Elagolix

Generic Name: Elagolix

Brand Names: Oriahnn 28 Day Kit, Orilissa

Drug Type: Small Molecule

Chemical Formula: C_₃₂H_₃₀F_₅N_₃O_₅

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

Clinical Trials

Hormonal Effects of the Oral Gonadotropin Releasing Hormone (GnRH) Antagonist at Different Periods of the Menstrual Cycle

Phase 4

Conditions: Ovulation; Failure or Lack of

Interventions: Drug: Elagolix 200 MG Oral Tablet [Orilissa]

First Posted Date: 2019-08-19

Last Posted Date: 2019-08-19

Lead Sponsor: University of Southern California

Target Recruit Count: 12

Registration Number: NCT04060992

Elagolix for Fertility Enhancement Clinical Trial

Phase 2

Completed

Conditions: Endometriosis
Unexplained Infertility

Interventions: Drug: Ortho Cyclen
Drug: Elagolix

First Posted Date: 2019-07-31

Last Posted Date: 2024-07-26

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 10

Registration Number: NCT04039204

Locations: 🇺🇸
Wake Forest Univesity Health Sciences, Winston-Salem, North Carolina, United States

Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

Phase 2

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Elagolix
Drug: Placebo

First Posted Date: 2019-05-15

Last Posted Date: 2022-06-08

Lead Sponsor: AbbVie

Target Recruit Count: 118

Registration Number: NCT03951077

Locations: 🇺🇸
Thomas Jefferson University /ID# 205614, Philadelphia, Pennsylvania, United States
🇺🇸
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 216266, Houston, Texas, United States
🇺🇸
Advances in Health, Inc. /ID# 211249, Houston, Texas, United States

and more 51 locations

A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Phase 4

Completed

Conditions: Uterine Fibroids

Interventions: Drug: Placebo
Drug: Elagolix

First Posted Date: 2019-03-22

Last Posted Date: 2022-03-31

Lead Sponsor: AbbVie

Target Recruit Count: 82

Registration Number: NCT03886220

Locations: 🇺🇸
Johns Hopkins University /ID# 211135, Baltimore, Maryland, United States
🇺🇸
Caceres Specialized Gynecology /ID# 214956, Kissimmee, Florida, United States
🇺🇸
Georgia Research for Women /ID# 211321, Atlanta, Georgia, United States

and more 45 locations

Cardiovascular Disease Risk in Women With Endometriosis

Early Phase 1

Recruiting

Conditions: Endometriosis

Interventions: Drug: Elagolix

First Posted Date: 2018-11-19

Last Posted Date: 2025-01-24

Lead Sponsor: Yale University

Target Recruit Count: 17

Registration Number: NCT03746535

Locations: 🇺🇸
Yale School of Medicine, New Haven, Connecticut, United States

A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain

Phase 3

Terminated

Conditions: Endometriosis

Interventions: Drug: elagolix
Drug: estradiol/norethindrone acetate (E2/NETA)

First Posted Date: 2017-11-17

Last Posted Date: 2019-11-27

Lead Sponsor: AbbVie

Target Recruit Count: 11

Registration Number: NCT03343067

Locations: 🇺🇸
Quad Clinical Research, LLC /ID# 168294, Chicago, Illinois, United States
🇺🇸
Seattle Reproductive Medicine /ID# 171079, Seattle, Washington, United States
🇺🇸
Central Ohio Clinical Research /ID# 170750, Columbus, Ohio, United States

and more 34 locations

Long-Term Safety Study 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: Other: Elagolix Placebo
Drug: E2/NETA
Drug: Elagolix
Other: E2/NETA Placebo

First Posted Date: 2017-09-05

Last Posted Date: 2024-07-19

Lead Sponsor: AbbVie

Target Recruit Count: 478

Registration Number: NCT03271489

Locations: 🇺🇸
Exordia Medical Research, Inc /ID# 160853, Fall River, Massachusetts, United States
🇺🇸
Health care Affiliates Medical Group /ID# 163324, Santa Ana, California, United States
🇺🇸
Duplicate_Northwell Health System - Manhasset /ID# 201058, Manhasset, New York, United States

and more 154 locations

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

Phase 3

Completed

Conditions: Endometriosis

Interventions: Drug: Estradiol/Norethindrone Acetate
Drug: Placebo for Elagolix
Drug: Elagolix
Drug: Placebo for E2/NETA

First Posted Date: 2017-07-11

Last Posted Date: 2024-12-20

Lead Sponsor: AbbVie

Target Recruit Count: 681

Registration Number: NCT03213457

Locations: 🇺🇸
Clinical Research Adv, Inc. /ID# 149257, Puyallup, Washington, United States
🇺🇸
Tidewater Clinical Research /ID# 145397, Virginia Beach, Virginia, United States
🇺🇸
Atlanta Women's Research Inst /ID# 145543, Atlanta, Georgia, United States

and more 194 locations

An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Phase 3

Completed

Conditions: Uterine Fibroids
Heavy Menstrual Bleeding

Interventions: Drug: Estradiol/Norethindrone Acetate
Drug: Elagolix

First Posted Date: 2016-10-06

Last Posted Date: 2021-07-13

Lead Sponsor: AbbVie

Target Recruit Count: 433

Registration Number: NCT02925494

Locations: 🇺🇸
Choice Research, LLC /ID# 153492, Dothan, Alabama, United States
🇺🇸
NECCR Fall River LLC /ID# 153274, Fall River, Massachusetts, United States
🇺🇸
Mount Vernon Clinical Res, LLC /ID# 153403, Atlanta, Georgia, United States

and more 121 locations

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 (Replicate Study)

Phase 3

Completed

Conditions: Heavy Menstrual Bleeding
Uterine Fibroids

Interventions: Drug: Placebo for Estradiol/Norethindrone Acetate
Drug: Elagolix
Drug: Placebo for Elagolix
Drug: Estradiol/Norethindrone Acetate

First Posted Date: 2016-02-25

Last Posted Date: 2021-07-13

Lead Sponsor: AbbVie

Target Recruit Count: 378

Registration Number: NCT02691494

Locations: 🇺🇸
University of California, Los Angeles /ID# 149760, Los Angeles, California, United States
🇺🇸
Mount Vernon Clinical Res, LLC /ID# 144297, Atlanta, Georgia, United States
🇺🇸
Clinical Trial Investigators /ID# 152470, Tustin, California, United States

and more 102 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy