Clinical Trials

Multiple clinical trials have evaluated lubiprostone across conditions including chronic idiopathic constipation, constipation-predominant irritable bowel syndrome, general constipation, and colorectal carcinoma. Spanning Phase 1, combined Phase 2/Phase 3, Phase 3, and unclassified designs, these investigations were conducted by academic medical centers alongside industry partners such as Takeda Pharmaceuticals. Although most studies investigating topics such as alimentary transit times and bowel preparation have completed recruitment, a clinical trial was withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01469819 Completed
Chronic Idiopathic Constipation
Texas Tech University Health Sciences Center El Paso|Takeda Pharmaceuticals North America Inc.
 2012-06 Phase 2|Phase 3
NCT01324284 Completed
Colorectal Carcinoma
Asian Institute of Gastroenterology India
 2011-03 Phase 3
NCT00934479 Completed
Other Constipation|Irritable Bowel Syndrome
Mayo Clinic|Arizona State University|Takeda Pharmaceuticals North America Inc.
 2010-04 Phase 1
NCT01085643 Completed
Constipation-predominant Irritable Bowel Syndrome
Cedars-Sinai Medical Center|Takeda Pharmaceuticals North America Inc.
 2010-03 Not Applicable
NCT00985569 Withdrawn
Constipation
Synergy Health Solutions
 2009-11 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lubiprostone specifically targets and activates ClC-2 chloride channels located on the apical membrane of gastrointestinal epithelial cells. This activation promotes the efflux of chloride and passive transport of water into the intestinal lumen, thereby enhancing motility and softening stool to relieve symptoms of chronic idiopathic constipation and constipation-predominant irritable bowel syndrome.

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>).

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Note: Technical data last updated: Sep 1, 2026.