Xylitol

Summary

Xylitol (CHEMBL96783) is a phase-3 clinical-stage small-molecule sweetening agent; indicated across 10 conditions including dental caries and otitis media.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• Indications: 10 conditions
• Clinical trials: 44
• Chemistry: 152.15 Da · C5H12O5

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL96783
Name	Xylitol
Type	Small molecule
Max phase	3
FDA approved	no
PubChem CID	6912
ChEBI	CHEBI:17151
Molecular formula	C5H12O5
Molecular weight	152.15
InChIKey	HEBKCHPVOIAQTA-NGQZWQHPSA-N

SMILES: C([C@H](C([C@H](CO)O)O)O)O

IUPAC name: (2R,4S)-pentane-1,2,3,4,5-pentol

ChEBI definition: A pentitol (five-carbon sugar alcohol) having meso-configuration, being derived from xylose by reduction of the carbonyl group.

Pharmacological roles (ChEBI): sweetening agent, allergen, hapten.

Other ChEBI roles (chemical / environmental): human metabolite, algal metabolite, Saccharomyces cerevisiae metabolite, mouse metabolite.

Also known as: C-xylidex cr 16055, E-967, E967, Eutrit, Fluorette, INS NO.967, INS-967, Kannit, Klinit, Kylit, NSC-25283, Torch

Patent coverage: 109,170 distinct patent families (292,293 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

10 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
dental caries	3	MONDO:0005276	EFO:0003819
otitis media	3	MONDO:0005441	MONDO:0024330
diabetes mellitus	2	MONDO:0005015	EFO:0000400
otitis media with effusion	2	MONDO:0005892	EFO:0007415
sinusitis	2	MONDO:0005961	EFO:0007486
chronic kidney disease	2	MONDO:0005300	EFO:0003884
bacterial infectious disease	1	MONDO:0005113	EFO:0000771
allergic disease	1	MONDO:0005271	MONDO:0005271
cystic fibrosis	1	MONDO:0009061	MONDO:0009061

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 44.

Phase distribution

Phase	Trials
Not specified	24
PHASE4	4
PHASE3	4
PHASE1/PHASE2	4
PHASE2/PHASE3	3
PHASE2	3
PHASE1	1
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00638677	PHASE4	COMPLETED	Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
NCT01578603	PHASE4	COMPLETED	Effects of Two Sugar Substituted Chewing Gums on Caries and Gingivitis Variables
NCT02036151	PHASE4	COMPLETED	Impact of Maternal Xylitol Consumption on Mutans Sterptococci
NCT02104596	PHASE4	UNKNOWN	Intraarticular Xylitol Injections for Knee Osteoarthritis
NCT00393055	PHASE3	COMPLETED	Xylitol Adult Caries Trial (X-ACT)
NCT01044030	PHASE3	COMPLETED	Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
NCT01062633	PHASE2/PHASE3	UNKNOWN	Effect of Erythritol and Xylitol on Dental Caries Prevention in Children
NCT03229551	PHASE2/PHASE3	COMPLETED	Xylitol for Chronic Sinusitis
NCT04399161	PHASE2/PHASE3	COMPLETED	Anticaries Effect of Xylitol,Probiotic and Chlorhexidine Mouth Rinses Among Individuals at High Risk
NCT04854486	PHASE3	WITHDRAWN	Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients
NCT05342272	PHASE3	COMPLETED	Comparison of Gum® HydralTM Moisturizing Gel and Biotene® Oral Gel in Dry Mouth Sensation Reduction
NCT05579639	PHASE2	RECRUITING	Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant
NCT00928135	PHASE1/PHASE2	COMPLETED	Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) Subjects
NCT01355796	PHASE1/PHASE2	COMPLETED	Inhaled Xylitol Versus Saline in Stable Subjects With Cystic Fibrosis
NCT01528969	PHASE1/PHASE2	COMPLETED	Effect of Xylitol on Oral Microbiota in Children
NCT01561508	PHASE2	WITHDRAWN	Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children
NCT01647737	PHASE1/PHASE2	COMPLETED	Green Tea Lozenges for the Management of Dry Mouth
NCT04117477	PHASE2	TERMINATED	Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients
NCT05852587	PHASE1	NOT_YET_RECRUITING	Xylitol Use for Decolonization of C. Difficile in Patients With IBD
NCT06799039	EARLY_PHASE1	NOT_YET_RECRUITING	Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease
NCT04731363	Not specified	ACTIVE_NOT_RECRUITING	Consumption of Oral Artificial Sweeteners on Platelet Aggregation and Polyol Excretion
NCT04966299	Not specified	ACTIVE_NOT_RECRUITING	Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents
NCT05635929	Not specified	RECRUITING	Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.
NCT06984848	Not specified	RECRUITING	Effect of Enzymatic-Containing Mouth Spray (Oral7®) on Xerostomia Symptoms, Salivary Flow Rate, and Oral Health-Related Quality of Life in Older Patients
NCT00530153	Not specified	UNKNOWN	School Intervention Study of Nutrition, Wellbeing and Dental Health
NCT00924404	Not specified	COMPLETED	Xylitol Versus Saline in Chronic Sinusitis
NCT01038479	Not specified	UNKNOWN	Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
NCT01468727	Not specified	COMPLETED	Study on Use of Xylitol-wipes to Prevent Dental Caries
NCT01823445	Not specified	COMPLETED	Xylitol Disk Use in Adults With Dry Mouth
NCT02274636	Not specified	UNKNOWN	Study of a Dietary Supplement for Reflux During Sleep
NCT02468388	Not specified	COMPLETED	Re-mineralization Effects of Sugar Free Chewing Gum Sweetened With Different Sugar-substitutes
NCT02592382	Not specified	COMPLETED	Nasal Xylitol in the Prevention of Otitis Media
NCT03039478	Not specified	COMPLETED	Effect of Different Concentrations of Xylitol and Erythritol on Gut Peptide Release and Gastric Emptying in Humans
NCT03055091	Not specified	UNKNOWN	Xylitol for the Prevention of Acute Otitis Media Episodes in Children
NCT03061422	Not specified	UNKNOWN	Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH
NCT04096599	Not specified	UNKNOWN	Is Xylitol Toothpaste Effective in Preventing Tooth Decay?
NCT04199897	Not specified	COMPLETED	Effect of a 2-week Sugar Stress on Bacterial Profiles in Whole Saliva
NCT04310514	Not specified	UNKNOWN	Effects of Rehydration During Physical Exercise on Acute Kidney Injury Biomarkers
NCT04585061	Not specified	COMPLETED	A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia.
NCT05671965	Not specified	COMPLETED	Effects of Oral Xylitol on Subsequent Energy Intake

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).