Niraparib - Janssen/Merck/GSK
Alternative Names: GSK-3985771; JNJ-64091742; MK-4827; niraparib hydrochloride; Zejula; ZL 2306Latest Information Update: 24 Jun 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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; 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
Most Recent Events
- 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)