CLENPIQ (citric acid)
CLENPIQ is a fixed-dose combination of sodium picosulfate, magnesium oxide, and anhydrous citric acid indicated for colon cleansing in preparation for colonoscopy in adults and pediatric patients aged 9 years and older. The formulation utilizes a dual-action mechanism, combining a stimulant laxative with an osmotic laxative to achieve thorough bowel evacuation.
How CLENPIQ Works
CLENPIQ exerts its effect through two distinct mechanisms. Sodium picosulfate is hydrolyzed by colonic bacteria into the active metabolite bis-(p-hydroxy-phenyl)-pyridyl-2-methane (BHPM), which directly stimulates the colonic mucosa to increase peristalsis. Concurrently, magnesium oxide and citric acid react in solution to form magnesium citrate; this osmotic agent induces water retention within the gastrointestinal lumen, increasing intraluminal pressure and facilitating colon clearance.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-11-28
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- SOLUTION
Companies
CLENPIQ Approval History
What CLENPIQ Treats
1 indicationsCLENPIQ is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Colon cleansing for colonoscopy preparation
CLENPIQ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04113382 PICCOLO | 000359 | Ph 1, Ph 2 | recruiting | Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy |
| NCT03198221 results posted | 17-127 | Ph 4 | terminated | Comparison of Clenpiq vs Golytely Bowel Preparation |
| NCT03769402 | 52-376 | Ph 4 | completed | The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CLENPIQ FDA Label Details
Indications & Usage
FDA Label (PDF)CLENPIQ is indicated for the treatment of Colon cleansing for colonoscopy preparation.
CLENPIQ Patents & Exclusivity
Patents (5 active)
Pro Intelligence Preview
Deep insights for CLENPIQ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 5 active patents
Trial Analysis
- • 3 total trials
- • Stage: Mature
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment