Reduces cumulative renal toxicity associated with repeated administration of cisplatin. Sold as Ethyol. Every FDA application for this active ingredient: 1 branded and 2 generic.
As of Nov 15, 2026, FDA lists 3 applications for Amifostine (sold as Ethyol), first approved Dec 8, 1995, with 2 new uses approved and 0 published complete response letters.
| A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast CancerRadiodermatitis; Acute · Graegis Pharmaceuticals Ltd | Phase 2 | Active, not recruiting | Sep 25, 2025 |
| A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment in Patients With Locally Advanced Pancreatic Cancer.Locally Advanced Pancreatic Adenocarcinoma, Locally Advanced Pancreas Cancer · Xerient Pharma | Phase 1 / Phase 2 | Recruiting | Sep 5, 2025 |
| Dec 8, 1995 | EthyolNDA 20221 · New molecular entity | Legacy | 22 | Marketed |
| Mar 14, 2008 | AmifostineANDA 77126 | Sun Pharm | 1 | Discontinued |
| Jul 17, 2017 | AmifostineANDA 204363 | Eugia Pharma Speclts | 0 | Discontinued |
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
