Last reviewed 2026-04-20 · How we verify

Zoladex (GOSERELIN ACETATE)

Zoladex (generic name: GOSERELIN ACETATE) is a Gonadotropin Releasing Hormone Receptor Agonist Recombinant protein drug developed by Tersera. It is currently FDA-approved (first approved 1989) for Advanced Prostatic Carcinoma, Endometrial Ablation Adjunct, Endometriosis.

Zoladex works by mimicking the body's natural hormone to reduce testosterone production.

Zoladex (Goserelin Acetate) is a gonadotropin-releasing hormone receptor agonist developed by AstraZeneca and currently owned by Tersera. It targets the gonadotropin-releasing hormone receptor, a small molecule modality approved by the FDA in 1989 for treating advanced prostatic carcinoma, endometrial ablation adjunct, endometriosis, and hormone receptor-positive malignant neoplasm of breast. Zoladex is off-patent, with no active Orange Book patents, and no generic manufacturers. Key safety considerations include its potential impact on hormone levels and reproductive health. It is a small molecule that works by mimicking the body's natural hormone to reduce testosterone production.

At a glance

Mechanism of action

ZOLADEX is synthetic decapeptide analogue of GnRH. ZOLADEX acts as an inhibitor of pituitary gonadotropin secretion when administered in the biodegradable formulation.In animal and in vitro studies, administration of goserelin resulted in the regression or inhibition of growth of the hormonally sensitive dimethylbenzanthracene (DMBA)-induced rat mammary tumor and Dunning R3327 prostate tumor.

Approved indications

• Advanced Prostatic Carcinoma
• Endometrial Ablation Adjunct
• Endometriosis
• Hormone receptor positive malignant neoplasm of breast

Common side effects

• Hot Flashes
• Diarrhea
• Pain (general)
• Gynecomastia
• Pelvic Pain
• Bone Pain
• Asthenia
• Nausea
• Skin Rash
• Rectum/Large Bowel
• Bladder
• Cystitis

Key clinical trials

• A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer (PHASE2)
• A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma (PHASE2)
• Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients (PHASE2)
• Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (PHASE3)
• Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (PHASE2,PHASE3)
• 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. (NA)
• Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer (PHASE2)
• Radiotherapy After Prostatectomy for Node Positive Prostate Cancer (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Zoladex CI brief — competitive landscape report
• Zoladex updates RSS · CI watch RSS
• Tersera portfolio CI

Frequently asked questions about Zoladex

Related

• Drug class: All Gonadotropin Releasing Hormone Receptor Agonist drugs
• Target: All drugs targeting Gonadotropin-releasing hormone receptor
• Manufacturer: Tersera — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Advanced Prostatic Carcinoma
• Indication: Drugs for Endometrial Ablation Adjunct
• Indication: Drugs for Endometriosis

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing