Drugs / Elagolix
Elagolix
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed endometriosis of pelvic peritoneum 1 milestone | |||||
| Filed | US (FDA) | — | endometriosis of pelvic peritoneum | 2017-09-06 | “submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the management of endometriosis-associated pain” gcs-web.com ↗ |
| Filed subserous uterine fibroid 1 milestone | |||||
| Filed | US (FDA) | — | subserous uterine fibroid | 2019-08-05 | “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for elagolix” gcs-web.com ↗ “announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for elagolix” gcs-web.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | ORILISSA | — | 2021-02-01 | fda.gov ↗ |
| Approved | US (FDA) | ORILISSA | — | 2018-07-23 | fda.gov ↗ |
Trials 30
| 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 · 4 met primary · 3 missed | ||||||
| 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 | Missed primary |
| Phase 2 | NCT01817530 | Apr 2013 → Jun 2015 | leiomyoma, uterine disorder | AbbVie | Completed | Met primary |
| Phase 2 | NCT01441635 | Sep 2011 → Nov 2013 | leiomyoma, uterine disorder | AbbVie | Completed | Met primary |
| Phase 2 | NCT00973973 | Oct 2009 → Sep 2010 | endometriosis | AbbVie | Completed | Met primary |
| Phase 2 | NCT00797225 | Nov 2008 → Feb 2010 | endometriosis | AbbVie | Completed | Missed primary |
| Phase 2 | NCT00619866 | Feb 2008 → Apr 2009 | endometriosis | AbbVie | Completed | Missed primary |
| Phase 2 | NCT00437658 | Dec 2006 → Nov 2008 | endometriosis | AbbVie | Completed | Met primary |
| Phase 2 | NCT00109512 | Apr 2005 → Jun 2006 | endometriosis | Abbott | Completed | No outcome recorded |
| Phase 313 trials · 5 met primary | ||||||
| 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 Stop: Business |
| Phase 3 | NCT03271489 | Sep 2017 → Jun 2024 | leiomyoma | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03213457 | Jul 2017 → Mar 2020 | endometriosis | AbbVie | Completed | Met primary |
| Phase 3 | NCT02925494 | Sep 2016 → May 2018 | leiomyoma | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02691494 | Feb 2016 → Feb 2018 | leiomyoma | AbbVie | Completed | Met primary |
| Phase 3 | NCT02654054 | Dec 2015 → Jan 2018 | uterine benign neoplasm | AbbVie | Completed | Met primary |
| Phase 3 | NCT02143713 | May 2014 → Jun 2016 | endometriosis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01931670 | Sep 2013 → Jan 2016 | endometriosis | AbbVie | Completed | Met primary |
| Phase 3 | NCT01760954 | Dec 2012 → May 2015 | endometriosis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01620528 | May 2012 → Nov 2014 | endometriosis | AbbVie | Completed | Met primary |
| Phase 45 trials · 1 met primary | ||||||
| Phase 4 | NCT07532876 | May → Oct 2026 expected | endometriosis | Pak Emirates Military Hospital | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06798571 | Mar 2025 → Dec 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 Stop: Enrollment |
| 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 | Met primary |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT04614246 Comparator | Jan 2021 → Jan 2022 | endometriosis | Bayer | Terminated | Missed primary |
| 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 4 | NCT07799246 Comparator | Oct 2026 → Apr 2029 expected | endometriosis | Colorado State University | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 37
| Date | Issuer | Release |
|---|---|---|
| 2020-05-29 | Neurocrine Biosciences | Regulatory FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women gcs-web.com ↗
AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (Nasdaq: NBIX), announced that the U.S. Food and Drug Administration (FDA) approved ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), with a treatment duration of up to 24 months. |
| 2019-08-05 | AbbVie | Regulatory 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 ↗ |
| 2019-08-05 | Neurocrine Biosciences | Regulatory AbbVie Submits New Drug Application to US FDA for Investigational Elagolix for Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Women gcs-web.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for elagolix, an investigational, oral gonadotropin-releasing hormone (GnRH) antagonist, for the management of heavy menstrual bleeding (HMB) associated with uterine fibroids in women. |
| 2018-11-14 | AbbVie | Results 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 ↗
At the final month of the six-month treatment period, results demonstrated that elagolix (300 mg twice daily), in combination with low-dose hormone (add-back) therapy (estradiol 1.0 mg / norethindrone acetate 0.5 mg), reduced heavy menstrual bleeding associated with uterine fibroids compared to placebo. |
| 2018-11-14 | Neurocrine Biosciences | Results AbbVie Presents Positive Phase 3 Data Demonstrating Investigational Elagolix Reduces Heavy Menstrual Bleeding in Women with Uterine Fibroids at 2018 AAGL Global Congress gcs-web.com ↗
In ELARIS UF-1, 68.5 percent (p<0.001) of women with uterine fibroids achieved clinical response compared to placebo (8.7 percent). |
| 2018-10-05 | Neurocrine Biosciences | Regulatory AbbVie Receives Health Canada Approval of ORILISSA™ (elagolix) for the Treatment of Moderate to Severe Pain Associated with Endometriosis gcs-web.com ↗ |
| 2018-08-22 | AbbVie | Results AbbVie Announces Positive Topline Results from Phase 3 Extension Study Evaluating Investigational Elagolix in Women with Uterine Fibroids abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that results from the Phase 3 ELARIS UF-EXTEND extension study (MI2-816) showed at month 12 that elagolix (300 mg twice daily), in combination with low-dose hormone (add-back) therapy (estradiol 1.0 mg / norethindrone acetate 0.5 mg), reduced heavy menstrual bleeding with 87.9 percent of women with uterine fibroids achieving clinical response. |
| 2018-08-22 | Neurocrine Biosciences | Results AbbVie Announces Positive Topline Results from Phase 3 Extension Study Evaluating Investigational Elagolix in Women with Uterine Fibroids gcs-web.com ↗
Study results (ELARIS UF-EXTEND) showed elagolix, in combination with add-back therapy, reduced heavy menstrual bleeding for up to 12 months |
| 2018-07-24 | AbbVie | Regulatory AbbVie Receives U.S. FDA Approval of ORILISSA™ (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that the U.S. Food and Drug Administration (FDA) approved ORILISSA™ (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. |
| 2018-07-24 | Neurocrine Biosciences | Regulatory AbbVie Receives U.S. FDA Approval of ORILISSA™ (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis gcs-web.com ↗
The FDA approved ORILISSA under priority review. |
| 2018-04-10 | AbbVie | Regulatory AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain abbvie.com ↗
The Prescription Drug User Fee Act (PDUFA) date has been extended three months to Q3 2018. |
| 2018-04-10 | Neurocrine Biosciences | Regulatory AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain gcs-web.com ↗
The Prescription Drug User Fee Act (PDUFA) date has been extended three months to Q3 2018. |
| 2018-03-13 | AbbVie | Results AbbVie Announces Positive Topline Results from Second Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids abbvie.com ↗
AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that the Phase 3 ELARIS UF-II study (M12-817) of elagolix met its primary endpoint. |
| 2018-03-13 | Neurocrine Biosciences | Results AbbVie Announces Positive Topline Results from Second Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids gcs-web.com ↗
AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that the Phase 3 ELARIS UF-II study (M12-817) of elagolix met its primary endpoint. |
| 2018-02-21 | AbbVie | Results AbbVie Announces Positive Topline Results from Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids abbvie.com ↗
AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that the Phase 3 ELARIS UF-I study (M12-815) of elagolix met its primary endpoint. |
| 2018-02-21 | Neurocrine Biosciences | Results AbbVie Announces Positive Topline Results from Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids gcs-web.com ↗
Results from the first of two pivotal Phase 3 studies demonstrated at month six that elagolix, in combination with low-dose hormone (add-back) therapy, reduced heavy menstrual bleeding with 68.5 percent (p<0.001) of women with uterine fibroids achieving clinical response compared to placebo (8.7 percent), as measured by the alkaline hematin method. |
| 2017-11-01 | AbbVie | Results AbbVie Announces Positive Phase 3 Extension Study Data for Investigational Oral Treatment Elagolix for Management of Endometriosis with Associated Pain abbvie.com ↗
In the extension studies, elagolix demonstrated sustained reduction in average monthly menstrual pelvic pain and non-menstrual pelvic pain in women through the 12-month treatment period. |
| 2017-11-01 | Neurocrine Biosciences | Results AbbVie Announces Positive Phase 3 Extension Study Data for Investigational Oral Treatment Elagolix for Management of Endometriosis with Associated Pain gcs-web.com ↗
In the extension studies, elagolix demonstrated sustained reduction in average monthly menstrual pelvic pain and non-menstrual pelvic pain in women through the 12-month treatment period. |
| 2017-10-27 | Neurocrine Biosciences | Regulatory AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain gcs-web.com ↗ |
| 2017-09-06 | Neurocrine Biosciences | Regulatory AbbVie Submits New Drug Application to U.S. FDA for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain gcs-web.com ↗ |
| 2017-04-07 | AbbVie | Results AbbVie Announces Positive Phase 2b Data Demonstrating Investigational Medicine Elagolix Significantly Reduced Heavy Menstrual Bleeding in Women with Uterine Fibroids abbvie.com ↗
The data demonstrated that elagolix, with and without add-back therapy, met the primary efficacy endpoint of reduced heavy menstrual bleeding as compared to placebo (p<0.001). |
| 2016-10-19 | AbbVie | Results 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 ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced detailed results from two replicate pivotal Phase 3 clinical trials evaluating the efficacy and safety of Elagolix in premenopausal women who suffer from endometriosis. |
| 2016-10-19 | Neurocrine Biosciences | Results 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 gcs-web.com ↗
Elagolix shows superiority compared to placebo in reducing daily menstrual and non-menstrual pelvic pain associated with endometriosis |
| 2016-02-10 | AbbVie | Results AbbVie Announces Positive Top-Line Results From Second Phase 3 Study Investigating Elagolix in Patients with Endometriosis abbvie.com ↗
Trial results show that after six months of continuous treatment, both doses of Elagolix (150 mg once daily and 200 mg twice daily) met the study's co-primary endpoints. |
| 2016-02-10 | Neurocrine Biosciences | Results AbbVie Announces Positive Top-Line Results From Second Phase 3 Study Investigating Elagolix in Patients with Endometriosis gcs-web.com ↗
Trial results show that after six months of continuous treatment, both doses of Elagolix (150 mg once daily and 200 mg twice daily) met the study's co-primary endpoints. |
| 2015-09-16 | Neurocrine Biosciences | Results AbbVie Announces Plans to Proceed to Phase 3 Evaluation of Elagolix in Patients with Uterine Fibroids gcs-web.com ↗
Preliminary results showed that all of the elagolix treatment arms, with and without add-back therapy, reduced heavy menstrual bleeding as compared to placebo (p<0.001). |
| 2015-01-08 | AbbVie | Results AbbVie Announces Positive Top-Line Results From Phase 3 Study of Investigational Medicine Elagolix in Patients with Endometriosis abbvie.com ↗
The positive results from this trial represent a significant milestone in the development of elagolix as a potential new treatment option for patients suffering from endometriosis. |
| 2015-01-08 | Neurocrine Biosciences | Results AbbVie Announces Positive Top-Line Results From Phase 3 Study of Investigational Medicine Elagolix in Patients with Endometriosis gcs-web.com ↗
AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced positive top-line results from the first of two ongoing Phase 3 clinical trials, designed to evaluate the efficacy and safety of elagolix in premenopausal women with endometriosis. |
| 2012-03-27 | Neurocrine Biosciences | Regulatory Elagolix Endometriosis Phase III Trials on Track to Commence in Second Quarter 2012 gcs-web.com ↗
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced that the United States Food and Drug Administration ( FDA ) has responded to the Special Protocol Assessment (SPA) filed with the FDA on the design of the Phase III program for elagolix in endometriosis. |
| 2010-05-24 | Neurocrine Biosciences | Results Neurocrine Biosciences Announces Positive Results in Daisy PETAL Study gcs-web.com ↗
The top-line data confirm that elagolix is associated with statistically significant reductions in Dysmenorrhea, Non-Menstrual Pelvic Pain, (co-primary endpoints) and Dyspareunia (exploratory endpoint) daily scores when compared to placebo (ITT population, ANCOVA). |
| 2009-12-09 | Neurocrine Biosciences | Results Neurocrine Announces Top-Line Results From 703 Study (Tulip PETAL Study) of Elagolix for Treatment of Endometriosis Pain gcs-web.com ↗
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced top-line efficacy and safety results from the Tulip PETAL Study (703 Study), its fifth Phase 2 clinical trial using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis. |
| 2009-07-29 | Neurocrine Biosciences | Results Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients With Endometriosis gcs-web.com ↗
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new six month safety and efficacy results from its fourth Phase II clinical trial using its proprietary, orally-active non-peptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis. |
| 2009-05-18 | Neurocrine Biosciences | Results Neurocrine Announces Full Year Results from 603 Study (Petal Study) of Elagolix for Treatment of Endometriosis Pain gcs-web.com ↗
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced additional positive safety and efficacy results from its Phase IIb clinical trial known as the Petal Study (603 study) using its proprietary, orally-active non-peptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis. |
| 2009-03-25 | Neurocrine Biosciences | Results Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain gcs-web.com ↗
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced top-line efficacy and safety results from its fourth Phase II clinical trial using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis. |
| 2007-01-08 | Neurocrine Biosciences | Results Neurocrine Biosciences Announces Positive Results From Second Phase II Study With Its Orally Active GnRH Receptor Antagonist in Endometriosis gcs-web.com ↗
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced positive preliminary results from its second 'proof of concept', safety and efficacy Phase II clinical trial over a 3-month treatment period using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist (NBI-56418) in patients with endometriosis. |
| 2006-04-27 | Neurocrine Biosciences | Results Neurocrine Biosciences Announces Positive Phase II Results With Its Orally Active GnRH Receptor Antagonist in Endometriosis gcs-web.com ↗
After treatment, there were reductions of 3.7 (placebo), 3.9 (75 mg) and 5.0 (150 mg) points in the score at week 12. |
| 2005-03-02 | Neurocrine Biosciences | Results Neurocrine Biosciences Announces Positive Phase I Results With Its Orally Active GnRH Receptor Antagonist gcs-web.com ↗
NBI-56418 demonstrated a dose-dependent suppression of estradiol that was observed throughout the duration of dosing. |
All press releases naming this drug 52 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Elagolix | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05648669 ↗ |
| Known as | ABT-620, elagolix sodium | “ABT-620, elagolix sodium” NCT01620528 ↗1“ABT-620, elagolix sodium” NCT01403038 ↗ |
| Known as | NBI-56418 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00109512 ↗ |
| Known as | Orilissa | “Elagolix 200 MG Oral Tablet [Orilissa]” NCT04060992 ↗ |
| Known as | Orlissa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07799246 ↗ |
| Action | Inhibit | “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 ↗ |