Product Description
Elagolix is used to manage pain due to endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy or irregular bleeding). Elagolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of certain hormones in the body. (Sourced from: https://medlineplus.gov/druginfo/meds/a618044.html)
Mechanisms of Action: GnRH Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Bangladesh | Canada | Israel | United States
Approved Indications: Pain Unspecified | Endometriosis | Leiomyoma | Myoma | Injuries/wounds Unspecified
Known Adverse Events: Depressive Disorder | Headache | Insomnia | Arthralgia
Company: AbbVie
Company Location: NORTH CHICAGO IL 60064
Company CEO: Richard A. Gonzalez
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, Puerto Rico, United States
Active Clinical Trial Count: 5
Highest Development Phases
Phase 3: Endometriosis|Leiomyoma|Menorrhagia|Myofibroma|Uterine Hemorrhage
Phase 1: Infertility
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| ELARIS EM-COC | P3 |
Recruiting |
Endometriosis |
2029-03-01 |
|
| ALGKNP2022-III | P3 |
Recruiting |
Endometriosis |
2026-09-30 |
63% |
| elagolix | P1 |
Active, not recruiting |
Infertility|Endometriosis |
2024-09-30 |
|
| M16-283 | P3 |
Completed |
Menorrhagia|Leiomyoma|Myofibroma|Uterine Hemorrhage |
2024-06-28 |