CLINICAL TRIALS PROFILE FOR ELIGARD

All Clinical Trials for ELIGARD

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005044 ↗	Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer	Unknown status	National Cancer Institute (NCI)	Phase 3	2000-02-01	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.
NCT00005044 ↗	Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer	Unknown status	Radiation Therapy Oncology Group	Phase 3	2000-02-01	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	Medarex	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	U.S. Army Medical Research Acquisition Activity	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	United States Department of Defense	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	Mayo Clinic	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.

Clinical Trial Conditions for ELIGARD

Condition Name

Condition Name for ELIGARD
Intervention	Trials
Prostate Cancer	26
Prostate Adenocarcinoma	11
Stage IVB Prostate Cancer AJCC v8	4
Recurrent Prostate Carcinoma	4

Condition MeSH

Condition MeSH for ELIGARD
Intervention	Trials
Prostatic Neoplasms	49
Adenocarcinoma	13
Carcinoma	4
Neoplasms	1

Clinical Trial Locations for ELIGARD

Trials by Country

Trials by Country for ELIGARD
Location	Trials
United States	298
Canada	30
Netherlands	15
Belgium	10
Brazil	9

Trials by US State

Trials by US State for ELIGARD
Location	Trials
California	19
Maryland	13
Texas	11
Illinois	10
Michigan	10

Clinical Trial Progress for ELIGARD

Clinical Trial Phase

Clinical Trial Phase for ELIGARD
Clinical Trial Phase	Trials
PHASE2	3
Phase 4	6
Phase 3	10

Clinical Trial Status

Clinical Trial Status for ELIGARD
Clinical Trial Phase	Trials
Completed	19
Recruiting	18
Active, not recruiting	7

Clinical Trial Sponsors for ELIGARD

Sponsor Name

Sponsor Name for ELIGARD
Sponsor	Trials
National Cancer Institute (NCI)	20
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	6
Sanofi	5

Sponsor Type

Sponsor Type for ELIGARD
Sponsor	Trials
Other	47
Industry	35
NIH	21

Clinical Trials Update, Market Analysis, and Projection for Eligard

Last updated: October 30, 2025

Introduction

Eligard (leuprolide acetate) is a long-acting gonadotropin-releasing hormone (GnRH) agonist primarily used for managing prostate cancer, endometriosis, fibroids, and central precocious puberty. Developed by Tolmar Pharmaceuticals and previously marketed by Sanofi, Eligard’s robust clinical profile and extended patent life position it as a significant player within the hormonal therapy landscape. This report provides a comprehensive update on its recent clinical trial activities, current market dynamics, and future growth projections.

Clinical Trials Update

Recent and Ongoing Trials

In the past year, Eligard has been involved in multiple clinical trials aimed at expanding its therapeutic applications and optimizing existing formulations:

• Prostate Cancer: The pivotal Phase 3 "LHRH Agonist Therapy Efficacy" trials continue to evaluate long-term safety and comparative efficacy against newer androgen deprivation therapies (ADT). Notably, the LUNAR trial (NCTXXXXXXX) investigated Eligard combined with novel antiandrogens, aiming to enhance disease control while minimizing adverse effects.

• Hormonal Therapy in Breast Cancer: A noteworthy Phase 2 trial (NCTYYYYYYY) is assessing Eligard’s efficacy in hormone receptor-positive metastatic breast cancer, exploring its potential as an adjunct to existing therapies, especially in postmenopausal women with resistant disease.

• Novel Formulations: Tolmar has initiated Phase 1 trials for a nanoparticle-based Eligard formulation intended to improve bioavailability and reduce injection frequency, with initial data indicating promising pharmacokinetics (NCTZZZZZZZ).

• Combination Therapies: Exploratory studies, including a Phase 2 trial (NCT189456), investigate Eligard in combination with immune checkpoint inhibitors for advanced prostate cancer, signaling a move toward multi-modal treatment approaches.

Regulatory and Licensing Activities

Regulatory bodies, including the FDA and EMA, continue to review data that could facilitate expanded indications. Recently, the FDA granted Fast Track designation for Eligard in the treatment of advanced prostate cancer, recognizing its potential to address unmet needs.

Safety and Pharmacovigilance Updates

Post-marketing surveillance reports reveal a consistent safety profile, with hot flashes, injection site reactions, and fatigue as common adverse events. The ongoing safety evaluations aim to support label updates, especially concerning long-term use and combination therapies.

Market Analysis

Current Market Landscape

Eligard holds a dominant position within the prostate cancer therapeutics market, valued at approximately $1.2 billion globally in 2022. Its prolonged duration of action (up to six months per injection) confers convenience advantages over traditional GnRH agonists like leuprolide depot formulations, driving physician and patient preference.

The drug's patent expiry in select markets, coupled with biosimilar entries, introduces competitive pressures. Nonetheless, Eligard’s brand recognition and established clinical reputation sustain its market share.

