Niraparib - Janssen/Merck/TESARO

Drug Profile

Niraparib - Janssen/Merck/TESARO

Alternative Names: JNJ-64091742; MK-4827; niraparib hydrochloride; Zejula; ZL 2306

Latest Information Update: 18 Oct 2018

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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; Georgetown University; Janssen; Merck & Co; Myriad Genetics; NeoGenomics; Resolution Bioscience; Sarcoma Alliance for Research through Collaboration; Takeda; TESARO; Thomas Jefferson University; University Health Network; University of Florida; University of Pennsylvania; University of Utah; ZAI Lab
  • Class Antineoplastics; Benzamides; Indazoles; Piperidines; Small molecules
  • Mechanism of Action Poly(ADP-ribose) polymerase 1 inhibitors; Poly(ADP-ribose) polymerase 2 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; Small cell lung cancer
  • Phase II Cholangiocarcinoma; Endometrial cancer; Mesothelioma; Non-small cell lung cancer; Pancreatic cancer; Prostate cancer; Renal cell carcinoma; Uveal melanoma
  • Phase I Ewing's sarcoma; Solid tumours
  • No development reported Haematological malignancies

Most Recent Events

  • 01 Oct 2018 Tesaro initiates the phase II OPAL trial for Ovarian cancer (Combination therapy, Recurrent, Second-line therapy or greater) in USA (NCT03574779)
  • 04 Sep 2018 Efficacy data from the phase II trial in Non-small cell lung cancer released by TESARO
  • 28 Aug 2018 Phase-III clinical trials in Small cell lung cancer in China (PO) (NCT03516084)
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