The DOI matches its Crossref record; 13 of the 13 references it cites were found in a registry or an index.
Elagolix: First Global Approval
Open accessAbstract
Elagolix (ORILISSA™), an orally bioavailable, second-generation, non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist, is being developed AbbVie and Neurocrine Biosciences for the treatment of reproductive hormone-dependent disorders in women. In July 2018, the US FDA approved elagolix tablets for the management of moderate to severe pain associated with endometriosis. This approval was based on positive results in two replicate phase III trials; additional phase III trials in the USA, Canada and Puerto Rico are currently evaluating elagolix as both monotherapy and in combination with low-dose hormone add-back therapy in the same indication. Elagolix with and without low-dose hormone add-back therapy is also undergoing phase III clinical development for heavy menstrual bleeding associated with uterine fibroids in the aforementioned locations. This article summarizes the milestones in the development of elagolix leading to its first approval for the management of moderate to severe pain associated with endometriosis.
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“One GnRH antagonist (elagolix) was approved by the US FDA in July 2018 [109].”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [109]
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Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist
Taylor, H. S., Giudice, L. C., Lessey, B. A., Abrao, M. S., Kotarski, J., Archer, D. F., Diamond, M. P., Surrey, E., Johnson, N. P., Watts, N. B., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1700089 · Cited by 511
Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies
Surrey, E., Taylor, H. S., Giudice, L., Lessey, B. A., Abrao, M. S., Archer, D. F., Diamond, M. P., Johnson, N. P., Watts, N. B., Gallagher, J. C., et al. (2018) · Obstetrics & Gynecology · doi:10.1097/aog.0000000000002675 · Cited by 139
Struthers, R. S., Nicholls, A. J., Grundy, J. S., Chen, T., Jimenez, R., Yen, S. S. C., & Bozigian, H. P. (2008) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2008-1695 · Cited by 127
Diamond, M. P., Carr, B. R., Dmowski, W. P., Koltun, W. D., O'Brien, C. F., Jiang, P. X., Burke, J., Jimenez, R., Garner, E. I. O., & Chwalisż, K. (2013) · Reproductive Sciences · doi:10.1177/1933719113497292 · Cited by 121
Carr, B., Dmowski, W. P., O’Brien, C., Jiang, P., Burke, J., Jimenez, R., Garner, E., & Chwalisz, K. (2014) · Reproductive Sciences · doi:10.1177/1933719114549848 · Cited by 114
Ng, J., Chwalisz, K., Carter, D. C., & Klein, C. E. (2017) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2016-3845 · Cited by 110
Archer, D. F., Stewart, E. A., Jain, R. I., Feldman, R., Lukes, A. S., North, J., Soliman, A. M., Gao, J., Ng, J., & Chwalisż, K. (2017) · Fertility and Sterility · doi:10.1016/j.fertnstert.2017.05.006 · Cited by 82
Elagolix, an Oral GnRH Antagonist for Endometriosis-Associated Pain: A Randomized Controlled Study
Carr, B. R., Giudice, L. C., Dmowski, W. P., O’Brien, C., Jiang, P. X., Burke, J., Jimenez, R., Hass, S., Fuldeore, M. J., & Chwalisż, K. (2013) · Journal of Endometriosis and Pelvic Pain Disorders · doi:10.5301/je.5000157 · Cited by 64
Ács, N., O’Brien, C., Jiang, P. X., Burke, J., Jimenez, R., Garner, E. I. O., & Chwalisż, K. (2015) · Journal of Endometriosis and Pelvic Pain Disorders · doi:10.5301/je.5000211 · Cited by 31
Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis
Winzenborg, I., Nader, A. M., Polepally, A. R., Liu, M., Degner, J. F., Klein, C. E., Mostafa, N. M., Noertersheuser, P. A., & Ng, J. (2018) · Clinical Pharmacokinetics · doi:10.1007/s40262-018-0629-6 · Cited by 27
Research works printed but not linked: 2
- Ng J, Salem A, Carter D, et al. Effects of the coadministration of single and multiple doses of rifampin on the pharmacokinetics and safety of elagolix in healthy premenopausal females. Clin Pharmacol Ther. 2016;99(Suppl 1):S54–5.
- Ng J, Salem A, Carter D, et al. Effect of the coadministration of ketoconazole on the pharmacokinetics and safety of elagolix in healthy premenopausal females. Clin Pharmacol Ther. 2016;99(Suppl 1):S55.
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U.S. FDA Approved Drugs from 2015–June 2020: A Perspective
Bhutani, P., Joshi, G., Raja, N., Bachhav, N., Rajanna, P. K., Bhutani, H., Paul, A. T., & Kumar, R. (2021) · Journal of Medicinal Chemistry · doi:10.1021/acs.jmedchem.0c01786 · Cited by 815
G protein-coupled receptors (GPCRs): advances in structures, mechanisms and drug discovery
Zhang, M., Chen, T., Lu, X., Lan, X., Chen, K., & Lu, S. (2024) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-024-01803-6 · Cited by 540
Fluorine‐Containing Drugs Approved by the FDA in 2018
Mei, H., Han, J., Fustero, S., Medio‐Simón, M., Sedgwick, D. M., Santi, C., Ruzziconi, R., & Soloshonok, V. A. (2019) · Chemistry - A European Journal · doi:10.1002/chem.201901840 · Cited by 466
Phenols in Pharmaceuticals: Analysis of a Recurring Motif
Scott, K. A., Cox, P. B., & Njardarson, J. T. (2022) · Journal of Medicinal Chemistry · doi:10.1021/acs.jmedchem.2c00223 · Cited by 224
Fluorine-containing pharmaceuticals approved by the FDA in 2020: Synthesis and biological activity
Yu, Y., Liu, A., Dhawan, G., Mei, H., Zhang, W., Izawa, K., Soloshonok, V. A., & Han, J. (2021) · Chinese Chemical Letters · doi:10.1016/j.cclet.2021.05.042 · Cited by 182
Metadata
- Authors
- Lamb, Y. N.
- Corresponding author
- Lamb, Yvette N.
- Venue
- Drugs
- Published
- 2018-09
- Volume
- 78
- Issue
- 14
- Pages
- 1501-1508
- ISSN
- 0012-6667 (ISSN-L)
- 1179-1950
- PMC
- PMC6244606
- OpenAlex
- W2889874928
- Cited by
- 104
- References
- 13
- Citations by year
- 2026: 5 · 2025: 9 · 2024: 15 · 2023: 15 · 2022: 24 · 2021: 14 · 2020: 14 · 2019: 5 · 2018: 3
- FWCI
- 9.65
- Type
- journal article
- Language
- en
- Update notices
- correction (2018-11-15)
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Drugs (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
- Health Sciences › Medicine › Reproductive Medicine › Hypothalamic control of reproductive hormones
- Keywords
- elagolix, GnRH antagonist, endometriosis-associated pain, FDA approval, menorrhagia, uterine fibroids, drug development milestones
- MeSH terms
- Drug Therapy, Combination, Endometriosis, Female, Hormone Antagonists, Humans, Hydrocarbons, Fluorinated, Pain, Pyrimidines, Receptors, LHRH, United States, United States Food and Drug Administration, Treatment Outcome, Drug Approval, Pain Management
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