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Linzagolix FDA Approval Status

Last updated by Judith Stewart, BPharm on Sep 16, 2021.

FDA Approved: No
Generic name: linzagolix
Company: ObsEva SA
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.

Development Timeline for linzagolix

DateArticle
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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