Drug Profile

Niraparib - Janssen/Merck/GSK

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

Latest Information Update: 19 May 2026

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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; 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; The Ivy Brain Tumor Center; 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; Glioblastoma; HER2 negative breast cancer; Non-small cell lung cancer; Prostate cancer; Small cell lung cancer
Phase II Cervical cancer; Cholangiocarcinoma; CNS cancer; Endometrial cancer; 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

23 Mar 2026 GSK completed phase III trial in Non-small cell lung cancer (Metastatic disease, Late-stage disease, Combination therapy, First-line therapy) in USA, Belgium, Bulgaria, Greece, Ireland, South Korea, Netherlands, Norway, Poland, Sweden, Turkey, Australia, Netherlands, Norway, Sweden, Argentina, Brazil, Chile, China, Colombia, Denmark, France, Germany, Hungary, Italy, Japan, Mexico, Peru, Romania, Russia, Spain, Switzerland, United Kingdom (PO) (NCT04475939) (EudraCT2020-002202-20)
28 Feb 2026 Efficacy data from the phase III AMPLITUDE trial in Prostate cancer presented at the 2026 Genitourinary Cancers Symposium (ASCO-GU-2026)
28 Feb 2026 Dana-Farber Cancer Institute completes a phase-II trial in Pancreatic cancer (Late-stage disease, Metastatic disease, Inoperable/Unresectable, Second-line therapy or greater) in USA (PO) (NCT03601923)

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