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.
NCT04039204 ↗	Elagolix for Fertility Enhancement Clinical Trial	Not yet recruiting	Wake Forest University Health Sciences	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.
NCT04333576 ↗	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	Recruiting	AbbVie	Phase 3	2020-08-10	Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain. Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico. Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18. There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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
Pennsylvania	4
New York	4
Nevada	4
Massachusetts	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
Other	4
Industry	4
NIH	1

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

Last updated: October 27, 2025

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Introduction

Orilissa (elagolix) has emerged as a significant player in the treatment landscape for endometriosis-associated pain and uterine fibroids. Developed by AbbVie, this oral gonadotropin-releasing hormone (GnRH) antagonist offers a novel approach for hormone regulation, addressing unmet needs in gynecological therapeutics. This article provides a comprehensive update on clinical trials, analyzes the current market landscape, and projects future prospects for Orilissa.

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Clinical Trials Update

Current Clinical Development Status

Orilissa's development pipeline is primarily established on its existing approvals and ongoing explorations of expanded indications. As of 2023, the drug has received FDA approval for:

• Management of Modest to Severe Pain Associated with Endometriosis (approved in 2018).
• Treatment of Uterine Fibroids (Uterine Leiomyomas), approved in 2021.

These approvals stem from robust phase III trials demonstrating the drug’s efficacy in reducing pain and fibroid volume.

Endometriosis Trials:

Post-approval, the focus has shifted to optimizing dosing strategies and evaluating long-term safety. The ongoing open-label extension studies observe the prolonged use effects, with data indicating sustained symptom relief. Notably, studies such as NCT03359105 evaluate the drug’s safety profile over a longer duration, primarily monitoring BMD (bone mineral density) changes due to estrogen suppression effects.

Uterine Fibroids Trials:

Recent trials, including NCT04560670, examine Orilissa's efficacy in reducing fibroid size and alleviating symptoms over extended periods. Early data indicate significant improvements in bleeding profiles and fibroid volume reduction, with emphasis on managing hypoestrogenic adverse effects.

Emerging Indications & Trials

• Endometriosis-Associated Severe Pain (Phase IV/Real-World Studies): Studies are investigating optimal dosing and combination therapy to mitigate hypoestrogenic side effects.
• Fibroid-Related Heavy Menstrual Bleeding: Newer trials explore combining elagolix with add-back therapy to balance efficacy and safety.
• Additional Gynecological Conditions: Trials are ongoing to assess potential efficacy in ovarian cysts and other hormonal disorders, though these are in early phases.

Safety Profile & Challenges

While Orilissa exhibits excellent efficacy, adverse effects such as bone density loss, hot flashes, and mood changes are noted, necessitating dose adjustments and add-back hormone therapy. Long-term safety data remains crucial, with regulatory agencies and physicians closely monitoring for osteoporosis risk [1].

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Market Landscape Analysis

Current Market Position

Since its FDA approval in 2018 for endometriosis and subsequent approval for fibroids in 2021, Orilissa has quickly secured a competitive position within hormonal therapies for gynecological conditions.

• Market Penetration: AbbVie launched comprehensive awareness campaigns, positioning Orilissa as a first-line oral treatment. Adoption has been bolstered by patient preference for oral over injectable or surgical options.
• Pricing & Reimbursement: The drug's cost remains premium, with pricing strategies affecting prescription patterns. Reimbursement coverage varies across regions, influencing market share.
• Competition: Key rivals include GnRH agonists like leuprolide and triptorelin, and emerging oral therapies such as relugolix (a GnRH antagonist like Orilissa). Notably, relugolix (marketed as Orgovyx) in prostate indications and its potential in gynecology pose competitive threats [2].

Market Drivers & Restraints

• Drivers:

  • Increasing prevalence of endometriosis (~10% of women of reproductive age).
  • Growing awareness of minimally invasive, oral therapies.
  • Patient preference shifting from surgical to medical management.
  • Supportive regulatory approvals for additional indications.

