ZEJULA
Details
- Status
- Prescription
- First Approved
- 2017-03-27
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
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
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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
ProIndications & Usage
FDA Label (PDF)ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: • for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recur...
ZEJULA Patents & Exclusivity
Patents (89 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.