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Linzagolix FDA Approval Status

Last updated by Judith Stewart, BPharm on Nov 1, 2022.

FDA Approved: No
Generic name: linzagolix
Company: Kissei Pharmaceutical Co., Ltd.
Treatment for: Uterine Fibroids

Linzagolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist in development for the treatment of women with uterine fibroids.

Development timeline for linzagolix

DateArticle
Aug 22, 2022Notice on withdrawal of New Drug Application in the US of GnRH antagonist Linzagolix
Nov 22, 2021Obseva Announces U.S. FDA Acceptance of New Drug Application for Linzagolix
Sep 15, 2021ObsEva Announces Submission of New Drug Application to U.S. FDA for Linzagolix for the Treatment of Uterine Fibroids
Jul  6, 2020ObsEva Announces Positive Results from two Phase 3 Studies, PRIMROSE 1 and 2, of Yselty┬« (linzagolix) for the Treatment of Uterine Fibroids
Jun  4, 2020ObsEva Announces Publication of Data Showing Efficacy of Linzagolix in a Potential New Indication for Treatment of Adenomyosis
Apr 22, 2020ObsEva Announces Publication of Abstracts from Phase 2b EDELWEISS Trial of Linzagolix in Endometriosis
Dec  9, 2019ObsEva Announces Positive Results from Uterine Fibroids Phase 3 Study (PRIMROSE 2) of Linzagolix

Further information

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