EXTRANEAL (icodextrin)
Extraneal (icodextrin) is indicated as a single daily exchange for the long dwell (8 to 16 hours) in patients with kidney failure undergoing continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD). It is specifically indicated to improve long-dwell ultrafiltration and the clearance of creatinine and urea nitrogen in patients with "high average" or "high" transport characteristics (as defined by PET), providing superior ultrafiltration compared to 4.25% dextrose solutions.
How EXTRANEAL Works
Extraneal is an isosmotic peritoneal dialysis solution that utilizes icodextrin, a starch-derived glucose polymer, as its primary osmotic agent. Unlike traditional dextrose-based solutions that rely on crystalloid osmosis, icodextrin functions as a colloid osmotic agent. It exerts osmotic pressure across small intercellular pores in the peritoneal membrane, resulting in sustained transcapillary ultrafiltration during
Development Insights
Details
- Status
- Prescription
- First Approved
- 2002-12-20
- Routes
- INTRAPERITONEAL
- Dosage Forms
- SOLUTION
EXTRANEAL Approval History
What EXTRANEAL Treats
1 indicationsEXTRANEAL is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Kidney Failure
EXTRANEAL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00567489 Impendia results posted | 31998 | Ph 4 | completed | IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients |
| NCT00567398 Impendia results posted | 34202 | Ph 3 | completed | IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients |
| NCT01944852 DIDo | UCL_2011_DIDo | Ph 4 | completed | Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental PD. |
| NCT01124227 PDinCHF | PDinCHF 2009-017711-15 | Ph 3 | terminated | Peritoneal Dialysis in Congestive Heart Failure |
| NCT01242904 | R-10-460 17193 | Ph 2 | completed | Use of a Bimodal Solution for Peritoneal Dialysis |
| NCT01044446 | CRE-2009.481 | Ph 4 | completed | Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EXTRANEAL FDA Label Details
Indications & Usage
FDA Label (PDF)EXTRANEAL is indicated for the treatment of Kidney Failure.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment