Treats confirmed Fabry disease. Sold as Fabrazyme. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Agalsidase Beta (sold as Fabrazyme), first approved Apr 24, 2003, with 4 new uses approved and 0 published complete response letters.
| Efficacy and Safety of Enzyme Replacement Therapy in Patients With Fabry DiseaseFabry Disease · NPO Petrovax | — | Enrolling by invitation | Mar 17, 2025 |
| Biomarkers and Cardiac Imaging Diagnostic Assay for Monitoring Patients With Fabry DiseaseFabry Disease · Mackay Memorial Hospital | — | Recruiting | Jan 26, 2023 |
| A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry DiseaseFabry Disease · Sanofi | Phase 3 | Active, not recruiting | Mar 15, 2022 |
| Fabry Disease Registry & Pregnancy Sub-registryFabry Disease · Genzyme, a Sanofi Company | — | Recruiting | Sep 20, 2005 |
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
