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Yselty (LINZAGOLIX)
LINZAGOLIX (Yselty), marketed by Obseva Ireland Ltd, is a gonadotropin-releasing hormone receptor antagonist indicated for the treatment of uterine fibroids. Its key strength lies in its mechanism of action, which effectively reduces the growth and size of uterine fibroids, positioning it as a competitive alternative to off-patent drugs like ganirelix and cetrorelix. The primary risk is the strong competition from other patent-protected drugs such as elagolix, which has a patent expiry in 2036, and estradiol, with a patent expiry in 2032.
At a glance
| Generic name | LINZAGOLIX |
|---|---|
| Sponsor | Obseva Ireland Ltd |
| Target | Gonadotropin-releasing hormone receptor |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2022 |
Approved indications
- Uterine fibroids
Common side effects
Key clinical trials
- A Clinical Study of KLH-2109 in Patients With Endometriosis (PHASE3)
- A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain (PHASE3)
- Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6) (PHASE3)
- Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (PHASE3)
- Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain. (PHASE3)
- A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain (PHASE3)
- A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia (PHASE3)
- A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Yselty CI brief — competitive landscape report
- Yselty updates RSS · CI watch RSS
- Obseva Ireland Ltd portfolio CI