Drugs / Polyethylene Glycol 3350
last change Aug 2026 re-read 3 minutes ago

Polyethylene Glycol 3350

Other / unclassified

Developed for
constipation disorder · colorectal carcinoma · intestinal disorder · liver disorder · nervous system injury · adenoma · colonic disorder · cystic fibrosis
+8 more · hepatic encephalopathy · intestinal impaction · peripheral nerve lesion · BD syndrome · enuresis · nocturnal enuresis · opioid-induced constipation · outlet dysfunction constipation
Investigated by
Norgine · Braintree Laboratories · Bayer · Gastroenterology Services, Ltd. · Agency for Healthcare Research and Quality (AHRQ) · Alfasigma S.p.A.
+43 more · Bausch Health Americas, Inc. · Chad R. Tracy · Dark Canyon Laboratories, LLC · Faculty of Medicine, University of Indonesia · Fundación Canaria Rafael Clavijo para la Investigación Biomédica · Hanyang University · Hospital de Clínicas Dr. Manuel Quintela · Indiana University · Istituto Clinico Humanitas · Jennifer Afton Cooper MD · Kangbuk Samsung Hospital · Katherine Smith MD · Kyunghee University Medical Center · Kyungpook National University Hospital · Maastricht University Medical Center · Michael Sprague MD · National Cancer Institute (NCI) · National Institute of Medical Sciences and Nutrition Salvador Zubiran · Neuraptive Therapeutics Inc. · Northwell Health · Nova Scotia Health Authority · Novartis · Oregon Health and Science University · Ottawa Hospital Research Institute · PT Meiji Indonesia · Pamela Frazzini-Padilla MD · Pierrel Research Europe GmbH · Post Graduate Institute of Medical Education and Research, Chandigarh · Sebela Pharmaceuticals Development LLC · Southern California Institute for Research and Education · St. Louis University · The Cleveland Clinic · Thomas Jefferson University · University Hospitals Cleveland Medical Center · University of Bologna · University of British Columbia · University of California, Irvine · University of Chicago · University of North Carolina, Chapel Hill · University of Rochester · Vanderbilt University Medical Center · Walter Reed National Military Medical Center · WellSpan Health

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) MIRALAX — 2009-03-13 fda.gov ↗
Approved US (FDA) GOLYTELY — 1984-07-13 fda.gov ↗

