Niraparib is under clinical development by GSK and currently in Phase III for Metastatic Breast Cancer. According to GlobalData, Phase III drugs for Metastatic Breast Cancer have a 47% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Niraparib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Niraparib overview

Niraparib (MK-4827, Zejula) is an anti-neoplastic agent. It is formulated as hard gelatin capsules, tablets and film coated tablets for oral route of administration. Zejula is indicated for the treatment of adult patients with recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy and also indicated for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous-recombination deficient (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.

It is under development for the treatment of advanced rectal cancer, recurrent glioblastoma, astrocytoma, oligodendroglioma, high-grade neuroendocrine carcinoma, advanced non-small cell lung cancer, refractory osteosarcoma, neuroblastoma, adrenocortical carcinoma, rhabdomyosarcoma, recurrent and metastatic nasopharyngeal carcinoma, metastatic castration-sensitive prostate cancer (mCSPC), recurrent and metastatic head and neck squamous cell carcinoma, recurrent glioblastoma, breast cancer, solid tumor, ovarian cancer, fallopian tube cancer, prostate cancer, pancreatic cancer, peritoneal cancer, metastatic urothelial cancer, gastric adenocarcinoma and gastroesophageal junction adenocarcinoma, metastatic colorectal cancer, melanoma, advanced or metastatic solid tumors, metastatic invasive carcinoma of the cervix, esophageal cancer, gastroesophageal Junction and proximal gastric adenocarcinoma, uterine serous carcinoma, metastatic pancreatic cancer, recurrent epithelial ovarian, fallopian tube, metastatic pancreatic ductal adenocarcinoma, primary peritoneal cancer, solid tumors, HR positive and HER2 negative recurrent gBRCA positive breast cancer, metastatic triple negative breast cancer, small cell lung cancer, Ewing's sarcoma, metastatic castration-resistant prostate cancer (CRPC), squamous non-small cell lung cancer, endometrial cancers, soft tissue sarcoma with at least one line of prior chemotherapy, mesothelioma, uveal melanoma, renal cell carcinoma and cholangiocarcinoma, metastatic biliary tract cancer and pancreatic cancer. It is a new molecular entity (NME). It was under development for the treatment of mantle cell lymphoma.

GSK overview

GSK is a healthcare company that focuses on developing, manufacturing and commercializing pharmaceuticals, vaccines and consumer healthcare products. It offers drugs for the treatment of diseases such as HIV, respiratory, cancer, immuno-inflammation, anti-viral, central nervous system (CNS), metabolic, cardiovascular and urogenital, anti-bacterials, dermatology and rare diseases. The company also offers over-the-counter (OTC) products for pain relief, oral health, nutrition, skin health and gastro-intestinal diseases. GSK’s vaccine portfolio covers various diseases including hepatitis, diphtheria, tetanus, whooping cough, rotavirus and HPV infections, measles and bacterial meningitis, among others. The company sells its products through wholesalers, pharmacies, hospitals, physicians and other groups worldwide. GSK is headquartered in Brentford, Middlesex, the UK.

For a complete picture of Niraparib’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.