Peptide reference
Goserelin
Zoladex ·ICI 118630 ·Goserelin acetate
What cited sources report about Goserelin
Goserelin is a synthetic decapeptide GnRH (LHRH) agonist developed by ICI (later AstraZeneca, now TerSera in the US) and marketed as Zoladex. It is supplied as a subcutaneous implant (3.6 mg monthly or 10.8 mg every 12 weeks) and is FDA-approved for palliative therapy of prostate cancer, advanced breast cancer in pre- and perimenopausal women, endometriosis, and endometrial thinning. The summaries below report what individual cited sources state; this page does not assert claims beyond what those sources report.
FDA DailyMed — Zoladex prescribing information
The Zoladex US prescribing information lists indications for advanced prostate cancer (alone or in combination with flutamide for locally confined Stage T2b-T4), advanced breast cancer in pre- and perimenopausal women, endometriosis, and endometrial thinning prior to endometrial ablation for dysfunctional uterine bleeding. The label documents the initial gonadotropin and sex-hormone surge during the first weeks of therapy.
ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate.
Pagani et al. (2014) — New England Journal of Medicine (SOFT-TEXT)
The combined SOFT-TEXT analysis was a randomized phase 3 trial in 4,690 premenopausal women with hormone-receptor-positive early breast cancer. The protocol assigned patients to exemestane plus ovarian suppression versus tamoxifen plus ovarian suppression; goserelin was the predominant ovarian-suppression agent. The authors reported a 5-year disease-free survival of 91.1% versus 87.3% (HR 0.72; 95% CI 0.60-0.85).
Adjuvant treatment with exemestane plus ovarian suppression, as compared with tamoxifen plus ovarian suppression, significantly reduced recurrence.
Weterings et al. (2025) — Cochrane Database of Systematic Reviews
A 2025 Cochrane systematic review surveyed randomized trials of fertility-preservation interventions during chemotherapy in women with cancer, including GnRH agonist co-administration (goserelin, leuprolide, triptorelin) for ovarian protection. The review summarized pooled estimates for premature ovarian insufficiency, resumption of menses, and pregnancy outcomes; the certainty of evidence for several outcomes was rated low to moderate.
ClinicalTrials.gov NCT00295646 — SOFT trial
The Suppression of Ovarian Function Trial registry record describes a phase 3 randomized study by the International Breast Cancer Study Group comparing tamoxifen alone, tamoxifen plus ovarian suppression, and exemestane plus ovarian suppression in premenopausal women with HR-positive early breast cancer. Goserelin was the predominant ovarian-suppression agent across study arms.
PubChem CID 47725 — National Center for Biotechnology Information
The PubChem record for goserelin lists the decapeptide pyroGlu-His-Trp-Ser-Tyr-D-Ser(tBu)-Leu-Arg-Pro-Azgly-NH2, molecular formula C59H84N18O14, molecular weight 1269.4 g/mol, and aggregated synonyms (Zoladex, ICI 118630, goserelin acetate).
Coverage notes
Goserelin is a long-established GnRH agonist with a mature evidence base in advanced prostate cancer, premenopausal HR-positive breast cancer (especially as part of the SOFT-TEXT regimen), endometriosis, and short-course endometrial preparation. The biodegradable subcutaneous implant differentiates it from the IM/SC depot formulations of leuprolide. This page reflects FDA labeling current as of the cited sources.