Trials 57

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07700277 Aug 2026 → Aug 2027 expected intestinal disorder Ottawa Hospital Research Institute Not yet recruiting No outcome recorded
Phase 13 trials
Phase 1 NCT03236064 May 2016 → May 2024 nervous system injury WellSpan Health Unknown No outcome recorded
Phase 1 NCT01834742 Apr → Sep 2011 colorectal cancer Norgine Completed No outcome recorded
Phase 1 NCT00868985 Jan → Aug 2008 constipation disorder Norgine Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04270019 Jun 2020 → Sep 2023 nervous system injury, peripheral nerve lesion Nova Scotia Health Authority Withdrawn No outcome recorded
Phase 26 trials · 1 met primary · 2 missed
Phase 2 NCT03332485 Nov 2017 → Mar 2018 — Sebela Pharmaceuticals Development LLC Completed No outcome recorded
Phase 2 NCT02910440 Jan → Nov 2017 — Dark Canyon Laboratories, LLC Completed No outcome recorded
Phase 2 NCT01714466 Oct 2012 → Jul 2013 colon carcinoma Norgine Completed Met primary
Phase 2 NCT01212445 Oct 2010 → Nov 2011 constipation disorder Bayer Completed Missed primary
Phase 2 NCT00828984 Oct 2009 → Oct 2014 adenoma, colorectal carcinoma National Cancer Institute (NCI) Completed Missed primary
Phase 2 NCT00403858 Oct 2000 → Apr 2002 intestinal impaction Norgine Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT05897086 Aug 2023 → Dec 2028 expected — Vanderbilt University Medical Center Enrolling by invitation No outcome recorded
Phase 313 trials · 1 met primary · 2 missed
Phase 3 NCT03957668 Dec 2019 → Sep 2020 constipation disorder Faculty of Medicine, University of Indonesia Unknown No outcome recorded
Phase 3 NCT03106922 Apr 2016 → Jul 2020 — Alfasigma S.p.A. Unknown No outcome recorded
Phase 3 NCT02292459 Dec 2015 constipation disorder Bayer Withdrawn No outcome recorded
Phase 3 NCT02540031 Sep 2015 → Apr 2018 — Kyungpook National University Hospital Completed No outcome recorded
Phase 3 NCT02273141 Nov 2014 → Aug 2015 colorectal carcinoma Norgine Completed Missed primary
Phase 3 NCT02273167 Oct 2014 → Aug 2015 colorectal carcinoma Norgine Completed Mixed
Phase 3 NCT02254486 Sep 2014 → Jun 2015 colon carcinoma Norgine Completed Missed primary
Phase 3 NCT01929590 Oct 2011 → Jun 2012 — National Institute of Medical Sciences and Nutrition Salvador Zubiran Completed No outcome recorded
Phase 3 NCT01251822 Nov 2010 → Sep 2011 constipation disorder Norgine Completed Met primary
Phase 3 NCT00503607 Jul → Nov 2007 — Braintree Laboratories Completed No outcome recorded
Phase 425 trials · 3 met primary · 2 missed
Phase 4 NCT06159777 Jun 2024 → Mar 2026 constipation disorder, pelvic organ prolapse University Hospitals Cleveland Medical Center Completed No outcome recorded
Phase 4 NCT05821309 Jun 2023 → Jul 2026 overdue constipation disorder Indiana University Recruiting No outcome recorded
Phase 4 NCT05805436 Jun 2023 → Mar 2026 overdue constipation disorder, kidney cancer, prostate cancer Chad R. Tracy Recruiting No outcome recorded
Phase 4 NCT04708366 Feb 2021 → Mar 2022 colonic disorder University of Bologna Unknown No outcome recorded
Phase 4 NCT04585542 Oct 2020 → Jan 2025 — University of California, Irvine Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT04210427 Dec 2019 → Jun 2023 cystic fibrosis St. Louis University Completed No outcome recorded
Phase 4 NCT04197869 Dec 2019 → Jun 2023 constipation disorder Northwell Health Completed Missed primary
Phase 4 NCT04263896 Aug 2019 → Jun 2024 constipation disorder University of Chicago Completed No outcome recorded
Phase 4 NCT03800745 Nov 2018 → May 2020 — The Cleveland Clinic Completed No outcome recorded
Phase 4 NCT03742232 Oct 2018 → Mar 2020 colon adenoma, polyp of colon Istituto Clinico Humanitas Completed Met primary
Phase not applicable7 trials · 1 missed
— NCT05726344 Feb → Dec 2023 — Hospital de Clínicas Dr. Manuel Quintela Completed No outcome recorded
— NCT01717456 Jan 2013 → Mar 2015 — University of North Carolina, Chapel Hill Terminated Missed primary Stop: Enrollment
— NCT01452737 Nov 2011 → May 2012 — University of British Columbia Withdrawn No outcome recorded
— NCT01518790 Sep 2010 → Aug 2011 — Walter Reed National Military Medical Center Completed No outcome recorded
— NCT01299779 Jun 2010 → May 2012 — Thomas Jefferson University Completed No outcome recorded
— NCT01044212 Nov 2009 → Feb 2011 intestinal disorder University of Rochester Completed No outcome recorded
— NCT01028573 Nov 2009 → Jul 2012 — Southern California Institute for Research and Education Unknown No outcome recorded
Comparator or background therapy42 trials
Phase 0 NCT07604025 Comparator Jul 2026 → Jul 2027 expected constipation disorder Shaare Zedek Medical Center Not yet recruiting No outcome recorded
Phase 0 NCT00765557 Comparator Dec 2007 → Jun 2014 constipation disorder University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 1 NCT06393400 Background Jan 2025 → Feb 2028 expected pancreatic ductal adenocarcinoma John Lenehan Recruiting No outcome recorded
Phase 1/2 NCT02272868 Background Jan 2015 → Oct 2016 Crohn disease Seattle Children's Hospital Terminated No outcome recorded
Phase 2 NCT06503978 Background Aug 2024 → Jul 2025 overdue autism spectrum disorder, constipation disorder, diarrheal disease Gut-Brain-Axis Therapeutics Inc. Active not recruiting No outcome recorded

