PeptideTrace
ApprovedGnRH AgonistSexual Health & Hormonal

Goserelin (Zoladex)

A

Evidence Grade A — Regulatory approved. 1197 published studies. 44 registered clinical trials.

44 trials1,197 studiesUSEUCA

Medically reviewed by a licensed medical professional

Licensed Indications

  • Advanced Breast Cancer
  • Advanced Prostate Cancer
  • Endometrial Thinning Prior to Ablation
  • Endometriosis

User Experience Reports

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Overview

Goserelin (sold as Zoladex) is a hormone-suppressing medication delivered as a tiny biodegradable implant injected under the skin of the abdomen, available in one-month and three-month formulations. It is used to treat prostate cancer, breast cancer in premenopausal women, and endometriosis by shutting down the body's production of sex hormones.

Also Known As

Goserelin is also known by these brand and alternate names:

Research Activity

1,197studies
Human 985
Animal 33
In-vitro 47
Reviews 164

1,197 published studies: 985 human, 33 animal, 47 in-vitro, 164 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
Not authorised by EMA(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUNot applicable (not authorised)
CAPrescription drug

Summary

Goserelin is marketed as Zoladex by AstraZeneca, available as 3.6 mg monthly and 10.8 mg three-monthly subcutaneous implants. First approved in 1989, it is used in advanced prostate cancer, premenopausal breast cancer, endometriosis, and for thinning the uterine lining before surgical procedures.

Goserelin achieves castrate-level testosterone suppression (below 50 ng/dL) within two to four weeks. Its unique implant delivery system means there is no liquid injection, reconstitution, or refrigeration required — a practical advantage in some clinical settings. Like all GnRH agonists, it causes an initial hormone flare before suppression takes effect. Goserelin holds an important niche in breast cancer treatment, where it is used to suppress ovarian function in premenopausal women with hormone-receptor-positive disease, often in combination with aromatase inhibitors.

Mechanism of Action

Goserelin works through the same mechanism as leuprolide — it mimics the brain's natural GnRH signalling hormone but provides a constant rather than pulsed signal, ultimately shutting down sex hormone production. What distinguishes goserelin is its delivery method: it is embedded in a small biodegradable implant that slowly dissolves over one or three months, providing a steady release of medication without the need for repeated injections or reconstitution.

Research Summary

Goserelin has decades of clinical data across multiple conditions. Its implant delivery system is distinctive — there is no liquid injection or reconstitution required, and it does not need refrigeration, which can be a practical advantage in some clinical settings. The three-monthly formulation reduces the number of clinic visits required. Like all GnRH agonists, goserelin causes an initial hormone surge before suppression takes effect (typically two to four weeks), which in prostate cancer patients requires co-prescribing an anti-androgen to manage. Long-term hormone suppression carries risks including bone density loss, cardiovascular effects, and metabolic changes. In breast cancer, goserelin holds an important niche for suppressing ovarian function in premenopausal women with hormone-receptor-positive disease, often combined with aromatase inhibitors.

Clinical Trials

PeptideTrace tracks 44 registered clinical trials for Goserelin sourced from ClinicalTrials.gov.

NCT07552506N/ANot Yet Recruiting

Clinical Study on the Preservation of Ovarian Function in Patients With Aplastic Anemia Following Allogeneic Hematopoietic Stem Cell Transplantation Using Goserelin

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyEndpoint: Menstrual recovery rate six months after transplantationCompletion: 2027-10-01
NCT07450599Phase IIRecruiting

A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.

BayerEndpoint: The proportion of participants achieving pathologic response rate (pRR: pathologic complete response [pCR] or minimal residual disease [MRD])Completion: 2030-10-15
NCT07460726N/ANot Yet Recruiting

PRIAPUS-PCa Study: Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) Impact on Sexual Function on Men With Unfavorable Intermediate Risk Prostate Cancer

CancerCare ManitobaEndpoint: Change in erectile dysfunction severity from baseline to 24 months, as measured by the change in International Index of Erectile Function 5-item version (IIEF-5) score.Completion: 2029-12-31
NCT07172685N/ARecruiting

Study on Triple Therapy Combined With HIFU for High-Tumor-Burden mHSPC

Qilu Hospital of Shandong UniversityEndpoint: PSA EvaluationCompletion: 2027-06-30
NCT06636591N/ARecruiting

Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer

Fudan UniversityEndpoint: Assessment of immune activating responseCompletion: 2026-10-07
View all 44 trials on ClinicalTrials.gov →

Regulatory Timeline

1989
Regulatory

FDA ORIG 1

1991
Regulatory

FDA SUPPL 1

1991
Regulatory

FDA SUPPL 2

1991
Regulatory

FDA SUPPL 3

1992
Regulatory

FDA SUPPL 7

1993
Regulatory

FDA SUPPL 5

1994
Regulatory

FDA SUPPL 10

1994
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FDA SUPPL 11

1994
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FDA SUPPL 8

1994
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FDA SUPPL 12

1994
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FDA SUPPL 13

1994
Regulatory

Health Canada Market Authorisation

1995
Regulatory

FDA SUPPL 15

1995
Regulatory

FDA SUPPL 17

1996
Regulatory

FDA ORIG 1

1996
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FDA SUPPL 16

1997
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FDA SUPPL 19

1997
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FDA SUPPL 20

1997
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FDA SUPPL 2

1997
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1997
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1997
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FDA SUPPL 23

