Drug Profile


Alternative Names: JNJ-64091742; MK-4827

Latest Information Update: 13 Jan 2017

Price : $50

At a glance

  • Originator Merck & Co
  • Developer European Network of Gynaecological Oncological Trial Groups; European Organisation for Research and Treatment of Cancer; Hoosier Cancer Research Network; Janssen; Merck & Co; Sarcoma Alliance for Research through Collaboration; TESARO
  • Class Antineoplastics; Benzamides; Indazoles; Piperidines; Small molecules
  • Mechanism of Action Poly(ADP-ribose) polymerase inhibitors
  • Orphan Drug Status

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

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Phase III Breast cancer
  • Phase II Prostate cancer
  • Phase I Ewing's sarcoma; Solid tumours
  • No development reported Haematological malignancies

Most Recent Events

  • 06 Jan 2017 University Health Network, Toronto and TESARO plan a phase II trial for Endometrial cancer (Recurrent, Late-stage disease, Second-line therapy or greater) in Canada (PO) (NCT03016338)
  • 23 Dec 2016 Niraparib receives priority review status for Ovarian, Fallopian tube, and Peritoneal cancer in the US
  • 20 Dec 2016 PDUFA action date of 30 June 2017 assigned by FDA for niraparib for Ovarian cancer, Fallopian tube, and Peritoneal cancer
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