GOLYTELY (polyethylene glycol 3350)
GoLYTELY is a combination of polyethylene glycol 3350 and electrolytes used to clear the colon in adult patients. It helps patients prepare for diagnostic procedures such as colonoscopies or barium enema X-ray exams. This medication ensures the bowel is thoroughly cleansed so that these medical examinations can be performed effectively.
How GOLYTELY Works
This medication works by using the osmotic effect of polyethylene glycol 3350 to retain water within the colon. This process results in the production of watery stools, which effectively flushes and cleanses the intestinal tract.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1984-07-13
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
Companies
GOLYTELY Approval History
What GOLYTELY Treats
2 indicationsGOLYTELY is approved for 2 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bowel cleansing before colonoscopy
- Bowel cleansing before barium enema X-ray examination
GOLYTELY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
18 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 |
| NCT05054036 results posted | 2000031169 000 | Ph 4 | completed | MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy |
| NCT07351019 | DDEAMC.2022.0044 | Ph 4 | recruiting | Colonoscopy Bowel Prep Comparison Among Diabetic Patients |
| NCT05897086 | 221616 | Ph 2, Ph 3 | enrolling by invitation | Polyethylene-glycol Assisted Nerve Repair in Phalloplasty |
| NCT07215000 COOP SIT | 2282829 | Ph 4 | recruiting | Cleansing Options in Out-Patient Setting to Improve Tolerance (COOP SIT) Trial |
| 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 |
| NCT03298945 results posted | IIR 15-346 | Ph 4 | completed | Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens |
| 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 |
| NCT03198221 results posted | 17-127 | Ph 4 | terminated | Comparison of Clenpiq vs Golytely Bowel Preparation |
| 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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
GOLYTELY FDA Label Details
Indications & Usage
FDA Label (PDF)GOLYTELY is indicated for the treatment of Bowel cleansing before colonoscopy; Bowel cleansing before barium enema X-ray examination.
Track GOLYTELY with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment