ZEJULA
PeakNDAORALCAPSULEPriority Review
Approved
Mar 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
ZEJULA by GSK is enzymes, including parp-1 and parp-2, that play a role in dna repair. First approved in 2017.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEJULA is an oral small-molecule PARP inhibitor approved by the FDA in March 2017 for oncology indications. The drug is currently in peak commercial lifecycle with strong Part D utilization (10,023 claims in 2023). Mechanism of action involves inhibition of poly(ADP-ribose) polymerase to induce synthetic lethality in DNA repair-deficient tumors.
$162MPart D
Peak11.5 years to LOEPeak-stage product with substantial Medicare utilization signals robust commercial infrastructure; brand team likely at full operational capacity with focus on market maintenance and indication expansion.
Mechanism of Action
enzymes, including PARP-1 and PARP-2, that play a role in DNA repair. In vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis, and cell death. Increased…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency
Started Feb 2024
33 enrolled
Efficacy
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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.