Gonadorelin
As of the edition of 20 October 2026, Gonadorelin is a protein: marketed, first approved in 1982 (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 1994
- Kind
- Protein
- Brand name
- Factrel
- First approved
- 30 September 1982 (US)
- Approvals on record
- 8 in 4 regions
- Holder of the most recent approval
- Ferring Pharmaceuticals; 3 holders in all
- Registered trials
- 35, 4 stopped early
- Disease areas
- Urinary and reproductive; Hormones; Pregnancy and women's health; Cancer; Inherited and neonatal; Nutrition and metabolism
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GNRHR | Gonadotropin-releasing hormone receptor | P30968 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 5 | 1 | 0 |
| Phase 1 | 10 | 6 | 2 | 2 |
| Phase 2 | 8 | 5 | 0 | 1 |
| Phase 3 | 5 | 2 | 1 | 1 |
| Phase 4 | 2 | 0 | 1 | 0 |
| All trials | 35 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Earlier holder | 1982 to now |
| Ferring Pharmaceuticals | Applicant and Lead sponsor of trials | 1986 to now |
| Hikma Pharmaceuticals | Acquired holder | 2021 to now |