icodextrin

Trade name: Extraneal

Small moleculeapprovedOrphan Drug FDA

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

Phase 1
2
Phase 2
5
Phase 3
2
Phase 4
9

Earliest trial started Dec 1, 2005 (NCT00725517)

Timeline

1990s

  1. Jul 18, 1997

    Orphan Drug Designation

2000s

  1. Dec 20, 2002

    Baxalta — Earliest FDA Approval

  2. Dec 20, 2002

    Baxalta — NDA Organization

  3. Dec 20, 2002

    Baxter — NDA Secondary Org

  4. Jan 1, 2006

    Baxalta — Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 2008

    Baxalta — Earliest Phase 3 Sponsor(trial)

2020s

  1. Jan 1, 2022

    Earliest Phase 1 Sponsor(trial)

Indications

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

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 IDPhaseStart dateSponsor(s)
NCT07168343N/ANov 1, 2025Fudan University, National University of Singapore
NCT06552546N/AAug 15, 2024Peking University
NCT05943470Phase 4Aug 1, 2023Jiao Tong University
NCT05721404Phase 4May 24, 2023Baxalta, Sun Yat-Sen University
NCT05780086Phase 1Feb 3, 2023Instituto Mexicano del Seguro Social, Sequana Medical AG
NCT05185999Phase 1Oct 17, 2022University of Western Ontario
NCT04086212Phase 2May 31, 2020D'Annunzio University of Chieti–Pescara, Iperboreal Pharma Srl
NCT02166359N/AJun 1, 2014Baxalta, Dong-A University
NCT01987128Phase 4Nov 1, 2013ASST Gaetano Pini-CTO, Istituto Ortopedico Gaetano Pini
NCT01944852Phase 4Mar 1, 2013Université catholique de Louvain, University of London
NCT01242904Phase 2Jun 1, 2011Baxalta, University of Western Ontario
NCT01119196N/ASep 30, 2010Vanderbilt University
NCT01170858N/AAug 1, 2010Yonsei University
NCT01124227Phase 3Apr 1, 2010Baxalta, Roche, University of Groningen
NCT01044446Phase 4Jan 1, 2010Chinese University of Hong Kong
NCT02318888N/ADec 1, 2009Uppsala University
NCT01021878Phase 4Oct 31, 2009Baxalta, Pontifícia Universidade Católica do Paraná
NCT00567398Phase 3Apr 1, 2008Baxalta
NCT00567489Phase 4Jan 1, 2008Baxalta
NCT00397358Phase 4Nov 1, 2006Baxalta
Showing 20 of 23 trials
Page 1 / 2

Organizations

Research & Development (24)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BaxaltaFor profit9442006
Jiao Tong UniversityAcademic/Hospital2212005
University of Western OntarioAcademic/Hospital2222011
Aarhus UniversityAcademic/Hospital1112006
ASST Gaetano Pini-CTOAcademic/Hospital1112013
Chinese University of Hong KongAcademic/Hospital1112010
D'Annunzio University of Chieti–PescaraAcademic/Hospital1012020
Dong-A UniversityAcademic/Hospital1112014
Fudan UniversityAcademic/Hospital1012025
Instituto Mexicano del Seguro SocialGovernment1112023
Iperboreal Pharma SrlFor profit1112020
Istituto Ortopedico Gaetano PiniAcademic/Hospital1012013
National University of SingaporeAcademic/Hospital1112025
Peking UniversityAcademic/Hospital1112024
Pontifícia Universidade Católica do ParanáAcademic/Hospital1112009
RocheFor profit1012010
Sequana Medical AGFor profit1012023
Sun Yat-Sen UniversityAcademic/Hospital1112023
Université catholique de LouvainAcademic/Hospital1112013
University of GroningenAcademic/Hospital1112010
24 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
BaxaltaFor profitNDADec 20, 2002
BaxterFor profitNDA2Dec 20, 2002