Nafarelin

Also known as: Synarel

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 1 application
Randomized controlled trials 59 of 274 publications on PubMed
Registered clinical trials 12 4 active
Adverse event reports 304 256 classified as serious
  • Nafarelin is an FDA-approved drug, marketed as Synarel (first approval: February 13, 1990).
  • PubMed lists 274 publications mentioning it, including 59 randomized controlled trials and 28 animal-only studies.
  • ClinicalTrials.gov lists 12 registered studies testing it (4 active).
  • FDA's adverse event system (FAERS) holds 304 reports mentioning it; 256 classified as serious. Reports do not prove causation.

Research topics

  • Gonadotropin-Releasing Hormone 77
  • Endometriosis 73
  • Hormones 47
  • Estradiol 39
  • Administration, Intranasal 33
  • Luteinizing Hormone 33
  • Leuprolide 28
  • Fertilization in Vitro 27
  • Danazol 25
  • Follicle Stimulating Hormone 24

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

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA019886 SYNAREL Approved, marketed February 13, 1990 PFIZER

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 274
  • Human (MeSH) 227
  • Animal only 28
  • Clinical trials 84
  • Randomized controlled trials 59
  • Systematic reviews & meta-analyses 2
  • Case reports 18
  • 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
12
Active
4
With posted results
0

Conditions studied

  • Infertility 3
  • Ovarian Hyperstimulation Syndrome 2
  • Fertility Preservation 1
  • GnRH Antagonist IVF Protocol 1
  • Fresh Embryo Transfer 1
  • Administration of Hormonal Luteal Support 1
  • Ivf 1
  • Frozen Embryo Transfer (FET) 1
  • In Vitro Fertilization 1
  • ICSI Intracytoplasmic Spermatozoid Injection 1
  • Hormone-receptor-positive Breast Cancer 1
  • Premenopausal Breast Cancer 1
Study Status Phase Start
Intranasal Nafarelin For Triggering Oocyte Maturation
NCT06763926 Fundacion Dexeus
Recruiting Phase 4 October 14, 2026
GnRH for Luteal Support - Mechanism of Action
NCT07620067 Heli Alexandroni
Recruiting — May 18, 2026
Comparison of Pregnancy Rates in Modified Natural Frozen Embryo Transfer (FET) Cycle After Luteal Support with GnRH Agonist Versus Progesterone
NCT06870266 Shaare Zedek Medical Center
Not yet recruiting Early phase 1 Mar 2025
Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles
NCT06150703 Assistance Publique - Hôpitaux de Paris
Recruiting Phase 3 June 27, 2024
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
Injection Free IVF
NCT04850261 Insel Gruppe AG, University Hospital Bern
Withdrawn Phase 2 May 1, 2021
GnRH Agonist for Luteal Phase Support.
NCT05484193 Shaare Zedek Medical Center
Unknown status N/A June 8, 2020
Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders
NCT04797338 Assaf-Harofeh Medical Center
Unknown status Phase 4 December 29, 2017
Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization
NCT02865681 New Hope Fertility Center
Completed N/A July 1, 2016
Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment
NCT00843570 University of Oxford
Completed Phase 4 Nov 2009
Show 2 more studies
Study Status Phase Start
Short Versus Long Protocol for IVF and IVF+ICSI
NCT00756028 Peter Hornnes, MD, DMSc
Completed Phase 4 Jan 2009
Endometriosis : Traditional Medicine vs Hormone Therapy
NCT00034047 National Center for Complementary and Integrative Health (NCCIH)
Completed Phase 1, Phase 2 Sep 2002

All 12 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
304
Serious
256
With death outcome
11

Most reported reactions

  • Ovarian hyperstimulation syndrome 51
  • Dyspnoea 21
  • Ascites 19
  • Condition aggravated 15
  • Abdominal pain 14
  • Nausea 14
  • Pain 14
  • Diarrhoea 13
  • Headache 13
  • Off label use 13
  • Drug ineffective 12
  • Abdominal distension 11

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

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

  • Synarel HUMAN PRESCRIPTION DRUG Pfizer Laboratories Div Pfizer Inc March 5, 2026

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.