4.6 Article

Linzagolix: First Approval

Journal

DRUGS
Volume 82, Issue 12, Pages 1317-1325

Publisher

ADIS INT LTD
DOI: 10.1007/s40265-022-01753-9

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Linzagolix is an orally administered drug developed for the treatment of uterine fibroids and endometriosis, with approval in the EU and undergoing regulatory review in the USA.
Linzagolix (Yselty (R)) is an orally administered, selective, non-peptide small molecule gonadotrophin releasing hormone (GnRH) receptor antagonist that is being developed by Kissei Pharmaceutical for the treatment of uterine fibroids and endometriosis in women of reproductive age. Linzagolix binds to and blocks the GnRH receptor in the pituitary gland, modulating the hypothalamic pituitary-gonadal axis and dose-dependently reducing serum luteinising hormone and follicle-stimulating hormone production and serum estradiol levels. In June 2022, linzagolix was approved for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age in the EU. Linzagolix is under regulatory review the USA for this indication and is in phase 3 clinical development in the treatment of pain associated with endometriosis. This article summarizes the milestones in the development of linzagolix leading to this first approval for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

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