Ganirelix
As of the edition of 20 October 2026, Ganirelix is a protein: marketed, first approved in 1999 (US); acts on GNRHR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Protein
- Brand name
- Orgalutran
- First approved
- 29 July 1999 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- Nippon Organon K.K.; 4 holders in all
- Registered trials
- 42, 3 stopped early
- Disease areas
- Urinary and reproductive; Hormones; Pregnancy and women's health; Cancer; Inherited and neonatal; Nervous system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Ganirelix.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GNRHR | Gonadotropin-releasing hormone receptor | P30968 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 11 | 1 | 0 |
| Phase 1 | 5 | 3 | 2 | 0 |
| Phase 2 | 3 | 3 | 0 | 0 |
| Phase 3 | 8 | 6 | 0 | 1 |
| Phase 4 | 12 | 5 | 1 | 2 |
| All trials | 42 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Originator, Applicant and Lead sponsor of trials | 1999 to now |