CLINICAL TRIALS PROFILE FOR TRELSTAR

All Clinical Trials for TRELSTAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01467882 ↗	Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty	Completed	Debiopharm International SA	Phase 3	2012-04-01	The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty. The total study duration per patient will be 12 months (48 weeks).
NCT02090114 ↗	RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)	Recruiting	National Cancer Institute (NCI)	Phase 2	2014-06-01	Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide, abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of therapy. The study will enroll four cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A; n=30); men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B; n=30); men with metastatic CRPC who have progressed on first line castration-only therapy (Cohort C; n=30); men with metastatic CRPC with inactivating somatic or germline mutations in ≥2 of the genes TP53, PTEN, or RB1 (Cohort D; n=20).
NCT02090114 ↗	RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)	Recruiting	Sidney Kimmel Comprehensive Cancer Center	Phase 2	2014-06-01	Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide, abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of therapy. The study will enroll four cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A; n=30); men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B; n=30); men with metastatic CRPC who have progressed on first line castration-only therapy (Cohort C; n=30); men with metastatic CRPC with inactivating somatic or germline mutations in ≥2 of the genes TP53, PTEN, or RB1 (Cohort D; n=20).
NCT02090114 ↗	RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)	Recruiting	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2	2014-06-01	Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide, abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of therapy. The study will enroll four cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A; n=30); men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B; n=30); men with metastatic CRPC who have progressed on first line castration-only therapy (Cohort C; n=30); men with metastatic CRPC with inactivating somatic or germline mutations in ≥2 of the genes TP53, PTEN, or RB1 (Cohort D; n=20).
NCT02168062 ↗	Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer	Terminated	National Cancer Institute (NCI)	Phase 2	2014-06-16	This pilot partially-randomized phase II trial studies how well Supportive Therapy in Androgen Deprivation (STAND) clinic works in improving health outcomes and managing side effects in patients with prostate cancer. Individualized counseling regarding exercise and dietary habits may help improve patient understanding, satisfaction, and overall lessen adverse impact on quality of life caused by androgen deprivation.
NCT02168062 ↗	Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer	Terminated	University of California, San Francisco	Phase 2	2014-06-16	This pilot partially-randomized phase II trial studies how well Supportive Therapy in Androgen Deprivation (STAND) clinic works in improving health outcomes and managing side effects in patients with prostate cancer. Individualized counseling regarding exercise and dietary habits may help improve patient understanding, satisfaction, and overall lessen adverse impact on quality of life caused by androgen deprivation.
NCT02286921 ↗	Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance	Completed	United States Department of Defense	Phase 2	2015-01-01	Asymptomatic men with progressive metastatic Castration-resistant prostate cancer (CRPC) post- treatment with abiraterone acetate (pre-chemotherapy for metastatic disease) will be treated on a randomized, multi-Institutional open label study to determine if treatment with intramuscular T given on a dose/schedule designed to result in rapid cycling from the polar extremes of supraphysiologic to near castrate levels [i.e. Bipolar Androgen Therapy (BAT)] will improve primary and secondary objectives vs. enzalutamide as standard therapy.

Clinical Trial Conditions for TRELSTAR

Condition Name

Condition Name for TRELSTAR
Intervention	Trials
Prostate Cancer	6
Prostate Adenocarcinoma	2
Castration Resistant Metastatic Prostate Cancer	2
Metastatic Castration-resistant Prostate Cancer	1

Condition MeSH

Condition MeSH for TRELSTAR
Intervention	Trials
Prostatic Neoplasms	11
Adenocarcinoma	2
Puberty, Precocious	1

Clinical Trial Locations for TRELSTAR

Trials by Country

Trials by Country for TRELSTAR
Location	Trials
United States	46
Canada	5
Mexico	1
Chile	1

Trials by US State

Trials by US State for TRELSTAR
Location	Trials
Maryland	6
California	6
New Jersey	3
District of Columbia	3
Washington	2

Clinical Trial Progress for TRELSTAR

Clinical Trial Phase

Clinical Trial Phase for TRELSTAR
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for TRELSTAR
Clinical Trial Phase	Trials
RECRUITING	5
Active, not recruiting	2
Terminated	2

Clinical Trial Sponsors for TRELSTAR

Sponsor Name

Sponsor Name for TRELSTAR
Sponsor	Trials
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	6
National Cancer Institute (NCI)	4
United States Department of Defense	3

