Treats pheochromocytoma. Sold as Demser. Every FDA application for this active ingredient: 1 branded and 3 generic.
As of Nov 15, 2026, FDA lists 4 applications for Metyrosine (sold as Demser), first approved Oct 3, 1979, with 0 new uses approved and 0 published complete response letters.
| Metyrosine | Part D | $4.9M | +20% | 34 |
| Demser | Part D | $0K | -100% | 0 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for SarcomaSarcoma, Ewing, Sarcoma · Sarcoma Oncology Research Center, LLC | Phase 2 | Active, not recruiting | Dec 19, 2018 |
| Oct 3, 1979 | DemserNDA 17871 · New molecular entity | Bausch | 11 | Marketed |
| Jul 24, 2020 | MetyrosineANDA 213734 | Amneal | 0 | Marketed |
| Sep 17, 2024 | MetyrosineANDA 215541 | Leading | 0 | Marketed |
| Apr 9, 2025 | MetyrosineANDA 218620 | Dr Reddys Labs SA | 0 | 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
