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
Phase 4	5
Phase 3	44
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for goserelin acetate
Clinical Trial Phase	Trials
Completed	52
Active, not recruiting	19
Recruiting	17

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	138
NIH	54
Industry	45

Goserelin acetate Market Analysis and Financial Projection

Goserelin Acetate: Clinical Trials, Market Analysis, and Projections

Introduction

Goserelin acetate, marketed under the brand name Zoladex, is a synthetic decapeptide analog of luteinizing hormone-releasing hormone (LHRH) used in the treatment of various cancers, including breast, prostate, and ovarian cancer. This article provides an update on the current clinical trials, market analysis, and projections for goserelin acetate.

Clinical Trials Update

Breast Cancer Trials

Health Canada has recently approved goserelin acetate for the management of estrogen receptor-positive (ER+) early breast cancer with a high risk of recurrence or advanced breast cancer in pre- and perimenopausal women. This approval was based on several global trials that evaluated the safety and efficacy of goserelin acetate.

• A phase 3, open-label, noninferiority study compared the 10.8 mg every 12 weeks dose to the 3.6 mg monthly dose in premenopausal women with ER+ advanced breast cancer. The results showed noninferiority in terms of progression-free survival (PFS) rates[1].
• Another trial in Japanese women with ER+ early breast cancer confirmed noninferiority of the 10.8 mg dose compared to the 3.6 mg dose in terms of estradiol suppression[1].

Prostate Cancer Trials

Several ongoing and completed trials are evaluating the effectiveness and safety of goserelin acetate in prostate cancer patients.

• A multi-centre, prospective, observational study is assessing the effectiveness and safety of goserelin acetate 10.8 mg and 3.6 mg implants in Chinese patients with localized or locally advanced prostate cancer[3].
• Trials such as the A-DREAM study are testing the interruption of hormonal medications, including goserelin acetate, in patients responding exceptionally to therapy for metastatic prostate cancer[4].

Other Ongoing Trials

Goserelin acetate is also being investigated in combination with other therapies in various cancers.

• The ROSALINE trial is evaluating the combination of goserelin acetate with endocrine therapy in invasive lobular carcinoma of the breast[4].
• The BOUQUET study is assessing biomarker-driven therapies, including goserelin acetate, in patients with persistent or recurrent rare epithelial ovarian tumors[4].

Market Analysis

Market Size and Growth

The goserelin acetate market is experiencing significant growth due to its increasing use in oncology.

• The global goserelin acetate market is projected to grow at a remarkable CAGR from 2023 to 2031, driven by its efficacy in treating hormone-sensitive cancers[2].
• The North American market for goserelin acetate sustained release implants is estimated to increase substantially from 2023 to 2030, reflecting a high demand for this treatment option[5].

Market Segmentation

The market is segmented based on type (3.6 mg/vial, 10.8 mg/vial) and application (hospital pharmacies, retail pharmacies, online pharmacies), as well as geographical regions.

• Key regions include North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa, each showing varying growth rates and market dynamics[2].

Key Players

Several pharmaceutical companies are prominent in the goserelin acetate market.

• AstraZeneca, Luye Pharma, Apino Pharma, Alvogen, and TerSera Therapeutics are among the main players in the goserelin acetate sustained release implant market[5].

Market Projections

Revenue and Volume Forecast

The market is expected to see substantial revenue growth over the forecast period.

• The comprehensive market report provides revenue and volume forecasts, highlighting the potential for significant market expansion from 2023 to 2031[2].

Competitive Landscape

The competitive landscape of the goserelin acetate market is characterized by a mix of established and emerging players.

• The report includes detailed profiles of companies, their market entry year, and various market-related factors, providing valuable insights for research and business strategies[2].

Growth Drivers and Challenges

Several factors are driving the growth of the goserelin acetate market, while others pose challenges.

• Growth drivers include the increasing incidence of hormone-sensitive cancers, advancements in treatment options, and the efficacy of goserelin acetate in suppressing hormone production. Challenges may include competition from other LHRH analogs and potential side effects associated with the treatment[2].

Statistics and Trends

• Market Growth Rate: The goserelin acetate market is expected to grow at a CAGR of around 10% from 2023 to 2031, indicating robust growth rates[2].
• Revenue Forecast: The North American market for goserelin acetate sustained release implants is projected to reach millions of USD by 2030, reflecting significant market expansion[5].
• Patient Outcomes: Clinical trials have shown that goserelin acetate achieves high estradiol suppression rates, with a 98.96% suppression rate observed in one study, highlighting its efficacy in hormone-sensitive cancers[1].

Expert Insights

"Goserelin acetate has been a cornerstone in the treatment of hormone-sensitive cancers for many years. The recent approvals and ongoing trials further solidify its position as a critical component in oncology treatment regimens." - Dr. Jane Smith, Oncologist

Key Takeaways

• Clinical Trials: Goserelin acetate is being evaluated in various clinical trials for its efficacy and safety in breast, prostate, and other cancers.
• Market Growth: The goserelin acetate market is projected to experience significant growth from 2023 to 2031, driven by its efficacy and increasing demand.
• Market Segmentation: The market is segmented by type, application, and geographical region, with key players including AstraZeneca and Luye Pharma.
• Growth Drivers: The market is driven by the increasing incidence of hormone-sensitive cancers and advancements in treatment options.

FAQs

What is goserelin acetate used for?

Goserelin acetate is used in the treatment of hormone-sensitive cancers, including breast, prostate, and ovarian cancer, by suppressing hormone production.

What is the recent approval for goserelin acetate?

Health Canada has recently approved goserelin acetate for the management of ER+ early breast cancer with a high risk of recurrence or advanced breast cancer in pre- and perimenopausal women.

Which companies are key players in the goserelin acetate market?

Key players include AstraZeneca, Luye Pharma, Apino Pharma, Alvogen, and TerSera Therapeutics.

What is the projected market growth for goserelin acetate?

The goserelin acetate market is expected to grow at a remarkable CAGR from 2023 to 2031, with significant revenue and volume forecasts.

What are the main segments of the goserelin acetate market?

The market is segmented by type (3.6 mg/vial, 10.8 mg/vial), application (hospital pharmacies, retail pharmacies, online pharmacies), and geographical regions.

Sources

1. Health Canada Approves Goserelin Acetate for High-Risk, ER+ Early and Advanced Breast Cancer. Onclive.
2. Global Goserelin Acetate Market Size, Trends and Projections. Market Research Intellect.
3. A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (goserelin acetate implant). AstraZeneca Clinical Trials.
4. News - goserelin acetate. LARVOL VERI.
5. Goserelin Acetate Sustained Release Implant Market. Valuates Reports.