ZEJULA (niraparib tosylate)
Zejula (niraparib tosylate) is a PARP inhibitor indicated for the maintenance treatment of adult patients with advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. It is utilized for patients who have achieved a complete or partial response to platinum-based chemotherapy. For first-line maintenance, the drug is indicated for patients with homologous recombination deficiency (HRD)-positive status, while for recurrent cases, it is indicated for patients with germline BRCA mutations. Treatment selection requires the use of an FDA-approved companion diagnostic to identify appropriate biomarkers.
How ZEJULA Works
Niraparib inhibits PARP-1 and PARP-2 enzymes, which play a critical role in the repair of DNA. The drug's activity involves the inhibition of enzymatic activity and the increased formation of PARP-DNA complexes, resulting in DNA damage and cell death. This cytotoxicity is particularly effective in tumor cells with homologous recombination deficiency or BRCA mutations, where DNA repair pathways are already compromised.
Details
- Status
- Discontinued
- First Approved
- 2017-03-27
- Patent Cliff
- 2039
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
ZEJULA Approval History
What ZEJULA Treats
3 indicationsZEJULA is approved for 3 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
ZEJULA Target & Pathway
ProTarget
ZEJULA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZEJULA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZEJULA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZEJULA
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZEJULA FDA Label Details
Indications & Usage
FDA Label (PDF)ZEJULA is indicated for the treatment of Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer.
ZEJULA Patents & Exclusivity
Patents (8 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ZEJULA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 89 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 13 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.