Cetrorelix
As of the edition of 20 October 2026, Cetrorelix is a protein: marketed, first approved in 1999 (EU); acts on GNRHR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Protein
- Brand name
- Cetrotide
- First approved
- 12 April 1999 (EU)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- SUN Pharmaceutical Industries; 5 holders in all
- Registered trials
- 47, 3 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Hormones; Cancer; Nutrition and metabolism; Bones, joints and muscles
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
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 Cetrorelix.
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 | 16 | 11 | 2 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 4 | 3 | 0 | 1 |
| Phase 3 | 9 | 5 | 1 | 1 |
| Phase 4 | 17 | 10 | 0 | 1 |
| All trials | 47 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck KGaA | Applicant, Acquired holder and Lead sponsor of trials | 1999 to now |
| Nippon Kayaku | Applicant and Lead sponsor of trials | 2006 to now |