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.

Linzagolix is a novel, orally administered GnRH receptor antagonist that potentially provides effective management of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) while mitigating bone mineral density loss and other adverse effects typically associated with currently approved treatments.
Linzagolix is also in late-stage clinical development for the treatment of pain associated with endometriosis.
On August 22, 2022, Kissei Pharmaceutical Co., Ltd. announced the withdrawal of the New Drug Application (NDA) for linzagolix for uterine fibroids.

Development timeline for linzagolix

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

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