NULYTELY (polyethylene glycol 3350)
NULYTELY is indicated for the treatment of Constipation.
Details
- Status
- Prescription
- First Approved
- 1991-04-22
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
Companies
NULYTELY Approval History
What NULYTELY Treats
1 indicationsNULYTELY is approved for 1 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Constipation
NULYTELY 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.
Drugs Similar to NULYTELY
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 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| NCT04270019 | 0644 | Ph 1, Ph 2 | withdrawn | Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration |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 |
| NCT01063049 results posted | 1220100180 | Ph 4 | completed | Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation |
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.
NULYTELY FDA Label Details
Indications & Usage
FDA Label (PDF)NULYTELY is indicated for the treatment of Constipation.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.