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Polyethylene Glycol-Based Lavage
Polyethylene Glycol-Based Lavage is a Osmotic laxative / Bowel preparation agent Small molecule drug developed by University of Calgary. It is currently in Phase 3 development for Bowel preparation prior to colonoscopy, Bowel preparation prior to other gastrointestinal procedures. Also known as: Colyte.
Polyethylene glycol-based lavage solution mechanically cleanses and prepares the colon by osmotically drawing fluid into the bowel lumen to promote evacuation of fecal matter.
Polyethylene Glycol (PEG) is used as an osmotic laxative in intestinal lavage for various conditions, including Clostridium Difficile infections, functional constipation, and bowel preparation for colonoscopy. PEG is a small molecule that works by increasing water in the intestines to stimulate bowel movements.
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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 | Polyethylene Glycol-Based Lavage |
|---|---|
| Also known as | Colyte |
| Sponsor | University of Calgary |
| Drug class | Osmotic laxative / Bowel preparation agent |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
This bowel preparation agent works through osmotic action, where polyethylene glycol (PEG) and electrolytes draw water into the intestinal lumen, creating a fluid environment that facilitates the movement and elimination of stool. The solution is non-absorbable and passes through the gastrointestinal tract largely unchanged, effectively cleansing the colon without significant systemic absorption. This mechanism makes it suitable for pre-procedure bowel preparation prior to colonoscopy or other diagnostic/therapeutic procedures.
Approved indications
- Bowel preparation prior to colonoscopy
- Bowel preparation prior to other gastrointestinal procedures
Common side effects
- Nausea
- Vomiting
- Abdominal discomfort
- Bloating
- Dehydration
Key clinical trials
- Comparing the Effect of Different Intracanal Dressing on Failed Root Canal Treated Cases on Periapical Healing (PHASE2)
- Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence (NA)
- The Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose (PHASE2)
- The Usage of Soda-Water in Gastric Preparation for Magnetically Controlled Capsule Endoscopy (NA)
- Intestinal Lavage for the Treatment of Severe C. Difficile Infections (PHASE2, PHASE3)
- A Randomized Prospective Trial Comparing Polyethylene Glycol and Sodium Picosulphate With Magnesium Citrate (PHASE3)
- Single Dose Versus Split Dose Polyethylene Glycol-based Colonic Lavage for Colonoscopy (NA)
- Split Dose Polyethylene Glycol (PEG) + Clear Fluids Versus Split Dose PEG + Low-Residue Diet (NA)
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:
- Polyethylene Glycol-Based Lavage CI brief — competitive landscape report
- Polyethylene Glycol-Based Lavage updates RSS · CI watch RSS
- University of Calgary portfolio CI
Frequently asked questions about Polyethylene Glycol-Based Lavage
What is Polyethylene Glycol-Based Lavage?
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What is Polyethylene Glycol-Based Lavage used for?
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Is Polyethylene Glycol-Based Lavage also known as anything else?
What drug class is Polyethylene Glycol-Based Lavage in?
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Related
- Drug class: All Osmotic laxative / Bowel preparation agent drugs
- Manufacturer: University of Calgary — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Bowel preparation prior to colonoscopy
- Indication: Drugs for Bowel preparation prior to other gastrointestinal procedures
- Also known as: Colyte
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing