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.
NCT00002582 ↗	Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer	Completed	Yorkshire Regional Clinical Trials Research Unit	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 IV 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
Michigan	26
Florida	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

Executive summary Goserelin acetate (marketed as Zoladex and generics) is a long-established GnRH agonist used across prostate cancer, advanced breast cancer, and endometriosis/gynecologic indications. The near-to-medium-term competitive outlook is driven by (1) slow-moving generic substitution in established oncology pathways, (2) payer and inventory dynamics for implant dosing, and (3) product-level differentiation tied to implant strengths, regimen scheduling, and manufacturing continuity. A clinical-trials “update” and a forward-looking market projection cannot be produced with complete accuracy without verified, drug-specific trial registries and consensus forecasts; no reliable, citable dataset is provided in the prompt.

Clinical trials update for goserelin acetate: what studies are ongoing and what endpoints matter?

Last updated: July 28, 2026

What trial phases and populations dominate goserelin acetate research?

Goserelin acetate is a mature therapy with limited new “first-in-class” development. Where new studies occur, they typically target:

• Label expansions within prostate cancer and breast cancer subpopulations
• Comparative clinical pharmacology (implant release kinetics, switching from other LHRH analogs)
• Combination regimens with androgen receptor pathway inhibitors or endocrine partners (oncology), or with surgical and hormonal comparators (endometriosis)

What endpoints are used in goserelin acetate trials?

Common endpoints cluster around:

• Testosterone suppression (prostate cancer)
• Estradiol or estrogen suppression and symptom control (endometriosis)
• Tumor response or progression-free outcomes when used in oncology combination settings
• Pharmacokinetics from implant release profiles and adherence/switching tolerability outcomes

Where do new trials usually appear: registry signals to watch?

For a clinical-trials update, the relevant pipeline signals are:

• ClinicalTrials.gov and EU CTR registrations for “goserelin acetate” or product names using implant strengths (3.6 mg, 10.8 mg)
• Investigator-initiated studies that test sequencing with radiation or systemic agents
• Sponsor trials focusing on switching studies (non-interchangeability issues with implant release)

Market analysis for goserelin acetate: who buys it and why does the implant format matter?

How is goserelin acetate used commercially?

Goserelin acetate’s core revenue drivers are:

• Oncology chronic administration (prostate cancer and advanced breast cancer)
• Chronic gynecologic use for endometriosis, where long-acting implant convenience supports adherence
• Reliance on durable supply chains for implant manufacturing and distribution

What is the competitive landscape: Zoladex vs generics?

Commercial dynamics typically reflect:

• Brand-to-generic transition history in each market
• Contracting behavior by wholesalers and group purchasing organizations
• Formulation and presentation differences (strength, pack size, implant delivery device)

What barriers affect entry for additional generic or “authorized” products?

Implant products face practical and regulatory constraints:

• Manufacturing reproducibility for implant composition and drug-release characteristics
• Device-adjacent quality controls for the injection system and implant integrity
• Batch-to-batch consistency aligned with regulatory comparability expectations

Market projection for goserelin acetate: how do growth and substitution trends translate into revenue?

What drives demand growth for goserelin acetate?

Projections in mature therapies usually hinge on:

• Incidence and treatment penetration in prostate cancer and endometriosis
• Adoption shifts among GnRH agonists and GnRH antagonists (class substitution)
• Risk-adjusted payer policies that may favor lower-cost agents once generics are established

What constrains growth?

Key headwinds typically include:

• Patent and exclusivity tail already spent in major markets (leading to sustained generic competition)
• Class switching toward newer GnRH agonist/antagonist profiles where clinically justified
• Price erosion from ongoing generic supply

How should market projection be modeled (practical framework)?

A credible model would separate:

• Volume: patient counts, treatment duration, and implant dosing schedule adherence
• Mix: strength utilization (3.6 mg vs 10.8 mg), line-of-therapy shifts, and switching
• Price: country-level generic discount curves, tenders, and reimbursement changes
• Competitive actions: new generic launches, authorized generics, and supply interruptions

Patent and exclusivity context for goserelin acetate: when does competition accelerate? A precise exclusivity and patent-expiration timeline is not provided in the prompt. Without verified Orange Book/Bolar and jurisdictional patent data for the exact marketed reference product(s) and dosage forms in specific countries, a reliable “when does exclusivity lose” analysis cannot be completed to a litigation-usable standard.

Key takeaways

• Goserelin acetate remains a mature, implant-based therapy with commercial demand anchored in chronic oncology and gynecologic indications.
• Market dynamics are dominated by generic competition, payer contracting, and manufacturing continuity rather than rapid innovation.
• A clinical-trials update and numerical market projections require a verified, citable dataset of active studies and market forecasts, which is not supplied in the prompt.

FAQs

1. How do GnRH agonists like goserelin acetate compare with GnRH antagonists in treatment selection for prostate cancer?
2. What dosing schedule differences (3.6 mg vs 10.8 mg implants) affect adherence and payor formularies?
3. What risk factors drive supply constraints for long-acting implant injectables like goserelin acetate?
4. How do tenders and reimbursement decisions accelerate price erosion for generic LHRH agonist implants?
5. Which clinical endpoints (testosterone suppression vs symptom control) are most relevant for goserelin acetate studies?

References

No sources were provided or can be cited from the prompt.