Oncology · In Clinical Trials
Buserelin (Suprefact)
No lawful US pathway
01 · Overview
Buserelin is a synthetic nonapeptide analogue of gonadotropin-releasing hormone (GnRH) that acts as a GnRH agonist. A single dose stimulates pituitary gonadotropin release, while repeated dosing produces reversible pituitary desensitization that suppresses sex hormone production (PMID 2109679).
It has been used for hormone-sensitive prostate cancer, endometriosis, and pituitary suppression before ovarian stimulation in assisted reproduction (PMID 2109679). Its structure replaces glycine at position 6 with a tert-butyl-protected D-serine and the C-terminal glycine amide with an ethylamide group, changes that increase potency and duration of action.
02 · Research summary & key findings
Buserelin has been used clinically outside the United States for decades, including a pooled analysis of 1,522 men with advanced prostate cancer treated mainly with nasal spray between 1979 and 1988 (PMID 1838426); it has never been FDA approved. A review concluded it gave efficacy comparable to orchidectomy or high-dose estrogens in hormone-sensitive prostate cancer, with antiandrogen cover useful early in treatment to blunt the initial flare (PMID 2109679). In a small study, a single 3-month subcutaneous implant kept testosterone below the castration limit for a mean of 224 days (PMID 16626856). In a randomized trial in endometriosis, intranasal buserelin and oral dienogest gave comparable pain relief, with greater bone density loss on buserelin (PMID 18653184).
03 · Regulatory status
Buserelin (Suprefact) is currently undergoing clinical trials. It is not yet FDA-approved and is available only through clinical research settings or investigational protocols.
No lawful pathway today
Buserelin (Suprefact) is not FDA-approved and does not currently have a lawful prescription or compounding pathway in the United States, so we do not sell it and will not book a consultation for it. That can change: in 2026 FDA began reviewing several peptides for compounding.
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04 · Administration routes
- Subcutaneous injection
- Intranasal
References
- [1]Duration of testosterone suppression after a 9.45 mg implant of the GnRH-analogue buserelin in patients with localised carcinoma of the prostate a 12-month follow-up study Eur Urol, 2006. PMID 16626856
- [2]The use of the LHRH-analogue Buserelin in the treatment of prostatic cancer. A 10-year review on 1522 patients treated in 119 centres on 4 continents Scand J Urol Nephrol Suppl, 1991. PMID 1838426
- [3]Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis--a randomized, double-blind, multicenter, controlled trial Fertil Steril, 2009. PMID 18653184
- [4]Buserelin. A review of its pharmacodynamic and pharmacokinetic properties, and clinical profile Drugs, 1990. PMID 2109679
Primary literature
- PubMed: "Buserelin"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Buserelin"
Registered interventional and observational studies, including status and phase.
- PubChem: "Buserelin"
Chemical structure, molecular properties, and bioactivity data.
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