Skip to Content

Orilissa Approval History

  • FDA approved: Yes (First approved July 23, 2018)
  • Brand name: Orilissa
  • Generic name: elagolix
  • Dosage form: Tablets
  • Company: AbbVie Inc.
  • Treatment for: Endometriosis

Orilissa (elagolix) is an orally administered gonadotropin-releasing hormone (GnRH) antagonist for the management of moderate to severe pain associated with endometriosis.

Development History and FDA Approval Process for Orilissa

DateArticle
Jul 24, 2018Approval FDA Approves Orilissa (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis
Apr 10, 2018AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain
Mar 13, 2018AbbVie Announces Positive Topline Results from Second Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids
Feb 21, 2018AbbVie Announces Positive Topline Results from Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids
Nov  1, 2017AbbVie Announces Positive Phase 3 Extension Study Data for Investigational Oral Treatment Elagolix for Management of Endometriosis with Associated Pain
Oct 27, 2017AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
Sep  6, 2017AbbVie Submits New Drug Application to FDA for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
Apr  7, 2017AbbVie Announces Positive Phase 2b Data Demonstrating Investigational Medicine Elagolix Significantly Reduced Heavy Menstrual Bleeding in Women with Uterine Fibroids
Oct 19, 2016AbbVie Announces Positive Pivotal Phase 3 Data Demonstrating Investigational Medicine Elagolix Reduces Menstrual and Non-Menstrual Pelvic Pain Associated with Endometriosis
Jan 28, 2016Abbvie Initiates Enrollment In Phase 3 Clinical Program For Elagolix In Patients With Uterine Fibroids
Sep 16, 2015Abbvie Announces Plans To Proceed To Phase 3 Evaluation Of Elagolix In Patients With Uterine Fibroids
Jan  8, 2015Abbvie Announces Positive Top-Line Results From Phase 3 Study Of Elagolix In Patients With Endometriosis
Sep 27, 2011Neurocrine Biosciences Announces Elagolix Scientific Presentations at the 67th Annual Meeting of the American Society for Reproductive Medicine
Dec 10, 2009Neurocrine Announces Top-Line Results From 703 Study (Tulip PETAL Study) of Elagolix for Treatment of Endometriosis Pain
Jul 29, 2009Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients With Endometriosis
May 19, 2009Neurocrine Announces Full Year Results from 603 Study (Petal Study) of Elagolix for Treatment of Endometriosis Pain
Mar 26, 2009Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain
Sep  3, 2008Neurocrine Biosciences Announces Successful Elagolix PETAL Study in Endometriosis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide