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Elagolix

Generic Name
Elagolix
Brand Names
Oriahnn 28 Day Kit, Orilissa
Drug Type
Small Molecule
Chemical Formula
C32H30F5N3O5
CAS Number
834153-87-6
Unique Ingredient Identifier
5B2546MB5Z
Background

Elagolix has been used in trials studying the basic science and treatment of Endometriosis, Folliculogenesis, Uterine Fibroids, Heavy Uterine Bleeding, and Heavy Menstrual Bleeding. As of 24 July 2018, however, the U.S. Food and Drug Administration (FDA) approved AbbVie's elagolix under the brand name Orilissa as the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain .

It has been determined that endometriosis is one of the most common gynecologic disorders in the United States . In particular, estimates suggest that one in ten women of reproductive age is affected by endometriosis and experience debilitating pain symptoms . Moreover, women who are affected by this condition can suffer for up to six to ten years and visit multiple physicians before receiving a proper diagnosis . Subsequently, as Orilissa (elagolix) was approved by the FDA under priority review , this expedited new approval gives healthcare professionals another valuable option for treating the potentially unmet needs of women who are affected by endometriosis, depending on their specific type and severity of endometriosis pain.

Indication

用于治疗子宫内膜异位症并伴有中度至重度疼痛。

Associated Conditions
Heavy Menstrual Bleeding, Moderate to severe pain

An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis

Phase 2
Completed
Conditions
Endometriosis, Pain
Interventions
Drug: placebo
First Posted Date
2008-02-21
Last Posted Date
2018-09-07
Lead Sponsor
AbbVie
Target Recruit Count
155
Registration Number
NCT00619866

Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis

Phase 2
Completed
Conditions
Endometriosis
Interventions
Drug: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC)
Drug: Placebo to DMPA-SC
First Posted Date
2007-02-21
Last Posted Date
2018-10-12
Lead Sponsor
AbbVie
Target Recruit Count
252
Registration Number
NCT00437658
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