Linzagolix
As of the edition of 20 October 2026, Linzagolix is a small molecule: marketed, first approved in 2022 (EU); acts on GNRHR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Yselty
- First approved
- 14 June 2022 (EU)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Labatec Pharma; 3 holders in all
- Registered trials
- 19, 2 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Cancer; Mental health; Digestive system
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Linzagolix.
See the 2 companies 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 | 2 | 0 | 2 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 5 | 5 | 0 | 0 |
| Phase 3 | 10 | 6 | 2 | 2 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Kissei Pharmaceutical | Applicant and Lead sponsor of trials | 2016 to now |
| Theramex | Applicant | 2022 to now |
| Labatec Pharma | Applicant | 2026 to now |