Emcure Pharma Gets CDSCO Panel Nod to Conduct Phase IV Trial on Drospirenone Tablets
New Delhi: Pune-based Emcure Pharmaceuticals Ltd has received a recommendation from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) to conduct a Phase IV clinical trial of Drospirenone Tablets 4 mg, a hormonal contraceptive approved for use in women of reproductive age.
The recommendation came during the SEC meeting held on September 18, 2025, at CDSCO Headquarters, New Delhi.
As per the condition attached to the product’s earlier manufacturing and marketing permission, the company presented its Phase IV post-marketing clinical trial protocol titled “A Multicentric, Open-Label, Single-Arm, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of Drospirenone Tablets 4 mg for Oral Contraception in Women of Reproductive Age” (Protocol No. EMC/DRSP/2025, Version 1.0, dated July 10, 2025). The submission included details on the study objectives, design, inclusion and exclusion criteria, sample size, discontinuation criteria, and study endpoints.
Following detailed deliberation, the SEC recommended granting permission to conduct the Phase IV clinical trial as per the protocol submitted. The committee further advised that the study should include safety monitoring for menstrual irregularities, weight changes, and blood pressure variations during the course of treatment. The company has also been directed to submit the final clinical trial report to CDSCO for evaluation upon completion of the study.
Drospirenone, a synthetic progestin derived from spironolactone, prevents pregnancy by inhibiting ovulation, thickening cervical mucus, and altering the endometrial lining. The 4 mg formulation is estrogen-free, making it suitable for women who cannot use combined hormonal contraceptives containing estrogen due to associated cardiovascular or metabolic risks.
Emcure Pharmaceuticals Ltd., headquartered in Pune, is known for its research and production across therapeutic areas including women’s health, cardiology, and metabolic disorders.
