elagolix
Trade name: orilissa
Small moleculeapproved
Approved
Jul 23, 2018
Elagolix (ABT-620) is an oral gonadotropin-releasing hormone antagonist being studied for the treatment of endometriosis and uterine fibroids. The U.S. Food and Drug Administration (FDA) approved AbbVie's elagolix under the brand name Orilissa as the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. — NCATS
Clinical trial activity
34 trials · 22 clinical orgs · 3 marketing orgs
Phase 1
2
Phase 2
29
Phase 3
18
Phase 4
3
Earliest trial started Apr 1, 2005 (NCT00109512)
Timeline
2000s
- Jan 1, 2005
Earliest Phase 2 Sponsor(trial)
2010s
2020s
- Jan 2, 2025
Teva — Marketing Organization
- Jul 1, 2025
Hetero Labs Ltd — Marketing Organization
Indications
Approved for
Mechanism of action
- Gonadotropin-releasing hormone receptorANTAGONIST
GNRHR antagonist
Combination products
oriahnn (copackaged)
with estradiol, norethindrone
Approval history
- approvedPriority reviewJul 23, 2018
Chemistry & pharmacology
Loading structure…
SMILES
COc1cccc(-c2c(C)n(Cc3c(F)cccc3C(F)(F)F)c(=O)n(C[C@H](NCCCC(=O)O)c3ccccc3)c2=O)c1F- Mol. weight
- 631.6 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
First in class
Sources
- ChEMBLCHEMBL1208155 ↗
- WikipediaElagolix ↗
- NCATS5B2546MB5Z ↗
- ChEMBLCHEMBL502182 ↗
Also known as
- elagolix
- elagolix
- elagolix
- elagolix
- elagolix
- elagolix sodium
- elagolix sodium
- elagolix sodium
- nbi-56418
- nbi-56418
- nbi-56418
- nbi-56418-na
- nbi-56418-na
- obe2109
- r-(+)-4-(2-(5-(2-fluoro-3-methoxyphenyl)-3-(2-fluoro-6-(trifluoromethyl)benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2h-pyrimidin-1-yl)-1-phenylethylamino)butyrate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06798571 | Phase 4 | Mar 1, 2025 | Pennsylvania State University |
| NCT06375811 | Phase 3 | Mar 16, 2024 | Duke University, Johns Hopkins University, Northwestern University, University of Colorado, Denver, University of North Carolina at Chapel Hill, Yale University |
| NCT06076486 | Phase 3 | Sep 14, 2023 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd, Peking University |
| NCT05648669 | Phase 3 | Sep 4, 2022 | Chinese Academy of Medical Sciences, Qilu Pharmaceutical Co., Ltd. |
| NCT05038878 | Phase 4 | Jul 6, 2021 | AbbVie, Icahn School of Medicine at Mount Sinai |
| NCT04614246 | Phase 2 | Jan 29, 2021 | Bayer |
| NCT04445025 | Early Phase 1 (Phase 1) | Sep 1, 2020 | AbbVie, Colorado Center for Reproductive Medicine |
| NCT04173169 | Phase 3 | Apr 30, 2020 | National Institutes of Health (NIH), Northwestern University, University of Colorado, Denver, University of North Carolina at Chapel Hill, Yale University |
| NCT04333576 | Phase 3 | Apr 3, 2020 | AbbVie |
| NCT04060992 | Phase 4 | Oct 1, 2019 | University of Southern California |
| NCT04039204 | Phase 2 | Aug 1, 2019 | Stanford University, University of North Carolina at Chapel Hill, Wake Forest University |
| NCT03951077 | Phase 2 | Jun 22, 2019 | AbbVie |
| NCT03886220 | Phase 3 | Apr 3, 2019 | AbbVie |
| NCT03343067 | Phase 3 | Dec 27, 2017 | AbbVie |
| NCT03271489 | Phase 3 | Sep 13, 2017 | AbbVie |
| NCT03213457 | Phase 3 | Jun 21, 2017 | AbbVie |
| NCT03070951 | Phase 3 | May 23, 2017 | ObsEva SA |
| NCT03070899 | Phase 3 | Apr 20, 2017 | ObsEva SA |
| NCT02925494 | Phase 3 | Sep 1, 2016 | AbbVie |
| NCT02778399 | Phase 2 | Jul 1, 2016 | ObsEva SA |
Showing 20 of 34 trials
Page 1 / 2
Organizations
Research & Development (22)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AbbVie | For profit | 22 | 20 | 4 | 2006 |
| ObsEva SA | For profit | 3 | 3 | 2 | 2016 |
| University of North Carolina at Chapel Hill | Academic/Hospital | 3 | 0 | 2 | 2019 |
| Northwestern University | Academic/Hospital | 2 | 0 | 1 | 2020 |
| University of Colorado, Denver | Academic/Hospital | 2 | 0 | 1 | 2020 |
| Yale University | Academic/Hospital | 2 | 2 | 1 | 2020 |
| Abbott | For profit | 1 | 1 | 1 | 2005 |
| Bayer | For profit | 1 | 1 | 1 | 2021 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Colorado Center for Reproductive Medicine | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Duke University | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd | For profit | 1 | 1 | 1 | 2023 |
| Johns Hopkins University | Academic/Hospital | 1 | 0 | 1 | 2024 |
| National Institutes of Health (NIH) | Government | 1 | 0 | 1 | 2020 |
| Neurocrine Biosciences | For profit | 1 | 0 | 1 | 2011 |
| Peking University | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Pennsylvania State University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Qilu Pharmaceutical Co., Ltd. | For profit | 1 | 1 | 1 | 2022 |
| Stanford University | Academic/Hospital | 1 | 0 | 1 | 2019 |
22 organizations
Page 1 / 2
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | NDA2 | Jul 23, 2018 |
| AbbVie | For profit | NDA | Jul 23, 2018 |
| AbbVie | For profit | SYN | Jul 23, 2018 |
| Hetero Labs Ltd | For profit | MKTG | Jul 1, 2025 |
| Teva | For profit | MKTG | Jan 2, 2025 |