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Miralax (PEG 3350)
PEG 3350 is an osmotic laxative that draws water into the intestinal lumen to soften stool and promote bowel movements.
PEG 3350 is an osmotic laxative that draws water into the intestinal lumen to soften stool and promote bowel movements. Used for Occasional constipation, Bowel preparation prior to colonoscopy or other GI procedures.
At a glance
| Generic name | Miralax (PEG 3350) |
|---|---|
| Sponsor | Brooke Army Medical Center |
| Drug class | Osmotic laxative |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Polyethylene glycol 3350 is a non-absorbable polymer that creates an osmotic gradient in the colon, pulling water from the bloodstream into the intestinal lumen. This increases stool bulk and moisture content, facilitating easier passage of bowel contents without being systemically absorbed or metabolized.
Approved indications
- Occasional constipation
- Bowel preparation prior to colonoscopy or other GI procedures
Common side effects
- Nausea
- Abdominal bloating or cramping
- Diarrhea
- Vomiting
Key clinical trials
- Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery (PHASE4)
- Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (PHASE3)
- Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study (PHASE2)
- Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy (PHASE1, PHASE2)
- Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults (PHASE3)
- Polyethylene Glycol Safety in Children
- Polyethylene-glycol Assisted Nerve Repair in Phalloplasty (PHASE2, PHASE3)
- Cleansing Options in Out-Patient Setting to Improve Tolerance (COOP SIT) Trial (PHASE4)
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:
- Miralax (PEG 3350) CI brief — competitive landscape report
- Miralax (PEG 3350) updates RSS · CI watch RSS
- Brooke Army Medical Center portfolio CI