Data updated: May 26, 2026
ZOLADEX (goserelin)
Trial Activity: Stable 15 active trials
Oncology
Approved 1989-12-29
Zoladex is a GnRH agonist indicated for the management of prostate cancer, specifically for locally confined Stage T2b-T4 (Stage B2-C) disease when used in combination with flutamide and radiation therapy, as well as for the palliative treatment of advanced prostatic carcinoma. It is also indicated for the palliative treatment of advanced breast cancer in pre- and perimenopausal women. Additionally, Zoladex is used for the management of endometriosis (to provide pain relief and reduce lesions) and as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding.
Source: FDA Label • TERSERA
How ZOLADEX Works
Goserelin is a synthetic decapeptide analogue of gonadotropin-releasing hormone (GnRH). Upon chronic administration, it acts as a potent inhibitor of pituitary gonadotropin secretion. Initially, goserelin causes a transient increase in serum levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH); however, continuous administration leads to downregulation of pituitary GnRH receptors. This results in a profound suppression of serum testosterone in men and serum estradiol in women to castrate/postmenopausal levels, thereby inhibiting the growth of hormone-dependent tumors and tissues.
Development Insights
National Cancer Institute (NCI) conducting 6 trials (17%)
64 indications explored (Broad Platform)
→ prostate adenocarcinoma (7 trials)
→ stage iv prostate cancer (6 trials)
→ prostate cancer (5 trials)
7
Indications
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Phase 3 Trials
36
Years on Market
Details
- Status
- Prescription
- First Approved
- 1989-12-29
- Revenue
- $266M (Q4-2025)
- Routes
- IMPLANTATION
- Dosage Forms
- IMPLANT
ZOLADEX Approval History
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Label Update
78 FDA actions from 1989 to 2026 · 4 indication expansions
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Dec 1989 ORIGINAL
New Drug
What ZOLADEX Treats
3 indicationsZOLADEX is approved for 3 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prostate Cancer
- Endometriosis
- Breast Cancer
Source: FDA Label
ZOLADEX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
10
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
1
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 16 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZOLADEX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZOLADEX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZOLADEX
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
63 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05827081 Adjuvant WIDER | CLEE011O12001 2022-503001-38-00 | Ph 3 | recruiting | Phase IIIb Study of Ribociclib + ET in Early Breast Cancer |
| NCT03070886 | NRG-GU002 NCI-2016-00963, NRG-GU002 | Ph 2, Ph 3 | completed | Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery |
| NCT05050084 | NRG-GU010 NCI-2021-08760, NRG-GU010 | Ph 3 | active not recruiting | Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial |
| NCT04513717 | NRG-GU009 NCI-2020-04705, NRG-GU009 | Ph 3 | active not recruiting | Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial |
| NCT02115282 results posted | NCI-2014-00746 NCI-2014-00746, ECOG-E2112 | Ph 3 | active not recruiting | Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic |
| NCT03860987 | 190062 19-C-0062 | Ph 2 | active not recruiting | Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer |
| NCT06378866 DIVINE | MC230502 R01CA286127, 23-012176 | Ph 2 | recruiting | 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 |
| NCT07287098 preEMBER | 27511 2025-523258-15-00, J2J-MC-JZLL | Ph 2 | not yet recruiting | A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer |
| NCT05694819 | YCU19003 jRCT2031190241 | Ph 2 | completed | Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY) |
| NCT05161195 | CLEE011A2412B 2024-514891-41-00 | Ph 4 | active not recruiting | Roll-over Study to Allow Continued Access to Ribociclib |
| NCT07310420 | TER-ZLDX-0101 | Ph 1 | recruiting | A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer |
| NCT07097259 | MS700623_0617 | Ph 1 | completed | A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants |
| NCT06348134 | IRB23-0502 | Ph 2 | recruiting | Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery |
| NCT07158021 | UMCC 2025.016 NCI-2025-03933, HUM00270281 | Ph 2 | recruiting | Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial |
| NCT03056755 BYLieve results posted | CBYL719X2402 2023-509167-24-00 | Ph 2 | completed | Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments |
| NCT01723774 results posted | 201301106 | Ph 2 | active not recruiting | PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer |
| NCT03671330 | CLEE011A2206 | Ph 2 | completed | Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer. |
| NCT05607004 EVANGELINE | ATOS-Z-201 | Ph 2 | recruiting | (Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer |
| NCT03822468 AMALEE results posted | CLEE011A2207 2018-004234-15 | Ph 2 | completed | Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer |
| NCT04478266 AMEERA-5 results posted | EFC15935 2020-001824-33, U1111-1233-0486 | Ph 3 | terminated | Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer |
| NCT05582499 FASCINATE-N | FASCINATE-N | Ph 2 | recruiting | Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy |
| NCT02476786 | 201611010 | Ph 2 | recruiting | Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score |
| NCT02430480 results posted | 150124 15-C-0124 | Ph 2 | completed | Using Multiparametric MRI to Evaluate Intraprostatic Tumor Responses and Androgen Resistance Patterns in Newly Diagnosed Prostate Cancer |
| NCT01964170 | 3550-CL-0010 | Ph 3 | completed | A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer |
| NCT03839823 RIGHT Choice results posted | CLEE011A3201C | Ph 2 | completed | Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer |
| NCT05594095 | BCTOP-L-M05 | Ph 2 | recruiting | SNF Platform Study of HR+/ HER2-advanced Breast Cancer |
| NCT05163106 NEOLETRIB | 2021/193780(REK) | Ph 2 | completed | Neoadjuvant Treatment of Locally-advanced Breast Cancer Patients With Ribociclib and Letrozole |
| NCT04862143 TELEPIK results posted | CBYL719A03201 2020-005882-15 | Ph 2 | terminated | Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant |
| NCT05720260 | 202109031MIPD | Ph 2 | recruiting | Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC |
| NCT02344472 | D-V 2014-002249-22 | Ph 3 | active not recruiting | Detect V / CHEVENDO (Chemo vs. Endo) |
| NCT03272477 TP-II | PH002-TP-II | Ph 2 | completed | Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients |
| NCT03007979 results posted | 201612098 | Ph 2 | completed | Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer |
| NCT02278120 MONALEESA-7 results posted | CLEE011E2301 2014-001931-36 | Ph 3 | completed | Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer |
| NCT02941926 COMPLEEMENT-1 results posted | CLEE011A2404 2016-003467-19 | Ph 3 | completed | Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC |
| NCT01377389 results posted | 2009-0378 NCI-2011-01125 | Ph 2 | terminated | Ipilimumab + Androgen Depravation Therapy in Prostate Cancer |
| NCT00651326 DART | PR12 CAN-NCIC-PR12, CDR0000589247 | Ph 3 | terminated | Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer |
| NCT02333370 | CLEE011A2115C | Ph 1 | completed | A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer |
| NCT00771017 | CDR0000616570 ECOG-E3806 | Ph 2 | withdrawn | Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer |
| NCT02789878 | NP 779/15 | Ph 2 | completed | Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer |
| NCT01989780 BOOSTER | JBCRG-M04 UMIN000012179 | Ph 2 | completed | Bevacizumab Plus Paclitaxel Optimization Study With Interventional Aintenance Endocrine Therapy in Breast Cancer |
| NCT03628066 | NSABP FB-13 | Ph 2 | completed | Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer |
| NCT02586675 results posted | MCC-18332 | Ph 1 | completed | TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer |
| NCT03096847 results posted | CLEE011XDE01 CLEE011XDE01, 2016-002556-24 | Ph 3 | completed | Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer |
| NCT01252693 | SPI-153-10-1 | Ph 2 | completed | International,Multi-Center,Open Label,Randomized Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot in Men With Prostate Cancer |
| NCT02907918 PALTAN results posted | 201610019 | Ph 2 | terminated | Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer |
| NCT02059213 results posted | UMCC 2013.117 HUM00082715 | Ph 2 | completed | A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer |
| NCT01738724 | FMRPUSP-UROGIN-002 | Ph 4 | terminated | Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin |
| NCT03450109 | LY01005/CT-USA-101 | Ph 1 | completed | A Study to Assess LY01005 Versus Goserelin Comparator (ZOLADEX®) in Patients With Prostate Cancer |
| NCT01496131 results posted | EMR 63325-015 BB-IND 7787 | Ph 2 | completed | Tecemotide (L-BLP25) in Prostate Cancer |
| NCT02483767 POF | PUMCH-BC-ovarian suppression | Ph 3 | completed | Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer |
Showing 50 of 63 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZOLADEX FDA Label Details
Indications & Usage
FDA Label (PDF)ZOLADEX is indicated for the treatment of Prostate Cancer; Endometriosis; Breast Cancer.
Pro Intelligence Preview
Deep insights for ZOLADEX
Revenue Insights
- • Q4-2025: $266M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 36 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment