CDSCO Clears Abbott's phase IV Trial Of Dydrogesterone MR Tablet

New Delhi: The Subject Expert Committee (SEC) under the Reproductive division of the Central Drugs Standard Control Organization (CDSCO) has approved the Phase IV clinical trial proposal submitted by Abbott India Limited for Dydrogesterone Extended Release (ER) Tablet 20 mg. The matter was considered during the 06th SEC (Reproductive) meeting held on 19th June 2025 at CDSCO Headquarters, New Delhi.

The application was submitted by the company for the indications of threatened miscarriage and habitual miscarriage. The firm presented the trial protocol along with the request for approval. After detailed deliberation, the committee recommended the conduct of the Phase IV study with key modifications to the protocol.

The committee advised that the title of the study be revised from “Observational Study” to “Phase IV Protocol” to align with regulatory standards. Additionally, the protocol must include an interim analysis after 25 percent of patient enrollment is completed.

Dydrogesterone is a synthetic progestogen first synthesized in the 1950s. Structurally related to natural progesterone, it is used to treat a variety of gynecological and obstetric conditions caused by progesterone deficiency. It is known for its selective action on progesterone receptors and minimal hormonal side effects. The Extended Release 20 mg formulation is designed for once-daily oral use, providing stable plasma levels to support therapeutic outcomes.

M/s Abbott India Limited, a subsidiary of global healthcare major Abbott Laboratories, markets hormone therapies and reproductive health products in India. The company has a long-standing presence in women’s health.