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”