MSN Labs Gets SEC Go-Ahead to Conduct Phase IV Clinical Trial on Elagolix for Endometriosis
New Delhi: Hyderabad-based MSN Laboratories Pvt 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 Elagolix Sodium Tablets 150 mg and 200 mg for the treatment of moderate to severe pain associated with endometriosis.
The approval came during the SEC meeting held on September 18, 2025, at CDSCO HQ New Delhi.
In line with the condition attached to the marketing permission for Elagolix Sodium Tablets, the firm presented its post-marketing study plan titled “A Multicentre, Open-Label, Single-Arm Phase IV Clinical Trial to Assess the Safety and Effectiveness of Elagolix Tablets 200 mg for Treatment of Patients with Moderate to Severe Pain Associated with Endometriosis” (Protocol No. 017/MSN/ELGLX/2025, Version 1.0, dated July 3, 2025).
After detailed deliberation, the SEC recommended grant of permission to conduct the Phase IV trial exactly as per the protocol presented and directed the firm to submit the study results to CDSCO for review once completed.
Elagolix, a gonadotropin-releasing hormone (GnRH) antagonist, works by reducing ovarian estrogen production, thereby relieving endometriosis-related pain. The drug represents a non-surgical treatment option for women who experience severe pain due to endometriosis and require long-term hormonal management. Elagolix has been approved in several global markets for the management of endometriosis-associated pain and is available under various brand names internationally.
MSN Laboratories Pvt Ltd, headquartered in Hyderabad, is one of India’s vertically integrated pharmaceutical companies with expertise in active pharmaceutical ingredients (APIs) and finished dosage formulations. The firm’s focus spans key therapeutic areas, including women’s health, oncology, and cardiology.
