Ganirelix (Orgalutran)
Ganirelix Acetate (N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N9,N10-diethyl-D-homoarginyl-L-leucyl-N9,N10-diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate)
Approved status applies to specific products, routes, and indications, not every use context discussed online.
Its effectiveness has been confirmed in multiple large clinical trials.
Ganirelix (Orgalutran) is FDA-approved.
Use according to current labeled indication and prescribing guidance.
Safety Summary
The overall safety profile of ganirelix is well-established from two pivotal RCTs (N=794 ganirelix-treated subjects) and extensive post-marketing surveillance. FDA label Table IV lists adverse events at ≥1% incidence without regard to causality, including fetal death (3.7%) which reflects the IVF population baseline rather than drug-attributable events. The most frequent drug-related events were abdominal pain (4.8%), headache (3.0%), OHSS (2.4%), vaginal bleeding (1.8%), injection site reaction (1.1%), and nausea (1.1%). Post-marketing pharmacovigilance identified shared signals with cetrorelix for OHSS-related events (ascites, pleural effusion, abdominal distension) that are attributable to the underlying infertility treatment rather than ganirelix specifically PMC12016398. A 1000-fetus neonatal safety study found no increase in major malformations with ganirelix versus GnRH agonist protocols (5.0% vs 5.4%, OR 0.94, 95% CI 0.62-1.42) PMID 20378616.
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Cited sources
Every claim on this page links to one of the 14 sources below. Identifiers are PubMed (PMID), ClinicalTrials.gov (NCT), or DOI; click through to the source of record before acting on a claim.
- 1PMID 9853849PubMed
- 2PMID 10875855PubMed
- 3PMID 11278211PubMed
- 4PMID 10593371PubMed
- 5PMID 10593372PubMed
- 6PMID 16855976PubMed
- 7PMID 16920869PubMed
- 8PMID 22429192PubMed
- 9PMID 11836309PubMed
- 10PMID 20378616PubMed
- 11PMID 16009165PubMed
- 12PMID 36594696PubMed
- 13PMID 10718102PubMed
- 14PMID 30927417PubMed