Drugs / Elagolix
Elagolix
also known as
ABT-620, elagolix sodium · Orilissa · ELAGOLIX SODIUM · Elagolix sodium component of oriahnn · Elagolix sodium salt · NBI-56418 · NBI-56418 NA · Orlissa
Small molecule targets GNRHR via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ORILISSA | — | 2021-02-01 | fda.gov ↗ |
| Approved | US (FDA) | ORILISSA | — | 2018-07-23 | fda.gov ↗ |
Trials 30 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03746535 | Jul 2022 → Dec 2025 overdue | endometriosis | Yale University | Recruiting | No outcome recorded |
| Phase 0 | NCT04445025 | Sep 2020 → Sep 2024 | endometriosis, infertility disorder | Colorado Center for Reproductive Medicine | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT01403038 | Jun 2011 → Oct 2012 | — | AbbVie | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT04039204 | Jan 2022 → Aug 2023 | endometriosis, infertility disorder | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 2 | NCT03951077 | Aug 2019 → Feb 2021 | polycystic ovary syndrome | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01817530 | Apr 2013 → Jun 2015 | leiomyoma, uterine disorder | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01441635 | Sep 2011 → Nov 2013 | leiomyoma, uterine disorder | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT00973973 | Oct 2009 → Sep 2010 | endometriosis | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT00797225 | Nov 2008 → Feb 2010 | endometriosis | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT00619866 | Feb 2008 → Apr 2009 | endometriosis | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT00437658 | Dec 2006 → Nov 2008 | endometriosis | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT00109512 | Apr 2005 → Jun 2006 | endometriosis | Abbott | Completed | No outcome recorded |
| Phase 313 trials | ||||||
| Phase 3 | NCT06076486 | Sep 2023 → Nov 2024 | endometriosis | Nanjing Chia-tai Tianqing Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT05648669 | Sep 2022 → Jul 2023 | endometriosis | Qilu Pharmaceutical (Hainan) Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04333576 | Aug 2020 → Jul 2027 expected | endometriosis | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03343067 | Dec 2017 → Oct 2018 | endometriosis | AbbVie | Terminated | No outcome recorded |
| Phase 3 | NCT03271489 | Sep 2017 → Jun 2024 | leiomyoma | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03213457 | Jul 2017 → Mar 2020 | endometriosis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02925494 | Sep 2016 → May 2018 | leiomyoma | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02691494 | Feb 2016 → Feb 2018 | leiomyoma | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02654054 | Dec 2015 → Jan 2018 | uterine benign neoplasm | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02143713 | May 2014 → Jun 2016 | endometriosis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01931670 | Sep 2013 → Jan 2016 | endometriosis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01760954 | Dec 2012 → May 2015 | endometriosis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01620528 | May 2012 → Nov 2014 | endometriosis | AbbVie | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07532876 | May → Oct 2026 expected | endometriosis | Pak Emirates Military Hospital | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06798571 | Mar 2025 → Sep 2026 expected | — | Penn State University | Recruiting | No outcome recorded |
| Phase 4 | NCT05038878 | Jul 2021 → Jun 2022 | Cushing syndrome due to cortisol-producing adrenocortical adenoma | Icahn School of Medicine at Mount Sinai | Terminated | No outcome recorded |
| Phase 4 | NCT04060992 | Oct 2019 → Oct 2020 | anovulation | University of Southern California | Unknown | No outcome recorded |
| Phase 4 | NCT03886220 | Apr 2019 → Mar 2021 | leiomyoma | AbbVie | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04614246 Comparator | Jan 2021 → Jan 2022 | endometriosis | Bayer | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06375811 Comparator | Mar 2024 → Mar 2027 expected | endometriosis, female infertility | Yale University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04173169 Comparator | Mar 2022 → May 2025 | endometriosis, female infertility | Yale University | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06253702 Background | Jul 2024 → May 2025 | cerebrovascular disorder | University of Wisconsin, Madison | Completed | No outcome recorded |
Press releases naming this drug 19 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-08-05 | AbbVie | AbbVie Submits New Drug Application to US FDA for Investigational Elagolix for Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Women abbvie.com ↗ |
| 2018-11-14 | AbbVie | AbbVie Presents Positive Phase 3 Data Demonstrating Investigational Elagolix Reduces Heavy Menstrual Bleeding in Women with Uterine Fibroids at 2018 AAGL Global Congress abbvie.com ↗ |
| 2018-08-22 | AbbVie | AbbVie Announces Positive Topline Results from Phase 3 Extension Study Evaluating Investigational Elagolix in Women with Uterine Fibroids abbvie.com ↗ |
| 2018-07-24 | AbbVie | AbbVie Receives U.S. FDA Approval of ORILISSA™ (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis abbvie.com ↗ |
| 2018-04-27 | AbbVie | AbbVie Presents New Investigational Data for Elagolix at the 2018 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting abbvie.com ↗ |
| 2018-04-10 | AbbVie | AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain abbvie.com ↗ |
| 2018-03-13 | AbbVie | AbbVie Announces Positive Topline Results from Second Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids abbvie.com ↗ |
| 2018-02-21 | AbbVie | AbbVie Announces Positive Topline Results from Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids abbvie.com ↗ |
| 2017-11-01 | AbbVie | AbbVie Announces Positive Phase 3 Extension Study Data for Investigational Oral Treatment Elagolix for Management of Endometriosis with Associated Pain abbvie.com ↗ |
| 2017-10-27 | AbbVie | AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain abbvie.com ↗ |
| 2017-09-06 | AbbVie | AbbVie Submits New Drug Application to U.S. FDA for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain abbvie.com ↗ |
| 2017-05-17 | AbbVie | AbbVie Presents Pivotal Phase 3 Data on Investigational Treatment Elagolix at the World Congress on Endometriosis abbvie.com ↗ |
| 2017-04-07 | AbbVie | AbbVie Announces Positive Phase 2b Data Demonstrating Investigational Medicine Elagolix Significantly Reduced Heavy Menstrual Bleeding in Women with Uterine Fibroids abbvie.com ↗ |
| 2016-10-19 | AbbVie | AbbVie Announces Positive Pivotal Phase 3 Data Demonstrating Investigational Medicine Elagolix Reduces Menstrual and Non-Menstrual Pelvic Pain Associated with Endometriosis at the American Society for Reproductive Medicine Scientific Congress abbvie.com ↗ |
| 2016-10-06 | AbbVie | AbbVie Presents Pivotal Phase 3 Data on Investigational Treatment Elagolix and Research on the Economic Burden of Endometriosis at the 72nd American Society for Reproductive Medicine Scientific Congress abbvie.com ↗ |
| 2016-02-10 | AbbVie | AbbVie Announces Positive Top-Line Results From Second Phase 3 Study Investigating Elagolix in Patients with Endometriosis abbvie.com ↗ |
| 2016-01-28 | AbbVie | AbbVie Initiates Enrollment in Phase 3 Clinical Program for Elagolix in Patients with Uterine Fibroids abbvie.com ↗ |
| 2015-09-16 | AbbVie | AbbVie Announces Plans to Proceed to Phase 3 Evaluation of Elagolix in Patients with Uterine Fibroids abbvie.com ↗ |
| 2015-01-08 | AbbVie | AbbVie Announces Positive Top-Line Results From Phase 3 Study of Investigational Medicine Elagolix in Patients with Endometriosis abbvie.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Elagolix | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03271489 ↗31 |
| Known as | ABT-620, elagolix sodium | “ABT-620, elagolix sodium” NCT01403038 ↗1“ABT-620, elagolix sodium” NCT01620528 ↗ |
| Known as | ELAGOLIX SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL1208155 ↗ |
| Known as | Elagolix sodium component of oriahnn | ChEMBL registry synonym — accepted as the source's own label CHEMBL1208155 ↗ |
| Known as | Elagolix sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1208155 ↗ |
| Known as | NBI-56418 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00109512 ↗ |
| Known as | NBI-56418 NA | ChEMBL registry synonym — accepted as the source's own label CHEMBL1208155 ↗ |
| Known as | Orilissa | “Elagolix 200 MG Oral Tablet [Orilissa]” NCT04060992 ↗ |
| Known as | Orlissa | ChEMBL registry synonym — accepted as the source's own label CHEMBL1208155 ↗ |
| Action | Inhibit | “Gonadotropin-releasing hormone receptor antagonist” CHEMBL1208155 ↗1“NBI-56418 (GnRH antagonist)” NCT00109512 ↗ |
| Modality | Small molecule | “Elagolix is a novel, orally active, non-peptide, competitive gonadotropin-releasing hormone (GnRH) receptor antagonist in development for the management of endometriosis with...” PMID 29476499 ↗ Oct 2018 |
| Route | Oral | “Elagolix 75 mg orally twice a day (BID)” NCT00437658 ↗ |
| Target | GNRHR | “Gonadotropin-releasing hormone receptor antagonist” CHEMBL1208155 ↗ |