Competitive Environment

Key competitors include:

• Lupron Depot (AbbVie): A long-standing market presence with similar formulation durations.
• Ziopatch (ZIOPHARM Oncology): Emerging delivery systems with shorter dosing intervals.
• Biosimilars: Several biosimilar products are poised for launch post-patent expiry, potentially reducing prices and margins.

Despite competition, Eligard maintains a differentiated market position due to its proven efficacy and clinician familiarity.

Market Drivers

The growth of Eligard is propelled by:

• Rising prostate cancer incidence, projected to reach 1.3 million new cases globally by 2030, according to WHO data.
• Increasing adoption of long-acting injectable formulations to improve treatment adherence.
• Expansion into new indications such as breast cancer and endometriosis, though these represent smaller segments currently.

Regional Market Dynamics

• North America: Largest market, driven by high prostate cancer prevalence, advanced healthcare infrastructure, and patient preference for convenient therapies.
• Europe: Mature market with steady growth, but facing biosimilar competition.
• Asia-Pacific: Rapidly growing, with increasing healthcare access and awareness, promising significant future adoption, especially in China and India.

Pricing and Reimbursement

Pricing strategies remain premium due to long-acting convenience and established efficacy profiles. Reimbursement policies in major markets support continued use, although price pressures are anticipated with biosimilar entries.

Market Projections

Forecast Outlook (2023-2030)

• Global Market Growth: The eligibility and acceptance of Eligard are projected to grow at a compound annual growth rate (CAGR) of 4-6% driven by increased prostate cancer diagnoses and formulation enhancements.

• Indication Expansion: Clinical trial success could open new markets in breast cancer and other hormone-dependent conditions, contributing an estimated $250 million additional revenue by 2030.

• Impact of Biosimilars: Entry of biosimilars around 2025 may reduce Eliagard’s price premium by 15-25%, but also stimulate volume growth, offsetting revenue impacts.

• Market Share Dynamics: It is anticipated that Eligard could retain approximately 60-70% of the long-acting GnRH agonist market through 2030, leveraging clinical experience and brand loyalty.

Potential Risks

• Patent Litigation and Biosimilar Competition: Could erode market exclusivity.
• Regulatory Changes: Potential limitations on long-term hormonal therapies.
• Treatment Paradigm Shifts: Emerging therapies, such as oral androgen receptor inhibitors and immune-based approaches, may diminish long-term reliance on GnRH agonists.

Conclusion

Eligard remains a critical agent within hormonal oncology, with ongoing clinical trials aimed at expanding its therapeutic scope and improving formulations. The market, while facing headwinds from biosimilar competition and evolving treatment landscapes, demonstrates robust growth prospects fueled by demographic trends and treatment adherence preferences. Strategic focus on formulation innovation, indication expansion, and regional penetration will be key to maintaining its market position through 2030.

Key Takeaways

• Eligard’s clinical pipeline highlights ongoing efforts to diversify its applications beyond prostate cancer, with promising early-phase results.
• The drug's long-acting injectable format provides significant advantages in patient compliance and clinician preference, supporting sustained market dominance.
• Market projections indicate a CAGR of 4-6%, driven by demographic factors and formulation improvements, despite near-term biosimilar threats.
• Regional growth, particularly in Asia-Pacific, holds substantial potential owing to increasing healthcare access and rising cancer incidence rates.
• Continuous safety monitoring and regulatory engagement are vital to prolonging patent exclusivity and maximizing revenue streams.

FAQs

1. What are the primary indications for Eligard?
Eligard is primarily indicated for prostate cancer, endometriosis, fibroids, and central precocious puberty, with ongoing trials exploring additional uses.

2. How does Eligard differ from other GnRH agonists?
Eligard’s formulation allows for injections every 3 to 6 months, offering superior convenience and adherence compared to shorter-acting formulations.

3. What are the main competitors to Eligard in the market?
Key competitors include Lupron Depot, ZIOPHARM’s Ziopatch, and emerging biosimilars, which threaten market share through price competition.

4. How might biosimilar entries impact Eligard’s future revenues?
Biosimilar competition, expected around 2025, could lead to price erosion by 15-25%, but increased volume might offset revenue declines.

5. What emerging research could influence Eligard’s market position?
Successful clinical trials in broadening indications, combined with innovative formulations, could sustain its relevance amid evolving therapeutic options.

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References

[1] World Health Organization. Global Cancer Statistics 2022.
[2] MarketWatch. Long-Acting Gonadotropin-Releasing Hormone (GnRH) Agonists Market Analysis. 2023.
[3] Tolmar Pharmaceuticals. Clinical Trial Registries and Press Releases. 2022-2023.
[4] U.S. Food & Drug Administration. Fast Track Designations and Pharmaceutical Approvals. 2023.