Manages kidney failure. Sold as Extraneal. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Icodextrin (sold as Extraneal), first approved Dec 20, 2002, with 1 new use approved and 0 published complete response letters.
| Iodine Starch Test Use in Pleuroperitoneal LeakPeritoneal Dialysis, Peritoneal Dialysis (PD) · Nottingham University Hospitals NHS Trust | Not applicable | Not yet recruiting | Oct 5, 2026 |
| Effectiveness of Two Icodextrin Exchanges on Fluid Status and Blood Pressure Control Compared to a Single Icodextrin ExchangeChildren on Chronic Peritoneal Dialysis · National University Health System, Singapore | Not applicable | Not yet recruiting | Sep 11, 2025 |
| CGM in Icodextrin PDDiabetes Mellitus (Diagnosis), End Stage Renal Disease (ESRD) · Elaine Chow | — | Not yet recruiting | Feb 21, 2025 |
| Elective Adhesiolysis vs. a Wait-and-see Policy to Prevent Recurrences After Conservative Treatment of Adhesive Small Bowel ObstructionAdhesive Small Bowel Obstruction · Radboud University Medical Center | Not applicable | Not yet recruiting | Jan 15, 2025 |
| Incremental PD With Single Icodextrin ExchangePeritoneal Dialysis Complication, Residual Kidney Function · RenJi Hospital | Not applicable | Not yet recruiting | Nov 7, 2023 |
| Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal DialysisPeritoneal Dialysis · First Affiliated Hospital, Sun Yat-Sen University | Phase 4 | Recruiting | Feb 10, 2023 |
| Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.End Stage Renal Disease · Iperboreal Pharma Srl | Phase 3 | Recruiting | Jun 21, 2019 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Dec 20, 2002 | ExtranealNDA 21321 · New molecular entity | Vantive US Hlthcare | 18 | 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
