Overview
Polyethylene glycol (PEG) is a synthetic polymer produced via polymerization of ethylene oxide molecules to make joining units of ethylene glycol by an ether linkage. PEGs are water-soluble polymers that can form hydrogen bonds in a ratio of 100 water molecules per one PEG molecule. Molecular weights of PEGs vary by time of the polymerization process and the molecular weight represents the weighted average of the individual PEG molecules. PEGs differ in their physical and chemical properties depending on their molecular weight: PEGs are liquids when molecular weights are <1000 and the molecule turns to waxy solids with increasing molecular weights. The most common preparations of PEGs include PEG 3350 and PEG 400. PEGs have various applications in many fields, ranging from medical to industrial areas. PEGs have a long history of gastroenterology: PEG 3350 is a common over-the-counter osmotic laxative used to relieve occasional constipation. PEG 3350 is also used for cleansing of the colon in preparation for colonoscopy in adults. The rationale of using PEG in gastroenterology is due to the physical properties of the compound: its potent water-binding capacity, negligible intestinal absorption with increasing molecular mass, lack of significant toxicity, and limited intestinal enzymatic degradation or bacterial metabolism all make PEG a useful therapeutic agent for the treatment of occasional constipation and bowel cleansing for preparation in colonoscopy.
Indication
Polyethylene glycol is indicated for use as an over-the-counter osmotic laxative to relieve occasional constipation. When used in combination with sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride, it is used for cleansing of the colon in preparation for colonoscopy in adults.
Associated Conditions
- Chronic Constipation
- Constipation
- Dry Eye Syndrome (DES)
- Dry Eyes
- Occasional Constipation
Research Report
Polyethylene Glycol (DB09287): A Comprehensive Monograph on its Pharmacological, Clinical, and Industrial Profile
Section 1: Introduction and Chemical Profile
1.1. Overview
Polyethylene glycol (PEG) is a synthetic, hydrophilic polyether compound derived from petroleum, recognized for its remarkable versatility and widespread use across numerous sectors.[1] It holds a unique dual identity, functioning both as a ubiquitous industrial polymer and as a crucial small molecule medication in clinical practice.[1] In the medical domain, PEG is most prominently known for its application as an osmotic laxative for the management of constipation and as a high-volume bowel cleansing agent essential for preparing the gastrointestinal tract for endoscopic and radiological procedures.[2] Beyond these primary uses, the inherent properties of the PEG polymer have led to its integration into a vast array of products and technologies, including cosmetics, food manufacturing, and advanced pharmaceutical drug delivery systems, most notably through the process of PEGylation.[1] This report provides a comprehensive monograph on polyethylene glycol, synthesizing information on its chemical nature, pharmacology, clinical applications, safety profile, and broader industrial uses.
1.2. Chemical Identity and Nomenclature
The fundamental structure of polyethylene glycol is that of a polymer composed of repeating ethylene glycol monomer units linked by ether bonds.[2] This structure is generally represented by the chemical formula
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/24 | Not Applicable | Not yet recruiting | General Hospital of Shenyang Military Region | ||
2025/05/29 | Not Applicable | Completed | |||
2025/02/20 | Phase 2 | Not yet recruiting | |||
2025/02/13 | Phase 4 | Recruiting | St. Joseph's Health, New York | ||
2025/02/11 | N/A | Recruiting | Colorado Ophthalmology Associates PC | ||
2025/01/15 | Not Applicable | ENROLLING_BY_INVITATION | Beijing Ditan Hospital | ||
2024/12/11 | Not Applicable | Not yet recruiting | |||
2024/05/01 | Phase 1 | Recruiting | |||
2024/04/15 | Not Applicable | Recruiting | |||
2023/12/07 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Kesin Pharma Corporation | 81033-762 | ORAL | 17 g in 17 g | 6/9/2025 | |
| Lupin Pharmaceuticals,Inc. | 43386-090 | ORAL | 236 g in 274.31 g | 12/20/2016 | |
| Nexgen Pharma, Inc. | 0722-6921 | ORAL | 17 g in 1 1 | 8/10/2011 | |
| Novel Laboratories, Inc. | 40032-090 | ORAL | 236 g in 274.31 g | 2/8/2023 | |
| Physicians Total Care, Inc. | 54868-5160 | ORAL | 1 g in 1 g | 5/1/2012 | |
| Strides Pharma Science Limited | 64380-769 | ORAL | 420 g in 4 L | 11/9/2022 | |
| Lupin Pharmaceuticals,Inc. | 43386-060 | ORAL | 240 g in 278.26 g | 11/16/2017 | |
| Physicians Total Care, Inc. | 54868-4233 | ORAL | 210 g in 2 L | 5/11/2011 | |
| Novel Laboratories, Inc. | 40032-060 | ORAL | 240 g in 278.26 g | 11/18/2009 | |
| Strides Pharma Science Limited | 64380-766 | ORAL | 236 g in 4 L | 11/9/2022 |
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 |
|---|---|---|---|---|---|
| FORLAX POWDER FOR ORAL SOLUTION 10 g/sachet | SIN12419P | POWDER, FOR SOLUTION | 10 g/sachet | 9/8/2003 | |
| FORTRANS FOR ORAL SOLUTION | SIN09234P | GRANULE, FOR SOLUTION | 64 g | 3/3/1997 |
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 |
|---|---|---|---|---|---|
| SYSTANE ULTRA LUBRICANT EYE DROPS PRESERVATIVE FREE | N/A | alcon hong kong ltd | N/A | N/A | 5/21/2012 |
| ISOCOLAN POWDER FOR ORAL SOLUTION | N/A | N/A | N/A | 8/19/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MOVICOL JUNIOR CHOCOLATE FLAVOUR powder for oral solution sachet | 207698 | Medicine | A | 4/3/2013 | |
| MACROVIC FLAVOURED JUNIOR powder for oral solution sachet | 220580 | Medicine | A | 2/27/2014 | |
| MACROVIC JUNIOR powder for oral solution sachet | 220582 | Medicine | A | 2/27/2014 | |
| MOVICOL FLAVOUR FREE powder for oral solution sachet | 181834 | Medicine | A | 4/4/2011 | |
| LAX-SACHETS HALF powder for oral solution sachet | 202203 | Medicine | A | 10/24/2012 | |
| Laxitol | 182402 | Medicine | A | 4/21/2011 | |
| OSMOLAX macrogol 3350 1g/g powder for oral solution jar | 203142 | Medicine | A | 11/21/2012 | |
| APOHEALTH CONSTIPATION RELIEF WITH ELECTROLYTES powder for oral solution sachet | 485587 | Medicine | A | 4/9/2025 | |
| MOVIPREP ORANGE powder for oral solution sachet | 206448 | Medicine | A | 2/27/2013 | |
| CLEARGOL LEMON FLAVOUR powder for oral solution sachet | 220588 | Medicine | A | 2/27/2014 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OCL SOLUTION | ABBOTT LABORATORIES, LIMITED | 00709298 | Solution - Oral | 60 MG / ML | 12/31/1988 |
| BI-PEGLYTE | pendopharm division of pharmascience inc | 02326302 | Tablet (Delayed-Release)
,
Powder For Solution
,
Kit - Oral | 59.55 G / SACHET | 6/6/2010 |
| COLAXOR | mantra pharma inc | 02450070 | Powder For Solution - Oral | 100 % / W/W | 3/13/2017 |
| PEGLYTE POWDER | pendopharm division of pharmascience inc | 00777838 | Powder For Solution - Oral | 238.18 G / BOTTLE | 12/31/1988 |
| SALINOL SOL 160MG | laboratoires charton laboratories | 00779288 | Spray - Nasal | 160 MG / ML | 12/31/1989 |
| RESTORALAX | Bayer Inc | 02318164 | Powder For Solution - Oral | 100 % / W/W | 10/16/2009 |
| PEG 3350 | angita pharma inc. | 02520796 | Powder For Solution - Oral | 100 % / W/W | 1/30/2023 |
| LAXATIVE | 02548933 | Powder For Solution - Oral | 100 % / W/W | N/A | |
| LAX-RELIEF | 02463970 | Powder For Solution - Oral | 100 % | N/A | |
| EMOLAX | 02374137 | Powder For Solution - Oral | 100 % / W/W | 10/4/2015 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| CASENLAX 4 g POLVO PARA SOLUCION ORAL EN SOBRES | Casen Recordati S.L. | 75277 | POLVO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| MOVICOL SABOR NARANJA CONCENTRADO PARA SOLUCION ORAL | Norgine Healthcare B.V. | 74839 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ATOLAXANT 13,7 G POLVO PARA SOLUCION ORAL | Sandoz Farmaceutica S.A. | 78180 | POLVO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| MOVICOL POLVO PARA SOLUCION ORAL EN SOBRE | Norgine Healthcare B.V. | 61494 | POLVO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| MOVICOL PEDIATRICO SABOR NEUTRO 6,9 G SOBRE POLVO PARA SOLUCION ORAL | Norgine Pharmaceuticals Limited | PL20011-0005IP | POLVO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| MOVICOL 13,8 G POLVO PARA SOLUCION ORAL EN SOBRE | Norgine Pharma | 3400934001024 | POLVO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| MOVIPREP POLVO PARA SOLUCION ORAL | 68125 | POLVO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| MOVICOL PEDIATRICO SABOR NEUTRO 6,9 g POLVO PARA SOLUCION ORAL EN SOBRE | Norgine Healthcare B.V. | 67853 | POLVO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| OMNILAX 4 G POLVO PARA SOLUCION ORAL EN SOBRE | Pro Health Pharma Sweden Ab | 85008 | POLVO PARA SOLUCION ORAL EN SOBRE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| Movicol 13,8g sobres polvo para solucion oral | Norgine Pharma | 340 010-2IP | POLVO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
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. | |||||
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