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NER1006, 2-Day Split-Dosing
NER1006 is a polyethylene glycol (PEG)-based bowel cleansing agent that osmotically draws fluid into the colon to evacuate intestinal contents.
NER1006 is a polyethylene glycol (PEG)-based bowel cleansing agent that osmotically draws fluid into the colon to evacuate intestinal contents. Used for Bowel preparation prior to colonoscopy.
At a glance
| Generic name | NER1006, 2-Day Split-Dosing |
|---|---|
| Sponsor | Norgine |
| Drug class | Bowel cleansing agent |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
NER1006 is a low-volume, iso-osmotic PEG solution designed for bowel preparation prior to colonoscopy. The 2-day split-dosing regimen involves administration on two separate days to improve patient tolerability and compliance compared to single-day high-volume preparations. It works by osmotic action to cleanse the colon without significant fluid and electrolyte shifts.
Approved indications
- Bowel preparation prior to colonoscopy
Common side effects
- Nausea
- Vomiting
- Abdominal pain
- Abdominal distension
Key clinical trials
- A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy (PHASE3)
- Real Word Evidence With 1L Polyethylene Glycol (PEG)+ Ascorbic Acid in Iberia
- Colon Cleansing Efficacy With 1L vs. 2L vs. 4L-PEG for Colonoscopy Among Inpatients (PHASE4)
- Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus a Sodium Picosulfate and Magnesium Salt Solution Using Day Before-Only Dosing Regimen in Adults. (PHASE3)
- Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults. (PHASE3)
- Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus Trisulfate Solution Using 2-Day Split-Dosing Regimen in Adults (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NER1006, 2-Day Split-Dosing CI brief — competitive landscape report
- NER1006, 2-Day Split-Dosing updates RSS · CI watch RSS
- Norgine portfolio CI