Sodium Picosulfate Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

A clinical trial is currently evaluating sodium picosulfate for bowel preparation prior to colon procedures. This active, industry-sponsored combined Phase 1 and Phase 2 study led by Ferring Pharmaceuticals is recruiting participants to evaluate the safety, efficacy, and pharmacokinetic properties of a cleansing formulation in a randomized, assessor-blinded, parallel-group design. Overall, clinical research on this compound remains targeted toward optimizing mucosal cleansing and gastrointestinal evacuation protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04113382	Recruiting	Bowel Preparation	Ferring Pharmaceuticals	2022-06-23	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Sodium Picosulfate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Following metabolic activation by colonic bacterial sulfatases into its active metabolite, Sodium Picosulfate directly stimulates the mucosal nerve plexus of the colon, which inhibits the absorption of water and electrolytes while simultaneously increasing their intestinal secretion. This driven osmotic fluid retention and accelerated peristalsis promote rapid intestinal cleansing, providing the physiological rationale for its clinical application in bowel preparation regimens.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).