscarriage. According to the official SEC minutes; “The firm informed that they will submit separately Phase IV CT protocol for indication of Threatened miscarriage.”
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