Goserelin

Also known as: Zoladex

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 3 applications
Randomized controlled trials 345 of 1,446 publications on PubMed
Registered clinical trials 417 122 active
Adverse event reports 14,741 13,375 classified as serious
  • Goserelin is an FDA-approved drug, marketed as Zoladex (first approval: December 29, 1989).
  • PubMed lists 1,446 publications mentioning it, including 345 randomized controlled trials and 59 animal-only studies.
  • ClinicalTrials.gov lists 417 registered studies testing it (122 active).
  • FDA's adverse event system (FAERS) holds 14,741 reports mentioning it; 13,375 classified as serious. Reports do not prove causation.

Research topics

  • Breast Neoplasms 41
  • Antineoplastic Agents, Hormonal 36
  • Prostatic Neoplasms 29
  • Antineoplastic Combined Chemotherapy Protocols 28
  • Gonadotropin-Releasing Hormone 24
  • Erb-b2 Receptor Tyrosine Kinases 20
  • Androgen Antagonists 18
  • Receptors, Estrogen 14
  • Aminopyridines 13
  • Purines 13

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA019726 ZOLADEX Approved, marketed December 29, 1989 TERSERA
NDA020515 ZOLADEX Approved, marketed December 18, 1995 TERSERA
NDA020578 ZOLADEX Approved, marketed January 11, 1996 TERSERA

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 1,446
  • Human (MeSH) 1,199
  • Animal only 59
  • Clinical trials 483
  • Randomized controlled trials 345
  • Systematic reviews & meta-analyses 34
  • Case reports 207
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
417
Active
122
With posted results
107

