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Polyethylene glycol

Generic Name
Polyethylene glycol
Brand Names
Bi-peglyte, Clearlax, Colyte, Gavilax, Gavilyte-C, Gavilyte-G, Gavilyte-H and Bisacodyl, Gavilyte-N, Gentlelax, Gialax, Glycolax, Golytely, Healthylax, Miralax, Moviprep, Nulytely, Peglyte, Pegylax, Plenvu, Purelax, Suflave
Drug Type
Small Molecule
CAS Number
25322-68-3
Unique Ingredient Identifier
3WJQ0SDW1A

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

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
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
2023/06/09
Phase 2
ENROLLING_BY_INVITATION

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
Polyethylene Glycol Eye Drops
国药准字HJ20160105
化学药品
眼用制剂
12/3/2020
Macrogol 4000 Powder
国药准字H20253498
化学药品
散剂
3/4/2025
Macrogol 4000 Powder
国药准字H20253647
化学药品
散剂
3/18/2025
Macrogol 4000 Powder
国药准字H20253591
化学药品
散剂
3/11/2025
Macrogol 4000 Powder
国药准字H20244574
化学药品
散剂
7/30/2024
Macrogol 4000 Powder
国药准字H20223308
化学药品
散剂
5/10/2022
Macrogol 4000 Powder
国药准字HJ20171247
化学药品
散剂
8/31/2022
Macrogol 4000 Powder
国药准字H20243040
化学药品
散剂
1/9/2024
Macrogol 4000 Powder
国药准字H20050809
化学药品
散剂
4/7/2020
Macrogol 4000 Powder
国药准字H20080092
化学药品
散剂
9/9/2022

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

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