Buserelin
As of the edition of 20 October 2026, Buserelin is a protein: marketed, first approved in 1986 (ES); acts on GNRHR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Protein
- Brand name
- Suprefact
- First approved
- 1 June 1986 (ES)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Registered trials
- 11, 2 stopped early
- Disease areas
- Urinary and reproductive; Cancer; Hormones; Pregnancy and women's health
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 Buserelin.
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 1 | 2 | 1 | 0 | 1 |
| Phase 3 | 6 | 2 | 3 | 0 |
| Phase 4 | 3 | 2 | 0 | 1 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Cheplapharm Arzneimittel | Applicant | 1997 to now |
| Sanofi | Applicant | 2022 to now |