NDAORALTABLET
Approved
Apr 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEJULA (niraparib) is an oral small-molecule poly(ADP-ribose) polymerase (PARP) inhibitor approved by the FDA on April 26, 2023, for treatment of multiple cancer indications including ovarian, fallopian tube, primary peritoneal, prostate, breast, pancreatic, colorectal, and other solid tumors, particularly those with homologous recombination deficiency (HRD). The drug works by inhibiting PARP enzymes, which are critical for DNA repair in cancer cells, leading to cell death. ZEJULA represents GSK's entry into the competitive PARP inhibitor oncology space and is positioned for maintenance and treatment-of-disease indications across a broad range of tumor types.
$0.2BPart D
12.7 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
Started Jun 2026
70 enrolled
Ovarian Cancer
Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
Started Oct 2025
0Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Deleterious HRR Gene MutationBRCA1 Gene Mutation+7 more
Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy
Started May 2025
68 enrolled
Pancreatic Adenocarcinoma Metastatic
Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer
Started Apr 2025
0Prostate CancerCastrate Resistant Prostate CancerHomologous Recombination Deficiency
A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian Cancer
Started Apr 2025
67 enrolled
Ovarian Neoplasms
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.