ZOLADEX (goserelin acetate) · TERSERA
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.
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
Details
- Status
- Prescription
- First Approved
- 1989-12-29
- Routes
- IMPLANTATION
- Dosage Forms
- IMPLANT
ZOLADEX Approval History
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
ZOLADEX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
TERSERA's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
34 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03070886 | NRG-GU002 NCI-2016-00963, NRG-GU002 | Ph 2, Ph 3 | active not recruiting | Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery |
| NCT04484818 | EA8183 NCI-2020-02383, EA8183 | Ph 3 | active not recruiting | Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study |
| NCT04423211 | EA8191 NCI-2020-02686, EA8191 | Ph 3 | recruiting | Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging |
| 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 |
| NCT03361735 results posted | 17085 NCI-2017-02192 | Ph 2 | active not recruiting | Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer |
| NCT07310420 | TER-ZLDX-0101 | Ph 1 | recruiting | A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer |
| NCT07460752 | MC250301 NCI-2026-00968, 25-006670 | Ph 2 | recruiting | Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer Patients |
| 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 |
| NCT01786265 | 2012-0993 NCI-2018-01856, 2012-0993 | Ph 2 | active not recruiting | Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer |
| NCT01674140 e3 results posted | S1207 S1207, U10CA032102 | Ph 3 | active not recruiting | S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer |
| NCT04455750 CASPAR | A031902 NCI-2020-02360, U10CA180821 | Ph 3 | active not recruiting | A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy |
| NCT04734730 | 20476 NCI-2020-10199, 20476 | Ph 2 | recruiting | Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer |
| NCT03942653 | BTCRC-HN17-111 | Ph 2 | active not recruiting | Androgen Deprivation Therapy (ADT) and Pembrolizumab for Advanced Stage Androgen Receptor-positive Salivary Gland Carcinoma |
| NCT02023463 | 13P.461 2013-027, JT 2970 | Ph 1 | active not recruiting | Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer |
| NCT03678025 | S1802 NCI-2018-01738, S1802 | Ph 3 | recruiting | Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer |
| NCT02003209 results posted | NCI-2013-02228 NCI-2013-02228, NSABP-B-52 | Ph 3 | completed | Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer |
| NCT02278185 results posted | 14-0909.cc NCI-2014-02219 | Ph 2 | completed | Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer |
| NCT02685397 PCS IX | PCS IX | Ph 2, Ph 3 | active not recruiting | Management of Castration-Resistant Prostate Cancer with Oligometastases |
| NCT02058706 results posted | 2013-083 NCI-2014-00212, 2013-083 | Ph 2 | completed | LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Hormone Sensitive Prostate 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 |
| NCT02168062 results posted | 135513 NCI-2015-01058 | Ph 2 | terminated | Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer |
| NCT00937768 results posted | MC0852 NCI-2009-01147, 08-001519 | Ph 2 | terminated | Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy |
| NCT01163084 results posted | NCI-2010-01737 NCI-2010-01737, CDR0000670590 | Ph 1, Ph 2 | terminated | Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer |
| NCT03450109 | LY01005/CT-USA-101 | Ph 1 | completed | A Study to Assess LY01005 Versus Goserelin Comparator (ZOLADEX®) in Patients With Prostate Cancer |
| NCT01776008 results posted | NCI-2013-00080 NCI-2013-00080, MC1139 | Ph 2 | terminated | Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer |
| NCT01120236 results posted | NCI-2011-02003 NCI-2011-02003, SWOG-S0925 | Ph 2 | completed | Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer |
| NCT01712893 | CD trial | Ph 3 | completed | Simultaneous Versus Sequential Use of Adjuvant Chemotherapy and GnRHa in Treating ER+,Premenopausal Breast Cancer |
| NCT01023061 RAD1 results posted | 7048 NCI-2009-01346, 7048 - AbiRAD | Ph 2 | completed | Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer |
| NCT02107391 | SP002 2011-004986-34 | Ph 2 | completed | Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer |
| NCT01242748 results posted | FE200486 CS35A 2010-021434-55 | Ph 3 | terminated | A Degarelix Trial in Patients With Prostate Cancer |
| NCT01149356 | NCI-2010-02181 NCI-2010-02181, MCC-8539 | Ph 1 | terminated | RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer |
| NCT01368263 results posted | 201106141 | Ph 2 | terminated | Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer |
| NCT01682642 results posted | 2012-000784-25 | Ph 4 | completed | The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis. |
| NCT00946920 results posted | FE200486 CS35 2008-005276-27 | Ph 3 | completed | A Trial of Degarelix in Patients With Prostate Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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 a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate Palliative treatment of advanced carcinoma of the prostate The management of endometriosis Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding Use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women 1.1 Stage B2-C Prostatic Carcinoma ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-...
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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