Drug Profile

Niraparib - Janssen/Merck/GSK

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

Latest Information Update: 24 Jun 2025

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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; Janssen; Katholieke Universiteit Leuven; Massachusetts General Hospital; Medica Scientia Innovation Research; Merck & Co; Myriad Genetics; NeoGenomics; Novocure Limited; OncoQuest; 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 2 inhibitors; Poly(ADP-ribose) polymerase-1 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

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; Glioblastoma; Mesothelioma; Neuroendocrine tumours; Pancreatic cancer; Renal cell carcinoma; Solid tumours; Squamous cell cancer; Triple negative breast cancer; Urogenital cancer; Uveal melanoma
No development reported Ewing's sarcoma; Gastric cancer; Haematological malignancies

11 Jun 2025 GlaxoSmithKline terminates a phase I trial in Solid tumours (Combination therapy, In infants, In children, In adolescents, Second-line therapy or greater) in Czech Republic, France, Germany, Hungary, Spain, the United Kingdom (IV) (NCT04544995)
09 May 2025 Tesaro termoinates phase-II clinical trials in Ovarian cancer (Neoadjuvant therapy, Newly diagnosed) in USA (PO) (NCT06964165)
04 Apr 2025 GSK withdraws a phase II trial in Ovarian cancer (Combination therapy, Late-stage disease, Recurrent, Second-line therapy or greater) prior to enrollment since it was never submitted to competent authority nor to ethics committee (NCT05126342) (EUCT2021-003572-14)

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