Niraparib

Drug Profile

Niraparib

Alternative Names: JNJ-64091742; MK-4827

Latest Information Update: 25 Mar 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

  • 14 Mar 2017 Thomas Jefferson University and Tesaro plan a phase I trial for Prostate cancer (Late-stage disease, Metastatic disease, Hormone refractory) in USA (NCT03076203)
  • 28 Feb 2017 Phase-II clinical trials in Ovarian cancer and Breast cancer (Combination therapy, Late-stage disease, Second-line therapy or greater) in USA (PO)
  • 17 Jan 2017 Tesaro initiates an expanded-access programme for Ovarian cancer (Recurrent, Second-line therapy) in USA
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