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.”
After reviewing the submitted protocol, the committee issued its recommendation, “The committee recommended to conduct Phase IV Clinical trial study as per protocol presented by the firm for indication Habitual miscarriage.”
It further added, “Committee recommended to submit Phase IV clinical trial protocol for indication of Threatened miscarriage to CDSCO within one month for further review by the Committee.”
Dydrogesterone is a synthetic oral progestogen that mimics the effects of natural progesterone, a hormone crucial for pregnancy maintenance and menstrual regulation. The 20 mg Extended Release (ER) formulation ensures sustained plasma levels over 24 hours, making it suitable for once-daily dosing—an advantage in terms of convenience and adherence for long-term therapy.
Zydus Healthcare Ltd, a subsidiary of Zydus Lifesciences Ltd (formerly Cadila Healthcare), is a key player in women’s health, with an extensive portfolio in gynecology and hormone therapy. Dydrogesterone is a cornerstone of its reproductive health offerings.
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