Treats chronic gout. Sold as Krystexxa. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Pegloticase (sold as Krystexxa), first approved Sep 14, 2010, with 1 new use approved and 0 published complete response letters.
| A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled GoutUncontrolled Gout · Amgen | Phase 3 | Recruiting | Feb 5, 2026 |
| Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed PatientsGout, Gouty Arthritis · Arthrosi Therapeutics | Phase 2 | Active, not recruiting | Aug 12, 2025 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Sep 14, 2010 | KrystexxaBLA 125293 · New molecular entity | Horizon Pharma | 13 | 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