1997
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FDA SUPPL 4

1998
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1998
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FDA SUPPL 5

1998
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1998
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FDA SUPPL 3

1998
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FDA SUPPL 26

1998
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FDA SUPPL 6

1998
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1998
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FDA SUPPL 7

1999
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FDA SUPPL 28

1999
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FDA SUPPL 8

1999
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FDA SUPPL 1

1999
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FDA SUPPL 30

1999
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1999
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2000
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FDA SUPPL 10

2000
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FDA SUPPL 33

2000
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FDA SUPPL 11

2001
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FDA SUPPL 12

2002
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FDA SUPPL 36

2002
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2002
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FDA SUPPL 13

2002
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FDA SUPPL 37

2002
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2002
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2004
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2004
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FDA SUPPL 20

2005
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FDA SUPPL 46

2005
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FDA SUPPL 25

2008
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FDA SUPPL 49

2009
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FDA SUPPL 52

2009
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2009
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FDA SUPPL 51

2009
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FDA SUPPL 30

2009
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FDA SUPPL 29

2009
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FDA SUPPL 28

2011
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FDA SUPPL 54

2011
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FDA SUPPL 32

2013
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FDA SUPPL 57

2013
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FDA SUPPL 56

2013
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FDA SUPPL 34

2013
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FDA SUPPL 35

2014
Regulatory

FDA SUPPL 58

2014
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FDA SUPPL 36

2015
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FDA SUPPL 59

2015
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FDA SUPPL 37

2016
Regulatory

FDA SUPPL 60

2021
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FDA SUPPL 66

2021
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FDA SUPPL 44

2023
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FDA SUPPL 69

2025
Regulatory

FDA SUPPL 74

2025
Regulatory

FDA SUPPL 51

Scientific Detail

Overview (Scientific)

Goserelin is a synthetic decapeptide (10 amino acids) GnRH agonist with D-Ser(tBu)6 and aza-Gly10 modifications. It is uniquely delivered as a biodegradable PLGA implant (Zoladex) injected subcutaneously in the anterior abdominal wall.

Mechanism of Action (Scientific)

Goserelin's mechanism is identical to other GnRH agonists: continuous non-pulsatile stimulation of the GnRH receptor leads to an initial hormonal flare followed by receptor downregulation, resulting in sustained suppression of LH, FSH, and downstream sex steroids to castrate or postmenopausal levels. The PLGA matrix biodegrades over the dosing interval, providing controlled release.

Summary (Scientific)

Goserelin is marketed as Zoladex (AstraZeneca), available as 3.6 mg monthly and 10.8 mg 3-monthly subcutaneous implants. First approved December 1989. Indications include advanced prostate cancer, breast cancer (pre/perimenopausal), endometriosis, and endometrial thinning prior to ablation. Testosterone suppression to castrate range achieved in approximately 91% of patients over 336 days.

Related Compounds

Carbetocin

Research Compound
Oxytocin Analogue (Long-Acting)

Carbetocin has not been approved by the FDA. It is registered in over 80 countries for prevention of uterine atony and excessive bleeding after caesarean delivery. A heat-stable formulation was added to the WHO Essential Medicines List in 2019. The CHAMPION trial (WHO, 2018; over 29,000 women) compared a heat-stable carbetocin formulation to oxytocin for preventing postpartum haemorrhage after vaginal delivery, and found it to be non-inferior. The heat-stable formulation addresses a significant limitation of oxytocin, which degrades in warm climates without refrigeration — a major concern in low-resource settings where postpartum haemorrhage causes the most deaths. Its regulatory status varies by jurisdiction.

Kisspeptin-54

Research Compound
Full-Length Kisspeptin (Investigational)

Kisspeptin-54 has no marketing authorisation. Phase II trials conducted primarily at Imperial College London have investigated its use as an IVF oocyte maturation trigger. One trial (60 patients) reported 95% oocyte maturation with zero cases of ovarian hyperstimulation syndrome. Kisspeptin-54 has a more advanced clinical evidence base than kisspeptin-10, with multiple Phase II studies in reproductive medicine. Its potential advantage over conventional IVF triggers relates to a lower risk of the serious complication of ovarian hyperstimulation. Clinical development is ongoing in academic settings. No Phase III trials have been completed.

Leuprolide

Approved
GnRH Agonist

Leuprolide is marketed as Lupron Depot, Eligard, and Fensolvi, and was first approved in 1985. It is available in depot formulations lasting one, three, four, or six months. Its clinical applications span multiple specialities: oncology (advanced prostate cancer), gynaecology (endometriosis, uterine fibroids), paediatric endocrinology (central precocious puberty), and reproductive medicine. Leuprolide's long clinical history provides extensive safety data. The initial hormone surge in the first one to two weeks can temporarily worsen symptoms — a well-known effect called 'flare' that is managed by co-prescribing an anti-androgen in prostate cancer patients. Long-term use carries risks including bone density loss, cardiovascular effects, and metabolic changes. Despite the availability of newer GnRH antagonists that avoid the initial flare, leuprolide remains the dominant treatment in this category due to its proven track record and range of formulations.

Related Research

This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.