Press releases naming this drug 13 releases

DateIssuerRelease
2025-03-10 Glenmark Pharmaceuticals Ltd. India Glenmark Therapeutics Inc., USA launches Polyethylene Glycol 3350, Powder for Solution, 17 grams/capful (OTC) glenmarkpharma.com ↗
2022-05-20 Eisai Inc. “MOVICOL® HD” Launched A New Dosage Form Added to Polyethylene Glycol Chronic Constipation Treatment for the First Time in Japan eisai.com ↗
2018-11-29 Eisai Inc. MOVICOL® Launched in Japan The First Polyethylene Glycol Preparation for Chronic Constipation in Japan eisai.com ↗
2018-10-22 Norgine PLENVU® (NER1006) the first 1 litre bowel preparation to show superior high-quality segmental cleansing of the colon compared to standard of care norgine.com ↗
2018-07-24 Norgine Endoscopy publishes the DAYB phase III trial for PLENVU® (NER1006), the first ONE LITRE PEG bowel preparation norgine.com ↗
2018-07-19 Norgine Endoscopy publishes the MORA phase III trial for PLENVU® (NER1006), the only 1 LITRE PEG based bowel preparation[i] norgine.com ↗
2018-06-05 Norgine Norgine and its partner Salix present new data from PLENVU® (NER1006) phase 3 studies at Digestive Disease Week (DDW) 2018 norgine.com ↗
2018-05-07 Norgine Norgine announces US FDA approval for PLENVU® (NER1006) – 1 LITRE PEG based bowel cleansing preparation for colonoscopy norgine.com ↗
2018-02-22 Norgine Positive new data show superiority of PLENVU® (1 LITRE PEG preparation) compared to MOVIPREP® (2 LITRE PEG + ASCORBATE) norgine.com ↗
2018-02-08 Norgine Norgine’s PLENVU® (NER1006) receives approval in Germany for bowel cleansing in adults prior to any procedure requiring a clean bowel norgine.com ↗
2018-01-15 Norgine Norgine’s PLENVU® (NER1006) receives Austrian, Australian, French, Irish, Italian and Portuguese approvals for bowel cleansing in adults prior to any procedure requiring a clean bowel norgine.com ↗
2009-10-06 Perrigo Company Perrigo Announces FDA Final Approval for Polyethylene Glycol 3350 perrigo.com ↗

Evidence & citations 27 cited values

Every value below carries the sentence it was read from. 106 sources stand behind the page.

FieldValueCited text
Known as polyethylene glycol 3350 “This multicenter, double-blind, placebo-controlled, parallel-group trial included adults with chronic idiopathic constipation randomized to polyethylene glycol 3350 17 g...” PMID 36120087 ↗ Sep 2022
43

“OBJECTIVES: The aim of this study was to compare the clinical efficacy and tolerance of polyethylene glycol 3350 (PEG) and lactulose for the treatment of functional...” PMID 30383579 ↗ Mar 2019

“This randomized phase II trial studies how well macrogol 3350-based oral osmotic laxative (polyethylene glycol 3350) works in preventing cancer in patients at risk of colorectal cancer.” NCT00828984 ↗

“To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.” NCT00319670 ↗

“Two common treatments are polyethylene glycol 3350 (PEG), an osmotic laxative, and Senna, a plant-based stimulant laxative.” NCT07604025 ↗

“Polyethylene Glycol 3350 17g should be mixed in 8 ounces of fluid for administration.” NCT04197869 ↗

“Patients will receive the Protocol with Polyethylene Glycol 3350.” NCT03148002 ↗

