CLINICAL TRIALS PROFILE FOR ORILISSA

All Clinical Trials for orilissa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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).
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.
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.

Clinical Trial Conditions for orilissa

Condition Name

Condition Name for orilissa
Intervention	Trials
Endometriosis	3
Uterine Fibroids	1
Polycystic Ovary Syndrome	1
Unexplained Infertility	1

Condition MeSH

Condition MeSH for orilissa
Intervention	Trials
Endometriosis	3
Menorrhagia	1
Leiomyoma	1
Dysmenorrhea	1

Clinical Trial Locations for orilissa

Trials by Country

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−

Trials by Country for orilissa
Location	Trials
United States	112
Puerto Rico	4
Canada	2

Trials by US State

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−

Trials by US State for orilissa
Location	Trials
North Carolina	5
Georgia	4
Florida	4
Washington	4
California	4

Clinical Trial Progress for orilissa

Clinical Trial Phase

Clinical Trial Phase for orilissa
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	2

Clinical Trial Status

Clinical Trial Status for orilissa
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	1
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	3

ORILISSA (Elagolix): A Breakthrough in Endometriosis Treatment

Introduction to ORILISSA

ORILISSA (elagolix) is a groundbreaking medication developed by AbbVie in collaboration with Neurocrine Biosciences, specifically designed to manage moderate to severe pain associated with endometriosis. Approved by the U.S. FDA in July 2018, ORILISSA marks the first oral gonadotropin-releasing hormone (GnRH) antagonist for this condition in over a decade[1][3].

Clinical Trials Overview

The FDA approval of ORILISSA was based on data from two replicate Phase 3 clinical trials, which are part of the largest endometriosis study program conducted to date. These trials involved nearly 1,700 women with moderate to severe endometriosis pain and were conducted at 338 sites across Canada, Europe, Latin America, South Africa, and the United States[4].

Trial Design and Participants

The trials were randomized, double-blind, and placebo-controlled. Participants were randomly assigned to receive either ORILISSA 150 mg once daily, ORILISSA 200 mg twice daily, or a placebo for a period of six months. The primary efficacy endpoints were the proportion of responders for dysmenorrhea (daily menstrual pelvic pain) and non-menstrual pelvic pain over a three-month treatment period[4].

Efficacy Outcomes

Clinical trial data demonstrated that ORILISSA significantly reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, non-menstrual pelvic pain, and pain with sex. A higher proportion of women treated with ORILISSA showed a reduction in pain compared to those receiving a placebo. Specifically, women treated with ORILISSA 150 mg once daily and 200 mg twice daily had a statistically significant greater reduction in pain with no increase in analgesic use[1][3][4].

Safety Profile

While ORILISSA has shown promising efficacy, it also comes with potential side effects. The FDA has noted that ORILISSA may cause serious side effects including bone loss, suicidal thoughts or behaviors, and worsening of mood including depression and anxiety. However, the approval did not include black-box warnings or monitoring requirements for bone mineral density changes, which is a significant advantage over other GnRH agonists[2][4].

Market Analysis

Market Need and Competition

The endometriosis market has historically been dominated by generic and off-label medications. The launch of ORILISSA in 2018 filled a significant gap by providing the first endometriosis-specific medication in over a decade. ORILISSA offers a more favorable side-effect profile compared to traditional GnRH agonists, which are associated with high bone mineral density loss and menopause-like symptoms[5].

Market Performance and Projections

Despite its potential, the uptake of ORILISSA has been described as "slow and disappointing" by key opinion leaders. However, industry analysts remain optimistic about its future. ORILISSA is expected to hit management expectations of over $2 billion by 2025, with projected sales of $65 million in the first year and swelling to $1 billion by 2020[2].

Marketing and Awareness Efforts

AbbVie has been proactive in raising awareness about endometriosis and promoting ORILISSA. The company has launched campaigns, including a doctor’s office TV ad and a partnership with Julianne Hough, to shorten the diagnosis timeline and educate the public about the disorder[2].

Pricing and Accessibility

ORILISSA was launched with a price tag of $845 per month, which is significant but reflects its innovative status and the lack of other targeted treatments in the market. The drug became available in U.S. retail pharmacies in early August 2018[2].

Future Indications and Expansion

Industry watchers anticipate that ORILISSA could eventually receive approval for additional indications, such as the treatment of uterine fibroids. This potential expansion could further solidify ORILISSA’s position in the market and increase its revenue potential[2].

Key Takeaways

• First Oral GnRH Antagonist: ORILISSA is the first oral GnRH antagonist approved for managing moderate to severe endometriosis pain in over a decade.
• Clinical Efficacy: Clinical trials demonstrated significant reductions in daily menstrual pelvic pain, non-menstrual pelvic pain, and pain with sex.
• Safety Profile: While effective, ORILISSA comes with potential side effects such as bone loss and mood changes, but without the need for black-box warnings or monitoring for bone mineral density.
• Market Potential: Despite slow initial uptake, ORILISSA is projected to achieve significant sales by 2025.
• Awareness and Marketing: AbbVie is actively promoting awareness about endometriosis and ORILISSA to improve diagnosis and treatment timelines.

FAQs

Q: What is ORILISSA, and how does it work? A: ORILISSA (elagolix) is an oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed to manage moderate to severe pain associated with endometriosis. It works by reducing the production of certain hormones that contribute to endometriosis pain.

Q: What were the key findings from the clinical trials of ORILISSA? A: Clinical trials showed that ORILISSA significantly reduced daily menstrual pelvic pain, non-menstrual pelvic pain, and pain with sex in women with moderate to severe endometriosis.

Q: What are the potential side effects of ORILISSA? A: ORILISSA may cause serious side effects including bone loss, suicidal thoughts or behaviors, and worsening of mood including depression and anxiety.

Q: How much does ORILISSA cost, and when was it made available? A: ORILISSA was launched with a price tag of $845 per month and became available in U.S. retail pharmacies in early August 2018.

Q: Are there any future indications or expansions planned for ORILISSA? A: Yes, there are expectations that ORILISSA could receive approval for additional indications, such as the treatment of uterine fibroids, in the future.

Sources

1. AbbVie Receives U.S. FDA Approval of ORILISSA™ (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis. AbbVie News.
2. AbbVie Grabs Blockbuster Approval, Clean Label for Endometriosis Drug Orilissa. FiercePharma.
3. AbbVie Receives U.S. FDA Approval of ORILISSA™ (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis. PR Newswire.
4. Drug Trials Snapshots: ORILISSA. FDA.
5. Endometriosis: how the market has developed and where it needs to go. Pharmaceutical Technology.