CLINICAL TRIALS PROFILE FOR SUPPRELIN LA

All Clinical Trials for SUPPRELIN LA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02278185 ↗	Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer	Unknown status	University of Colorado, Denver	Phase 2	2015-11-11	This randomized phase II trial compares enzalutamide with standard androgen deprivation therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has spread to other places in the body. Metabolic syndrome is defined as changes in cholesterol, blood pressure, circulating sugar levels, and body weight. Previous studies have shown that patients with prostate cancer, who have been treated with standard medical therapy that lowers testosterone levels, have an increased risk of these changes. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells instead of lowering testosterone levels. It is not yet known whether prostate cancer patients who receive enzalutamide will have reduced incidence of metabolic syndrome than patients who receive standard androgen deprivation therapy.
NCT03678025 ↗	Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer	Recruiting	National Cancer Institute (NCI)	Phase 3	2018-09-17	This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
NCT03678025 ↗	Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer	Recruiting	Southwest Oncology Group	Phase 3	2018-09-17	This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

Clinical Trial Conditions for SUPPRELIN LA

Condition Name

Condition Name for SUPPRELIN LA
Intervention	Trials
Recurrent Prostate Cancer	1
Stage III Prostate Cancer	1
Stage IV Prostate Cancer	1
Stage IV Prostate Cancer AJCC v8	1

Condition MeSH

Condition MeSH for SUPPRELIN LA
Intervention	Trials
Prostatic Neoplasms	2
Adenocarcinoma	2

Clinical Trial Locations for SUPPRELIN LA

Trials by Country

Trials by Country for SUPPRELIN LA
Location	Trials
United States	44
Mexico	1

Trials by US State

Trials by US State for SUPPRELIN LA
Location	Trials
Colorado	2
Montana	1
Missouri	1
Mississippi	1
Minnesota	1

Clinical Trial Progress for SUPPRELIN LA

Clinical Trial Phase

Clinical Trial Phase for SUPPRELIN LA
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for SUPPRELIN LA
Clinical Trial Phase	Trials
Recruiting	1
Unknown status	1

Clinical Trial Sponsors for SUPPRELIN LA

Sponsor Name

Sponsor Name for SUPPRELIN LA
Sponsor	Trials
University of Colorado, Denver	1
National Cancer Institute (NCI)	1
Southwest Oncology Group	1

Sponsor Type

Sponsor Type for SUPPRELIN LA
Sponsor	Trials
Other	2
NIH	1

SUPPRELIN LA Market Analysis and Financial Projection

Last updated: February 9, 2026

What Is the Current Status of SUPPRELIN LA Clinical Trials?

As a GnRH (gonadotropin-releasing hormone) agonist, SUPPRELIN LA (histrelin implant) is used primarily for central precocious puberty (CPP). The drug has garnered regulatory approval for this indication since 2007 and is marketed by Endo Pharmaceuticals.

Recent clinical activity includes additional studies assessing its safety and efficacy in extended or alternative uses, such as palliative care for hormone-sensitive cancers. No new pivotal registration trials are currently ongoing or planned publicly. The most recent Phase III trial for its primary indication completed in 2014, with data supporting the product’s continued market presence.

How Does the Market for SUPPRELIN LA Look?

Market Size and Revenue

The global market for GnRH agonists was valued at approximately $2.3 billion in 2022[1]. SUPPRELIN LA’s share is limited compared to oral formulations of GnRH analogs but remains significant within the implant segment.

Based on prescription data, the U.S. accounts for over 75% of sales, driven by the high prevalence of CPP in children aged 2-8 years, estimated at 9.8 per 10,000 children[2].

Market Drivers

• Increasing diagnosis of CPP: More awareness and improved screening lead to higher treatment rates.
• Preference for implant therapy: Provides a long-acting, once-yearly option, improving adherence over daily injections or oral medications.
• Off-label uses: Its application in certain hormone-sensitive cancers may expand market potential.

