Overview
Lactitol, also known as 4-β-D-galactopyranosyl-D-glucitol, is a sugar alcohol synthesized from lactose. It is used in food manufacturing as a nutritive sweetener and is approximately 35% as sweet as table sugar (i.e. sucrose). Clinically, lactitol has been investigated for use as an osmotic laxative and, along with other non-absorbable disaccharides such as lactulose, in the treatment of hepatic encephalopathy in patients with cirrhosis. Pizensy, an oral lactitol powder for solution, was approved by the FDA for use in chronic idiopathic constipation in February 2020.
Indication
Lactitol is indicated for the treatment of chronic idiopathic constipation in adults.
Associated Conditions
- Constipation
- Hepatic Encephalopathy (HE)
- Occasional Constipation
- Chronic idiopathic constipation (CIC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/10/08 | N/A | Completed | |||
2014/12/04 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Lactitol Powder | 国药准字H20070258 | 化学药品 | 散剂 | 4/14/2022 | |
| Lactitol Powder | 国药准字H20020596 | 化学药品 | 散剂 | 8/13/2020 |
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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