Ulipristal - HRA Pharma

Drug Profile

Ulipristal - HRA Pharma

Alternative Names: CDB-2914; ella; ellaOne; Esmya; Fibristal; HRP 2000; PGL-4001; RTI 3021-12; RU 44675; Ulipristal acetate; UPA; UPA C-IUS; UPA C-ring; UPA-IUS; UPA-UF; UPA-VR; VA-2914

Latest Information Update: 10 Jul 2018

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At a glance

  • Originator HRA Pharma; National Institutes of Health (USA)
  • Developer Allergan; ASKA Pharmaceutical; Gedeon Richter; HRA Pharma; Population Council (USA); PregLem
  • Class Norpregnadienes; Oral contraceptives; Small molecules
  • Mechanism of Action Selective progesterone receptor modulators
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes - Female genital diseases; Uterine leiomyoma

Highest Development Phases

  • Marketed Pregnancy; Uterine leiomyoma
  • Discontinued Breast cancer; Endometriosis; Menopausal syndrome

Most Recent Events

  • 29 Jun 2018 Preregistration for Uterine leiomyoma (Neoadjuvant therapy) in European Union (PO)
  • 29 Jun 2018 CHMP adopted a positive opinion for ulipristal acetate for the Uterine leiomyoma (Neoadjuvant therapy) in the European Union
  • 15 Mar 2018 Health Canada to review a potential safety risk of ulipristal (Fibristal) following reports of serious adverse events affecting the liver
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