icodextrin
Trade name: Extraneal
Approved
Dec 20, 2002
Icodextrin is a colloid osmotic agent, derived from maltodextrin, used in form of an aqueous solution for peritoneal dialysis under the trade name Extraneal and after gynecological laparoscopic surgery for the reduction of post-surgical adhesions (fibrous bands that form between tissues and organs) under the trade name Adept. Icodextrin is a starch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds. Icodextrin. Icodextrin acts in the peritoneal cavity by exerting osmotic pressure across small intercellular pores resulting in transcapillary ultrafiltration throughout the dwell. Like other peritoneal dialysis solutions, Extraneal also contains electrolytes to help normalize electrolyte balance and lactate to help normalize acid-base status. Absorption of icodextrin from the peritoneal cavity follows zero-order kinetics consistent with convective transport via peritoneal lymphatic pathways. Icodextrin is metabolized by alpha-amylase into oligosaccharides with a lower degree of polymerization, including maltose, maltotriose, maltotetraose, and higher molecular weight species — NCATS
Clinical trial activity
23 trials · 24 clinical orgs · 2 marketing orgs
Earliest trial started Dec 1, 2005 (NCT00725517)
Timeline
Indications
Approved for
Studied for
- Auditory Perceptual Disorders · Phase 4
- Diabetes Mellitus · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Hallux Valgus · Phase 4
- Hamartoma · Phase 4
- Heart Failure · Phase 3
- Hypertriglyceridemia · Phase 4
- Kidney Failure, Chronic · Phase 4
- Peritoneal Dialysis · Phase 4
- Peritoneal Dialysis, Continuous Ambulatory · Phase 4
- Peritonitis · Phase 4
- Renal Insufficiency · Phase 4
- Renal Insufficiency, Chronic · Phase 4
Mechanism of action
- Unspecified targetOTHER
Osmotic agent
Peritoneal dialysis solution
- UnclearUnclear
Unclear unclear
Approval history
- approvedDec 20, 2002
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaIcodextrin ↗
- NCATS2NX48Z0A9G ↗
- ChEMBLCHEMBL1201472 ↗
Also known as
- adept
- extraneal
- extraneal
- extraneal
- extraneal
- extraneal
- icodextrin
- icodextrin
- icodextrin
- icodextrin
- icodextrin
- icodextrin
- icodextrin
- icodextrin
- icodextrin
- icodextrina
- icodextrine
- icodextrinum
- icodial
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07168343 | N/A | Nov 1, 2025 | Fudan University, National University of Singapore |
| NCT06552546 | N/A | Aug 15, 2024 | Peking University |
| NCT05943470 | Phase 4 | Aug 1, 2023 | Jiao Tong University |
| NCT05721404 | Phase 4 | May 24, 2023 | Baxalta, Sun Yat-Sen University |
| NCT05780086 | Phase 1 | Feb 3, 2023 | Instituto Mexicano del Seguro Social, Sequana Medical AG |
| NCT05185999 | Phase 1 | Oct 17, 2022 | University of Western Ontario |
| NCT04086212 | Phase 2 | May 31, 2020 | D'Annunzio University of Chieti–Pescara, Iperboreal Pharma Srl |
| NCT02166359 | N/A | Jun 1, 2014 | Baxalta, Dong-A University |
| NCT01987128 | Phase 4 | Nov 1, 2013 | ASST Gaetano Pini-CTO, Istituto Ortopedico Gaetano Pini |
| NCT01944852 | Phase 4 | Mar 1, 2013 | Université catholique de Louvain, University of London |
| NCT01242904 | Phase 2 | Jun 1, 2011 | Baxalta, University of Western Ontario |
| NCT01119196 | N/A | Sep 30, 2010 | Vanderbilt University |
| NCT01170858 | N/A | Aug 1, 2010 | Yonsei University |
| NCT01124227 | Phase 3 | Apr 1, 2010 | Baxalta, Roche, University of Groningen |
| NCT01044446 | Phase 4 | Jan 1, 2010 | Chinese University of Hong Kong |
| NCT02318888 | N/A | Dec 1, 2009 | Uppsala University |
| NCT01021878 | Phase 4 | Oct 31, 2009 | Baxalta, Pontifícia Universidade Católica do Paraná |
| NCT00567398 | Phase 3 | Apr 1, 2008 | Baxalta |
| NCT00567489 | Phase 4 | Jan 1, 2008 | Baxalta |
| NCT00397358 | Phase 4 | Nov 1, 2006 | Baxalta |
Organizations
Research & Development (24)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Baxalta | For profit | 9 | 4 | 4 | 2006 |
| Jiao Tong University | Academic/Hospital | 2 | 2 | 1 | 2005 |
| University of Western Ontario | Academic/Hospital | 2 | 2 | 2 | 2011 |
| Aarhus University | Academic/Hospital | 1 | 1 | 1 | 2006 |
| ASST Gaetano Pini-CTO | Academic/Hospital | 1 | 1 | 1 | 2013 |
| Chinese University of Hong Kong | Academic/Hospital | 1 | 1 | 1 | 2010 |
| D'Annunzio University of Chieti–Pescara | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Dong-A University | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Fudan University | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Instituto Mexicano del Seguro Social | Government | 1 | 1 | 1 | 2023 |
| Iperboreal Pharma Srl | For profit | 1 | 1 | 1 | 2020 |
| Istituto Ortopedico Gaetano Pini | Academic/Hospital | 1 | 0 | 1 | 2013 |
| National University of Singapore | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Peking University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Pontifícia Universidade Católica do Paraná | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Roche | For profit | 1 | 0 | 1 | 2010 |
| Sequana Medical AG | For profit | 1 | 0 | 1 | 2023 |
| Sun Yat-Sen University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Université catholique de Louvain | Academic/Hospital | 1 | 1 | 1 | 2013 |
| University of Groningen | Academic/Hospital | 1 | 1 | 1 | 2010 |