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Data updated: May 26, 2026

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL (bisacodyl)

Gastrointestinal Approved 2014-08-20
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Discontinued
First Approved
2014-08-20
Routes
ORAL
Dosage Forms
FOR SOLUTION, TABLET, DELAYED RELEASE

Companies

NOVEL LABS INC
Active Ingredient: BISACODYL , POLYETHYLENE GLYCOL 3350 , POTASSIUM CHLORIDE , SODIUM BICARBONATE , SODIUM CHLORIDE

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2014 to 2021
May 2021 SUPPL
Label · Labeling
Aug 2014 ORIGINAL
Update · Not Applicable

What PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
📋

Clinical Trial Registry

15 trials
Trial Sponsor ID Phase Status Title
NCT06455813 Laxatives26092019 Ph 4 recruiting What Laxative Should be Used After Hip Fracture Surgery?
NCT05409157 IM018-010 Ph 1 completed A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants
NCT02609607 results posted PRO15100104 Ph 2 terminated Treating Anorectal Dysfunction in MS
NCT01982240 results posted SP304203-00 Ph 3 completed 12-Week Study of Plecanatide for CIC (The CIC3 Study)
NCT03279341 S54750 Ph 4 completed Effect of PEG, Bisacodyl and Prucalopride on Colonic Motility in Healthy Subjects
NCT02980562 Korea University preparation Ph 3 completed Comparison of Low Volume PEG-Asc and Lower Volume PEG-Asc With Bisacodyl
NCT02386449 CLEAR PREP 000180 Ph 4 completed A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy
NCT01917773 results posted 1305011397 Ph 4 completed Effect of Octreotide on the Colonic Motility in Pediatric Patients
NCT01655095 DMED-1478-12 Ph 3 completed Improving Bowel Preparation for the Colon Capsule
NCT02211911 122.57 Ph 1 completed Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females
NCT01887158 PEGOP PEGOP0613 Ph 4 completed 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
NCT01011426 08-148 Ph 2 completed Bisacodyl Use in the Post-operative Care of Obstetrical/Gynecological (OB/GYN) Patients
NCT01063049 results posted 1220100180 Ph 4 completed Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation
NCT01073930 results posted 2009-01 Ph 3 completed Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep
NCT01073943 results posted 2009-02 Ph 3 completed Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep
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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, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL FDA Label Details

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Data Sources

FDA Approval: ANDA202217 → Trials: ClinicalTrials.gov →

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