Elagolix History and Updates

130 events · 2008 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026.

FDA Approvals

Label Revisions

116

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-08Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Elagolix since 2008, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (4)

2025

Results postedElagolix Combination Therapy Long-Term Safety Results Posted for Uterine…· Jul 22, 2025
Primary completionElagolix Phase 3 Trial for Endometriosis-Related Infertility Completes Primary…· May 2, 2025
Results postedElagolix Trial for Mild Autonomous Cortisol Excess Posts Results· Mar 18, 2025

2017

Pivotal publicationElagolix Pivotal Study Published for Endometriosis-Associated Pain· Jan 1, 2017

Upcoming & expected milestones

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06375811

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

Primary completionOct 1, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT07532876

Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain

Primary completionMar 31, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06375811

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

Primary completionMar 31, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT04333576

Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Fem

Past events

2026

Primary completionJun 1, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT06798571

Role of Menopause in Thermoregulation

Trial startedMay 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07532876

Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain

Trial registeredApr 16, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07532876

Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain

2025

FDA approval (supplemental)Dec 17, 2025· FDA

FDA approved supplemental application for Oriahnn (elagolix and estradiol and norethisterone) — Labeling (NDA 213388 S-6)

Sponsor: ABBVIE. Class: Labeling.

FDA approval (supplemental)Dec 17, 2025· FDA

FDA approved supplemental application for Orilissa (elagolix) — Labeling (NDA 210450 S-11)

Sponsor: ABBVIE. Class: Labeling.

Primary completionDec 1, 2025· ClinicalTrials.gov

EARLY_Phase 1 primary completion: NCT03746535

Cardiovascular Disease Risk in Women With Endometriosis

Results postedJul 22, 2025· ClinicalTrials.gov

Trial results posted: NCT03271489

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associ

Primary completionJun 30, 2025· ClinicalTrials.gov

Primary completion: NCT04856306

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

Primary completionMay 31, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT06253702

Brain Blood Flow Responses to Stress: Sex Differences

Primary completionMay 2, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT04173169

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

Results postedMar 18, 2025· ClinicalTrials.gov

Trial results posted: NCT05038878

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

Trial startedMar 1, 2025· ClinicalTrials.gov

Phase 4 trial started: NCT06798571

Role of Menopause in Thermoregulation

Trial registeredJan 29, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06798571

Role of Menopause in Thermoregulation

2024

Primary completionNov 22, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT06076486

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

Primary completionSep 30, 2024· ClinicalTrials.gov

EARLY_Phase 1 primary completion: NCT04445025

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

FDA approval (supplemental)Jul 30, 2024· FDA

FDA approved supplemental application for Oriahnn (elagolix and estradiol and norethisterone) — Manufacturing (CMC) (NDA 213388 S-5)

Sponsor: ABBVIE. Class: Manufacturing (CMC).

Results postedJul 26, 2024· ClinicalTrials.gov

Trial results posted: NCT04039204

Elagolix for Fertility Enhancement Clinical Trial

Trial startedJul 24, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06253702

Brain Blood Flow Responses to Stress: Sex Differences

Primary completionJun 28, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT03271489

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associ

Trial registeredApr 19, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06375811

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

Trial startedMar 16, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06375811

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

Trial registeredFeb 12, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06253702

Brain Blood Flow Responses to Stress: Sex Differences

2023

Trial registeredOct 10, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06076486

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

Trial startedSep 14, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT06076486

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

Primary completionAug 9, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT04039204

Elagolix for Fertility Enhancement Clinical Trial

Primary completionJul 31, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT05648669

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

FDA approval (supplemental)Jun 5, 2023· FDA

FDA approved supplemental application for Orilissa (elagolix) — Labeling (NDA 210450 S-9)

Sponsor: ABBVIE. Class: Labeling.

FDA approval (supplemental)Jun 5, 2023· FDA

FDA approved supplemental application for Oriahnn (elagolix and estradiol and norethisterone) — Labeling (NDA 213388 S-3)

Sponsor: ABBVIE. Class: Labeling.

Results postedMay 31, 2023· ClinicalTrials.gov

Trial results posted: NCT04614246

Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive P

2022

Trial registeredDec 13, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05648669

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

Trial startedSep 4, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05648669

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

Trial startedJul 1, 2022· ClinicalTrials.gov

EARLY_Phase 1 trial started: NCT03746535

Cardiovascular Disease Risk in Women With Endometriosis

Primary completionJun 24, 2022· ClinicalTrials.gov

Phase 4 primary completion: NCT05038878

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

Results postedJun 8, 2022· ClinicalTrials.gov

Trial results posted: NCT03951077

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

Results postedMar 31, 2022· ClinicalTrials.gov

Trial results posted: NCT03886220

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

Trial startedMar 15, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT04173169

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

Primary completionJan 17, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT04614246

Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive P

Trial startedJan 15, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT04039204

Elagolix for Fertility Enhancement Clinical Trial

2021

Trial registeredSep 9, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05038878

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

FDA approval (supplemental)Aug 2, 2021· FDA

FDA approved supplemental application for Oriahnn (elagolix and estradiol and norethisterone) — Labeling (NDA 213388 S-1)

Sponsor: ABBVIE. Class: Labeling.

Trial startedJul 6, 2021· ClinicalTrials.gov

Phase 4 trial started: NCT05038878

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

Trial registeredApr 23, 2021· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT04856306

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

Results postedApr 20, 2021· ClinicalTrials.gov

Trial results posted: NCT03213457

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

Trial startedApr 12, 2021· ClinicalTrials.gov

Trial started: NCT04856306

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

Primary completionMar 31, 2021· ClinicalTrials.gov

Phase 4 primary completion: NCT03886220

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

RecallMar 15, 2021· FDA

ORILISSA recall — Class II: CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack contains 7 tablets of el

Primary completionFeb 10, 2021· ClinicalTrials.gov

Phase 2 primary completion: NCT03951077

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

FDA approval (supplemental)Feb 1, 2021· FDA

FDA approved supplemental application for Orilissa (elagolix) — Efficacy (NDA 210450 S-4)

Sponsor: ABBVIE. Class: Efficacy.

FDA approval (supplemental)Feb 1, 2021· FDA

FDA approved supplemental application for Orilissa (elagolix) — Efficacy (NDA 210450 S-6)

Sponsor: ABBVIE. Class: Efficacy.

FDA approval (supplemental)Feb 1, 2021· FDA

FDA approved supplemental application for Orilissa (elagolix) — Efficacy (NDA 210450 S-5)

Sponsor: ABBVIE. Class: Efficacy.

Trial startedJan 29, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04614246

Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive P

2020

Trial registeredNov 3, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04614246

Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive P

Primary completionOct 30, 2020· ClinicalTrials.gov

Phase 4 primary completion: NCT04060992

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

Trial startedSep 1, 2020· ClinicalTrials.gov

EARLY_Phase 1 trial started: NCT04445025

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

Trial startedAug 10, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04333576

Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Fem

Results postedJul 21, 2020· ClinicalTrials.gov

Trial results posted: NCT01817530

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

Results postedJul 15, 2020· ClinicalTrials.gov

Trial results posted: NCT01441635

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

Results postedJun 30, 2020· ClinicalTrials.gov

Trial results posted: NCT02691494

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associate

Results postedJun 30, 2020· ClinicalTrials.gov

Trial results posted: NCT02925494

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

Results postedJun 29, 2020· ClinicalTrials.gov

Trial results posted: NCT02654054

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associate

Trial registeredJun 24, 2020· ClinicalTrials.gov

EARLY_Phase 1 trial registered on ClinicalTrials.gov: NCT04445025

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

FDA approvalMay 29, 2020· FDA

FDA approved Oriahnn (elagolix and estradiol and norethisterone) (NDA 213388)

Sponsor: ABBVIE. Class: Type 4 - New Combination.

Trial registeredApr 3, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04333576

Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Fem

Primary completionMar 27, 2020· ClinicalTrials.gov

Phase 3 primary completion: NCT03213457

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

2019

Results postedNov 27, 2019· ClinicalTrials.gov

Trial results posted: NCT03343067

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

Trial registeredNov 21, 2019· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04173169

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

Trial startedOct 1, 2019· ClinicalTrials.gov

Phase 4 trial started: NCT04060992

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

FDA approval (supplemental)Aug 28, 2019· FDA

FDA approved supplemental application for Orilissa (elagolix) — Labeling (NDA 210450 S-2)

Sponsor: ABBVIE. Class: Labeling.

Trial registeredAug 19, 2019· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT04060992

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

Trial startedAug 12, 2019· ClinicalTrials.gov

Phase 2 trial started: NCT03951077

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

Trial registeredJul 31, 2019· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04039204

Elagolix for Fertility Enhancement Clinical Trial

Trial registeredMay 15, 2019· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03951077

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

Trial startedApr 12, 2019· ClinicalTrials.gov

Phase 4 trial started: NCT03886220

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

Trial registeredMar 22, 2019· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT03886220

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

2018

Trial registeredNov 19, 2018· ClinicalTrials.gov

EARLY_Phase 1 trial registered on ClinicalTrials.gov: NCT03746535

Cardiovascular Disease Risk in Women With Endometriosis

Primary completionOct 23, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT03343067

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

Results postedOct 12, 2018· ClinicalTrials.gov

Trial results posted: NCT00437658

Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis

Results postedSep 26, 2018· ClinicalTrials.gov

Trial results posted: NCT00973973

Efficacy and Safety Study of Elagolix in Women With Endometriosis

Results postedSep 18, 2018· ClinicalTrials.gov

Trial results posted: NCT01620528

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

Results postedSep 10, 2018· ClinicalTrials.gov

Trial results posted: NCT00797225

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

Results postedSep 7, 2018· ClinicalTrials.gov

Trial results posted: NCT01931670

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

Results postedSep 7, 2018· ClinicalTrials.gov

Trial results posted: NCT02143713

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

Results postedSep 7, 2018· ClinicalTrials.gov

Trial results posted: NCT00619866

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

Results postedSep 6, 2018· ClinicalTrials.gov

Trial results posted: NCT01760954

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

FDA approvalJul 23, 2018· FDA

FDA approved Orilissa (elagolix) (NDA 210450)

Sponsor: ABBVIE. Class: Type 1 - New Molecular Entity.

Primary completionMay 7, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT02925494

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

Primary completionFeb 14, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT02691494

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associate

Primary completionJan 18, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT02654054

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associate

2017

Trial startedDec 27, 2017· ClinicalTrials.gov

Phase 3 trial started: NCT03343067

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

Trial registeredNov 17, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03343067

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

Trial startedSep 13, 2017· ClinicalTrials.gov

Phase 3 trial started: NCT03271489

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associ

Trial registeredSep 5, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03271489

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associ

Trial registeredJul 11, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03213457

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

Trial startedJul 7, 2017· ClinicalTrials.gov

Phase 3 trial started: NCT03213457

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

Pivotal publicationJan 1, 2017· PubMed

Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. (N Engl J Med)

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

2016

Trial registeredOct 6, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02925494

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

Trial startedSep 14, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02925494

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

Primary completionJun 22, 2016· ClinicalTrials.gov

Phase 3 primary completion: NCT02143713

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

Trial registeredFeb 25, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02691494

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associate

Trial startedFeb 3, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02691494

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associate

Trial registeredJan 13, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02654054

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associate

Primary completionJan 6, 2016· ClinicalTrials.gov

Phase 3 primary completion: NCT01931670

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

2015

Trial startedDec 22, 2015· ClinicalTrials.gov

Phase 3 trial started: NCT02654054

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associate

Primary completionJun 30, 2015· ClinicalTrials.gov

Phase 2 primary completion: NCT01817530

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

Primary completionMay 31, 2015· ClinicalTrials.gov

Phase 3 primary completion: NCT01760954

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

2014

Primary completionNov 14, 2014· ClinicalTrials.gov

Phase 3 primary completion: NCT01620528

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

Trial startedMay 27, 2014· ClinicalTrials.gov

Phase 3 trial started: NCT02143713

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

Trial registeredMay 21, 2014· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02143713

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

2013

Primary completionNov 30, 2013· ClinicalTrials.gov

Phase 2 primary completion: NCT01441635

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

Trial startedSep 9, 2013· ClinicalTrials.gov

Phase 3 trial started: NCT01931670

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

Trial registeredAug 29, 2013· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT01931670

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

Trial startedApr 8, 2013· ClinicalTrials.gov

Phase 2 trial started: NCT01817530

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

Trial registeredMar 25, 2013· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT01817530

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

Trial registeredJan 4, 2013· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT01760954

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

2012

Trial startedDec 28, 2012· ClinicalTrials.gov

Phase 3 trial started: NCT01760954

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

Primary completionOct 31, 2012· ClinicalTrials.gov

Phase 1 primary completion: NCT01403038

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

Trial registeredJun 15, 2012· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT01620528

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

Trial startedMay 22, 2012· ClinicalTrials.gov

Phase 3 trial started: NCT01620528

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

2011

Trial registeredSep 28, 2011· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT01441635

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

Trial startedSep 8, 2011· ClinicalTrials.gov

Phase 2 trial started: NCT01441635

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

Trial registeredJul 27, 2011· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT01403038

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

Trial startedJun 30, 2011· ClinicalTrials.gov

Phase 1 trial started: NCT01403038

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

2010

Primary completionSep 22, 2010· ClinicalTrials.gov

Phase 2 primary completion: NCT00973973

Efficacy and Safety Study of Elagolix in Women With Endometriosis

Primary completionFeb 24, 2010· ClinicalTrials.gov

Phase 2 primary completion: NCT00797225

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

2009

Primary completionApr 20, 2009· ClinicalTrials.gov

Phase 2 primary completion: NCT00619866

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

2008

Primary completionNov 24, 2008· ClinicalTrials.gov

Phase 2 primary completion: NCT00437658

Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.