Approved

Buserelin: Uses, Evidence, and Trial Data

Molecular formulaC60H86N16O13
Molecular weight1239.4 g/mol
Registered trials43
PubChem CID50225

What buserelin is

Buserelin is a synthetic peptide with a molecular formula of C60H86N16O13 and a molecular weight of about 1,239 daltons (PubChem CID 50225). It belongs to the class of gonadotropin-releasing hormone (GnRH) agonists, compounds that act on the pituitary gland to regulate the release of reproductive hormones.

Regulatory status

Buserelin has an approved drug label on file, indicating it has gone through formal regulatory review for at least one indication. Specific label details such as approved indications, mechanism text, and brand names were not available in the data used for this monograph, so those sections are omitted here.

What the evidence shows

Buserelin has been studied across 43 registered clinical trials. Several of these trials focus on prostate cancer treatment approaches. One phase 3 trial examined androgen suppression combined with radiation therapy, with or without docetaxel, in patients with high-risk localized prostate cancer, though it was terminated. Another phase 3 trial evaluated radiation therapy with or without androgen-deprivation therapy in prostate cancer patients and reached completion. A related phase 3 study looked at short-term androgen deprivation therapy alongside radiation targeting the prostate and pelvic lymph nodes, though its final status is unknown.

Reported side effects

Side effect report data from the FDA Adverse Event Reporting System (FAERS) was not available for buserelin in this dataset, so no side effect summary is presented here.

FAQ

What is buserelin?
Buserelin is a synthetic peptide classified as a gonadotropin-releasing hormone (GnRH) agonist. It has a molecular weight of approximately 1,239 daltons. It has an approved drug label on file, reflecting formal regulatory review.
What is buserelin used for?
Detailed approved indications were not available in the data reviewed for this monograph. Clinical trial activity involving buserelin has concentrated on prostate cancer treatment strategies, often alongside radiation therapy.
How many clinical trials have studied buserelin?
Buserelin appears in 43 registered clinical trials. Several of these are phase 3 studies examining its role in prostate cancer treatment in combination with radiation or other therapies.
Are there known side effects of buserelin?
This monograph did not have access to FDA Adverse Event Reporting System (FAERS) data for buserelin, so a side effect summary could not be included. Any side effect information would reflect reported cases, not confirmed causation.
Is buserelin FDA approved?
The data reviewed indicates buserelin has an approved drug label on file. Specific approved indications and brand names were not detailed in the available data.
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Sources: PubChem CID 50225 ClinicalTrials.gov DailyMed

Updated 2026-09-19