Which Diseases is Elagolix FDA-Approved For?

Elagolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis. It is used to manage pain due to endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy or irregular bleeding).

In 2018, the U.S. Food and Drug Administration (FDA) approved elagolix (Orilissa®) for treating pain associated with endometriosis—the first and only pill specifically approved for endometriosis pain relief. In 2020, the FDA also approved the drug Oriahnn®, which contains elagolix, for treating heavy menstrual bleeding caused by uterine fibroids. Oriahnn® is the first pill approved specifically for this symptom.