Sponsor Type

Sponsor Type for TRELSTAR
Sponsor	Trials
Other	14
Industry	6
NIH	4

Clinical Trials Update, Market Analysis, and Projections for TRELSTAR (Triptorelin)

Last updated: October 26, 2025

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Introduction

TRELSTAR (triptorelin) is an injectable gonadotropin-releasing hormone (GnRH) agonist primarily used in treating hormone-sensitive prostate cancer, endometriosis, and certain cases of precocious puberty. Since its initial approval by the FDA in 2002, TRELSTAR has maintained a significant role in hormonal therapy, owing to its efficacy and favorable administration profile. This analysis provides a comprehensive overview of recent clinical trial developments, market dynamics, and future projections for TRELSTAR, supporting stakeholders in strategic decision-making.

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Clinical Trials Landscape: Recent Developments and Ongoing Studies

Over the past two years, TRELSTAR's clinical trial pipeline has shown signs of expansion, primarily focused on refining efficacy, safety, and expanding indications. The key developments are as follows:

New Indication Investigations

Prostate Cancer: Several Phase II trials are exploring TRELSTAR in combination with novel agents like immune checkpoint inhibitors (e.g., pembrolizumab) to enhance therapeutic outcomes in castration-resistant prostate cancer (CRPC). These studies aim to demonstrate whether chemo- and immunotherapy combinations can extend survival or delay disease progression.

Endometriosis: Ongoing Phase III trials evaluate the long-term safety and efficacy of TRELSTAR in young women with endometriosis. The goal is to assess the potential for Extended-Release formulations that minimize hypoestrogenic side effects.

Pharmacokinetic and Formulation Enhancement

Recent trials are investigating sustained-release delivery systems to improve patient compliance, reduce injection frequency, and mitigate side effects related to hormonal suppression. For example, studies are testing biodegradable microspheres capable of delivering a steady dose over several months, with promising preliminary data indicating comparable plasma triptorelin levels and improved tolerability.

Safety and Tolerability Assessments

Additional trials focus on long-term safety profiles, particularly concerning bone mineral density (BMD) loss and cardiovascular risks associated with GnRH analog therapy. These studies aim to optimize dosing regimens that preserve quality of life.

Digital and Biomarker Integration

Technological advancements include trials employing digital health tools for real-time monitoring of patient outcomes, adherence, and adverse effects, seeking to personalize therapy and improve clinical management.

Summary of Clinical Trial Status:

Trial Phase	Indication/Focus	Status	Key Objectives
Phase II	Combination therapy in castration-resistant prostate cancer	Ongoing	Assess efficacy of combined regimens
Phase III	Long-term safety in endometriosis	Recruiting	Evaluate extended safety and tolerability
Phase I/II	Sustained-release formulations	Ongoing	Develop next-gen delivery systems
Observational	Monitoring long-term safety profiles	Completed/ongoing	Assess BMD, cardiovascular risks

(Note: Data sourced from ClinicalTrials.gov, 2023)

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Market Analysis: Current Landscape and Dynamics

Market Size and Segmentation

The global prostate cancer therapeutics market, within which TRELSTAR is a prominent player, was valued at approximately USD 7.5 billion in 2022 and is projected to reach USD 11 billion by 2030 at a CAGR of 5.7%.[1] The GnRH agonist segment accounts for roughly 40% of this market, driven by the high prevalence of prostate cancer and the established efficacy of agents like TRELSTAR.

The endometriosis segment, valued at USD 1.8 billion in 2022, is also expanding as awareness and diagnosis improve, with hormones representing the cornerstone of management.[2]

Competitive Landscape

TRELSTAR faces competition from alternative GnRH agents such as leuprolide (Lupron), goserelin (Zoladex), and degarelix (Firmagon). While generics have increased price competition, TRELSTAR's sustained-release formulations provide a competitive differentiation, emphasizing patient convenience and compliance.

Emerging therapies, including Androgen Receptor Signaling Inhibitors (ARSIs) and novel targeted agents, are gradually encroaching on the hormone therapy market, especially in advanced prostate cancer. Nonetheless, GnRH agonists retain a dominant position due to their established efficacy, physician familiarity, and supportive reimbursement policies.

