Last reviewed 2026-04-20 · How we verify

Zoladex (goserelin)

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

ZOLADEX inhibits pituitary gonadotropin secretion, leading to regression or inhibition of hormonally sensitive tumors.

Zoladex (goserelin) is a gonadotropin-releasing hormone receptor agonist, originally developed by AstraZeneca and currently owned by Tersera. It targets the gonadotropin-releasing hormone receptor, a small molecule modality that was FDA-approved in 1989 for various indications, including 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 the potential for hot flashes, osteoporosis, and changes in lipid profiles. It is essential to monitor patients for these side effects, especially those with a history of osteoporosis or cardiovascular disease.

At a glance

Mechanism of action

ZOLADEX is a synthetic decapeptide that mimics GnRH. When administered, it inhibits the secretion of gonadotropins from the pituitary gland. This reduction in gonadotropins can lead to the regression or inhibition of growth of hormonally sensitive tumors, such as certain types of breast and prostate cancers.

Approved indications

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

Common side effects

• hot flashes
• sexual dysfunction
• decreased erections
• lower urinary tract symptoms
• lethargy
• pain (worsened in the first 30 days)
• edema
• upper respiratory infection
• rash
• sweating
• anorexia
• chronic obstructive pulmonary disease

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

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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 pituitary gonadotropin secretion
• 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