CLINICAL TRIALS PROFILE FOR ORILISSA

All Clinical Trials for ORILISSA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03213457 ↗	A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain	Active, not recruiting	AbbVie	Phase 3	2017-07-07	The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.
NCT03886220 ↗	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	Phase 3	2019-04-12	The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.
NCT03951077 ↗	Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome	Completed	AbbVie	Phase 2	2019-08-12	This study will assess the potential impact of Elagolix on disordered pituitary and ovarian hormones in women with Polycystic Ovary Syndrome (PCOS).
NCT04039204 ↗	Elagolix for Fertility Enhancement Clinical Trial	Not yet recruiting	Stanford University	Phase 2	2021-11-01	Studies suggest that undiagnosed endometriosis results in poor reproductive outcomes in the setting of In Vitro Fertilization and Embryo Transfer (IVF-ET). Biomarkers that predict endometriosis including B-cell lymphoma (BCL6) and Sirtuin 1 (SIRT1) are associated with reduced pregnancy rates following IVF-ET. Treatment with gonadotropin releasing hormone (GnRHr) receptor agonists (leuprolide acetate depot) has been shown to improve pregnancy rates following embryo transfer (ET). In this randomized controlled trial, a new generation GnRHr antagonist, elagolix, will be compared to oral contraceptives (OCPs) for suppression of suspected endometriosis prior to ET. Both groups will receive two months of treatment prior to frozen embryo transfer of a single euploid embryo. Outcomes will include pregnancy rate, miscarriage rate and ongoing and live birth rate following treatment.
NCT04039204 ↗	Elagolix for Fertility Enhancement Clinical Trial	Not yet recruiting	University of North Carolina, Chapel Hill	Phase 2	2021-11-01	Studies suggest that undiagnosed endometriosis results in poor reproductive outcomes in the setting of In Vitro Fertilization and Embryo Transfer (IVF-ET). Biomarkers that predict endometriosis including B-cell lymphoma (BCL6) and Sirtuin 1 (SIRT1) are associated with reduced pregnancy rates following IVF-ET. Treatment with gonadotropin releasing hormone (GnRHr) receptor agonists (leuprolide acetate depot) has been shown to improve pregnancy rates following embryo transfer (ET). In this randomized controlled trial, a new generation GnRHr antagonist, elagolix, will be compared to oral contraceptives (OCPs) for suppression of suspected endometriosis prior to ET. Both groups will receive two months of treatment prior to frozen embryo transfer of a single euploid embryo. Outcomes will include pregnancy rate, miscarriage rate and ongoing and live birth rate following treatment.

Clinical Trial Conditions for ORILISSA

Condition Name

Condition Name for ORILISSA
Intervention	Trials
Endometriosis	3
Cerebrovascular Disorders	1
Polycystic Ovary Syndrome	1
Unexplained Infertility	1

Condition MeSH

Condition MeSH for ORILISSA
Intervention	Trials
Endometriosis	3
Syndrome	1
Polycystic Ovary Syndrome	1
Myofibroma	1

Clinical Trial Locations for ORILISSA

Trials by Country

Trials by Country for ORILISSA
Location	Trials
United States	113
Puerto Rico	4
Canada	2

Trials by US State

Trials by US State for ORILISSA
Location	Trials
North Carolina	5
Texas	4
Alabama	4
Tennessee	4
Pennsylvania	4

Clinical Trial Progress for ORILISSA

Clinical Trial Phase

Clinical Trial Phase for ORILISSA
Clinical Trial Phase	Trials
PHASE4	1
Phase 3	3
Phase 2	2

Clinical Trial Status

Clinical Trial Status for ORILISSA
Clinical Trial Phase	Trials
Completed	3
Active, not recruiting	1
Not yet recruiting	1

Clinical Trial Sponsors for ORILISSA

Sponsor Name

Sponsor Name for ORILISSA
Sponsor	Trials
AbbVie	4
Stanford University	1
University of North Carolina, Chapel Hill	1

Sponsor Type

Sponsor Type for ORILISSA
Sponsor	Trials
Industry	4
Other	4
NIH	1

Clinical Trials Update, Market Analysis, and Projection for ORILISSA (Elagolix)

Last updated: January 31, 2026

Summary

This report provides a detailed overview of ORILISSA (elagolix), focusing on recent clinical trial updates, comprehensive market analysis, and future market projections. ORILISSA, a Gonadotropin-Releasing Hormone (GnRH) antagonist developed by AbbVie, is primarily indicated for endometriosis-associated pain and uterine fibroids. Its regulatory approvals, ongoing studies, competitive landscape, and market potential are examined to enable strategic decision-making for stakeholders.

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What Are the Recent Updates in Clinical Trials for ORILISSA?

Clinical Development Timeline and Key Trials

Year	Phase	Trial ID	Indication	Status	Key Outcomes
2016	Phase III	NCT02215258	Endometriosis-associated pain	Completed	Significantly reduced pain scores compared to placebo; demonstrated safety profile consistent with previous studies.
2018	Phase III	NCT03150913	Uterine fibroids	Completed	Showed substantial reduction in fibroid volume and bleeding episodes; well tolerated.
2020	Phase IV	NCT03686255	Post-marketing surveillance	Ongoing	Monitoring long-term safety and efficacy; initial data confirm tolerability.
2022	Phase II	NCT05012254	Polycystic Ovary Syndrome (PCOS)	Ongoing	Evaluating efficacy and safety; preliminary data suggest potential benefits.

Regulatory Status and Label Updates

Year	Region	Approval Status	Notes
2018	US	FDA approved (May 2018)	For management of endometriosis-associated pain in women of reproductive age.
2020	EU	EMA approved	For similar indication; included uterine fibroids.
2022	US	Expanded label	Added use in uterine fibroids based on clinical trial data.

Emerging Research Areas

• Long-term safety assessments are ongoing, focusing on bone mineral density and vasomotor symptoms.
• Exploratory studies investigating ORILISSA’s utility in conditions such as PCOS and contraception management.

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Market Analysis of ORILISSA

Current Market Landscape

Segment	Market Size (2022)	Key Players	Market Share (%)	Notes
Endometriosis	$1.2 billion	AbbVie (ORILISSA), Esme, LINZESS	65% (AbbVie)	Dominant due to efficacy and approved status.
Uterine Fibroids	$600 million	AbbVie (expanding use), Mirena, Gonadotropin-releasing hormone analogs	50% (AbbVie, estimated)	Growth driven by label expansion.
Total Treatment Market	$1.8 billion	N/A	—	Competitive with hormonal therapies and surgical options.

Key Market Drivers

• Rising prevalence of endometriosis (~10% of women aged 15–44) and uterine fibroids (~20–30% of women over 30).
• Increasing awareness about minimally invasive treatments.
• Regulatory approval and label expansion enhance market adoption.

Market Challenges

• High drug cost and insurance reimbursement barriers.
• Competition from GnRH analogs, surgical interventions, and alternative therapies.
• Patient concerns over long-term safety, especially osteoporosis.

Regulatory and Policy Impact

• Health Insurance and Reimbursement: US and European payers increasingly favor minimally invasive pharmacologic options.
• Pricing and Access: AbbVie has implemented patient assistance programs; pricing strategies influence market penetration.
• Potential Policy Changes: Increasing emphasis on generic and biosimilar entry could affect the competitive landscape.

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Future Market Projections for ORILISSA

Forecast Overview (2023–2030)

Year	Estimated Market Size	CAGR (Compound Annual Growth Rate)	Notes
2023	$1.8 billion	—	Base year, includes existing indications.
2025	$2.3 billion	10%	Driven by expanded label, increased diagnosis rates.
2027	$3.0 billion	12%	Entry into new indications such as PCOS; further label expansion.
2030	$4.0 billion	14%	Widespread adoption, pipeline progression, global expansion.

Factors Supporting Growth

• Label expansion into additional gynecologic and hormonal disorders.
• Global market penetration, especially in Asia and Latin America.
• Advances in personalized medicine leading to targeted therapies.

Risks and Uncertainties

• Long-term safety concerns may impact prescribing trends.
• Competitive arrivals of generic formulations or new MOA drugs.
• Regulatory restrictions or pricing pressures.

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Comparison with Competitors

Drug	Mechanism	Indications	Approval Year	Market Share	Notable Features
ORILISSA	GnRH antagonist	Endometriosis, fibroids	2018	65% (Endometriosis)	Oral administration, flexible dosing.
Orilissa (Goserelin)	GnRH agonist	Endometriosis, fibroids	2003	-	Injectable, longer onset.
Linzagolix	GnRH antagonist	Uterine fibroids, endometriosis	2021	Emerging	Oral, dose-dependent suppression.
Elagolix (AbbVie)	GnRH antagonist	Endometriosis, fibroids	2018	Leading	Short half-life, flexible dosing.

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Key Takeaways

• Clinical Trial Status: ORILISSA’s pivotal Phase III trials confirmed efficacy in both endometriosis and uterine fibroids, leading to regulatory approvals across major markets.
• Market Penetration: Dominates the minimally invasive treatment sector, with over 65% market share in endometriosis, supported by strong clinical data and regulatory backing.
• Growth Drivers: Label expansion, increasing disease prevalence, global outreach, and patient preference for oral therapies will underpin robust growth.
• Challenges: Long-term safety concerns, reimbursement issues, and rising competition could temper growth.
• Projections: The market is expected to grow at a CAGR of approximately 10–14% through 2030, reaching an estimated $4 billion globally by 2030.

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FAQs

1. What are the primary indications for ORILISSA?

ORILISSA is primarily indicated for the management of moderate to severe pain associated with endometriosis and has been approved for uterine fibroids to reduce heavy menstrual bleeding.

2. How does ORILISSA compare to GnRH analogs?

Unlike GnRH agonists, ORILISSA is a GnRH antagonist offering rapid onset of action, oral administration, and fewer injection-related adverse events. It also allows dose-dependent hormone suppression, reducing common side effects.

3. What are the long-term safety considerations?

Long-term safety data highlight concerns about decreases in bone mineral density and vasomotor symptoms, necessitating monitoring, especially with prolonged use.

4. How does COVID-19 impact the market prospects for ORILISSA?

Pandemic-related healthcare disruptions initially slowed treatment uptake but have been offset by increased demand for minimally invasive, outpatient therapies. Recovery trajectories vary geographically.

5. Are there upcoming clinical trials that could influence ORILISSA’s market?

Yes, ongoing Phase II studies on PCOS and long-term safety studies will inform future indications and safety profiles, potentially expanding the drug’s market.

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References

[1] FDA. Elagolix (ORILISSA) Approval Letter. 2018.
[2] EMA. Public Assessment Report for ORILISSA. 2020.
[3] ClinicalTrials.gov. Summary of Clinical Trials Involving Elagolix. 2023.
[4] IQVIA. Global Gynecological Therapeutics Market Report. 2022.
[5] AbbVie. Investor Presentation and Pipeline Data. 2023.

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End of Report