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 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEJULA is an oral small-molecule drug approved by the FDA in March 2017, currently in peak commercial lifecycle. The indication and mechanism of action are not specified in available data, but the product is positioned as an NDA with ongoing clinical relevance.
$162MPart D
Peak11.8 years to LOEZEJULA generated $162M in Part D spending in 2023 with 10,023 claims, indicating a mature established product with stable market presence and likely mid-sized commercial team supporting promotion and patient management.
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.