Niraparib

Drug Profile

Niraparib

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.

    No
  • 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
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top