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

Pre-IVF Treatment with a GnRH Antagonist in Women with Endometriosis_temp

Phase 3

Recruiting

Conditions: Endometriosis
Infertility

Interventions: Drug: Elagolix 200 MG
Other: Placebo or SOC IVF

First Posted Date: 2024-04-19

Last Posted Date: 2025-03-10

Lead Sponsor: Yale University

Target Recruit Count: 288

Registration Number: NCT06375811

Locations: 🇺🇸
University of Colorado Department of Obstetrics & Gynecology, Aurora, Colorado, United States
🇺🇸
Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences, New Haven, Connecticut, United States
🇺🇸
Northwestern University Department of Obstetrics and Gynecology, Chicago, Illinois, United States

and more 2 locations

Brain Blood Flow Responses to Stress: Sex Differences

Phase 4

Recruiting

Conditions: Cerebrovascular Disorders

Interventions: Drug: Indomethacin
Drug: Placebo
Drug: Orilissa
Drug: Testosterone gel
Drug: Estradiol
Drug: Anastrozole

First Posted Date: 2024-02-12

Last Posted Date: 2025-04-04

Lead Sponsor: University of Wisconsin, Madison

Target Recruit Count: 26

Registration Number: NCT06253702

Locations: 🇺🇸
University of Wisconsin, Madison, Wisconsin, United States

A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated Pain

Phase 3

Recruiting

Conditions: Endometriosis

Interventions: Drug: Elagolix placebo
Drug: Elagolix

First Posted Date: 2023-10-10

Last Posted Date: 2023-10-10

Lead Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

Target Recruit Count: 330

Registration Number: NCT06076486

Locations: 🇨🇳
Peking University First Hospital, Beijing, Beijing, China

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

Phase 3

Recruiting

Conditions: Endometriosis

Interventions: Drug: Elagolix placebo
Drug: Elagolix

First Posted Date: 2022-12-13

Last Posted Date: 2022-12-13

Lead Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.

Target Recruit Count: 336

Registration Number: NCT05648669

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China

An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women

Phase 4

Terminated

Conditions: Mild Autonomous Cortisol Excess

Interventions: Drug: Elagolix

First Posted Date: 2021-09-09

Last Posted Date: 2025-03-18

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Target Recruit Count: 4

Registration Number: NCT05038878

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L

Active, not recruiting

Conditions: Heavy Menstrual Bleeding
Fibroid Uterus

Interventions: Other: Groups 1 and 2 myomectomy and uterine artery embolization, respectively, are surgical/procedure
Drug: Elagolix Oral Product

First Posted Date: 2021-04-23

Last Posted Date: 2022-05-05

Lead Sponsor: Medstar Health Research Institute

Target Recruit Count: 300

Registration Number: NCT04856306

Locations: 🇺🇸
MedStar Washington Hospital Center, Washington, District of Columbia, United States

Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb

Phase 2

Terminated

Conditions: Endometriosis

Interventions: Drug: BAY1817080
Drug: Placebo
Drug: Elagolix

First Posted Date: 2020-11-03

Last Posted Date: 2023-08-01

Lead Sponsor: Bayer

Target Recruit Count: 215

Registration Number: NCT04614246

Locations: 🇺🇸
Physician Care Clinical Research, Sarasota, Florida, United States
🇺🇸
Medisense, Inc., Atlanta, Georgia, United States
🇺🇸
HWC Women's Research Center, Englewood, Ohio, United States

and more 141 locations

Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis

Early Phase 1

Completed

Conditions: Endometriosis
Infertility

Interventions: Drug: Elagolix 200 MG
Drug: Leuprolide Acetate 3.75 MG/ML
Diagnostic Test: Lab work

First Posted Date: 2020-06-24

Last Posted Date: 2025-02-20

Lead Sponsor: Colorado Center for Reproductive Medicine

Target Recruit Count: 30

Registration Number: NCT04445025

Locations: 🇺🇸
Colorado Center for Reproductive Medicine, Lone Tree, Colorado, United States

Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain

Phase 3

Recruiting

Conditions: Endometriosis

Interventions: Drug: Elagolix
Drug: Placebo
Drug: Combined Oral Contraceptive

First Posted Date: 2020-04-03

Last Posted Date: 2025-05-11

Lead Sponsor: AbbVie

Target Recruit Count: 800

Registration Number: NCT04333576

Locations: 🇺🇸
MomDoc Womens Health Research /ID# 221661, Phoenix, Arizona, United States
🇺🇸
Pinnacle Research Group /ID# 217062, Anniston, Alabama, United States
🇺🇸
ACCEL Research Sites /ID# 218044, Birmingham, Alabama, United States

and more 176 locations

Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis

Phase 3

Active, not recruiting

Conditions: Infertility
Endometriosis

Interventions: Other: Placebo or SOC IVF
Drug: Elagolix 200 MG

First Posted Date: 2019-11-21

Last Posted Date: 2025-04-22

Lead Sponsor: Yale University

Target Recruit Count: 103

Registration Number: NCT04173169

Locations: 🇺🇸
Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences, New Haven, Connecticut, United States
🇺🇸
University of Colorado Department of Obstetrics & Gynecology, Aurora, Colorado, United States
🇺🇸
Duke Fertility, Morrisville, North Carolina, United States

and more 2 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