MedPath

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

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Phase 3
Completed
Conditions
Uterine Fibroids
Heavy Menstrual Bleeding
Interventions
First Posted Date
2016-01-13
Last Posted Date
2020-06-29
Lead Sponsor
AbbVie
Target Recruit Count
413
Registration Number
NCT02654054
Locations
🇺🇸

Houston Ctr for Clin Research /ID# 149149, Sugar Land, Texas, United States

🇺🇸

Fellows Research Alliance, Inc /ID# 139655, Savannah, Georgia, United States

🇺🇸

University of California, Los Angeles /ID# 144107, Los Angeles, California, United States

and more 93 locations

Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain

Phase 3
Completed
Conditions
Endometriosis
Interventions
First Posted Date
2014-05-21
Last Posted Date
2021-07-13
Lead Sponsor
AbbVie
Target Recruit Count
496
Registration Number
NCT02143713

A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Phase 3
Completed
Conditions
Endometriosis
Interventions
Other: placebo
First Posted Date
2013-08-29
Last Posted Date
2018-09-07
Lead Sponsor
AbbVie
Target Recruit Count
815
Registration Number
NCT01931670

Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

Phase 2
Completed
Conditions
Heavy Uterine Bleeding
Uterine Fibroids
Interventions
First Posted Date
2013-03-25
Last Posted Date
2020-07-21
Lead Sponsor
AbbVie
Target Recruit Count
571
Registration Number
NCT01817530

Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain

Phase 3
Completed
Conditions
Endometriosis
Interventions
First Posted Date
2013-01-04
Last Posted Date
2021-07-13
Lead Sponsor
AbbVie
Target Recruit Count
506
Registration Number
NCT01760954

A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Phase 3
Completed
Conditions
Endometriosis
Interventions
Other: placebo
First Posted Date
2012-06-15
Last Posted Date
2018-09-18
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
872
Registration Number
NCT01620528

Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

Phase 2
Completed
Conditions
Heavy Uterine Bleeding
Uterine Fibroids
Interventions
First Posted Date
2011-09-28
Last Posted Date
2021-07-13
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
271
Registration Number
NCT01441635

An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females

Phase 1
Completed
Conditions
Folliculogenesis
Interventions
First Posted Date
2011-07-27
Last Posted Date
2013-01-08
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
216
Registration Number
NCT01403038
Locations
🇺🇸

Site Reference ID/Investigator# 50805, Colorado Springs, Colorado, United States

🇺🇸

Site Reference ID/Investigator# 51270, Colorado Springs, Colorado, United States

🇺🇸

Site Reference ID/Investigator# 50884, Denver, Colorado, United States

and more 19 locations

Efficacy and Safety Study of Elagolix in Women With Endometriosis

Phase 2
Completed
Conditions
Endometriosis, Pain
Interventions
Drug: Placebo
First Posted Date
2009-09-09
Last Posted Date
2018-09-26
Lead Sponsor
AbbVie
Target Recruit Count
137
Registration Number
NCT00973973

Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis

Phase 2
Completed
Conditions
Endometriosis
Interventions
First Posted Date
2008-11-25
Last Posted Date
2018-09-10
Lead Sponsor
AbbVie
Target Recruit Count
174
Registration Number
NCT00797225
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