Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
4L PegLyte+ bisacodyl · 1 trial · 2 indications
BBPS total score ≥6 and/or all segment scores ≥2.
| Arm | Type | Description |
|---|---|---|
| Regimen A | EXPERIMENTAL | 4L PegLyte + 15 mg bisacodyl |
| Regimen B | EXPERIMENTAL | 6L PegLyte + 15 mg bisacodyl |
| Name | Type | Description |
|---|---|---|
| 4L PegLyte + 15 mg bisacodyl | DRUG | Randomized |
| 6L PegLyte + 15 mg bisacodyl | DRUG | Randomized |
Inclusion Criteria: 1. Anyone undergoing a repeat colonoscopy due to failed bowel preparation at index colonoscopy. Failure is defined as preparation quality inadequate to detect lesions \> 5 mm after washing and requiring a shortened colonoscopy interval as a result. 2. Age \> 18 years 3. Outpatie...
4L PegLyte+ bisacodyl is used for bowel preparation in patients undergoing colonoscopy. It is a small molecule gastrointestinal product being developed by Edesa Biotech, Inc. The drug is intended to improve bowel cleansing for the procedure.
Edesa Biotech, Inc. (NASDAQ: EDSA) is developing 4L PegLyte+ bisacodyl. The company is conducting clinical research on this product for use in colonoscopy bowel preparation.
4L PegLyte+ bisacodyl is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed.
4L PegLyte+ bisacodyl has one completed Phase 3 trial, NCT02976805, titled 'Multi-centre Failed Bowel Prep RCT'. This randomized, controlled study enrolled 196 participants in Canada and evaluated the drug for colonoscopy and bowel preparation.
4L PegLyte+ bisacodyl is a combination product that includes bisacodyl, a stimulant laxative, along with a 4L polyethylene glycol (PEG) solution. It is being studied specifically for bowel preparation before colonoscopy.