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Elagolix - Abbvie/Neurocrine Biosciences

Drug Profile

Elagolix - Abbvie/Neurocrine Biosciences

Alternative Names: ABT-620; Elagolix sodium; NBI-56418; ORILISSA

Latest Information Update: 12 Nov 2019

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At a glance

  • Originator Icahn School of Medicine at Mount Sinai
  • Developer AbbVie; Neurocrine Biosciences
  • Class Antineoplastics; Fluorinated hydrocarbons; Pyrimidines; Small molecules
  • Mechanism of Action LHRH receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Endometriosis; Pain
  • Preregistration Menorrhagia
  • Phase III Uterine leiomyoma
  • Phase I Polycystic ovary syndrome
  • Discontinued Benign prostatic hyperplasia; Prostate cancer

Most Recent Events

  • 04 Nov 2019 FDA assigns PDUFA action date for Menorrhagia in second quarter of 2020
  • 05 Aug 2019 Preregistration for Menorrhagia in USA (PO)
  • 11 Jul 2019 Phase-I clinical trials in Polycystic ovary syndrome in Puerto Rico and USA (PO) (NCT03951077)
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