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Zydus Healthcare Ltd, a prominent name in the pharmaceutical industry, has recently received the green light from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) to initiate a Phase IV clinical trial for Dydrogesterone Extended Release (ER) tablets.
The approval was granted during the 133rd meeting of the SEC held in June 2025, where Zydus proposed to study Dydrogesterone ER 20 mg tablets in women experiencing habitual miscarriages.
The committee noted that the drug was already approved and marketed in India, and agreed to the proposal after detailed deliberation.
This development, announced following a pivotal meeting in June 2025, could potentially transform the landscape of reproductive health for those facing recurrent pregnancy loss.
Breaking Barriers in Women’s Reproductive Health
Habitual miscarriage, defined as the loss of three or more consecutive pregnancies, is a deeply personal and often silent struggle for many women. The emotional toll it takes is immeasurable, leaving families searching for answers and solutions. Zydus Healthcare’s latest endeavor aims to address this critical gap in medical care by testing the efficacy of Dydrogesterone ER, a synthetic progestogen designed to mimic the natural progesterone hormone vital for sustaining pregnancy.
The SEC’s approval is a testament to the rigorous scientific groundwork laid by Zydus. During the June meeting, the committee meticulously reviewed the proposed trial protocol for the 20 mg formulation, ultimately endorsing the company’s plan to explore its impact on habitual miscarriage.
The Science Behind Dydrogesterone ER
At the heart of this trial is Dydrogesterone, a medication long recognized for its role in supporting early pregnancy.
By replicating the effects of progesterone, it helps prepare the uterine lining for implantation and maintains a nurturing environment for the developing embryo. What sets the extended-release (ER) formulation apart is its ability to provide a steady release of the drug over time, ensuring consistent hormone levels in the bloodstream.
This innovation is particularly significant for women requiring long-term therapy. A single daily dose could mean the difference between adherence and frustration, making the treatment not only effective but also user-friendly. For those who have faced the despair of miscarriage time and again, such advancements in drug delivery could be life-changing, blending science with a much-needed human touch.
Zydus Healthcare: Pioneering Care for Women
Zydus Healthcare, a subsidiary of Zydus Lifesciences Ltd, is no stranger to the realm of women’s health. With a robust portfolio of gynecological therapies, the company has consistently demonstrated a commitment to addressing unmet medical needs. Their focus on habitual miscarriage through this Phase IV trial underscores a broader mission to empower women with solutions that enhance their reproductive journeys.
Beyond this specific trial, Zydus has also been tasked by the SEC to submit a protocol for testing Dydrogesterone ER in cases of threatened miscarriage within a month.
In addition to the trial for habitual miscarriage, the SEC has requested Zydus to submit a separate protocol for evaluating Dydrogesterone ER in cases of threatened miscarriage within a month.
This dual focus highlights the company’s comprehensive approach to tackling pregnancy-related challenges, ensuring that no stone is left unturned in in the quest for better maternal outcomes.
A Step Toward Healing and Hope
Zydus’s initiative is more than a scientific pursuit; it’s a compassionate response to a profound human need. The Phase IV trial will not only evaluate the clinical effectiveness of Dydrogesterone ER but also pave the way for broader conversations about reproductive health challenges that often remain in the shadows.
As the trial progresses, it will likely involve close monitoring of participants, gathering critical data on the drug’s impact. This phase is crucial, as it tests the medication in real-world settings, providing insights into its practical benefits and any potential side effects.
Looking Ahead: What Does the Future Hold?
While the approval of this trial marks a significant step forward, it also brings with it a sense of cautious optimism. Phase IV trials are inherently complex, involving larger populations and real-world variables that can influence outcomes. The medical community, along with hopeful families, will be watching closely as Zydus navigates this critical stage of research.
(Rh/Dr. Divina Johncy Rosario/MSM/SE)
