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Niraparib - Janssen/Merck/GSK

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Drug Profile

Niraparib - Janssen/Merck/GSK

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

Latest Information Update: 01 Apr 2024

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At a glance

  • Originator Merck & Co
  • Developer Bayer; Dana-Farber Cancer Institute; Emory University; European Network of Gynaecological Oncological Trial Groups; European Organisation for Research and Treatment of Cancer; Georgetown University; GSK; Hunan Cancer Hospital; Indiana University School of Medicine; Janssen; Katholieke Universiteit Leuven; Massachusetts General Hospital; Medica Scientia Innovation Research; Merck & Co; Myriad Genetics; NeoGenomics; Novocure Limited; Resolution Bioscience; Sarcoma Alliance for Research through Collaboration; Takeda; Tempus; TESARO; Thomas Jefferson University; University Health Network; University of Florida; University of Kansas Medical Center; University of Oklahoma; University of Pennsylvania; University of Texas M. D. Anderson Cancer Center; 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; HER2 negative breast cancer; Non-small cell lung cancer; Prostate cancer; Small cell lung cancer
  • Phase II Cervical cancer; Cholangiocarcinoma; CNS cancer; Endometrial cancer; Gastric cancer; Glioblastoma; Mesothelioma; Neuroendocrine tumours; Oesophageal cancer; Pancreatic cancer; Renal cell carcinoma; Solid tumours; Squamous cell cancer; Triple negative breast cancer; Urogenital cancer; Uveal melanoma
  • No development reported Ewing's sarcoma; Haematological malignancies

Most Recent Events

  • 26 Mar 2024 GlaxoSmithKline terminates a phase II trial in Glioma (Recurrent) in the US (NCT05297864)
  • 01 Dec 2023 Bayer and GlaxoSmithKline terminates a Phase-I clinical trials in Solid tumours and Ovarian cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater, Recurrent, Combination therapy) in USA (PO) due to no anticipated benefits from experimental combinations (NCT04267939) (EudraCT2018-003930-34)
  • 21 Nov 2023 GlaxoSmithKline completes phase-II LUZERN trial in HER2-negative-breast-cancer (Late-stage disease, Metastatic disease, Combination therapy, Second-line therapy or greater, Inoperable/Unresectable) in Spain (PO) due to lack of recruitment (NCT04240106)
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