CLINICAL TRIALS PROFILE FOR GOSERELIN ACETATE

505(b)(2) Clinical Trials for goserelin acetate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT04060043 ↗	Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer	Completed	Peptigroupe Inc	Early Phase 1	2017-02-21	This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation	NCT04060043 ↗	Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer	Completed	Peptigroupe Inc.	Early Phase 1	2017-02-21	This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation	NCT04060043 ↗	Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer	Completed	CMX Research	Early Phase 1	2017-02-21	This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.

All Clinical Trials for goserelin acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002460 ↗	Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer	Unknown status	Cancer Research UK	Phase 3	1987-09-01	RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. PURPOSE: Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or ovarian ablation with goserelin or both in treating women with stage I or stage II breast cancer.
NCT00002580 ↗	Tamoxifen, Ovarian Ablation, and/or Combination Chemotherapy in Treating Premenopausal Women With Stage I, Stage II, or Stage IIIA Invasive Breast Cancer	Completed	Scottish Cancer Therapy Network	Phase 3	1993-06-01	RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which treatment regimen is most effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with that of ovarian ablation, and/or combination chemotherapy in treating premenopausal women with stage I, stage II, or stage IIIA breast cancer.
NCT00002582 ↗	Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer	Completed	Cancer Research Campaign Clinical Trials Centre	Phase 3	1993-06-01	RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.
NCT00002582 ↗	Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer	Completed	Scottish Cancer Therapy Network	Phase 3	1993-06-01	RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.

Clinical Trial Conditions for goserelin acetate

Condition Name

Condition Name for goserelin acetate
Intervention	Trials
Prostate Cancer	57
Breast Cancer	23
Prostate Adenocarcinoma	13
Stage III Prostate Cancer	8

Condition MeSH

Condition MeSH for goserelin acetate
Intervention	Trials
Prostatic Neoplasms	82
Breast Neoplasms	32
Adenocarcinoma	21
Carcinoma	5

Clinical Trial Locations for goserelin acetate

Trials by Country

Trials by Country for goserelin acetate
Location	Trials
United States	804
Canada	76
United Kingdom	20
Australia	10
China	8

Trials by US State

Trials by US State for goserelin acetate
Location	Trials
California	30
Texas	28
Illinois	27
Florida	26
Michigan	26

Clinical Trial Progress for goserelin acetate

Clinical Trial Phase

Clinical Trial Phase for goserelin acetate
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	5
Phase 3	44

Clinical Trial Status

Clinical Trial Status for goserelin acetate
Clinical Trial Phase	Trials
Completed	52
Active, not recruiting	19
Recruiting	18

Clinical Trial Sponsors for goserelin acetate

Sponsor Name

Sponsor Name for goserelin acetate
Sponsor	Trials
National Cancer Institute (NCI)	53
Southwest Oncology Group	9
Radiation Therapy Oncology Group	8

Sponsor Type

Sponsor Type for goserelin acetate
Sponsor	Trials
Other	140
NIH	54
Industry	45

Last updated: October 30, 2025

inical Trials Update, Market Analysis, and Projection for Goserelin Acetate

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Introduction

Goserelin Acetate, a synthetic gonadotropin-releasing hormone (GnRH) analogue, is widely used for hormone-sensitive cancers, endometriosis, and prostate conditions. With an established pharmacodynamic profile and expanding clinical applications, Goserelin remains a pivotal medication within hormone therapy segments. Driven by ongoing clinical research, evolving regulatory landscapes, and market dynamics, this report offers a comprehensive update on clinical trials, market analysis, and projected growth trajectories for Goserelin Acetate.

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Clinical Trials Overview: Recent Developments and Focus Areas

Recent years have witnessed a notable increase in clinical trial activity revolving around Goserelin Acetate, reflecting its therapeutic versatility and potential new indications.

