Trimebutine Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

A Phase 2 proof-of-concept clinical trial evaluated Trimebutine (investigated as GIC-1001) for managing visceral pain in patients undergoing medical procedures related to colonic diseases and cancer. Sponsored by gicare Pharma Inc. in collaboration with JSS Medical Research Inc. and Algorithme Pharma Inc., this randomized, double-blind, placebo-controlled study has been completed. The investigation highlights the therapeutic interest in utilizing peripheral opioid receptor modulation for gastrointestinal pain conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01926444	Completed	Pain\|Cancer\|Colonic Diseases	gicare Pharma Inc.\|JSS Medical Research Inc.\|Algorithme Pharma Inc	2013-07	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trimebutine functions as an agonist of peripheral mu, kappa, and delta opioid receptors, engaging Gi/o-protein signaling to inhibit adenylate cyclase and modulate ion channel conductance in smooth muscle cells. This activity suppresses smooth muscle hyperreactivity and attenuates peripheral nociceptive signaling, providing a clear mechanistic rationale for its clinical study in managing visceral pain associated with colonic diseases and cancer.

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>).