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Ganirelix Acetate (GANIRELIX)
Ganirelix Acetate (GANIRELIX) is a small molecule gonadotropin-releasing hormone receptor antagonist developed by Organon USA INC and currently owned by Organon Usa Organon. It targets the gonadotropin-releasing hormone receptor to prevent luteinizing hormone surge during controlled ovarian hyperstimulation and ovulation induction. GANIRELIX is a generic medication with 7 available manufacturers and is off-patent. It has a half-life of 9.09 hours and was FDA approved in 1999. As a gonadotropin-releasing hormone receptor antagonist, GANIRELIX is used to prevent premature ovulation in women undergoing fertility treatments.
At a glance
| Generic name | GANIRELIX |
|---|---|
| Sponsor | Organon Usa Organon |
| Drug class | Gonadotropin Releasing Hormone Receptor Antagonist |
| Target | Gonadotropin-releasing hormone receptor |
| Modality | Recombinant protein |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 1999 |
Approved indications
- Ovulation induction
- Prevention of Luteinizing Hormone Surge when undergoing Controlled Ovarian Hyperstimulation
Common side effects
- Abdominal Pain (gynecological)
- Death Fetal
- Headache
- Ovarian Hyperstimulation Syndrome
- Vaginal Bleeding
- Injection Site Reaction
- Nausea
- Abdominal Pain (gastrointestinal)
Key clinical trials
- Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation. (PHASE4)
- INTEnsity of ovariaN Stimulation and Embryo Quality (PHASE4)
- IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols (NA)
- PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study (PHASE4)
- DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCT (NA)
- Ovarian Hyperstimulation and Fibrin Clot Properties. (NA)
- Human Cerebral Blood Flow Regulation (EARLY_PHASE1)
- Is the Diurnal Variation in Circulating Levels of Cortisol Reflected in Follicular Fluid of Preovulatory Follicles Close to Ovulation?
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ganirelix Acetate CI brief — competitive landscape report
- Ganirelix Acetate updates RSS · CI watch RSS
- Organon Usa Organon portfolio CI