“PEG 3350 (polyethylene glycol 3350)” NCT03957668 ↗

NCT00856843 ↗

NCT05805436 ↗

NCT00153153 ↗

Show 33 more sources

Known as BAY81-8430 “PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)” NCT01212445 ↗
Known as Golytely “1. Split dose 4 liter polyethylene glycol with electrolytes (PEG+E): Brand name GoLytely” NCT02124447 ↗
17

“Subjects will be asked to take 4L of Golytely the day prior to procedure.” NCT01452737 ↗

“Polyethylene glycol 3350 - electrolyte solution (GoLYTELY)” NCT07605897 ↗

“Golytely (polyethylene glycol)” NCT00953017 ↗

“Drug: Go Lytely” NCT01169220 ↗

“Drug: Golytely” NCT07215000 ↗

NCT00953017 ↗

NCT01533688 ↗

NCT03298945 ↗

NCT07215000 ↗

NCT02910440 ↗

Show 7 more sources

Known as Golytely Oral Product “Drug: Golytely Oral Product” NCT04504292 ↗
Known as LVPEG-4 “Named NER1006, LVPEG-4 demonstrated clinical proof of concept and warrants further investigation.” PMID 31146679 ↗ May 2019
Known as Macrogol “Randomised clinical trial: macrogol/PEG 3350+electrolytes versus prucalopride in” PMID 23480216 ↗ Mar 2013
1

“PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)” NCT01212445 ↗

Known as Macrogol 3350 “macrogol 3350 59.000 g, anhydrous sodium sulphate 5.685 g, sodium bicarbonate 1.685 g, sodium chloride 1.465 g, potassium chloride 0.7425 g.” NCT03106922 ↗
3

“One sachet consists of 13,125 gr Macrogol 3350, 178,5 mg Sodium bicarbonate, 350,7 mg Sodium chloride and 46,6 mg Potassium chloride.” NCT01429779 ↗

NCT02073552 ↗

NCT00828984 ↗

Known as Macrogol 3350 and electrolytes ClinicalTrials.gov intervention name — accepted as the source's own label NCT06455813 ↗
Known as MiraLax “Polyethylene glycol (PEG) 3350 (MiraLax) and tegaserod (Zelnorm), a serotonin subtype 4 receptor partial agonist, are currently approved for treatment of constipation.” PMID 17573794 ↗ Jun 2007
17

“Patients will be randomized to either receive or not receive three days of polyethylene glycol (PEG, also known as MiraLAX) on the three days before surgery.” NCT05805436 ↗

“All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily for total of 2 weeks.” NCT04210427 ↗

“Miralax at a dose of one packet (17 grams) daily may be used for constipation if unresponsive to fiber.” NCT01717456 ↗

“238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy” NCT01028573 ↗

“MiraLax (polyethylene glycol 3350)” NCT00889655 ↗

“Miralax 1 packet daily” NCT01044212 ↗

“Miralax (PEG 3350)” NCT00953017 ↗

NCT00765557 ↗

NCT02272868 ↗

NCT04182633 ↗

Show 7 more sources

Known as Miralax (polyethylene glycol) “Miralax (polyethylene glycol)” NCT01717456 ↗
Known as Movicol “The use of Macrogol (Movicol®) as laxative during one week prior to partial liver resection will further enhance early return of gastro-intestinal function and accelerate...” NCT01429779 ↗
2

“PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)” NCT01212445 ↗

“Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)” NCT00403858 ↗

Known as MoviPrep “MoviPrep® (PEG 3350)” NCT02402270 ↗
Known as NER1006 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04708366 ↗
5

NCT02254486 ↗

NCT02273141 ↗

NCT02273167 ↗

NCT01834742 ↗

NCT01714466 ↗

Known as NuLYTELY “NuLYTELY® (PEG 3350)” NCT02402270 ↗
Known as PEG “Safety of polyethylene glycol (PEG) formulations has been validated in several studies, it presents little severe side effects and the advantage of its applicability to...” NCT05726344 ↗
6

“Polyethylene glycol (PEG) is a hydrophilic compound that enhances the fusion of the lipid bilayer membrane of severed axons, restoring the nerve's immediate ability to conduct...” NCT05897086 ↗

