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Drug

Ganirelix

Established medicine
ClassGonadotropin-releasing hormone receptor antagonistResearchOngoing clinical research

Also known as Antagon, Fyremadel, Ganirelix Acetate.

4
Active clinical trials
GNRHR
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women

Clinical trial2022-07-24Primary completion · ClinicalTrials.gov

Hormonal Mechanisms of Sleep Restriction - Axis Study

Clinical trial2020-10-30Primary completion · ClinicalTrials.gov

Approval: Orgalutran (EMA)

Regulatory2000-05-16EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ganirelix
Aliases & brands
AntagonFyremadelGanirelix Acetate
RxNorm CUI
35825
ChEMBL ID
CHEMBL1251
ATC codes
H01CC01
UNII
IX503L9WN0
Primary mechanism
Gonadotropin-releasing hormone receptor antagonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

ANTAGONISTGonadotropin-releasing hormone receptor antagonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2000-05-16
Latest approval
2000-05-16
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2000-05-16Approval
Approval: Orgalutran (EMA)
Indication: The prevention of premature luteinising-hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques. In clinical studies,Show full indication

The prevention of premature luteinising-hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques. In clinical studies, Orgalutran was used with recombinant human follicle-stimulating hormone or corifollitropin alfa, the sustained follicle stimulant.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

32 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
32
registered trials across all phases
LATEST COMPLETION 2025
4
Active studies
2
Recruiting
25
Late-stage (III+)
20
Completed
8
Discontinued
PHASE DISTRIBUTIONn = 32
Early Phase 13Phase 11Phase 1 / 21Phase 22Phase 38Phase 413Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.