• Restraints:

  • Long-term safety concerns, especially regarding bone health.
  • Cost and reimbursement limitations.
  • Competition from oral GnRH antagonists with similar efficacy but potentially fewer side effects.

Market Size & Revenue Projections

Based on global epidemiological data, the endometriosis market alone is estimated to reach USD 1.5 billion by 2025, with uterine fibroids contributing an additional USD 2 billion [3].

AbbVie’s Orilissa is projected to capture approximately 25-35% of the endometriosis segment within five years, assuming ongoing clinical validation and expanded insurance coverage. Growth in the fibroids segment is expected to accelerate, especially if combination therapies with add-back agents gain approval.

Revenue projections suggest:

• 2023: USD 600 million (post-launch year for fibroid indication).
• 2025: USD 1.2-1.5 billion, driven by broader indications and increased market penetration.
• Long-term: Potential growth beyond USD 2 billion, contingent on new indications and sustained safety profiles.

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Future Projections and Strategic Outlook

Innovation & Differentiation

AbbVie aims to differentiate Orilissa through improved formulations, extended-release options, and combination therapies that mitigate adverse effects. There is also momentum in exploring personalized dosing regimens and developing companion diagnostics to identify optimal patient responders.

Regulatory Trends & Market Expansion

Regulatory agencies are increasingly receptive to broader indications and combination therapies, which could position Orilissa advantageously. Expansion into markets like Europe, Asia-Pacific, and Latin America depends on approval timelines and local healthcare policies.

Challenges to Growth

• Safety Concerns: Long-term impact on bone density may hinder sustained use, warranting further studies.
• Competitive Landscape: Entry of newer oral GnRH antagonists and non-hormonal therapies could dilute market share.
• Pricing Pressures: Payers' cost containment initiatives could limit revenue growth unless managed strategically.

Strategic Recommendations

• Enhance long-term safety data to build confidence among clinicians.
• Advance combination therapy research for improved tolerability.
• Strengthen reimbursement strategies through advocacy and health economics studies.
• Expand into underserved markets with tailored regulatory strategies.

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Key Takeaways

• Clinical advancements position Orilissa as a transformative oral therapy for endometriosis and uterine fibroids, with ongoing trials to expand its indications and optimize safety.
• Market penetration is growing, driven by patient preference and unmet needs, although cost and safety considerations remain pivotal.
• Revenue projections anticipate substantial growth, reaching over USD 2 billion globally by 2025, supported by expanded indications and increased acceptance.
• Strategic focus on safety, combination therapies, and market expansion will be critical to sustain long-term growth amid intensifying competition.
• Continued innovation and evidence-based positioning will determine Orilissa’s future success in the evolving landscape of gynecological therapeutics.

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FAQs

1. What are the primary indications for Orilissa?
Orilissa is approved for the management of moderate to severe pain associated with endometriosis and the treatment of uterine fibroids, particularly heavy menstrual bleeding.

2. How does Orilissa compare to GnRH agonists?
As a GnRH antagonist, Orilissa suppresses gonadotropins more rapidly and reversibly, with fewer injection-related side effects. However, hypoestrogenic adverse effects like bone density loss are common to both classes.

3. What are the main safety concerns with Orilissa?
Long-term use may result in bone mineral density reduction, hot flashes, and mood changes. Addition of hormone therapy (add-back therapy) can mitigate some adverse effects.

4. When are new indications expected to be approved?
Further studies are required to confirm safety and efficacy in additional indications, with potential new approvals anticipated by 2025, depending on clinical trial outcomes.

5. How does the competitive landscape influence Orilissa’s market share?
The emergence of oral GnRH antagonists like relugolix and non-hormonal options could challenge Orilissa’s market dominance. Strategic differentiation and safety management will be key.

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References

[1] Food and Drug Administration (FDA). Orilissa (elagolix) prescribing information. 2018.

[2] MarketWatch. Relugolix and other GnRH antagonists market overview. 2022.

[3] Grand View Research. Endometriosis Treatment Market Size, Share & Trends. 2021.

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(Note: Data and projections are based on publicly available sources and industry estimates as of 2023, subject to change with evolving clinical and regulatory developments.)