PeptideTrace
ApprovedGnRH AntagonistSexual Health & Hormonal

Ganirelix (Antagon, Fyremadel)

A

Evidence Grade A — Regulatory approved. 188 published studies. 82 registered clinical trials.

82 trials188 studiesUSEUCA

Medically reviewed by a licensed medical professional

Licensed Indications

  • Assisted Reproductive Techniques
  • Female Infertility
  • Ovulation Induction
  • Controlled Ovarian Stimulation

User Experience Reports

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Overview

Ganirelix (originally sold as Antagon) is an injectable medication used during IVF to prevent premature ovulation, ensuring eggs can be collected at the optimal time. It was the first GnRH antagonist approved in the US for fertility treatment and comes in a convenient prefilled syringe for daily self-injection. In clinical practice, it is considered interchangeable with cetrorelix.

Also Known As

Ganirelix is also known by these brand and alternate names:

Research Activity

188studies
Human 159
Animal 8
In-vitro 62
Reviews 21

188 published studies: 159 human, 8 animal, 62 in-vitro, 21 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
EMA-authorised(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUPrescription medicine (EU centralised authorisation)
CAPrescription drug

Summary

Ganirelix was originally marketed as Antagon (approved July 1999), making it the first GnRH antagonist approved in the US. It is indicated for prevention of premature LH surges during controlled ovarian stimulation, administered as a daily 250 mcg subcutaneous injection starting mid-cycle.

In clinical practice, ganirelix and cetrorelix are considered therapeutically equivalent, with fertility clinic preference often determined by practical factors such as prefilled syringe convenience, local availability, and cost. Both have been instrumental in the shift from longer GnRH agonist protocols to the shorter, safer antagonist protocols that now dominate IVF practice worldwide.

Mechanism of Action

Ganirelix works identically to cetrorelix — it directly blocks the GnRH receptor in the pituitary gland to prevent the premature LH surge that would trigger ovulation before eggs are ready for collection during IVF. It provides immediate suppression of LH (approximately 74% reduction within four hours of injection) with rapid reversibility once stopped. The practical difference from cetrorelix is primarily in formulation: ganirelix comes as a ready-to-use prefilled syringe, while cetrorelix requires reconstitution.

Research Summary

Ganirelix and cetrorelix are clinically equivalent — no head-to-head trials have shown meaningful differences in pregnancy rates or safety between them. The choice is typically driven by formulary availability, cost, and practical factors like prefilled syringe convenience versus the need for reconstitution. Together, these two drugs helped shift IVF practice worldwide from longer GnRH agonist protocols to shorter antagonist protocols that reduce the risk of ovarian hyperstimulation syndrome and require fewer injections. Generic ganirelix has improved affordability and access. No major new research programmes are active for ganirelix specifically.

Clinical Trials

PeptideTrace tracks 82 registered clinical trials for Ganirelix sourced from ClinicalTrials.gov.

NCT06877429N/ANot Yet Recruiting

Is the Diurnal Variation in Circulating Levels of Cortisol Reflected in Follicular Fluid of Preovulatory Follicles Close to Ovulation?

ART Fertility Clinics LLCEndpoint: Evaluate the concentration of cortisol and cortisone in serum and follicular fluid samples collected at 8 am versus collection at 8 p.m.Completion: 2027-12-31
NCT07409493N/ARecruiting

IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols

Hanoi Medical UniversityEndpoint: Blastocyst formation rateCompletion: 2028-10-01
NCT07108621Phase IIIRecruiting

hCG Priming in Women With Diminished Ovarian Reserve

Kristine LoesslEndpoint: Number of oocytes retrievedCompletion: 2031-03-31
NCT06175832Phase IVRecruiting

PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study

University Hospital, GhentEndpoint: Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cyclesCompletion: 2027-12-31
NCT06745466Phase IVRecruiting

Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women

University of DelawareEndpoint: Endothelium-dependent dilation (EDD)Completion: 2027-10-01
View all 82 trials on ClinicalTrials.gov →

Regulatory Timeline

1999
Regulatory

FDA ORIG 1

2000
Regulatory

EMA Marketing Authorisation

2001
Regulatory

FDA SUPPL 2

2001
Regulatory

FDA SUPPL 1

2002
Regulatory

Health Canada Market Authorisation

2002
Regulatory

FDA SUPPL 3

2008
Regulatory

FDA SUPPL 7

2014
Regulatory

FDA SUPPL 10

2015
Regulatory

FDA SUPPL 13

2016
Regulatory

FDA SUPPL 9

2016
Regulatory

FDA SUPPL 15

2018
Regulatory

FDA ORIG 1

2019
Regulatory

FDA SUPPL 1

2020
Regulatory

FDA SUPPL 20

2021
Regulatory

FDA SUPPL 6

2022
Regulatory

FDA ORIG 1

2022
Regulatory

FDA ORIG 1

2023
Regulatory

FDA ORIG 1

2023
Regulatory

FDA SUPPL 19

2023
Regulatory

FDA SUPPL 17

2023
Regulatory

FDA SUPPL 21

2023
Regulatory

FDA SUPPL 14

2023
Regulatory

FDA ORIG 1

2024
Regulatory

FDA SUPPL 1

2024
Regulatory

FDA SUPPL 2

2024
Regulatory

FDA SUPPL 10

2024
Regulatory

FDA SUPPL 24

2025
Regulatory

FDA ORIG 1

Scientific Detail

Overview (Scientific)

Ganirelix is a synthetic decapeptide (10 amino acids) GnRH antagonist and was the first GnRH antagonist approved in the United States. It is formulated as a ready-to-use prefilled syringe for subcutaneous injection.

Mechanism of Action (Scientific)

Ganirelix competitively antagonizes the GnRH receptor, suppressing LH by approximately 74% within 4 hours of administration. Like cetrorelix, it provides rapid-onset, rapidly reversible gonadotropin suppression without initial hormonal flare. The effects dissipate within 48 hours, allowing for precise timing of ovulation trigger in IVF cycles.

Summary (Scientific)

Ganirelix was originally marketed as Antagon (approved July 29, 1999—the first GnRH antagonist in the US). Indicated for inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation. Available as a prefilled syringe (250 mcg/0.5 mL) for daily subcutaneous injection starting mid-stimulation. Functionally interchangeable with cetrorelix in clinical practice.

Related Compounds

Carbetocin

Research Compound
Oxytocin Analogue (Long-Acting)

Carbetocin has not been approved by the FDA. It is registered in over 80 countries for prevention of uterine atony and excessive bleeding after caesarean delivery. A heat-stable formulation was added to the WHO Essential Medicines List in 2019. The CHAMPION trial (WHO, 2018; over 29,000 women) compared a heat-stable carbetocin formulation to oxytocin for preventing postpartum haemorrhage after vaginal delivery, and found it to be non-inferior. The heat-stable formulation addresses a significant limitation of oxytocin, which degrades in warm climates without refrigeration — a major concern in low-resource settings where postpartum haemorrhage causes the most deaths. Its regulatory status varies by jurisdiction.

Kisspeptin-54

Research Compound
Full-Length Kisspeptin (Investigational)

Kisspeptin-54 has no marketing authorisation. Phase II trials conducted primarily at Imperial College London have investigated its use as an IVF oocyte maturation trigger. One trial (60 patients) reported 95% oocyte maturation with zero cases of ovarian hyperstimulation syndrome. Kisspeptin-54 has a more advanced clinical evidence base than kisspeptin-10, with multiple Phase II studies in reproductive medicine. Its potential advantage over conventional IVF triggers relates to a lower risk of the serious complication of ovarian hyperstimulation. Clinical development is ongoing in academic settings. No Phase III trials have been completed.

Goserelin

Approved
GnRH Agonist

Goserelin is marketed as Zoladex by AstraZeneca, available as 3.6 mg monthly and 10.8 mg three-monthly subcutaneous implants. First approved in 1989, it is used in advanced prostate cancer, premenopausal breast cancer, endometriosis, and for thinning the uterine lining before surgical procedures. Goserelin achieves castrate-level testosterone suppression (below 50 ng/dL) within two to four weeks. Its unique implant delivery system means there is no liquid injection, reconstitution, or refrigeration required — a practical advantage in some clinical settings. Like all GnRH agonists, it causes an initial hormone flare before suppression takes effect. Goserelin holds an important niche in breast cancer treatment, where it is used to suppress ovarian function in premenopausal women with hormone-receptor-positive disease, often in combination with aromatase inhibitors.

Related Research

This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.