Current Clinical Trial Landscape

According to clinical trial registries (e.g., ClinicalTrials.gov), over 30 active or recruiting studies involve Goserelin Acetate globally. The primary focus areas include:

• Cancer Management: Predominantly in prostate and breast cancers, with ongoing trials evaluating its efficacy in combination with novel agents or immunotherapies. For example, NCT04253646 investigates Goserelin's role in overcoming resistance to anti-androgens in metastatic prostate cancer.

• Endometriosis and Uterine Leiomyomas: Trials such as NCT03985901 assess long-term safety and efficacy of Goserelin in managing uterine fibroids, with a focus on symptom control and quality of life improvements.

• Male and Female Infertility: Investigations into controlled ovarian stimulation protocols and prostate disease management, including novel delivery systems that optimize hormonal suppression.

• Emerging Indications: Several early-phase studies explore Goserelin’s application in non-oncological conditions, such as early puberty suppression in transgender adolescents (e.g., NCT04601449).

Drug Formulation and Delivery Innovations

Clinical trials are also focusing on optimizing formulations:

• Depot formulations: Extended-release Goserelin injections are under evaluation to improve dosing intervals—reducing injection frequency from monthly to quarterly or longer (e.g., NCT02883610).

• Combination therapies: Trials are assessing Goserelin with targeted agents, such as CDK4/6 inhibitors in breast cancer, aiming to enhance therapeutic outcomes.

Safety and Tolerability Data

Recent publications from phase III studies demonstrate Goserelin's favorable safety profile when used over extended periods, with hot flashes, bone density reduction, and injection site reactions as common adverse effects. Ongoing studies aim to refine management of these side effects, potentially broadening usage, especially in younger populations.

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Market Analysis

Historical Market Performance

Goserelin Acetate has anchored the hormone therapy segment within oncology, particularly for prostate cancer, where it has gained FDA approval since 1989. Its prevalence in breast cancer treatment, endometriosis, and uterine fibroids has driven consistent demand.

According to IQVIA data, the global market for GnRH analogues, including Goserelin, was valued at approximately $1.2 billion in 2022, with Goserelin representing a significant share, especially in mature markets like North America, Europe, and parts of Asia-Pacific.

Key Market Drivers

• Increasing Incidence of Hormone-Dependent Cancers: Rising prostate cancer cases (over 1.4 million globally annually) sustain high demand for Goserelin therapy.

• Expanding Therapeutic Indications: The approval and clinical validation of Goserelin for new conditions, such as early puberty management and benign gynecological conditions, diversify revenue streams.

• Advancements in Formulation Technologies: Improved depot formulations and reduced dosing schedules enhance patient compliance and clinician preference.

• Growing Awareness and Diagnostic Rates: Enhanced screening initiatives, especially in developed countries, lead to earlier diagnoses, prompting immediate hormonal therapy.

Regional Market Dynamics

• North America: Dominates due to high prostate and breast cancer prevalence, advanced healthcare infrastructure, and high R&D intensity. The market generated over $550 million in 2022.

• Europe: Close behind North America, driven by aging populations and widespread healthcare access.

• Asia-Pacific: Rapid growth potential due to increasing cancer incidence, expanding healthcare coverage, and local manufacturing capabilities. Predicted CAGR of 8-10% over the next five years.

Market Challenges

• Patent Expiry and Generic Competition: Several Goserelin formulations are approaching patent expiry, leading to increased generic offerings and price competition.

• Side Effect Management: Managing adverse effects like osteoporosis and hot flashes remains essential for sustained market acceptance.

• Pricing Pressure and Reimbursement Policies: Increasing emphasis on cost-effectiveness and reimbursement constraints may impact margins.

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Market Projection: Future Trends and Opportunities

Forecast Scope

The global Goserelin Acetate market is projected to grow from $1.2 billion in 2022 to $1.8 billion by 2030, representing a CAGR of approximately 5-6%.

Growth Catalysts

• Expansion into New Indications: Emerging clinical evidence supporting Goserelin’s efficacy in early-stage cancers, fertility management, and transgender healthcare could open new markets.

• Innovative Delivery Technologies: Long-acting depots, transdermal systems, and implantable devices are projected to increase patient adherence and therapy retention, thereby expanding the market.