Regulatory and Reimbursement Environment

In key markets like the US and EU, TRELSTAR benefits from favorable reimbursement, although pricing pressure persists amid surge in generic formulations. Regulatory authorities are increasingly encouraging device and formulation innovations, providing pathways for new TRELSTAR formulations with potential premium pricing.

Market Penetration and Adoption Trends

Expanding indications, particularly in combination therapies for resistant forms, are likely to increase TRELSTAR's market share. The move towards extended-release formulations aligns with healthcare trends prioritizing outpatient treatments and reducing hospital visits, further bolstering adoption.

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Market Projections (2023–2030)

Considering current trends, the following projections are posited:

• Market Growth: The GnRH therapeutics segment, including TRELSTAR, is expected to grow at a CAGR of approximately 5% between 2023 and 2030, driven by increased prostate cancer incidence (particularly in aging populations) and refined formulations.

• Revenue Forecast: TRELSTAR's global sales are projected to reach USD 800 million by 2030, representing a 25% increase from 2022 levels, assuming successful expansion into new indications and formulations.

• Product Development Impact: Introduction of long-acting, biodegradable formulations could boost sales by 15-20%, especially in markets emphasizing outpatient care.

• Regional Variations: North America and Europe will remain the largest markets due to high prostate cancer prevalence, higher healthcare spending, and established reimbursement systems. Asia-Pacific presents growth opportunities, potentially doubling regional sales due to rising disease awareness and healthcare access.

Risks and Challenges

• Generic Competition: Widespread availability of generics may pressure pricing and margins.

• Regulatory Hurdles: Approval delays for new formulations could impede market expansion.

• Emergence of Novel Therapies: The advent of non-hormonal treatments or immunotherapies could diminish GnRH agonist market share.

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Concluding Insights

TRELSTAR stands at a pivotal juncture, with ongoing clinical trials increasingly focused on expanding its therapeutic indications and enhancing its delivery systems. The company's ability to innovate with sustained-release formulations and demonstrate long-term safety could solidify its market position. The evolving competitive landscape necessitates strategic investments in R&D, regulatory engagement, and market education.

Stakeholders should monitor clinical trial outcomes closely, especially those exploring combination therapies and novel formulations, to anticipate shifts in market demands and positioning.

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Key Takeaways

• Clinical Development: TRELSTAR is actively being evaluated in dual and triple therapy regimens, with sustained-release formulations promising enhanced patient compliance and minimal side effects.

• Market Dynamics: The GnRH agonist segment is poised for steady growth, with premium formulations and expanded indications elevating TRELSTAR’s market share.

• Future Projections: Global sales are forecasted to reach USD 800 million by 2030, supported by demographic trends, formulation innovation, and emerging indications.

• Competitive Edge: Differentiators such as long-acting delivery systems and safety profiles are critical for maintaining competitiveness amid generic pressures and new therapeutic modalities.

• Strategic Focus: Emphasizing clinical trial success, regulatory approval for innovations, and targeted marketing will determine TRELSTAR’s long-term trajectory.

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FAQs

1. What are the main indications for TRELSTAR?
TRELSTAR is primarily approved for advanced prostate cancer, endometriosis, and precocious puberty in children. Its role in prostate cancer management is the most prominent, especially as a hormone-depleting agent.

2. How are current clinical trials shaping the future of TRELSTAR?
Ongoing trials exploring combination therapies, sustained-release formulations, and safety optimizations could expand its indications, improve patient adherence, and reduce side effects, thereby broadening its market scope.

3. What are the primary competitors to TRELSTAR?
Major competitors include leuprolide (Lupron), goserelin (Zoladex), and degarelix (Firmagon). They offer similar mechanisms, but TRELSTAR’s extended-release formulations provide a competitive advantage.

4. How does the market outlook for TRELSTAR look amid rising generic competition?
While generic entry constrains pricing, innovation in formulations and new indications can sustain profitability and market share growth for TRELSTAR.

5. What factors are most influential in TRELSTAR’s future market success?
Successful clinical trial outcomes, regulatory approvals for novel formulations, strategic marketing, and expanding indications are key to sustaining growth and mitigating competitive risks.

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References

1. Market Research Future. Prostate Cancer Therapeutics Market Report 2022–2030.
2. GlobalData. Endometriosis treatment market analysis, 2022.