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NER1006, Day Before-Only Dosing
NER1006, Day Before-Only Dosing is a Osmotic laxative / Bowel cleansing agent Small molecule drug developed by Norgine. It is currently in Phase 3 development for Bowel cleansing prior to colonoscopy.
NER1006 is a polyethylene glycol (PEG)-based bowel cleansing agent that osmotically draws fluid into the colon to evacuate intestinal contents.
NER1006 is a small molecule used in a study to compare its bowel cleansing efficacy, safety, and tolerability against a sodium picosulfate and magnesium salt solution in adults with conditions such as colorectal cancer, colorectal carcinoma, and colon cleansing. The study, NER1006-03/2014 (DAYB), used a day before-only dosing regimen.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | NER1006, Day Before-Only Dosing |
|---|---|
| Sponsor | Norgine |
| Drug class | Osmotic laxative / Bowel cleansing agent |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
NER1006 works as an osmotic laxative containing PEG 3350 and electrolytes that create an osmotic gradient in the bowel, pulling water into the intestinal lumen and promoting rapid evacuation of fecal material. The 'Day Before-Only' formulation is designed to be administered as a single-day regimen (typically the day before colonoscopy) rather than split-dose protocols, improving patient compliance and tolerability while maintaining efficacy for bowel preparation.
Approved indications
- Bowel cleansing prior to colonoscopy
Common side effects
- Nausea
- Vomiting
- Abdominal discomfort
- Abdominal pain
- Diarrhea
Key clinical trials
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, Day Before-Only Dosing CI brief — competitive landscape report
- NER1006, Day Before-Only Dosing updates RSS · CI watch RSS
- Norgine portfolio CI
Frequently asked questions about NER1006, Day Before-Only Dosing
What is NER1006, Day Before-Only Dosing?
How does NER1006, Day Before-Only Dosing work?
What is NER1006, Day Before-Only Dosing used for?
Who makes NER1006, Day Before-Only Dosing?
What drug class is NER1006, Day Before-Only Dosing in?
What development phase is NER1006, Day Before-Only Dosing in?
What are the side effects of NER1006, Day Before-Only Dosing?
Related
- Drug class: All Osmotic laxative / Bowel cleansing agent drugs
- Manufacturer: Norgine — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Bowel cleansing prior to colonoscopy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing