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Ganirelix 0.25 mg.
Ganirelix is a gonadotropin-releasing hormone (GnRH) antagonist that suppresses luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion to prevent premature ovulation during assisted reproductive procedures.
Ganirelix is a gonadotropin-releasing hormone (GnRH) antagonist that suppresses luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion to prevent premature ovulation during assisted reproductive procedures. Used for Prevention of premature luteinizing hormone surge in women undergoing controlled ovarian hyperstimulation for assisted reproductive technology (ART) procedures.
At a glance
| Generic name | Ganirelix 0.25 mg. |
|---|---|
| Also known as | ORGALUTRAN®. |
| Sponsor | Instituto de Investigacion Sanitaria La Fe |
| Drug class | GnRH antagonist |
| Target | GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Reproductive Medicine / Fertility |
| Phase | Phase 3 |
Mechanism of action
Ganirelix competitively binds to GnRH receptors in the pituitary gland, rapidly blocking the release of LH and FSH without an initial surge. This prevents the natural LH surge that would trigger ovulation prematurely, allowing controlled ovarian stimulation and egg retrieval in fertility treatment cycles. The drug provides immediate suppression without the flare effect seen with GnRH agonists.
Approved indications
- Prevention of premature luteinizing hormone surge in women undergoing controlled ovarian hyperstimulation for assisted reproductive technology (ART) procedures
Common side effects
- Injection site reactions (erythema, bruising, pain)
- Headache
- Abdominal pain
- Nausea
- Ovarian hyperstimulation syndrome (OHSS)
Key clinical trials
- INTEnsity of ovariaN Stimulation and Embryo Quality (PHASE4)
- IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols (NA)
- DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCT (NA)
- Ovarian Hyperstimulation and Fibrin Clot Properties. (NA)
- hCG Priming in Women With Diminished Ovarian Reserve (PHASE3)
- Impact of IVF Hormonal Therapy on Endometrial Receptivity and Endometrial Senescent Cell Pathological Accumulation
- Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women (PHASE4)
- To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (PHASE3)
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 |
|---|---|
| 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 0.25 mg. CI brief — competitive landscape report
- Ganirelix 0.25 mg. updates RSS · CI watch RSS
- Instituto de Investigacion Sanitaria La Fe portfolio CI