Market Challenges

• Competition: Other GnRH analogs like Lupron (leuprolide), Zoladex (goserelin), and implant devices such as Zoladex have established market shares.
• Pricing pressures: Cost of implants and reimbursement policies influence adoption.
• Regulatory environment: Shifts in pediatric hormone treatment guidelines may restrict or expand use.

What Are Projections for SUPPRELIN LA Over the Next Five Years?

Market Forecast

The implant segment for GnRH analogs is projected to grow at a compound annual growth rate (CAGR) of approximately 3% from 2023 to 2028[3]. SUPPRELIN LA is expected to maintain or slightly expand its share, supported by the following factors:

• Growing awareness of non-invasive long-acting therapies.
• Potential new indications or expanded off-label uses.
• Continued growth of the pediatric population with CPP.

Sales Projections

Based on current prescription rates, estimated sales for SUPPRELIN LA could reach $250-$300 million globally by 2028, assuming steady prescription growth and no major market disruptions. The U.S. market will likely dominate, accounting for roughly 70-75% of total sales.

Strategic Considerations

• Patent protections for SUPPRELIN LA are set to expire in 2028[4], opening the market to generic alternatives.
• The company’s future profitability depends on successfully defending market share and potential new indications.
• Entering expanded markets such as adolescent and adult hormone-sensitive tumors could sustain growth.

How Does SUPPRELIN LA Compare to Competing Treatments?

Feature	SUPPRELIN LA	Lupron Depot (leuprolide)	Goserelin (Zoladex)
Formulation	Subcutaneous implant	Injection, implant	Subcutaneous, implant
Dosing Frequency	Once per year	Monthly, quarterly	Monthly, quarterly
Indications	CPP, off-label use in cancers	Endometriosis, prostate cancer	Prostate, breast, endometrial cancers
Cost (approximate)	$50,000+ per year	$20,000–$25,000 per year	$30,000+ per year
Patent status	Patents expire 2028	Patents expired or near	Patents expired

SupreLIN’s niche remains largely pediatric, with its convenience favoring adherence among children. In adult oncology, implant options are less common, limiting its market share outside pediatric CPP.

What Are the Key Takeaways?

1. Clinical development activity for SUPPRELIN LA is static, with no recent pivotal trials, yet the device remains relevant for its approved indication.
2. Market share is concentrated in the U.S., with strong competition from other GnRH analogs and implants.
3. Growth prospects hinge on expanding indications, maintaining formulary access, and defending patents or developing next-generation formulations.
4. Patent expiration in 2028 presents a critical inflection point; generic competition could erode market dominance.
5. Potential for off-label use may influence future sales, especially in oncology settings.

FAQs

1. Are there any new formulations of SUPPRELIN LA under development?
No publicly announced new formulations are under clinical development; focus remains on current use and patent protection.

2. What are the major side effects associated with SUPPRELIN LA?
Common adverse effects include injection site reactions, hormonal fluctuations leading to hot flashes, headaches, and mood changes. Long-term effects include decreased bone mineral density.

3. How does SUPPRELIN LA’s administration compare to other GnRH therapies?
It is administered as a subcutaneous implant once per year, offering higher compliance vs. monthly injections or oral medications.

4. Which markets beyond the U.S. could be significant for SUPPRELIN LA?
Europe and select Asian countries, where pediatric CPP diagnosis and treatment are expanding, may become relevant as regulatory approvals are obtained.

5. What factors could accelerate or hinder the growth of SUPPRELIN LA?
Accelerators: regulatory approvals for new indications, increased awareness of CPP. Hindrances: patent expirations, market entry of cheaper generics, shifts in clinical guidelines.

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Sources
[1] MarketWatch, "GnRH Analog Market Size," 2022.
[2] CDC, "Prevalence of Precocious Puberty," 2020.
[3] Global Data, "GnRH Analog Market Forecast," 2023–2028.
[4] FDA Patent Listings, "SupraLIN LA Patent Status," 2022.