sorbitol

Small moleculeapproved

Approved

Aug 20, 1971

Sorbitol is a polyhydric alcohol with about half the sweetness of sucrose. Sorbitol occurs naturally and is produced synthetically from glucose. It was formerly used as a diuretic and may still be used as a laxative and in irrigating solutions for some surgical procedures. Used as a non-stimulant laxative via an oral suspension or enema. Sorbitol exerts its laxative effect by drawing water into the large intestine, thereby stimulating bowel movements. Sorbitol plays a vital step in the 'polyol pathway'. The sudden injection of extra sorbitol can ruin the equilibrium of enzymes that regulate the conversion of glucose to fructose in a process associated with the onset of diabetes and its complications. Further, the polyol pathway is involved with a complex network of metabolic activities; disruption leads to a cascade of problems (citations here, here and here) such as mitochondrial failure, cell apoptosis (cell death), and DNA fragmentation. In general, sorbitol induces cell hyperosmotic stress resulting in phosphorylation (uptake of phosphorus into cell) — an important on/off switch regulating enzymes and signaling networks. — NCATS

Clinical trial activity

39 trials · 73 clinical orgs · 5 marketing orgs

Phase 1
4
Phase 2
6
Phase 3
7
Phase 4
8

Earliest trial started Sep 1, 2006 (NCT00374881)

Timeline

1970s

  1. Aug 20, 1971

    Earliest FDA Approval

  2. Aug 20, 1971

    Hospira — Marketing Organization

  3. Jun 21, 1976

    Hospira — NDA Secondary Org

  4. Feb 16, 1978

    B. Braun — NDA Secondary Org

1980s

  1. Feb 22, 1980

    ICU Medical Inc — Marketing Organization

  2. Feb 22, 1980

    ICU Medical Inc — NDA Secondary Org

  3. May 30, 1980

    Baxalta — NDA Secondary Org

  4. May 30, 1980

    Baxter — NDA Secondary Org

2000s

  1. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Combination products

Approval history

  • approvedAug 20, 1971

Chemistry & pharmacology

Loading structure…

SMILES

OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO
Mol. weight
182.1718 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • d-glucitol
  • d-glucitol
  • d-glucitol
  • d-sorbit
  • d-sorbit
  • d-sorbitol
  • d-sorbitol
  • d-sorbitol
  • d-sorbitol
  • d-sorbitol
  • d-(−)-sorbitol
  • d-(−)-sorbitol
  • e420
  • e420
  • glucarine
  • g-ol
  • g-ol
  • l-gulitol
  • l-gulitol
  • l-gulitol
  • sorbitol
  • sorbitol
  • sorbitol
  • sorbitol
  • sorbitol
  • sorbitol
  • sorbitol
  • sorbitol
  • (-)-sorbitol
  • (−)-sorbitol
  • (−)-sorbitol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07195656N/ASep 30, 2025FemPulse Corporation
NCT06971172N/AJun 1, 2025Cairo University
NCT06946979N/AApr 30, 2025Zhejiang Chinese Medical University
NCT06883864N/AApr 1, 2025Abbott, Capital Medical University
NCT06693934N/ANov 30, 2024Asia Diabetes Foundation, Chinese University of Hong Kong
NCT06826079Phase 2/Phase 3 (Phase 3)Nov 1, 2024Huazhong University of Science and Technology
NCT06299514N/AApr 25, 2024University of Western Ontario
NCT07016451Early Phase 1 (Phase 1)Apr 2, 2024Mahidol University
NCT06377826N/AApr 1, 2024Riphah International University
NCT06261801N/AFeb 7, 2024Hangzhou Third Hospital, Zhejiang University
NCT06101368N/AJan 1, 2024Health Education Research Foundation (HERF), University of Hail
NCT05450458Phase 2/Phase 3 (Phase 3)Jul 1, 2022Hospital Regional Tlalnepantla
NCT05480566N/AJun 1, 2022Hasselt University
NCT05320094Phase 1Apr 15, 2022Bristol-Myers Squibb
NCT04762758Phase 3Mar 30, 2021Aix-University of Marseille, Pharnext SA, University of Miami, Worldwide Clinical Trials
NCT04594226N/ANov 30, 2020Lishui Hospital of Traditional Chinese Medicine, Zhejiang University
NCT04573153Phase 2/Phase 3 (Phase 3)Sep 21, 2020Alanya Alaaddin Keykubat University, Bagcilar Research and Training Hospital, Bakirkoy Dr. Sadi Konuk Research and Training Hospital, Canakkale 18 Mart University Health Research and Application Hospital, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Istanbul Medipol University, Kanuni Sultan Suleyman Training and Research Hospital, MonitorCRO, ScandiBio Therapeutics AB, Umraniye Education and Research Hospital, University of Health Sciences, Turkey
NCT04489641N/AJan 16, 2020Universidad de Cordoba
NCT04044131Phase 2Sep 1, 2019Alanya Alaaddin Keykubat University, Istanbul Medipol University, KTH Royal Institute of Technology, ScandiBio Therapeutics AB, University of Gothenburg
NCT04330326Phase 2Jul 20, 2019Koç University, KTH Royal Institute of Technology, MonitorCRO, ScandiBio Therapeutics AB, University of Gothenburg, University of Helsinki
Showing 20 of 39 trials
Page 1 / 2

Organizations

Research & Development (73)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Yuria-PharmFor profit4412016
ScandiBio Therapeutics ABFor profit3222019
Alanya Alaaddin Keykubat UniversityAcademic/Hospital2022019
Cairo UniversityAcademic/Hospital2212018
Columbia UniversityAcademic/Hospital2022012
Duke UniversityAcademic/Hospital2022012
Istanbul Medipol UniversityAcademic/Hospital2122019
KTH Royal Institute of TechnologyAcademic/Hospital2012019
MonitorCROFor profit2022019
National Heart, Lung, and Blood Institute (NHLBI)Government2022012
New York UniversityAcademic/Hospital2222012
Stanford UniversityAcademic/Hospital2022012
University of GothenburgAcademic/Hospital2012019
University of TurkuAcademic/Hospital2022008
Zhejiang UniversityAcademic/Hospital2112020
AbbottFor profit1012025
Aix-University of MarseilleAcademic/Hospital1012021
Asia Diabetes FoundationAcademic/Hospital1112024
Bagcilar Research and Training HospitalAcademic/Hospital1012020
Bakirkoy Dr. Sadi Konuk Research and Training HospitalAcademic/Hospital1012020
73 organizations
Page 1 / 4

Marketing (7)

OrganizationOrg typeRelationshipDate
B. BraunFor profitNDA2Feb 16, 1978
BaxaltaFor profitNDA2May 30, 1980
BaxterFor profitNDA2May 30, 1980
HospiraFor profitMKTGAug 20, 1971
HospiraFor profitNDA2Jun 21, 1976
ICU Medical IncFor profitMKTGFeb 22, 1980
ICU Medical IncFor profitNDA2Feb 22, 1980