Sun Pharma Laboratories Gets CDSCO Panel Nod for Phase III Clinical Trial of Hormonal FDC Tablet

New Delhi: The Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organisation (CDSCO), has granted approval to Sun Pharma Laboratories Limited to conduct a Phase III clinical trial for the fixed-dose combination (FDC) of Drospirenone and Estetrol Tablets (3 mg + 14.2 mg).

This came after the firm presented the proposal for grant of permission to manufacture and market Drospirenone and Estetrol Tablets (3 mg + 14.2 mg) along with a bioequivalence (BE) study report (Study No: CS24127, dated 03-Sep-2025) and Phase III Clinical Trial Protocol (Protocol No: ICR/24/014, Protocol Version No: 1.0, dated 24-Apr-2025) before the committee.

Drospirenone and estetrol is a hormonal combination being developed as an oral formulation. Drospirenone, in combination with ethinyl estradiol or estetrol, is indicated as an oral contraceptive for the prevention of pregnancy.

Drospirenone and ethinyl estradiol in combination suppress the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), preventing ovulation. Other changes induced by this drug that may aid in the prevention of pregnancy include alterations in cervical mucus consistency, hindering sperm movement, and lowering the chance of embryo implantation.

At the recent SEC meeting, the expert panel reviewed the proposal for a grant of permission to manufacture and market Drospirenone and Estetrol Tablets (3 mg + 14.2 mg) along with a bioequivalence (BE) study report.

After detailed deliberation, the committee considered the BE study results of Drospirenone and Estetrol Tablets (3 mg + 14.2 mg) and recommended the grant of permission to conduct a Phase III clinical trial as per the protocol presented.

In addition to this, the expert panel stated that the results of the Phase III clinical trial should be submitted to CDSCO for further review by the committee.