At a glance
- Ganirelix is an FDA-approved drug, marketed as Ganirelix, Fyremadel (first approval: July 29, 1999).
- PubMed lists 196 publications mentioning it, including 48 randomized controlled trials and 8 animal-only studies.
- ClinicalTrials.gov lists 106 registered studies testing it (11 active).
- FDA's adverse event system (FAERS) holds 2,644 reports mentioning it; 1,400 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA021057 | GANIRELIX ACETATE | Approved, marketed | July 29, 1999 | ORGANON USA ORGANON |
| ANDA204246 | FYREMADEL | Approved, marketed | November 30, 2018 | SUN PHARM |
| ANDA212613 | GANIRELIX ACETATE | Approved, marketed | April 7, 2022 | AMPHASTAR PHARMS INC |
| ANDA214996 | GANIRELIX ACETATE | Approved, marketed | June 6, 2022 | MEITHEAL |
| ANDA215658 | GANIRELIX ACETATE | Approved, marketed | February 28, 2023 | GLAND |
| ANDA216075 | GANIRELIX ACETATE | Approved, marketed | November 16, 2023 | LUPIN |
| ANDA218855 | GANIRELIX ACETATE | Approved, marketed | April 23, 2025 | QILU |
| ANDA219454 | GANIRELIX ACETATE | Approved, discontinued | June 27, 2025 | TRIS PHARMA INC |
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
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
- GnRH-receptor antagonism as a targeted approach to reproductive dysfunction in polycystic ovary syndrome.
- GnRH Agonists and Antagonists in IVF/ICSI Cycles of PCOS Women: A Network Meta-Analysis.
- IgA Vasculitis With Nephritis Following Controlled Ovarian Stimulation and Oocyte Donation.
- Real-World Safety and Effectiveness of Ganirelix for Ovarian Stimulation in Chinese Women: A Multicenter, Prospective, Single-Arm, Observational Study.
- Comparison of pregnancy outcomes and safety between cetrorelix and ganirelix in IVF/ICSI antagonist protocols: a retrospective cohort study.
- Post-marketing safety profile of ganirelix in women: a 20-year pharmacovigilance analysis of global adverse drug event databases (2004-2024).
- Freeze-all indications in women with subfertility undergoing IVF: a cohort study.
- Reduction in minipubertal gonadotropin levels alters reproductive lifespan and ovarian follicular loss in female mice.
- Elagolix Represents a Less Invasive and Cheaper Option Than Injectable GnRH Antagonist for Ovulation Suppression in IVF.
- GnRH Peptide Antagonist: Comparative Analysis of Chemistry and Formulation with Implications for Clinical Safety and Efficacy.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 106
- Active
- 11
- With posted results
- 16
Conditions studied
Show 40 more studies
All 106 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 2,644
- Serious
- 1,400
- With death outcome
- 12
Most reported reactions
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.
- Ganirelix Acetate
- Ganirelix Acetate
- Ganirelix Acetate
- Ganirelix Acetate
- Ganirelix Acetate
- Ganirelix Acetate
- GANIRELIX ACETATE
- Ganirelix Acetate
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.