inulin

Trade name: inulin

Small moleculeapproved

Approved

Apr 30, 1940

Inulin is a water soluble storage polysaccharide used as a prebiotic, fat replacer, sugar replacer, and texture modifier. Inulin is a soluble fiber which is not digested by human enzymes and produces distinctive fiber-alike results on the effectiveness of the gut, thus, lowering the pH of intestine, providing assistance in relieving constipation and increasing stool load or rate. Inulin decrease the risk of many diseases of the intestinal tract, particularly irritable bowel diseases and colon cancer. Inulin products contain mainly short-chain molecules which enhance the sweetness of sucrose up to 35%, thus it is useful to partially replace sucrose molecule’s flavor. Inulin has been proved an attractive applicant as a low-calorie bulking agent in chocolate, mostly in combination with a polyol which replaces sugar contents without any effect on fat contents. Further uses of inulin include colon specific drug administration and stabilizing and adjuvating vaccine formulations. — NCATS

Clinical trial activity

143 trials · 175 clinical orgs · 1 marketing orgs

Phase 1
12
Phase 2
20
Phase 3
4
Phase 4
4

Earliest trial started Feb 1, 1997 (NCT00167700)

Timeline

1940s

  1. Apr 30, 1940

    IsoTex — Earliest FDA Approval

  2. Apr 30, 1940

    IsoTex — NDA Secondary Org

  3. Apr 30, 1940

    IsoTex — NDA Organization

2000s

  1. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedApr 30, 1940

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • inulin
  • inulin
  • inulin
  • inulin
  • inulin
  • inulin
  • inulin
  • inulin
  • inulin and sodium chloride
  • inulin and sodium chloride

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07189585Phase 2Apr 1, 2026Department of Veteran Affairs, National Center for Complementary and Integrative Health (NCCIH), Yale University
NCT07300553Phase 2Dec 31, 2025Assistance Publique - Hôpitaux de Paris
NCT06372249Phase 2Dec 31, 2025National Institutes of Health (NIH), Northern Arizona University, University of Arizona
NCT07112248N/ASep 1, 2025Huazhong University of Science and Technology
NCT07095426N/AMay 20, 2025Ball State University
NCT07050888N/AMay 9, 2025Free University of Amsterdam, University of Amsterdam
NCT06866262Phase 1/Phase 2 (Phase 2)Apr 1, 2025Department of Defense, University of Michigan
NCT06823557Phase 1Feb 28, 2025University of Minho, University of Porto
NCT06668922N/ANov 28, 2024University of California, Los Angeles
NCT06697626N/ANov 14, 2024Biotechnology and Biological Sciences Research Council, Ulster University, University of Auckland, University of Leeds
NCT06494137N/AOct 31, 2024Quadram Institute, University of Nottingham
NCT06607523N/AOct 1, 2024The Moody Foundation, University of Texas, Galveston
NCT06551961N/AAug 9, 2024University of East Anglia, University of Nottingham
NCT06528041N/AAug 1, 2024Purdue University
NCT06420401N/AMay 15, 2024Sun Yat-Sen University
NCT06404749N/AMay 3, 2024Future Biome SA
NCT06347198Early Phase 1 (Phase 1)Apr 10, 2024Huazhong University of Science and Technology
NCT06551948N/AJan 1, 2024University of East Anglia, University of Nottingham
NCT06291272N/AOct 15, 2023Quadram Institute, University of Nottingham
NCT05532488N/AAug 1, 2023University of Belgrade
Showing 20 of 143 trials
Page 1 / 8

Organizations

Research & Development (175)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of NottinghamAcademic/Hospital8812013
University of ReadingAcademic/Hospital7612008
University of GlasgowAcademic/Hospital6412015
Scottish Universities Environmental Research CentreAcademic/Hospital4112015
Beneo GmbHFor profit3312011
Maastricht UniversityAcademic/Hospital3312009
Université catholique de LouvainAcademic/Hospital3312016
University of CalgaryAcademic/Hospital3322015
University of East AngliaAcademic/Hospital3012023
Biotechnology and Biological Sciences Research CouncilAcademic/Hospital2012019
DaniscoFor profit2012008
Department of DefenseGovernment2022022
Dr. Sami Ulus Children's HospitalAcademic/Hospital2212012
Duke UniversityAcademic/Hospital2212018
Federal University of Santa CatarinaAcademic/Hospital2212013
Huazhong University of Science and TechnologyAcademic/Hospital2222024
Humboldt UniversityAcademic/Hospital2112021
Indiana UniversityAcademic/Hospital2222019
Institut PasteurAcademic/Hospital2222008
Katholieke Universiteit LeuvenAcademic/Hospital2222006
175 organizations
Page 1 / 9

Marketing (2)

OrganizationOrg typeRelationshipDate
IsoTexFor profitNDA2Apr 30, 1940
IsoTexFor profitNDAApr 30, 1940