Last reviewed · How we verify
SODIUM PICOSULFATE
SODIUM PICOSULFATE is a Calculi Dissolution Agent [EPC] drug. It is currently FDA-approved (first approved 2012).
Sodium picosulfate is a small molecule stimulant laxative used for bowel preparation before colonoscopy and in the treatment of colorectal cancer, among other conditions. It is often administered in combination with other substances, such as lactulose or polyethylene glycol, as part of bowel cleansing solutions.
At a glance
| Generic name | SODIUM PICOSULFATE |
|---|---|
| Drug class | Calculi Dissolution Agent [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2012 |
Approved indications
Common side effects
- Nausea
- Vomiting
- Abdominal pain
- Watery diarrhea
- Abdominal bloating
- Abdominal distention
- Diarrhea
Serious adverse events
- Hypoglycemia (abnormally low glucose levels)
- Electrolyte abnormalities
- Rash
- Urticaria
- Purpura
Key clinical trials
- A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy (PHASE3)
- Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy (PHASE1, PHASE2)
- Comparing the Bowel Cleansing Efcacy of Picosulfate Sodium/ Citric Acid / Magnesium Oxide and Polyethylene Glycol: A Randomized Trial in Taiwan (NA)
- The Effect of Video-Based Education on Colonoscopy Preparation (NA)
- PEG-Asc Vs. SPMC for Bowel Preparation in Capsule-based Procedures (NA)
- Efficacy, Tolerance and Safety of Split Dose Bowel Preparation for Colonoscopy: 4L Polyethylene Glycol (PEG) Versus 1L Polyethylene Glycol Plus Sodium Picosulfate-magnesium Citrate (SPMC) (PHASE4)
- Validation of a Prediction Model for Inadequate Bowel Preparation
- A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- SODIUM PICOSULFATE CI brief — competitive landscape report
- SODIUM PICOSULFATE updates RSS · CI watch RSS
Frequently asked questions about SODIUM PICOSULFATE
What is SODIUM PICOSULFATE?
What drug class is SODIUM PICOSULFATE in?
When was SODIUM PICOSULFATE approved?
What development phase is SODIUM PICOSULFATE in?
What are the side effects of SODIUM PICOSULFATE?
Related
- Drug class: All Calculi Dissolution Agent [EPC] drugs
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing