Gonadorelin

Also known as: gonadorelin acetate · Factrel

Approved, discontinued

Last verified: October 30, 2026

At a glance

FDA approval Approved, discontinued 2 applications
Randomized controlled trials 16 of 307 publications on PubMed
Registered clinical trials 16 6 active
Adverse event reports 611 589 classified as serious
  • Gonadorelin was approved by the FDA (Factrel, Lutrepulse, September 30, 1982), but the products are no longer marketed.
  • PubMed lists 307 publications mentioning it, including 16 randomized controlled trials and 132 animal-only studies.
  • ClinicalTrials.gov lists 16 registered studies testing it (6 active).
  • FDA's adverse event system (FAERS) holds 611 reports mentioning it; 589 classified as serious. Reports do not prove causation.

Research topics

  • Gonadotropin-Releasing Hormone 114
  • Progesterone 60
  • Insemination, Artificial 59
  • Estrus Synchronization 56
  • Ovulation 29
  • Dinoprost 28
  • Lactation 24
  • Luteinizing Hormone 24
  • Estradiol 21
  • Pregnancy Rate 20

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

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA018123 FACTREL Approved, discontinued September 30, 1982 HIKMA
NDA019687 LUTREPULSE KIT Approved, discontinued October 10, 1989 FERRING

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 307
  • Human (MeSH) 121
  • Animal only 132
  • Clinical trials 28
  • Randomized controlled trials 16
  • Systematic reviews & meta-analyses 12
  • Case reports 29
  • Retracted 0

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
16
Active
6
With posted results
6

Conditions studied

  • Obesity 4
  • Infertility 3
  • Sleep Restriction 2
  • Hypogonadotropic Hypogonadism 2
  • Prostate Cancer (CRPC) 1
  • PTSD - Post Traumatic Stress Disorder 1
  • Cognitive Dysfunction 1
  • Brain Injury 1
  • Depression - Major Depressive Disorder 1
  • Suicidal Ideation 1
  • Down Syndrome 1
  • Cognitive Decline 1
Study Status Phase Start
Study on Human Bioequivalence of Triprerelin Acetate for Injection
NCT06683066 The Affiliated Hospital of Qingdao University
Recruiting Phase 1 December 4, 2024
Trifecta Research Study
NCT07717866 Axial Therapeutic Research
Active, not recruiting — August 1, 2022
GnRH Therapy on Cognition in Down Syndrome
NCT04390646 Nelly Pitteloud
Recruiting Phase 2, Phase 3 August 27, 2020
Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women
NCT04037605 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Active, not recruiting Early phase 1 February 9, 2020
Hormonal Mechanisms of Sleep Restriction - Axis Study
NCT03142893 Peter y. Liu
Active, not recruiting Phase 1 May 8, 2017
Reprometabolic Syndrome Mediates Subfertility in Obesity
NCT02653092 University of Colorado, Denver Results posted
Active, not recruiting N/A Jun 2016
Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH
NCT05184374 Huashan Hospital
Unknown status N/A January 1, 2022
Testing the Addition of a New Anti-Cancer Drug, Niraparib, to the Usual Treatment (Hormone and Radiation Therapy) for Prostate Cancer With a High Chance of Recurring
NCT04037254 NRG Oncology Results posted
Completed Phase 1, Phase 2 October 8, 2019
Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome
NCT03989024 RenJi Hospital
Unknown status Phase 4 July 1, 2019
Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome
NCT02705014 Peking Union Medical College Hospital
Unknown status N/A Jan 2016
Show 6 more studies
Study Status Phase Start
Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women
NCT01894581 University of Colorado, Denver Results posted
Completed N/A Jul 2014
LutrePulse Hypogonadotropic Hypogonadism
NCT01976728 Ferring Pharmaceuticals Results posted
Completed Phase 3 April 1, 2014
Estrogen Sensitivity and Ovulatory Dysfunction in Obesity
NCT01381016 University of Colorado, Denver Results posted
Completed N/A Jun 2011
Reproductive Hormonal Alterations in Obesity
NCT01457703 University of Colorado, Denver Results posted
Completed N/A Jun 2010
Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
NCT01278290 Hospital de Niños R. Gutierrez de Buenos Aires
Completed Phase 3 Dec 2009
Psychostimulant Abuse - Novel Treatment Approaches - 1
NCT00000325 National Institute on Drug Abuse (NIDA)
Completed Phase 1 —

All 16 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
611
Serious
589
With death outcome
41

Most reported reactions

  • Neutropenia 96
  • Malignant neoplasm progression 51
  • Metastases to bone 45
  • Fatigue 37
  • Nausea 34
  • Alanine aminotransferase increased 33
  • Asthenia 33
  • Diarrhoea 32
  • Aspartate aminotransferase increased 31
  • Anaemia 28
  • Headache 28
  • Hot flush 28

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.