Sorbitol

Overview

A polyhydric alcohol with about half the sweetness of sucrose. Sorbitol occurs naturally and is also 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.

Indication

Used as a non-stimulant laxative via an oral suspension or enema.

Associated Conditions

Constipation
Constipation caused by Pregnancy
Occasional Constipation

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Efficacy Study of Sorbitol with Neoadjuvant Chemotherapy Combined with Tirellizumab (PD-1 Inhibitor) in Patients with Locally Advanced Gastric Cancer	2025/02/13	NCT06826079	Phase 2	Recruiting	Wuhan Union Hospital, China
Metabolic Cofactor Supplementation in Obese Patients with Non-Alcoholic Fatty Liver Disease	2020/04/01	NCT04330326	Phase 2	Completed	ScandiBio Therapeutics AB
Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) and Parkinson's Disease (PD) Patients	2019/08/05	NCT04044131	Phase 2	Completed	Istanbul Medipol University Hospital
Palatability (Taste) of Oral Formulations of Bosutinib	2018/11/20	NCT03747679	Phase 1	Completed	Pfizer
A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers	2015/12/17	NCT02634073	Phase 4	Completed	ViiV Healthcare
A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human Subjects	2006/09/12	NCT00374881	Phase 1	Completed	BioLineRx, Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sorbitol	Baxter Healthcare Corporation	0338-0295	IRRIGATION	30.00 g in 1000.00 mL	1/1/2018
Sorbitol-Mannitol	ICU Medical Inc.	0990-7981	URETHRAL	2.7 g in 100 mL	4/7/2021

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
OSMOFUNDIN INJECTION 20%	B BRAUN MEDICAL INDUSTRIES SDN BHD	SIN05957P	INJECTION	2.5 g/100 ml	5/27/1991

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
LA-FLAMING INJ.	N/A	FALKAN MEDICAL LIMITED	N/A	N/A	1/28/2010
PAN-AMIN G INJ	N/A	LUEN CHEONG HONG	N/A	N/A	5/17/1979
PAN-AMIN G SOLUTION FOR INFUSION 500ML	N/A	otsuka pharmaceutical (h.k.) limited	N/A	N/A	4/5/2012
AMINOGEN-S SOLUTION FOR INFUSION	N/A	wings pharmaceutical ltd	N/A	N/A	8/15/2013
PAN-VASOL SOLUTION FOR INJECTION	N/A	FALKAN MEDICAL LIMITED	N/A	N/A	4/23/2011

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CARBOSORB XS activated charcoal 50 g/250 mL and sorbitol 70.75 g/250 mL suspension bottle	307429	Phebra Pty Ltd	Medicine	A	7/25/2018
MICROLAX ENEMA tube	14480	Johnson & Johnson Pacific Pty Ltd	Medicine	A	9/5/1991
Caneryou Prune & Bowel Cleansing Tablets	466865	Fortune Land (Aust) Pty Ltd	Medicine	A	11/1/2024
CARBOSORB XS CHARCOAL AND SORBITOL SUSPENSION oral liquid bottle	106469	Phebra Pty Ltd	Medicine	A	7/23/2004

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SORBITOL ROUGIER PWS 5GM	rougier pharma division of ratiopharm inc	00337048	Powder For Solution - Oral	5 G / PCK	12/31/1975
CHAR-FLO WITH SORBITOL - SUS	ballard medical products	02205424	Suspension - Oral	400 MG / ML	8/20/1997
SALIVART AER	all star sales and service ltd.	00894397	Aerosol - Oral	3 %	12/31/1990
SORBITOL MANNITOL IRRIGATION	ICU Medical Canada Inc	00498807	Solution - Irrigation	27 MG / ML	12/31/1980
MICROLAX MICRO-ENEMA	kabi pharmacia canada inc.	02004666	Liquid - Rectal	625 G / 1 L	12/31/1993
MICROLAX MICRO ENEMA	mcneil consumer healthcare division of johnson & johnson inc	02063905	Liquid , Enema - Rectal	625 MG / ML	12/31/1995

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

AI-Powered Research

Premium Access