Sold as Miralax. Every FDA application for this active ingredient: 2 branded and 19 generic.
As of Nov 15, 2026, FDA lists 21 applications for Polyethylene Glycol 3350 (sold as Miralax), first approved Feb 18, 1999, with 2 new uses approved and 0 published complete response letters.
| A Pilot Study of Commercially Available Bowel Preparation Regimens Packaged and Ingested Via Vegan CapsulesLower Gastrointestinal Disorder, Tolerance · Ottawa Hospital Research Institute | Early phase 1 | Not yet recruiting | Jul 14, 2026 |
| Effect of Miralax NPO Time on Residual Gastric Volumes and Bowel PreparationResidual Gastric Contents, Polyethylene Glycol · Stanford University | Not applicable | Not yet recruiting | Jun 1, 2026 |
| Senna vs. Polyethylene Glycol 3350 for the Treatment of Retentive Encopresis in ChildrenEncopresis With Constipation and Overflow Incontinence · Shaare Zedek Medical Center | Early phase 1 | Not yet recruiting | May 22, 2026 |
| Cleansing Options in Out-Patient Setting to Improve Tolerance (COOP SIT) TrialColorectal Cancer Screening, Bowel Cleansing for Colonoscopy · Morehouse School of Medicine | Phase 4 | Recruiting | Oct 9, 2025 |
| Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional ConstipationConstipation · Ferass Abu Hanna | Phase 4 | Recruiting | May 7, 2025 |
| A Trial of Actazin Versus PEG 3350 for Maintenance Therapy in Children With ConstipationConstipation - Functional, Constipation · Hamilton Health Sciences Corporation | Phase 2 / Phase 3 | Not yet recruiting | Feb 20, 2025 |
| PEG3350 vs Senna After Urogyn SurgeryObstructive Defecation Syndrome, Postoperative Constipation · St. Joseph's Health, New York | Phase 4 | Recruiting | Feb 13, 2025 |
| Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.Bacterial Vaginosis (BV), Recurrent Bacterial Vaginosis · S.I.I.T. Srl | Not applicable | Recruiting | Dec 10, 2024 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Bayer Healthcare LLC
Mylan
Strides Pharma Intl