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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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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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