Overview
Xylitol is a naturally occurring five-carbon sugar alcohol found in most plant material, including many fruits and vegetables. Xylitol-rich plant materials include birch and beechwood . It is widely used as a sugar substitute and in "sugar-free" food products. The effects of xylitol on dental caries have been widely studied, and xylitol is added to some chewing gums and other oral care products to prevent tooth decay and dry mouth. Xylitol is a non-fermentable sugar alcohol by most plaque bacteria, indicating that it cannot be fermented into cariogenic acid end-products . It works by inhibiting the growth of the microorganisms present in plaque and saliva after it accummulates intracellularly into the microorganism . The recommended dose of xylitol for dental caries prevention is 6–10 g/day, and most adults can tolerate 40 g/day without adverse events .
Indication
Indicated for use as a sugar substitute, and oral hygiene active ingredient.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/01/29 | Early Phase 1 | Not yet recruiting | |||
2023/10/31 | Not Applicable | Completed | |||
2023/05/10 | Phase 1 | Not yet recruiting | |||
2020/05/22 | Phase 2 | Completed | Dr. Krupa NC | ||
2019/10/07 | Phase 2 | Terminated | |||
2017/07/25 | Phase 2 | Completed | |||
2017/07/18 | Phase 4 | Completed | |||
2016/11/01 | Phase 2 | Withdrawn | |||
2014/01/14 | Phase 4 | Completed | |||
2011/05/18 | Phase 1 | Completed | Joseph Zabner |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
TOOTHFILM INC. | 82711-106 | DENTAL | 2 mg in 20 mg | 4/21/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Xylitol for Injection | 国药准字H20060302 | 化学药品 | 注射剂 | 11/9/2020 | |
Xylitol for Injection | 国药准字H20060147 | 化学药品 | 注射剂 | 9/5/2020 | |
Xylitol Tablets | 国药准字H11022384 | 化学药品 | 片剂 | 11/20/2020 | |
Xylitol Tablets | 国药准字H33021818 | 化学药品 | 片剂 | 8/23/2024 | |
Xylitol Tablets | 国药准字H33021819 | 化学药品 | 片剂 | 8/23/2024 | |
Xylitol and Sodium Chloride Injection | 国药准字H20041077 | 化学药品 | 注射剂 | 5/22/2020 | |
Xylitol and Sodium Chloride Injection | 国药准字H20041076 | 化学药品 | 注射剂 | 5/15/2020 | |
Xylitol Granules | 国药准字H33021847 | 化学药品 | 颗粒剂 | 4/29/2020 | |
Xylitol Granules | 国药准字H22024312 | 化学药品 | 颗粒剂 | 7/23/2020 | |
Xylitol Granules | 国药准字H22026532 | 化学药品 | 颗粒剂 | 5/6/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
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