sorbitol
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
Earliest trial started Sep 1, 2006 (NCT00374881)
Timeline
1970s
1980s
- Feb 22, 1980
ICU Medical Inc — Marketing Organization
- Feb 22, 1980
ICU Medical Inc — NDA Secondary Org
- May 30, 1980
Baxalta — NDA Secondary Org
- May 30, 1980
Baxter — NDA Secondary Org
2010s
- Jan 1, 2011
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Studied for
- Acute Pain · Phase 1/Phase 2
- Alcoholic Intoxication · Phase 4
- Alzheimer Disease · Phase 2
- Bacterial Infections · Phase 1/Phase 2
- Body Mass Index · Phase 2/Phase 3
- Burns · Phase 4
- Cardiovascular Diseases · Phase 4
- Charcot-Marie-Tooth Disease · Phase 3
- Constipation · Phase 4
- Coronary Artery Disease · Phase 4
- COVID-19 · Phase 2/Phase 3
- Cumulative Trauma Disorders · Phase 2/Phase 3
- Cystitis · Early Phase 1
- Dental Caries · Phase 2/Phase 3
- Gait · Phase 2/Phase 3
- General Surgery · Phase 4
- Glaucoma, Open-Angle · Phase 4
- Healthy Volunteers · Phase 1
- Heart Diseases · Phase 4
- HIV · Phase 4
- Ileus · Phase 4
- Immunotherapy · Phase 2/Phase 3
- Injections · Phase 2/Phase 3
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Myocardial Ischemia · Phase 4
- Neoadjuvant Therapy · Phase 2/Phase 3
- Non-alcoholic Fatty Liver Disease · Phase 2
- Ocular Hypertension · Phase 4
- Osteoarthritis, Knee · Phase 2/Phase 3
- Parkinson Disease · Phase 2
- Peritonitis · Phase 4
- Pneumonia · Phase 4
- Sepsis · Phase 4
- Stomach Neoplasms · Phase 2/Phase 3
Mechanism of action
- UnclearUnclear
Unclear unclear
Combination products
sorbitol-mannitol
with mannitol
Approval history
- approvedAug 20, 1971
Chemistry & pharmacology
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
- WikipediaSorbitol ↗
- NCATS506T60A25R ↗
- ChEMBLCHEMBL1682 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07195656 | N/A | Sep 30, 2025 | FemPulse Corporation |
| NCT06971172 | N/A | Jun 1, 2025 | Cairo University |
| NCT06946979 | N/A | Apr 30, 2025 | Zhejiang Chinese Medical University |
| NCT06883864 | N/A | Apr 1, 2025 | Abbott, Capital Medical University |
| NCT06693934 | N/A | Nov 30, 2024 | Asia Diabetes Foundation, Chinese University of Hong Kong |
| NCT06826079 | Phase 2/Phase 3 (Phase 3) | Nov 1, 2024 | Huazhong University of Science and Technology |
| NCT06299514 | N/A | Apr 25, 2024 | University of Western Ontario |
| NCT07016451 | Early Phase 1 (Phase 1) | Apr 2, 2024 | Mahidol University |
| NCT06377826 | N/A | Apr 1, 2024 | Riphah International University |
| NCT06261801 | N/A | Feb 7, 2024 | Hangzhou Third Hospital, Zhejiang University |
| NCT06101368 | N/A | Jan 1, 2024 | Health Education Research Foundation (HERF), University of Hail |
| NCT05450458 | Phase 2/Phase 3 (Phase 3) | Jul 1, 2022 | Hospital Regional Tlalnepantla |
| NCT05480566 | N/A | Jun 1, 2022 | Hasselt University |
| NCT05320094 | Phase 1 | Apr 15, 2022 | Bristol-Myers Squibb |
| NCT04762758 | Phase 3 | Mar 30, 2021 | Aix-University of Marseille, Pharnext SA, University of Miami, Worldwide Clinical Trials |
| NCT04594226 | N/A | Nov 30, 2020 | Lishui Hospital of Traditional Chinese Medicine, Zhejiang University |
| NCT04573153 | Phase 2/Phase 3 (Phase 3) | Sep 21, 2020 | Alanya 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 |
| NCT04489641 | N/A | Jan 16, 2020 | Universidad de Cordoba |
| NCT04044131 | Phase 2 | Sep 1, 2019 | Alanya Alaaddin Keykubat University, Istanbul Medipol University, KTH Royal Institute of Technology, ScandiBio Therapeutics AB, University of Gothenburg |
| NCT04330326 | Phase 2 | Jul 20, 2019 | Koç University, KTH Royal Institute of Technology, MonitorCRO, ScandiBio Therapeutics AB, University of Gothenburg, University of Helsinki |
Organizations
Research & Development (73)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Yuria-Pharm | For profit | 4 | 4 | 1 | 2016 |
| ScandiBio Therapeutics AB | For profit | 3 | 2 | 2 | 2019 |
| Alanya Alaaddin Keykubat University | Academic/Hospital | 2 | 0 | 2 | 2019 |
| Cairo University | Academic/Hospital | 2 | 2 | 1 | 2018 |
| Columbia University | Academic/Hospital | 2 | 0 | 2 | 2012 |
| Duke University | Academic/Hospital | 2 | 0 | 2 | 2012 |
| Istanbul Medipol University | Academic/Hospital | 2 | 1 | 2 | 2019 |
| KTH Royal Institute of Technology | Academic/Hospital | 2 | 0 | 1 | 2019 |
| MonitorCRO | For profit | 2 | 0 | 2 | 2019 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 2 | 0 | 2 | 2012 |
| New York University | Academic/Hospital | 2 | 2 | 2 | 2012 |
| Stanford University | Academic/Hospital | 2 | 0 | 2 | 2012 |
| University of Gothenburg | Academic/Hospital | 2 | 0 | 1 | 2019 |
| University of Turku | Academic/Hospital | 2 | 0 | 2 | 2008 |
| Zhejiang University | Academic/Hospital | 2 | 1 | 1 | 2020 |
| Abbott | For profit | 1 | 0 | 1 | 2025 |
| Aix-University of Marseille | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Asia Diabetes Foundation | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Bagcilar Research and Training Hospital | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Bakirkoy Dr. Sadi Konuk Research and Training Hospital | Academic/Hospital | 1 | 0 | 1 | 2020 |
Marketing (7)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| B. Braun | For profit | NDA2 | Feb 16, 1978 |
| Baxalta | For profit | NDA2 | May 30, 1980 |
| Baxter | For profit | NDA2 | May 30, 1980 |
| Hospira | For profit | MKTG | Aug 20, 1971 |
| Hospira | For profit | NDA2 | Jun 21, 1976 |
| ICU Medical Inc | For profit | MKTG | Feb 22, 1980 |
| ICU Medical Inc | For profit | NDA2 | Feb 22, 1980 |