Goserelin
Goserelin is an FDA-approved GnRH receptor agonist. Goserelin is a synthetic decapeptide analog of GnRH delivered from a biodegradable implant. Continuous rather than pulsatile receptor occupancy first stimulates and then downregulates pituitary GnRH receptors, so an initial rise in gonadotropins and sex steroids is followed within about two to four weeks by sustained suppression to castrate concentrations.
For research use only.
Key Facts
- CAS
- —
- Molecular Weight (MW)
- 1269.4 g/mol
- Half-life
- —
- FDA status
- Approved
- Evidence level
- FDA Approved
- Human dose established
- Yes
- Administration Route
- Subcutaneous implant
- Frequency
- Every 28 days (3.6 mg) or every 12 weeks (10.8 mg)
- Last updated
- Nov 7, 2026
- Reviewed
- Nov 7, 2026
Research summary
Depot GnRH receptor agonist approved for advanced prostate cancer, breast cancer, endometriosis, and endometrial thinning before ablation.
Research evidence
- Regulatory review (FDA label)4 reviewed sources
- Controlled human trialsNone in reviewed sources
- Early or uncontrolled human studiesNone in reviewed sources
- Lab & animal studiesNone in reviewed sources
How it works
Each step shows whether the sources Peptide Library has reviewed include that kind of research. Counts are reviewed sources, not every study ever published. Reviews and programme summaries that describe human use are shown as "reported", not as trials, and registered trials without published results are listed but not counted. A higher step means research has progressed further; it does not mean a compound works better or is safer. Compounds whose evidence has not been reviewed yet show "Not reviewed" instead of a guess.
Peptide Library's Goserelin profile summarises 5 cited studies listed in the Science section, the compound's regulatory status, and research-protocol parameters reported for it. It is a research reference, not medical advice.
Goserelin dosage evidence
Goserelin has FDA-approved human dosages as the ZOLADEX implant, injected under the skin of the lower abdominal wall. ZOLADEX 3.6 mg is given every 28 days for prostate cancer, endometriosis (6 months, women 18 and over), endometrial thinning before ablation (one or two implants) and advanced breast cancer in pre- and perimenopausal women. ZOLADEX 10.8 mg is given every 12 weeks for prostate cancer only.
| Human dosing established | Yes |
|---|---|
| Route | Subcutaneous implant |
| Frequency | Every 28 days (3.6 mg) or every 12 weeks (10.8 mg) |
| Duration studied | Long-term for prostate and breast cancer; 6 months for endometriosis |
| Evidence level | FDA Approved |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — ZOLADEX 3.6 mg, prostate cancerFDA-approved label · FDA prescribing information | Men with advanced prostate cancer, or Stage T2b-T4 (B2-C) prostate cancer with flutamide and radiotherapy | 3.6 mg. For Stage B2-C, started 8 weeks before radiotherapy: either one 3.6 mg implant followed 28 days later by one 10.8 mg implant, or four 3.6 mg implants 28 days apart | Subcutaneous, anterior abdominal wall below the navel line | Every 28 days | Long-term in advanced prostate cancer | Palliative treatment of advanced prostate cancer; management of locally confined prostate cancer | ZOLADEX (goserelin implant) 3.6 mg — FDA prescribing information (TerSera), DailyMed |
| FDA label — ZOLADEX 3.6 mg, endometriosis and endometrial thinningFDA-approved label · FDA prescribing information | Women aged 18 and over with endometriosis; women having endometrial ablation for dysfunctional uterine bleeding | 3.6 mg. Endometrial thinning: one or two implants four weeks apart, with surgery at four weeks (one implant) or two to four weeks after the second | Subcutaneous, anterior abdominal wall below the navel line | Every 28 days | 6 months for endometriosis; retreatment cannot be recommended | Management of endometriosis; endometrial thinning before ablation | ZOLADEX (goserelin implant) 3.6 mg — FDA prescribing information (TerSera), DailyMed |
| FDA label — ZOLADEX 3.6 mg, advanced breast cancerFDA-approved label · FDA prescribing information | Pre- and perimenopausal women with advanced breast cancer | 3.6 mg | Subcutaneous, anterior abdominal wall below the navel line | Every 28 days | Long-term unless clinically inappropriate | Palliative treatment of advanced breast cancer | ZOLADEX (goserelin implant) 3.6 mg — FDA prescribing information (TerSera), DailyMed |
| FDA label — ZOLADEX 10.8 mg, prostate cancerFDA-approved label · FDA prescribing information | Men with advanced prostate cancer, or Stage T2b-T4 (B2-C) prostate cancer with flutamide and radiotherapy | 10.8 mg | Subcutaneous, anterior abdominal wall below the navel line | Every 12 weeks | Long-term in advanced prostate cancer | Palliative treatment of advanced prostate cancer | ZOLADEX (goserelin implant) 10.8 mg — FDA prescribing information (TerSera), DailyMed |
Where sources disagree
- The 10.8 mg implant is not indicated in women: its label says the data are insufficient to show reliable suppression of serum estradiol. Women are treated with the 3.6 mg implant only.
