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GoLYTELY

(polyethylene glycol)

ApprovedSmall molecule

Polyethylene glycol is used to treat constipation by drawing water into the intestines to soften stool and make bowel movements easier. It's also used to cleanse the colon before medical procedures like colonoscopies.[2] GoLYTELY is currently approved and in use across 26 indications[4].[1]

GoLYTELY is one of 492 small molecule programs targeting Type 2 Diabetes Mellitus. It is currently in Approved.

26

Indications

51

Total Trials

4

Active Trials

491

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Type 2 Diabetes MellitusActive, not recruiting

Inflammatory Bowel DiseaseActive, not recruiting

Anemia (phenotype)Approved

HIV InfectionApproved

Gastrointestinal HemorrhageApproved

Klebsiella InfectionsApproved

Peripheral Nerve InjuryApproved

RadiodermatitisApproved

Hepatocellular CarcinomaApproved

Cystic FibrosisApproved

Type 2 Diabetes MellitusPreclinical

Active, not recruiting

Inflammatory Bowel DiseasePreclinical

Active, not recruiting

Anemia (phenotype)Approved

Approved

HIV InfectionApproved

Approved

Gastrointestinal HemorrhageApproved

Approved

Klebsiella InfectionsApproved

Approved

Peripheral Nerve InjuryApproved

Approved

RadiodermatitisApproved

Approved

Hepatocellular CarcinomaApproved

Approved

Cystic FibrosisApproved

Approved

Showing 10 of 25 indications

Competition

Competitive Landscape

265 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

GoLYTELY

Ibrance

Cysteine Hydrochloride

Hepsera

Doptelet

Miraclid

TTechpool Bio-Pharma Co., Ltd.

Vermox

Valemetostat

Bristol-Myers Squibb

Alcohol

Anti-PD-1 Monoclonal Antibody

IiTeos Therapeutics

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Slow Transit Constipation

NCT07277907

Q3 2028

Phase 1Recruiting

Function

NCT02359825

Q4 2028

PreclinicalRecruiting

Metastatic Sarcoma

NCT04199026

Clinical

Trials by Indication[1]

Bowel Preparation11 trials

Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation

Unknown status·FFirst People's Hospital of Hangzhou·N/A·NCT04794049·800 enrolled

Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy

Completed·—·N/A·NCT01533090·162 enrolled

Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model

Completed·SShandong University·N/A·NCT03142854·429 enrolled

Show 8 more trials

A Predictive Model for Inadequate Bowel Preparation

Completed·SShandong University·N/A·NCT03704571·429 enrolled

The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors

Completed·—·N/A·NCT04434625·900 enrolled

Mechanical Bowel Preparation for Elective Colorectal Anastomosis

Completed·IInstituto Mexicano del Seguro Social·Phase 3·NCT02731963·81 enrolled

The Best Dosage and Timing of Polyethylene Glycol for Bowel Preparation Before Capsule Endoscopy

Completed·ZZhizheng Ge·Phase 4·NCT02486536·410 enrolled

Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

Completed·RRegion Skane·Phase 3·NCT05726097·147 enrolled

Patient Tolerability and Efficacy of Bowel Preparation With Split Dose Picosalax vs. Split Dose PEG

Terminated·QQueen's University·Phase 4·NCT02070341·5 enrolled

Renal Safety of Bowel Preparation With Polyethylene Glycol

Completed·—·N/A·NCT02657564·1,237 enrolled

Impact of a Predictive Score of Bowel Preparation Quality in Clinical Practice

Completed·HHospital Universitario de Canarias·Phase 4·NCT03830489·260 enrolled

Colonoscopy10 trials

PEG Versus PEG+Bisacodyl Versus Sennosides for Colon Cleansing Before Colonoscopy

Completed·MMedical University of Warsaw·Phase 4·NCT01531140·240 enrolled

Evaluation of One-day Polyethylene Glycol Powder Solution for Colonoscopy in Children

Completed·—··NCT01626040·178 enrolled

HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy

Withdrawn·HHyGIeaCare, Inc.·N/A·NCT02893748

Show 7 more trials

Efficacy, Safety and Tolerability of Split-dose of PEG Compared With NaP Solution for Colonoscopy Preparation: A Randomized, Controlled Trial

Completed·IInje University·Phase 3·NCT01229800·207 enrolled

Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy

Completed·—·Phase 4·NCT02507037·300 enrolled

Randomized Controlled Trail of Polyethylene Glycol vs Sodium Phosphate for Colonic Cleansing of Colonoscopy

Completed·DDong Yang·Phase 4·NCT03817788·586 enrolled

Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy

Terminated·SSheba Medical Center·N/A·NCT00558376·23 enrolled

Single Dose Versus Split Dose Polyethylene Glycol-based Colonic Lavage for Colonoscopy

Completed·UUniversity of Calgary·N/A·NCT01610856·250 enrolled

Preparation Prior to Colonoscopy in Children

Completed·SSkane University Hospital·N/A·NCT02009202·71 enrolled

Evaluation of the Efficacy, Tolerability, and Safety of Two Colonoscopy Preparation Regimens in Children With Inflammatory Bowel Disease: a Randomized Study.

