Cited by 104Endometriosis Research and TreatmentReproductive Health and ContraceptionHypothalamic control of reproductive hormones

Elagolix: First global approval

Open access
Lamb, Yvette N.·2018·Drugs

Abstract

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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  1. [15]Carr B Giudice L Dmowski WP Elagolix, an oral GnRH antagonist for endometriosis-associated pain: a randomized controlled study J Endometr Pelvic Pain Disord. 2013 5 3 105 115 30320043 PMC6166402

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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
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
Open access
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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