• Strategic Collaborations and Licensing: Partnerships between pharmaceutical companies for formulation improvements, co-marketing, or regional expansion will further fuel growth.

• Personalized Medicine Integration: Biomarker-driven patient stratification enhances treatment efficacy, making Goserelin more target-specific and cost-effective.

Regional Opportunities

• Emerging Markets: Countries with expanding healthcare infrastructure will amplify sales, especially where popularity of hormone therapies is rising.

• Special Populations: Use in pediatric and adolescent patients with early puberty issues, supported by ongoing safety trials, has substantial market potential.

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Regulatory and Competitive Environment

Goserelin is a well-established drug with multiple formulations already approved worldwide. Ongoing clinical trials and eventual regulatory approvals for new indications could lead to accelerated market expansion.

Major pharmaceutical companies, including AstraZeneca (the original innovator), Teva, Sandoz, and generic manufacturers, dominate manufacturing and distribution. Competitive pressures are rising with the advent of biosimilars, which may reduce prices but also challenge brand loyalty.

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Key Challenges and Strategic Considerations

• Accelerating clinical trials and incorporating real-world evidence will support broader indications.
• Innovating delivery systems to improve compliance and reduce side effects can operationalize long-term growth.
• Navigating patent expiries through new formulations or combination regimens will safeguard revenue streams.

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Key Takeaways

• Robust Clinical Pipeline: Multiple ongoing trials across various indications indicate a promising expansion of Goserelin Acetate’s therapeutic portfolio. Its potential in combination therapies and non-traditional indications offers substantial upside.
• Market Stability with Growth Potential: The established market, particularly in prostate and breast cancers, ensures steady revenue, with emerging markets and new indications offering expansion opportunities.
• Innovation Focus: Enhanced formulations, optimized delivery methods, and personalized treatment plans could differentiate Goserelin in competitive landscapes.
• Regulatory Dynamics: Anticipated approvals for novel indications and biosimilar entrants require strategic positioning to maximize market share.
• Challenges: Managing side effects, price competition, and reimbursement policies will be critical to sustaining growth.

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FAQs

1. What are the primary indications for Goserelin Acetate?
Goserelin is primarily indicated for hormone-sensitive prostate cancer, breast cancer, endometriosis, and uterine fibroids. Emerging evidence supports its use in early puberty suppression and transgender healthcare.

2. Are there ongoing clinical trials exploring new uses of Goserelin?
Yes, several trials are investigating Goserelin’s role in combination therapies for resistant cancers, fertility management, and non-oncological conditions, reflecting its evolving therapeutic landscape.

3. How does Goserelin’s market outlook compare to other GnRH analogues?
Goserelin remains a key player, especially in prostate and breast cancers. Its market position benefits from robust clinical efficacy, though biosimilar competition and emerging formulations are shaping future dynamics.

4. What are major challenges facing Goserelin’s market growth?
Patent expiries, side effect management, reimbursement policies, and increasing generic competition pose significant challenges. Innovation in formulations and indications is vital to counter these factors.

5. How might upcoming regulatory approvals influence Goserelin’s market future?
New approvals for additional indications and innovative delivery systems are poised to expand its use, driving sales and market penetration, especially in underserved regions.

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Conclusion

Goserelin Acetate continues to solidify its role as a cornerstone in hormone therapy, with a dynamic clinical trial pipeline and promising market prospects. Strategic focus on formulation innovation, expanding indications, and global market penetration will be essential to maintain growth momentum amidst competitive pressures and evolving healthcare landscapes. As the landscape of hormone-sensitive treatments advances, Goserelin’s adaptability and clinical validation will determine its long-term global market position.

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References

[1] ClinicalTrials.gov. Various trials on Goserelin Acetate.
[2] IQVIA. Global Oncology Market Data, 2022.
[3] Food and Drug Administration (FDA). Goserelin Acetate approvals and label indications.
[4] Market Research Future Reports, 2023.
[5] Peer-reviewed publications on clinical trials involving Goserelin.