Completed·MMedical University of Warsaw·Preclinical·NCT07786363·125 enrolled

Constipation3 trials

Safety and Tolerability of Oral Polyethylene Glycol (PEG 3350) Solution in Participants With Constipation (MK-8114-003)

Completed· Bayer logo

Bayer·Phase 2·NCT01885104·65 enrolled

Comparative Study on the Efficacy of Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation

Unknown status·—·N/A·NCT06364111·45 enrolled

The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit

Withdrawn·MMassachusetts General Hospital·Phase 3·NCT02705378

Bowel Preparation for Colonoscopy2 trials

Second Bowel Preparation for Colonoscopy Failure

Terminated·—·Phase 4·NCT01510977·150 enrolled

Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy

Enrolling by invitation·HHaifeng Lan·Phase 4·NCT06748638·444 enrolled

Colorectal Surgery2 trials

Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery

Unknown status·TThomas Jefferson University·Phase 1·NCT03042091·224 enrolled

Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery

Unknown status·PPVS Memorial Hospital··NCT01797770·90 enrolled

21 more indications

Endoscopy2 trials

Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy

Unknown status·—·Phase 4·NCT02396017·50 enrolled

Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination

Completed·QQueen's University·Phase 4·NCT00677794·198 enrolled

Efficacy and Safety2 trials

Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing

Completed·LLaboratoires Mayoly Spindler·Phase 3·NCT01840553·461 enrolled

Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy

Unknown status·RRabin Medical Center·N/A·NCT01093274·200 enrolled

Anal fissure1 trial

Pediatrics Anal Fissures Treatment With Polyethylene Glycol

Unknown status·KKing Saud University·Phase 4·NCT02419534·46 enrolled

Colorectal1 trial

Efficacy of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colorectal Resection

Completed·OOspedale Santa Maria delle Croci·Phase 4·NCT01887158·116 enrolled

Pneumonia1 trial

Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia

Unknown status·HHadassah Medical Organization·Phase 1/2·NCT00722410·60 enrolled

Effectiveness1 trial

Effectiveness of Fixed PC Interval Using SMS for Afternoon Colonoscopy

Completed·IInje University·N/A·NCT01675739·280 enrolled

Hospitalized Patients1 trial

Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients

Unknown status·CCorporacion Parc Tauli·Phase 4·NCT01853709·162 enrolled

Efficacy1 trial

Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose

Completed·IIncheon St.Mary's Hospital·Phase 3·NCT03315949·352 enrolled

Preoperative1 trial

Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy

Completed·NNorthwell Health·Phase 4·NCT04197869·71 enrolled

Function1 trial

Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function

Recruiting·VVanderbilt University Medical Center·Phase 1·NCT02359825·18 enrolled

Acceptability1 trial

Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements.

Completed· Bayer logo

Bayer·Phase 4·NCT04534465·50 enrolled

Chronic constipation1 trial

Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT02228616·280 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing

Completed·BBausch Health Americas, Inc.·Phase 4·NCT01427296·2,154 enrolled

Prospective1 trial

A Randomized Prospective Trial Comparing Polyethylene Glycol and Sodium Picosulphate With Magnesium Citrate

Completed·KKorea University Anam Hospital·Phase 3·NCT01778192·200 enrolled

Lactulose1 trial

Efficacy of Polyethylene Glycol vs Lactulose With Isabgol in Acute Fissure-in-Ano: PEGASIS Trial

Completed·—·Phase 2/3·NCT05341180·144 enrolled

Ascorbic Acid1 trial

Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC Patients

Completed·KKyungpook National University Hospital·N/A·NCT01929668·114 enrolled

Contrast Agent1 trial

Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography

Unknown status·SShandong University·N/A·NCT03495804·60 enrolled

Encephalopathy1 trial

PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy

Unknown status·SSherief Abd-Elsalam·Phase 4·NCT03100513·100 enrolled

Metastatic Sarcoma1 trial

Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT04199026·20 enrolled

Slow Transit Constipation1 trial

Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation: A Multicenter, Randomized Controlled Trial

Recruiting·TThird Military Medical University·Phase 3·NCT07277907·346 enrolled

Unspecified1 trial

Effect of PEG, Bisacodyl and Prucalopride on Colonic Motility in Healthy Subjects

Completed·UUniversity Hospital, Gasthuisberg·Phase 4·NCT03279341·10 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 6, 2006

MIRALAX

NDA NDA022015

Sources

References

[1]
ClinicalTrials.gov — 51 trial records for polyethylene glycol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — GoLYTELY drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — polyethylene glycol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for polyethylene glycol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022015). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bayer

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