For Parkinson’s disease (PD) experiencing “off” episodes. Sold as Ongentys. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Opicapone (sold as Ongentys), first approved Apr 24, 2020, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Ongentys | Part D | $17.2M | +12% | 3,303 |
| REal-life ON PARKinson's - ITaly (REONPARK-IT)Parkinson Disease · Bial - Portela C S.A. | — | Active, not recruiting | Feb 11, 2026 |
| Fall Risk Assessment in Parkinson's Disease Using Kinetikos HealthIdiopathic Parkinsonism · Taipei Medical University Shuang Ho Hospital | — | Not yet recruiting | Dec 2, 2025 |
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