Conditions studied

  • Prostate Cancer 139
  • Breast Cancer 83
  • Prostate Adenocarcinoma 15
  • Metastatic Breast Cancer 13
  • Advanced Breast Cancer 12
  • Adenocarcinoma of the Prostate 10
  • Stage IV Prostate Cancer 9
  • Breast Neoplasms 8
  • Endometriosis 8
  • Recurrent Prostate Cancer 8
  • HER2-negative Breast Cancer 8
  • Stage III Prostate Cancer 8
Study Status Phase Start
Tolerability of Dalpiciclib vs. Abemaciclib/Ribociclib in Early HR+/HER2- Breast Cancer
NCT07706933 Henan Cancer Hospital
Not yet recruiting N/A November 1, 2026
A Phase 3 Study of Deutenzalutamide in Patients With High-Risk BCR Prostate Cancer
NCT07875881 Hinova Pharmaceuticals Inc.
Not yet recruiting Phase 3 October 31, 2026
A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer
NCT07310420 TerSera Therapeutics LLC
Recruiting Phase 1 October 30, 2026
QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant Chemotherapy
NCT07782840 Hebei Medical University Fourth Hospital
Not yet recruiting Phase 2 October 1, 2026
ADT De-escalation in Selected High-Risk Prostate Cancer Patients (ADaPPt Trial) a GROUQ Led PCS Study (PCS XIV)
NCT07777263 Dr. Tamim Niazi
Not yet recruiting Phase 3 Oct 2026
Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast Cancer
NCT07801898 The Second Hospital of Anhui Medical University
Not yet recruiting Phase 2 September 30, 2026
Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With Fulvestrant for the Treatment of Patients With Hormone Receptor Positive (HR+) and HER2 Negative (HER2-) Breast Cancer Extended to Other Organs.
NCT07340619 UNICANCER
Not yet recruiting Phase 2 September 18, 2026
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
NCT07596212 University of Illinois Chicago
Not yet recruiting Phase 1, Phase 2 Sep 2026
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer
NCT07751133 University College, London
Recruiting Phase 3 August 28, 2026
Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer.
NCT07730151 RenJi Hospital
Not yet recruiting Phase 2 August 1, 2026
Show 40 more studies
Study Status Phase Start
Impact of Formulation Change on Ovarian Suppression in Young Breast Cancer Patients.
NCT07610733 Fudan University
Not yet recruiting Phase 2 June 1, 2026
Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer Patients
NCT07460752 Mayo Clinic
Recruiting Phase 2 May 22, 2026
Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy/25) Versus 20 Fractions (52.5 Gy/20) for Recurrent Prostate Cancer After Surgery.
NCT07483658 CHU de Quebec-Universite Laval
Recruiting N/A May 13, 2026
A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
NCT07287098 Eli Lilly and Company
Recruiting Phase 2 May 13, 2026
Clinical Study on the Preservation of Ovarian Function Following Autologous Hematopoietic Stem Cell Transplantation Using Goserelin
NCT07552493 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Not yet recruiting N/A May 1, 2026
Clinical Study on the Preservation of Ovarian Function Following Hematopoietic Stem Cell Transplantation in Patients With Malignant Hematologic Diseases Using Goserelin
NCT07552480 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Not yet recruiting N/A May 1, 2026
Clinical Study on the Preservation of Ovarian Function in Patients With Aplastic Anemia Following Allogeneic Hematopoietic Stem Cell Transplantation Using Goserelin
NCT07552506 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Not yet recruiting N/A May 1, 2026
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.
NCT07450599 Bayer
Recruiting Phase 2 April 27, 2026
Safety and Efficacy of Docetaxel, Darolutamide, and Homoharringtonine Combined With Androgen Deprivation Therapy in Neoadjuvant Treatment of High-Risk Prostate Cancer: A Multicenter Prospective, Single-Arm Clinical Study
NCT07516704 Zhongda Hospital
Not yet recruiting Early phase 1 April 1, 2026
Radiotherapy After Prostatectomy for Node Positive Prostate Cancer
NCT07477626 Sun Yat-sen University
Recruiting Phase 3 March 20, 2026
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
NCT07460726 CancerCare Manitoba
Not yet recruiting — March 16, 2026
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
NCT07142551 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Recruiting Phase 2 March 9, 2026
Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
NCT07389187 Shanghai Changzheng Hospital
Not yet recruiting Early phase 1 Feb 2026
Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer
NCT07389174 Shanghai Changzheng Hospital
Not yet recruiting Early phase 1 Feb 2026
Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial
NCT07158021 University of Michigan Rogel Cancer Center
Recruiting Phase 2 January 22, 2026
CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate Cancer
NCT07268794 Fudan University
Not yet recruiting Phase 2 November 30, 2025
Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)
NCT07313241 University of Texas Southwestern Medical Center
Recruiting Phase 2 November 14, 2025
Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study
NCT07179939 Fudan University
Not yet recruiting Phase 2 September 10, 2025
The COSMYC Trial (COmbined Suppression of MYC)
NCT06922318 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Recruiting Phase 2 August 19, 2025
Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients
NCT06832774 Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Recruiting Phase 2 August 1, 2025
Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer
NCT07182279 The Methodist Hospital Research Institute
Recruiting Phase 1, Phase 2 August 1, 2025
Study on Triple Therapy Combined With HIFU for High-Tumor-Burden mHSPC
NCT07172685 Qilu Hospital of Shandong University
Recruiting N/A July 30, 2025
Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy
NCT06953882 Yale University
Recruiting Phase 2 July 9, 2025
Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery
NCT06348134 University of Chicago
Recruiting Phase 2 March 18, 2025
Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer
NCT06291064 University of Chicago
Recruiting Phase 2 March 18, 2025
Effect of a GnRH Analog on Hepatic Steatosis
NCT06523530 Aristotle University Of Thessaloniki
Active, not recruiting Phase 4 November 26, 2024
Artificial Intelligence Driven Personalisation of Radiotherapy and Concomitant Androgen Deprivation Therapy for Prostate Cancer Patients (the HypoPro Trial)
NCT06772441 German Oncology Center, Cyprus
Recruiting Phase 2 November 1, 2024
A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer
NCT07553988 R-Pharm International, LLC
Active, not recruiting Phase 2 October 24, 2024
Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)
NCT06582446 German Oncology Center, Cyprus
Recruiting Phase 2 September 16, 2024
Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients
NCT06225284 National Taiwan University Hospital
Recruiting Phase 2 August 22, 2024
Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)
NCT06656624 The First Affiliated Hospital with Nanjing Medical University
Recruiting Phase 2 August 13, 2024
Pyrotinib and Subcutaneous Preparation of Trastuzumab Combined With Capecitabine Neoadjuvant Therapy for HER2+ Study of Breast Cancer
NCT06483386 Tianjin Medical University Cancer Institute and Hospital
Not yet recruiting Phase 2 July 15, 2024
Adaptions and Resiliency to Multi-Stressor OpeRations
NCT06455969 Bradley Nindl
Recruiting Phase 4 July 15, 2024
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
NCT06447623 Fudan University
Active, not recruiting Phase 3 June 11, 2024
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
NCT06378866 Mayo Clinic
Recruiting Phase 2 June 3, 2024
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
NCT06575257 Xijing Hospital
Recruiting Phase 2 May 1, 2024
Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO)
NCT06387056 The First Affiliated Hospital of Xiamen University
Recruiting Phase 2 April 1, 2024
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
NCT05827081 Novartis Pharmaceuticals
Active, not recruiting Phase 3 February 28, 2024
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers
NCT06282588 Cancer Research Antwerp
Recruiting Phase 2, Phase 3 December 13, 2023
Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
NCT06177015 The First Affiliated Hospital with Nanjing Medical University
Recruiting Phase 3 December 11, 2023

All 417 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
14,741
Serious
13,375
With death outcome
2,708

Most reported reactions

  • Death 1,779
  • Malignant neoplasm progression 1,439
  • Fatigue 955
  • Metastases to bone 732
  • Neutropenia 689
  • Nausea 642
  • Asthenia 559
  • Hot flush 545
  • Diarrhoea 542
  • Off label use 515
  • Pain 508
  • Dyspnoea 481

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

  • ZOLADEX HUMAN PRESCRIPTION DRUG TerSera Therapeutics LLC March 24, 2026
  • ZOLADEX HUMAN PRESCRIPTION DRUG TerSera Therapeutics LLC March 24, 2026

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.