“Patients will be randomized to either receive or not receive three days of polyethylene glycol (PEG, also known as MiraLAX) on the three days before surgery.” NCT05805436 ↗

“All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily for total of 2 weeks.” NCT04210427 ↗

“Polyethylene glycol (PEG) 3350 electrolyte solution can ensure rapid gut catharsis, which may resolve HE more effectively than lactulose.” PMID 33060437 ↗ Jan 2022

“Comparison of Braintree PolyethyleneGlycol(PEG) Laxative and Placebo for Relief of Constipation From Constipating Medications” NCT00153127 ↗

“Polyethylene glycol 3350 (PEG) will be used within it's FDA indication and dosing for constipation.” NCT06159777 ↗

Known as PEG + E “OBJECTIVES: To assess the efficacy of polyethylene glycol 3350 plus electrolytes (PEG + E; Movicol) as oral monotherapy in the treatment of faecal impaction in children, and to...” PMID 16819379 ↗ Jul 2006
1

NCT02124447 ↗

Known as PEG 3350 “Polyethylene glycol (PEG) 3350 (MiraLax) and tegaserod (Zelnorm), a serotonin subtype 4 receptor partial agonist, are currently approved for treatment of constipation.” PMID 17573794 ↗ Jun 2007
28

“Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g” NCT02540031 ↗

“Eligible subjects ≥ 17 years of age were randomized to receive either placebo or PEG 3350 17 g once daily in this multicenter, double-blind trial.” PMID 27158544 ↗ May 2016

“Polyethylene glycol (PEG) 3350 electrolyte solution can ensure rapid gut catharsis, which may resolve HE more effectively than lactulose.” PMID 33060437 ↗ Jan 2022

“238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy” NCT01028573 ↗

“This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.” NCT03236064 ↗

“Subjects will be asked to take 4L of PEG-3350 solution the day prior to procedure.” NCT02290093 ↗

“a laxative, polyethylene glycol 3350 (PEG-3350) taken with 4 liters of water.” NCT07605897 ↗

“Polyethylene Glycol 3350 Powder for Solution (PEG 3350)” NCT02292459 ↗

“with PEG-3350 119 gram bottle (labeled #1)” NCT01299779 ↗

“ECP (PEG 3350) Colon Prep Kit” NCT03332485 ↗

Show 18 more sources

Known as PEG 3350 with electrolytes “split-dose (PEG) 3350 with electrolytes (GoLytely; Braintree Laboratories, Inc, Braintree, MA)” PMID 21115134 ↗ Nov 2010
Known as PEG 3350+E “Randomised clinical trial: macrogol/PEG 3350+electrolytes versus prucalopride in” PMID 23480216 ↗ Mar 2013
Known as PEG-ELS-(GoLytely) “4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy” NCT01533688 ↗
Known as PGE + E “Treatment of faecal impaction with polyethelene glycol plus electrolytes (PGE + E) followed by a double-blind comparison of PEG + E versus lactulose as maintenance therapy.” PMID 16819379 ↗ Jul 2006
Known as Polyethylene glycol “Patients will be randomized to either receive or not receive three days of polyethylene glycol (PEG, also known as MiraLAX) on the three days before surgery.” NCT05805436 ↗
3

“Polyethylene glycol (PEG) 3350 electrolyte solution can ensure rapid gut catharsis, which may resolve HE more effectively than lactulose.” PMID 33060437 ↗ Jan 2022

“Comparison of Braintree PolyethyleneGlycol(PEG) Laxative and Placebo for Relief of Constipation From Constipating Medications” NCT00153127 ↗

“Golytely (polyethylene glycol)” NCT00953017 ↗

Known as Polyethylene Glycol (PEG) “subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E)” NCT01212445 ↗
Known as polyethylene glycol (PEG) 3350 “This study is to compare the efficacy and safety of polyethylene glycol (PEG) 3350 with that of prucalopride in the treatment of chronic constipation in females.” NCT01251822 ↗
Known as polyethylene glycol electrolyte lavage solution “Golytely (polyethylene glycol electrolyte lavage solution) and placebo” NCT01533688 ↗