NDAORALFOR SOLUTION
Approved
Jul 2012
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
2
Data completeness
4/8 — Partial
PREPOPIK (citric acid; magnesium oxide; sodium picosulfate) by Ferring Pharmaceuticals is metabolite: bis-(p-hydroxy-phenyl)-pyridyl-2-methane, bhpm, which acts directly on the colonic mucosa to stimulate colonic peristalsis. First approved in 2012.
Drug data last refreshed 33m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREPOPIK is an oral bowel preparation solution containing sodium picosulfate, magnesium oxide, and citric acid approved in 2012 for colon cleansing prior to colonoscopy. Sodium picosulfate metabolizes to BHPM, which stimulates colonic peristalsis, while magnesium citrate (formed in situ) acts as an osmotic agent to retain water in the GI tract. The dual-mechanism approach provides effective bowel evacuation with a lower fluid volume requirement.
LOE Approaching1.9 years to LOE
Product is approaching loss of exclusivity with moderate competitive pressure (15 competitors), signaling a defensive commercial phase with likely team consolidation and shift toward cost management and brand loyalty initiatives.
Mechanism of Action
metabolite: bis-(p-hydroxy-phenyl)-pyridyl-2-methane, BHPM, which acts directly on the colonic mucosa to stimulate colonic peristalsis. Magnesium oxide and citric acid react to create magnesium citrate in solution, which is an osmotic agent that causes water to be retained within the…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy
Started Feb 2017
917 enrolled
Bowel Preparation
Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy
Started Jun 2014
78 enrolled
Need for Bowel Preparation
Why This Matters for Your Career
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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.