Overview
Linzagolix is a non-peptide, selective antagonist of the gonadotropin-releasing hormone (GnRH) receptor. It has been studied for the treatment of estrogen-dependent conditions such as uterine fibroids and endometriosis. It is similar to other GnRH receptor antagonists like cetrorelix, relugolix, and elagolix. Uterine fibroids occur in >70% of women of reproductive age, and when symptomatic are associated with heavy menstrual bleeding, anemia, abdominal pain and pressure, bloating, increased urinary frequency, and reproductive dysfunction. As these fibroids are essentially estrogen-dependent phenomena, hormone therapies which suppress estrogen activity - including GnRH receptor antagonists like linzagolix - are thought to be beneficial by preventing intramyometrial growths in the endometrial glands. Linzagolix was approved for use in the European Union in June 2022 for the management of symptoms caused by uterine fibroids.
Indication
Linzagolix is indicated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Associated Conditions
- Moderate Uterine Fibroids
- Severe Uterine Fibroids
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/02/22 | Phase 2 | Not yet recruiting | Bio Genuine (Shanghai) Biotech Co., Ltd. | ||
2022/11/17 | Phase 3 | Recruiting | Bio Genuine (Shanghai) Biotech Co., Ltd. | ||
2020/05/01 | Phase 3 | Terminated | |||
2020/04/06 | Phase 3 | Completed | |||
2019/06/20 | Phase 3 | Completed | |||
2019/06/14 | Phase 3 | Terminated | |||
2019/05/23 | Phase 1 | Completed | |||
2019/05/23 | Phase 1 | Completed | |||
2017/03/06 | Phase 3 | Completed | |||
2017/03/06 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.