- The labels warn of tumor flare in the first weeks of treatment (including ureteral obstruction and spinal cord compression), hyperglycemia and diabetes, and cardiovascular disease in men. Pregnancy must be excluded before use in benign gynecological conditions.
- A third DailyMed listing for ZOLADEX 3.6 mg is a repackager's copy (A-S Medication Solutions, 2021); the TerSera labels cited here are the current ones.
Sequence & molecular data
| Molecular formula | C59H84N18O14 |
|---|---|
| Molecular weight | 1269.4 g/mol |
| PubChem CID | 5311128 |
| FDA UNII | 0F65R8P09N |
| ChEMBL | CHEMBL1201247 |
| DrugBank | DB00014 |
Identifiers link to the public PubChem, FDA Substance Registration (UNII), ChEMBL and DrugBank records for the same entity.
Science
Mechanism of Action
Goserelin is a synthetic decapeptide analog of GnRH delivered from a biodegradable implant. Continuous rather than pulsatile receptor occupancy first stimulates and then downregulates pituitary GnRH receptors, so an initial rise in gonadotropins and sex steroids is followed within about two to four weeks by sustained suppression to castrate concentrations.
Studies
- Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial
- Roles of Goserelin in Gynecological Disorders
- Are all gonadotrophin-releasing hormone agonists equivalent for the treatment of prostate cancer? A systematic review
- Goserelin acetate (Zoladex) with or without hormone replacement therapy for the treatment of endometriosis
- Treatment of patients with advanced cancer of the prostate using a slow-release (depot) formulation of the LHRH agonist ICI 118630 (Zoladex)
Research statistics
1,957 PubMed publications · 73.7% human clinical research · 301 registered trials
Counts of published research through 2026-11-01, not evidence that it works. Publications by year, study types and trials · How publications are counted
Regulatory & research status
Goserelin is an FDA-approved product for specific labelled indications. Approval does not extend to the research contexts described on this page, and approved products are prescription medicines.
| FDA status | Approved |
|---|---|
| Research status | Approved product (see FDA status) |
| Availability | Prescription-Only |
| WADA (sport) | Unknown / Not Listed |
| Library classification | FDA-Approved |
How FDA approval, compounding and research-only status differ
Benefits
—
Goserelin side effects
No side effects listed yet for this entry.
Storage & stability
This compound is not supplied as a powder to be mixed, so the freeze-dried powder and reconstitution handling described for research peptides does not apply. Storage conditions are product-specific: follow the label or packaging of the product itself.
Goserelin: frequently asked questions
What is Goserelin?
Depot GnRH receptor agonist approved for advanced prostate cancer, breast cancer, endometriosis, and endometrial thinning before ablation.
How does Goserelin work?
Goserelin is a synthetic decapeptide analog of GnRH delivered from a biodegradable implant. Continuous rather than pulsatile receptor occupancy first stimulates and then downregulates pituitary GnRH receptors, so an initial rise in gonadotropins and sex steroids is followed within about two to four weeks by sustained suppression to castrate concentrations.
Is Goserelin FDA approved?
Yes. Goserelin is approved by the FDA, and approved products are prescription medicines. Approval is always for specific indications studied in clinical trials, so an approved status does not mean the compound is approved for every use it is discussed for. Research-chemical material sold under the same name is not the approved product.
What peptides are similar to Goserelin?
Compounds most often compared with Goserelin include Leuprolide, Triptorelin, Nafarelin and Histrelin. They are grouped by shared mechanism or research area rather than by equivalence, and their regulatory status and evidence base differ.
References
- Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial — Chin Med J (Engl), 2023External reference
- Roles of Goserelin in Gynecological Disorders — Drug Des Devel Ther, 2026External reference
- Are all gonadotrophin-releasing hormone agonists equivalent for the treatment of prostate cancer? A systematic review — BJU Int, 2018External reference
- Goserelin acetate (Zoladex) with or without hormone replacement therapy for the treatment of endometriosis — Fertil Steril, 1998External reference
- Treatment of patients with advanced cancer of the prostate using a slow-release (depot) formulation of the LHRH agonist ICI 118630 (Zoladex) — J Endocrinol, 1984External reference
Related research, comparisons & guides
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Compiled by Peptide Library Editorial · Reviewed Aug 30, 2026 · Updated Nov 7, 2026 · Version 2
This Goserelin profile is compiled from published literature (5 cited studies linked above), public regulatory records and chemical registries. It describes what research reports; it is not medical advice, and nothing here is a dosing recommendation for humans. Peptide Library does not sell peptides. Editorial policy · How profiles are compiled · Report an error
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