Niraparib

Drug Profile

Niraparib

Alternative Names: JNJ-64091742; MK-4827; niraparib hydrochloride; Zejula

Latest Information Update: 13 Oct 2017

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At a glance

  • Originator Merck & Co
  • Developer Bayer; Dana-Farber Cancer Institute; 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; Thomas Jefferson University; University of Utah
  • Class Antineoplastics; Benzamides; Indazoles; Piperidines; Small molecules
  • Mechanism of Action Poly(ADP-ribose) polymerase 1 inhibitors; Poly(ADP-ribose) polymerase 2 inhibitors; 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.

    Yes - Ovarian cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed 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

  • 22 Sep 2017 Phase-I clinical trials in Prostate cancer (Combination therapy, Hormone refractory, Metastatic disease) in USA (PO) (NCT03076203)
  • 15 Sep 2017 CHMP issued a positive opinion for approval of niraparib in Fallopian tube cancer (Recurrent, Second-line therapy or greater), Ovarian cancer (Recurrent, Second-line therapy or greater) and Peritoneal cancer (Recurrent, Second-line therapy or greater) in European Union (PO)
  • 11 Sep 2017 Efficacy and safety data from the phase I/II TOPACIO trial in Ovarian cancer and Breast cancer released by TESARO
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