Treats Duchenne muscular dystrophy (DMD). Sold as Amondys 45. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 1 application for Casimersen (sold as Amondys 45), first approved Feb 25, 2021, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Amondys-45 | Part D | $17.6M | +25% | 13 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| A Long-term Observational Study Evaluating Eteplirsen, Golodirsen, or Casimersen in Routine Clinical PracticeDuchenne Muscular Dystrophy · Sarepta Therapeutics, Inc. | — | Enrolling by invitation | Sep 23, 2024 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Feb 25, 2021 | Amondys 45NDA 213026 · New molecular entity | Sarepta Theraps Inc | 3 | 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
