Goserelin

FDA-approved GnRH receptor agonistEstablished

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.

Calculate Dose

For research use only.

Key Facts

CAS
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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.

FDA Approved
Dosage evidence summary for Goserelin
Human dosing establishedYes
RouteSubcutaneous implant
FrequencyEvery 28 days (3.6 mg) or every 12 weeks (10.8 mg)
Duration studiedLong-term for prostate and breast cancer; 6 months for endometriosis
Evidence levelFDA Approved
Last reviewed2026-11-07

Research-reported dosing

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for Goserelin, one row per studied regimen
Study / contextPopulationDoseRouteFrequencyDurationOutcome studiedSource
FDA label — ZOLADEX 3.6 mg, prostate cancerFDA-approved label · FDA prescribing informationMen with advanced prostate cancer, or Stage T2b-T4 (B2-C) prostate cancer with flutamide and radiotherapy3.6 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 apartSubcutaneous, anterior abdominal wall below the navel lineEvery 28 daysLong-term in advanced prostate cancerPalliative treatment of advanced prostate cancer; management of locally confined prostate cancerZOLADEX (goserelin implant) 3.6 mg — FDA prescribing information (TerSera), DailyMed
FDA label — ZOLADEX 3.6 mg, endometriosis and endometrial thinningFDA-approved label · FDA prescribing informationWomen aged 18 and over with endometriosis; women having endometrial ablation for dysfunctional uterine bleeding3.6 mg. Endometrial thinning: one or two implants four weeks apart, with surgery at four weeks (one implant) or two to four weeks after the secondSubcutaneous, anterior abdominal wall below the navel lineEvery 28 days6 months for endometriosis; retreatment cannot be recommendedManagement of endometriosis; endometrial thinning before ablationZOLADEX (goserelin implant) 3.6 mg — FDA prescribing information (TerSera), DailyMed
FDA label — ZOLADEX 3.6 mg, advanced breast cancerFDA-approved label · FDA prescribing informationPre- and perimenopausal women with advanced breast cancer3.6 mgSubcutaneous, anterior abdominal wall below the navel lineEvery 28 daysLong-term unless clinically inappropriatePalliative treatment of advanced breast cancerZOLADEX (goserelin implant) 3.6 mg — FDA prescribing information (TerSera), DailyMed
FDA label — ZOLADEX 10.8 mg, prostate cancerFDA-approved label · FDA prescribing informationMen with advanced prostate cancer, or Stage T2b-T4 (B2-C) prostate cancer with flutamide and radiotherapy10.8 mgSubcutaneous, anterior abdominal wall below the navel lineEvery 12 weeksLong-term in advanced prostate cancerPalliative treatment of advanced prostate cancerZOLADEX (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.
Goserelin dosage in published studies and labels →

Sequence & molecular data

Sequence and molecular data for Goserelin
Molecular formulaC59H84N18O14
Molecular weight1269.4 g/mol
PubChem CID5311128
FDA UNII0F65R8P09N
ChEMBLCHEMBL1201247
DrugBankDB00014

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.

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.

Regulatory and research status for Goserelin
FDA statusApproved
Research statusApproved product (see FDA status)
AvailabilityPrescription-Only
WADA (sport)Unknown / Not Listed
Library classificationFDA-Approved

How FDA approval, compounding and research-only status differ

Benefits

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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

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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