Treats advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. Sold as Zejula. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Niraparib Tosylate (sold as Zejula), first approved Mar 27, 2017, with 5 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Zejula | Part D | $253M | +13% | 2,048 |
| A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)Ovarian Cancer · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Phase 1 / Phase 2 | Recruiting | Sep 19, 2024 |
| Niraparib/TTFields in GBMGlioblastoma, Recurrent Glioblastoma · Abramson Cancer Center at Penn Medicine | Phase 2 | Active, not recruiting | Jan 9, 2020 |
| Mar 27, 2017 | ZejulaNDA 208447 · New molecular entity | Glaxosmithkline | 12 | Discontinued |
| Apr 26, 2023 | ZejulaNDA 214876 · New dosage form | Glaxosmithkline | 4 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Glaxosmithkline