Buserelin

Also known as: Suprefact

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 166 of 1,496 publications on PubMed
Registered clinical trials 42 4 active
Adverse event reports 232 226 classified as serious
  • Buserelin is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 1,496 publications mentioning it, including 166 randomized controlled trials and 486 animal-only studies.
  • ClinicalTrials.gov lists 42 registered studies testing it (4 active).
  • FDA's adverse event system (FAERS) holds 232 reports mentioning it; 226 classified as serious. Reports do not prove causation.

Research topics

  • Gonadotropin-Releasing Hormone 80
  • Progesterone 51
  • Insemination, Artificial 47
  • Estrus Synchronization 34
  • Ovulation Induction 28
  • Estradiol 26
  • Chorionic Gonadotropin 25
  • Ovulation 24
  • Fertility 18
  • Pregnancy Rate 17

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 1,496
  • Human (MeSH) 910
  • Animal only 486
  • Clinical trials 269
  • Randomized controlled trials 166
  • Systematic reviews & meta-analyses 15
  • Case reports 69
  • Retracted 1

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
42
Active
4
With posted results
8

Conditions studied

  • Prostate Cancer 13
  • Infertility 6
  • Ovarian Stimulation 3
  • Prostate Adenocarcinoma 2
  • In Vitro Fertilization 2
  • Metastatic Castration-resistant Prostate Cancer 1
  • Stage III Prostate Cancer AJCC v8 1
  • Stage IVA Prostate Cancer AJCC v8 1
  • to Evaluate the Feasibility and Accuracy of Using cfDNA Analysis of Spent Embryo Culture Media as a Non-invasive Approach for PGD 1
  • Hormone-receptor-positive Breast Cancer 1
  • Premenopausal Breast Cancer 1
  • Breast Cancer Patients at Intermediate to High Risk 1
Study Status Phase Start
A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer
NCT07553988 R-Pharm International, LLC
Active, not recruiting Phase 2 October 24, 2024
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial
NCT05050084 NRG Oncology
Active, not recruiting Phase 3 December 6, 2021
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial
NCT04513717 NRG Oncology
Active, not recruiting Phase 3 January 21, 2021
Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
NCT01492972 Proton Collaborative Group
Recruiting Phase 3 Jan 2012
Cell-free DNA Analysis of Spent Embryo Culture Media as a Non-invasive Approach for Preimplantation Genetic Diagnosis
NCT07076719 Sohag University
Completed — October 1, 2023
Comparative Evaluation of Efficacy and Safety of Toremifene, Tamoxifen, and Aromatase Inhibitor Plus Ovarian Function Suppression in Hormone Receptor-Positive Early Breast Cancer Among Non-Low-Risk Premenopausal Women: A Real-World Study
NCT05801705 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Unknown status — June 1, 2023
Effect of GnRH Agonist Treatment Protocols on Ovarian Reserve
NCT05567731 Tanta University
Completed N/A October 15, 2022
A Study Called AWARENESS Using Data From Men in Alberta to Observe Treatment Patterns for Metastatic Castration-sensitive Prostate Cancer
NCT05149131 Bayer
Completed — January 17, 2022
Modified Downregulation for Women With Adenomyosis of the Uterus Prior to Frozen-thawed Embryo Transfer.
NCT03946722 University College, London
Unknown status Phase 4 August 17, 2020
An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
NCT04854707 IVFarma LLC Results posted
Completed — January 12, 2020
Show 32 more studies
Study Status Phase Start
Anti-Müllerian Hormone (AMH) Measured With Fully Automated Assay Versus AFC in the Prediction of Ovarian Response
NCT04168892 Andros Day Surgery Clinic
Completed — September 20, 2019
Dual Ovarian Stimulation (Duostim) and Shanghai Protocols in Poor Ovarian Responders
NCT06199960 Royan Institute
Completed Phase 3 August 2, 2019
Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome
NCT05638529 Mount Sinai Hospital, Canada
Unknown status Phase 4 May 1, 2019
Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation
NCT02703584 Mount Sinai Hospital, Canada
Completed Phase 4 Mar 2016
Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)
NCT02742675 Fudan University
Unknown status Phase 2 Sep 2015
Efficacy of Ovarian Stimulation Based on FSHR Genotype Status
NCT00749853 Medical University of Vienna
Suspended Phase 3 May 2015
The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Pilot Study in Normo-responder IVF Patients
