Sold as Trasylol. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Aprotinin (sold as Trasylol), first approved Dec 29, 1993, with 2 new uses approved and 0 published complete response letters.
| New Microbiota-endocrine Axis in Fructose Malabsorption-caused Visceral Hypersensitivity in Irritable Bowel Syndrome.Irritable Bowel Syndrome (IBS) · University Hospital, Rouen | Not applicable | Not yet recruiting | Jan 13, 2026 |
| Clinical Trial With Aprotinin in the Acute Respiratory Distress Syndrome TreatmentAcute Respiratory Distress Syndrome (ARDS) · Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion | Phase 3 | Recruiting | Jan 5, 2026 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Dec 29, 1993 | TrasylolBLA 20304 · New molecular entity | Bayer Hlthcare | 12 | 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
Bayer Hlthcare