GOLYTELY
LOE Approachingpolyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride
NDAORALFOR SOLUTION
Approved
Jul 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
5/8 — Partial
GOLYTELY (polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride) by R-Pharm US is osmotic activity [moa]. First approved in 1984.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GOLYTELY is an oral osmotic laxative solution containing polyethylene glycol 3350 and electrolytes, approved in 1984 for bowel preparation. It works by drawing water into the intestinal lumen through osmotic activity, producing complete bowel evacuation without systemic absorption. This is a mature, non-proprietary formulation used primarily for colonoscopy preparation.
$0.261MPart D
LOE ApproachingStable
Product is mature and facing patent expiration; commercial teams are likely small and focused on defensive positioning against generic erosion rather than expansion.
Mechanism of Action
Osmotic Activity
Pharmacologic Class:
Osmotic Laxative
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Comparison of Clenpiq vs Golytely Bowel Preparation
Started Jul 2018
14 enrolled
Bowel Preparation Solutions
Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy
Started Apr 2010
136 enrolled
Colon Cancer
A Trial Comparing Bowel Preparation and Patient Tolerability of Miralax Versus Golytely
Started May 2009
432 enrolled
Colonoscopy
Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation
Started Mar 2008
158 enrolled
Colonoscopy
Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy
Started Oct 2007
191 enrolled
Bowel Preparation for Colonoscopy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.