NCT01980680 Peter Humaidan
Completed Phase 4 Dec 2014
Dose Finding Study of BKM 120 in Combination With LH-RH Agonists and Bicalutamide in Men With Non Castrate Metastatic Prostate Cancer
NCT02487823 Institut Paoli-Calmettes
Terminated Phase 1 Oct 2014
Molecular Evaluation of Endometrium After Endometrial Injury
NCT02480127 Royan Institute
Completed N/A Sep 2014
Age Versus Ovarian Reserve Markers Based Therapy in IVF (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycles
NCT01816789 Andros Day Surgery Clinic
Terminated Phase 4 Mar 2013
The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation Protocol
NCT01636505 European Hospital
Unknown status Phase 3 Sep 2012
External Beam Radiation With or Without Chemotherapy to Treat High Risk Prostate Cancer
NCT01603420 Proton Collaborative Group Results posted
Terminated Phase 2, Phase 3 Jul 2012
Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer
NCT01546987 Radiation Therapy Oncology Group Results posted
Completed Phase 3 May 2012
Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist
NCT01888744 Universitair Ziekenhuis Brussel
Completed Phase 4 Sep 2010
Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer
NCT00936390 Radiation Therapy Oncology Group Results posted
Completed Phase 3 Sep 2009
Mild Stimulation Protocol Versus Microdose Gonadotropin-releasing Hormone Agonist Flare up Protocol in Poor Responders
NCT01213147 Yazd Medical University
Completed Phase 4 Apr 2009
Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles
NCT00627406 Regionshospitalet Viborg, Skive Results posted
Completed Phase 4 Jan 2009
Replacement of Fresh Embryo Transfers (ETs) by Frozen Embryo Transfers (FETs) Using Vitrification
NCT00823121 Yazd Research & Clinical Center for Infertility
Unknown status Phase 1, Phase 2 Aug 2008
Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer
NCT00651326 NCIC Clinical Trials Group
Terminated Phase 3 June 2, 2008
Antagonist/Letrozole in Poor Responders
NCT00823004 Yazd Research & Clinical Center for Infertility
Completed Phase 1, Phase 2 Jun 2008
Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
NCT00528866 Radiation Therapy Oncology Group Results posted
Completed Phase 2 Apr 2008
Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH
NCT00823602 Yazd Research & Clinical Center for Infertility
Unknown status Phase 3 Mar 2008
Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer
NCT00567580 Radiation Therapy Oncology Group Results posted
Unknown status Phase 3 Feb 2008
Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist
NCT00830492 Yazd Research & Clinical Center for Infertility
Completed Phase 4 Jan 2008
Duration of GnRH-analogue Downregulation and Pregnancy Rates
NCT00436319 Aristotle University Of Thessaloniki
Terminated Phase 4 May 2006
Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin
NCT00461916 Tehran University of Medical Sciences
Completed Phase 4 May 2005
Androgen Suppression Combined With Elective Nodal and Dose Escalated Radiation Therapy
NCT00175396 University of British Columbia
Unknown status Phase 3 May 2004
Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
NCT00054106 NCIC Clinical Trials Group
Completed Phase 1 December 10, 2002
Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
NCT00004054 Radiation Therapy Oncology Group Results posted
Completed Phase 3 Jan 2000
Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer
NCT00003653 NCIC Clinical Trials Group
Completed Phase 3 January 5, 1999
Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
NCT00002633 NCIC Clinical Trials Group
Completed Phase 3 February 8, 1995
Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer
NCT01819285 European Organisation for Research and Treatment of Cancer - EORTC
Completed Phase 3 Feb 1990

All 42 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
232
Serious
226
With death outcome
21

Most reported reactions

  • Ovarian hyperstimulation syndrome 36
  • Pyrexia 15
  • Alanine aminotransferase increased 13
  • Aspartate aminotransferase increased 13
  • Muscular weakness 13
  • Product prescribing error 13
  • Blood creatine phosphokinase increased 12
  • Blood lactate dehydrogenase increased 12
  • Dyspnoea 12
  • Gamma-glutamyltransferase increased 12
  • Nausea 11
  • Ectopic pregnancy 10

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.