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Data updated: Sep 20, 2026

GLYCOLAX (polyethylene glycol 3350) · LANNETT CO INC

Gastrointestinal Approved 2004-07-02
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Discontinued
First Approved
2004-07-02
Routes
ORAL
Dosage Forms
FOR SOLUTION

Companies

LANNETT CO INC
Active Ingredient: POLYETHYLENE GLYCOL 3350

GLYCOLAX Approval History

2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 2004 to 2012
Jun 2012 SUPPL
Label · Labeling
Oct 2011 SUPPL
Mfg · Manufacturing (CMC)
Mar 2010 SUPPL
Label · Labeling

What GLYCOLAX Treats

2 FDA approvals

Originally approved for its first indication in 2004 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

13 trials
Trial Sponsor ID Phase Status Title
NCT04585542 KBindER results posted HS# 2020-5780 Ph 4 terminated Comparison of Potassium Binders in the ER
NCT06159777 STUDY20231417 Ph 4 completed Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
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
NCT05805436 202209015 Ph 4 recruiting Preop Laxatives in Robotic Urologic Surgery
NCT06825260 StJosephNewYork Ph 4 recruiting PEG3350 vs Senna After Urogyn Surgery
NCT04210427 results posted 30114 Ph 4 completed Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit
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NCT04270019 0644 Ph 1, Ph 2 withdrawn Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration
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
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NCT02337413 rmc130342ctil Ph 4 withdrawn Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis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
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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.

GLYCOLAX FDA Label Details

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Data Sources

FDA Approval: ANDA076652 → Trials: ClinicalTrials.gov →

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