TheraRadar
Data updated: Jun 17, 2026

PEG 3350 AND ELECTROLYTES (polyethylene glycol 3350)

Osmotic Activity
Gastrointestinal Approved 2009-06-01

PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.

Source: FDA Label • NOVEL LABS INC
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2009-06-01
Routes
ORAL
Dosage Forms
FOR SOLUTION

Companies

NOVEL LABS INC EXTROVIS
Active Ingredient: POLYETHYLENE GLYCOL 3350 , POTASSIUM CHLORIDE , SODIUM BICARBONATE , SODIUM CHLORIDE , SODIUM SULFATE ANHYDROUS

PEG 3350 AND ELECTROLYTES Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2009 to 2010
Jan 2010 ORIGINAL
Update
Jun 2009 ORIGINAL
Update

What PEG 3350 AND ELECTROLYTES Treats

2 FDA approvals

Originally approved for its first indication in 2009 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

54 trials
Trial Sponsor ID Phase Status Title
NCT04984226 Senergy-CKD 1785131 5R01DK129793 Ph 2 recruiting Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
NCT07424625 25-002104 Ph 4 not yet recruiting A Study of Tris-Hydroxymethyl Aminomethane (THAM) Versus Sodium Bicarbonate in Cardiac Surgical Patients
NCT04585542 KBindER results posted HS# 2020-5780 Ph 4 terminated Comparison of Potassium Binders in the ER
NCT05697770 SODa-BIC ANZIC-RC/ASN001 Ph 3 active not recruiting SODium BICarbonate for Metabolic Acidosis in the ICU
NCT06159777 STUDY20231417 Ph 4 completed Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
NCT05564130 BIHCA 00004 Ph 4 active not recruiting Bicarbonate for In-Hospital Cardiac Arrest
NCT07408076 IRB-24-5580 IRB-24-5580 Ph 1, Ph 2 not yet recruiting Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney Stones
NCT05928936 IRB00078214a 2R01HL135183 Ph 2 recruiting Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
NCT05897086 221616 Ph 2, Ph 3 enrolling by invitation Polyethylene-glycol Assisted Nerve Repair in Phalloplasty
NCT04263896 results posted IRB19-0436 Ph 4 completed Bowel Function After Minimally Invasive Hysterectomy
NCT06999993 2022/0098 Ph 2, Ph 3 active not recruiting Efficacy and Safety of Sodium Hyaluronate Gel Combined With Sodium Bicarbonate Versus Sodium Bicarbonate Alone in Prevention of Failed Back Surgery Syndrome
NCT06335537 2405 Ph 1 recruiting Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers
NCT05805436 202209015 Ph 4 recruiting Preop Laxatives in Robotic Urologic Surgery
NCT05005793 21-3447 R01DK130255 Ph 4 recruiting Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
NCT06825260 StJosephNewYork Ph 4 recruiting PEG3350 vs Senna After Urogyn Surgery
NCT06047366 results posted 17799 Ph 4 terminated Combination of Buffered Anesthetic to Treat Mandibular Molars
NCT02411773 Sym-CKD IRB00078214 2025P011323 Ph 1 recruiting Sympatholysis in Chronic Kidney Disease
NCT04210427 results posted 30114 Ph 4 completed Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit
NCT06186622 results posted 18631 J2A-MC-GZPG Ph 1 completed A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants
NCT02476253 (BICAR-ICU) 9260 Ph 3 completed Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill
NCT05719467 SAINT 235247 Ph 3 recruiting SAINT: Safe Induction of Labor Trial
NCT02765256 Holiday results posted 823635 Ph 2 completed Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
NCT04270019 0644 Ph 1, Ph 2 withdrawn Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration
NCT04530448 results posted 2005006707 Ph 4 terminated Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization
NCT02627846 LAMA R1788 Ph 4 completed Laser Ablation Versus Mechanochemical Ablation Trial
NCT02647892 0787-15-EP Ph 4 terminated Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia
NCT05818007 YYU-06/03.07.2019 Ph 4 completed Is Hyaluronic Acid Gel Effective on Oral Mucositis in Children Who Receiving Chemotherapy
NCT02046135 results posted 13-007B Ph 2 terminated Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
NCT00888290 results posted 2008-376 Ph 2, Ph 3 completed Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects
NCT02303548 results posted BicarbonateinCPR001 Ph 2 completed Bicarbonate in Patients With Out-of-hospital Cardiac Arrest
NCT03476317 Holiday results posted 17-014343 5K23DK109136-02 Ph 2 completed Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
NCT02502071 Alk-UA results posted 15-0541 Ph 4 completed Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults With Type 1 Diabetes
NCT04579419 RC19/371 Ph 3 completed Injection Site Pain Botulinum Toxin Reconstituted in NS With and Without Sodium Bicarbonate
NCT01452412 results posted 2009-408 R01DK087783 Ph 2, Ph 3 completed Alkali Therapy in Chronic Kidney Disease
NCT01894594 09-12-13 Ph 1 terminated Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease
NCT01920126 4-2013-0376 Ph 4 completed The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
NCT03060512 results posted D3820L00017 Ph 4 completed To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation
NCT02337413 rmc130342ctil Ph 4 withdrawn Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis
NCT02336906 rmc130348ctil Ph 4 withdrawn Urotherapy vs. Urotherapy With Constipation Treatment for Children With Lower Urinary Tract Dysfunction
NCT02427594 ABC Pro00058905 K23DK095949 Ph 1 completed Acid-Base Compensation in Chronic Kidney Disease
NCT02226913 193396 Ph 3 completed Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of IAN Block of Teeth With Irreversible Pulpitis
NCT02761577 16012011 Ph 4 completed A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia
NCT02531919 1300000483 Ph 1 completed Extended Use of Sodium Bicarbonate in Patients With Cancer
NCT02726737 941456 Ph 3 completed Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block
NCT01846429 MCC-17136 Ph 1 terminated Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
NCT00674115 results posted 18133 CL2007-17, P07813 Ph 3 completed A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)
NCT00706771 BLISS TNH 18/08 Ph 2 completed Bicarbonate and Lipocalin in Systemic Inflammatory Response Syndrome (SIRS) Study
NCT00921518 results posted CMC AKICS Ph 2 completed Prevention of Acute Kidney Injury in Cardiac Surgery Patients
NCT01622296 BufferDent results posted 1107214 Ph 4 completed Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients
NCT00930436 BOSS MDS001 Ph 3 terminated Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease

Showing 50 of 54 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PEG 3350 AND ELECTROLYTES FDA Label Details

Indications & Usage

PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults. PEG-3350 and Electrolytes for Oral Solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults.

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Data Sources

FDA Approval: ANDA090231 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.