NDAORALFOR SOLUTION
Approved
Feb 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
3/8 — Basic
MIRALAX (polyethylene glycol 3350) by ANI Pharmaceuticals is osmotic activity [moa]. First approved in 1999.
Drug data last refreshed 18h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MIRALAX is a polyethylene glycol 3350 oral solution used to treat constipation through osmotic activity, drawing water into the bowel to promote bowel movements. It is a non-systemic laxative that has been a cornerstone of OTC and prescription constipation management since 1999. The drug works by creating an osmotic gradient that increases stool water content without systemic absorption.
LOE Approaching
As LOE approaches, the brand team is likely consolidating and focusing on market defense rather than growth initiatives; expect smaller commercial footprint compared to peak years.
Mechanism of Action
Osmotic Activity
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation
Started Mar 2017
276 enrolled
Opioid Induced Constipation
Efficacy and Safety of Polyethylene Glycol 3350 (PEG 3350) for Relief of Constipation (MK-8114-005)
Started Dec 2015
0Constipation
Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
Started Feb 2013
13 enrolled
Chronic Constipation
Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
Started Oct 2010
154 enrolled
Constipation
Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy
Started Apr 2010
136 enrolled
Colon Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.