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Niraparib - Janssen/Merck/GlaxoSmithKline

Drug Profile

Niraparib - Janssen/Merck/GlaxoSmithKline

Alternative Names: GSK-3985771; JNJ-64091742; MK-4827; niraparib hydrochloride; Zejula; ZL 2306

Latest Information Update: 15 Oct 2021

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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; GlaxoSmithKline; Hunan Cancer Hospital; Indiana University School of Medicine; Janssen; Katholieke Universiteit Leuven; Massachusetts General Hospital; Merck & Co; Myriad Genetics; NeoGenomics; Novocure Limited; Resolution Bioscience; Sarcoma Alliance for Research through Collaboration; Takeda; TESARO; Thomas Jefferson University; University Health Network; University of Florida; University of Kansas Medical Center; University of Oklahoma; University of Pennsylvania; University of Turin; 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; Non-small cell lung cancer; Prostate cancer; Small cell lung cancer
  • Phase II Cervical cancer; Cholangiocarcinoma; Endometrial cancer; Gastric cancer; Glioblastoma; Head and neck cancer; Mesothelioma; Oesophageal cancer; Pancreatic cancer; Renal cell carcinoma; Urogenital cancer; Uveal melanoma
  • Phase I Ewing's sarcoma; Solid tumours
  • No development reported Haematological malignancies

Most Recent Events

  • 27 Sep 2021 University of Florida and TESARO suspends a phase II trial for Cholangiocarcinoma (Second-line therapy or greater), Mesothelioma (Second-line therapy or greater), Renal cell carcinoma (Second-line therapy or greater) and Uveal melanoma (Second-line therapy or greater) in USA (PO) (for interim analysis) (NCT03207347)
  • 01 Aug 2021 West Cancer Center plans a phase II trial for Solid tumors (Combination therapy, Inoperable/unresectable, Recurrent) in US (NCT04983745)
  • 07 Jun 2021 GlaxoSmithKline plans phase III ZEST trial for Breast cancer (Second-line therapy or greater) in August 2021 (PO) (NCT04915755)
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