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Orilissa

(elagolix)

ApprovedSmall molecule

Elagolix is used to treat moderate to severe pain caused by endometriosis, a condition where tissue similar to the uterine lining grows outside the uterus. It works by reducing the hormones that cause this tissue to grow and cause pain.[2] Orilissa is currently approved and in use across 5 indications[4].[1]

Orilissa is one of 179 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

5

Indications

32

Total Trials

4

Active Trials

178

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

9

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

AdenomaActive, not recruiting

Uterine FibroidApproved

Polycystic Ovary SyndromeActive, not recruiting

EndometriosisActive, not recruiting

Cardiovascular DiseasePhase 1

Active, not recruiting

AdenomaApproved

Active, not recruiting

Uterine FibroidApproved

Approved

Polycystic Ovary SyndromePhase 2

Active, not recruiting

EndometriosisPhase 3

Active, not recruiting

Competition

Competitive Landscape

274 competitors in Cardiovascular Disease

#DrugCompanyPhaseTrials

Orilissa

Nicotine Free Cigarettes

Tryngolza (autoinjector)

Ionis Pharmaceuticals

Olpasiran

Repatha

Farxiga

Mounjaro

Praluent

Calciferol

Alnylam Pharmaceuticals

Myrbetriq

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

ApprovedRecruiting

Study completion

NCT06798571

Phase 3Recruiting

Endometriosis

NCT06375811

Q4 2026

Phase 1Recruiting

Cardiovascular Disease

NCT03746535

Q2 2030

Phase 3Active, not recruiting

Endometriosis

NCT04333576

Clinical

Trials by Indication[1]

Endometriosis16 trials

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT01620528·872 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 2·NCT00619866·155 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT03213457·681 enrolled

Show 13 more trials

Efficacy and Safety Study of Elagolix in Women With Endometriosis

Completed· AbbVie logo

AbbVie·Phase 2·NCT00973973·137 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 2·NCT00797225·174 enrolled

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

Completed·NNanjing Chia-tai Tianqing Pharmaceutical·Phase 3·NCT06076486·202 enrolled

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

Terminated· AbbVie logo

AbbVie·Phase 3·NCT03343067·11 enrolled

Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis

Completed· AbbVie logo

AbbVie·Phase 2·NCT00437658·252 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT02143713·496 enrolled

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

Unknown status·QQilu Pharmaceutical (Hainan) Co., Ltd.·Phase 3·NCT05648669·336 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT01931670·815 enrolled

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

Completed·CColorado Center for Reproductive Medicine·Phase 1·NCT04445025·30 enrolled

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

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT04333576·800 enrolled

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

Completed·YYale University·Phase 3·NCT04173169·103 enrolled

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

Recruiting·YYale University·Phase 3·NCT06375811·297 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT01760954·506 enrolled

Uterine Fibroid7 trials

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT02654054·413 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 2·NCT01441635·271 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 4·NCT03886220·82 enrolled

Show 4 more trials

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT03271489·478 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 2·NCT01817530·571 enrolled

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)

Completed· AbbVie logo

AbbVie·Phase 3·NCT02691494·378 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT02925494·433 enrolled

Adenoma1 trial

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

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT05038878·4 enrolled

Menstrual Cycle1 trial

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

Unknown status·UUniversity of Southern California·Phase 4·NCT04060992·12 enrolled

Polycystic Ovary Syndrome1 trial

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

Completed· AbbVie logo

AbbVie·Phase 2·NCT03951077·118 enrolled

6 more indications

Premenopausal1 trial

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

Completed· AbbVie logo

AbbVie·Phase 1·NCT01403038·216 enrolled

Cardiovascular Disease1 trial

Cardiovascular Disease Risk in Women With Endometriosis

Recruiting·YYale University·Phase 1·NCT03746535·40 enrolled

GnRH Antagonist1 trial

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

Unknown status·MMedstar Health Research Institute··NCT04856306·300 enrolled

Clinical Trial1 trial

Elagolix for Fertility Enhancement Clinical Trial

Completed·WWake Forest University Health Sciences·Phase 2·NCT04039204·10 enrolled

Women1 trial

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

Terminated· Bayer logo

Bayer·Phase 2·NCT04614246·215 enrolled

Unspecified1 trial

The Influence of Estrogen on the Thermoregulatory Responses to Heat Stress in Pre and Postmenopausal Women

Recruiting·PPenn State University·Approved·NCT06798571·24 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 23, 2018

ORILISSA

NDA NDA210450

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for elagolix. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Orilissa drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — elagolix compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for elagolix. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210450). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Orilissa. U.S. Food & Drug Administration.
[7]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Gonadotropin-Releasing Hormone Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[6]

Patent Cliff

Jul 6, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7419983Jul 6, 2029

11707464Mar 14, 2034

11344551Mar 14, 2034

10537572Sep 1, 2036

10682351Sep 1, 2036

4 more patents

11690854Apr 19, 2038

12102637Aug 20, 2038

11542239Jul 23, 2039

11690845Aug 27, 2040

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