Alvimopan Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Several late-stage clinical trials, including Phase III and Phase IV studies sponsored by academic and industrial entities such as the University of Puerto Rico, Merck Sharp & Dohme LLC, Cubist Pharmaceuticals, and GlaxoSmithKline, have evaluated the efficacy and safety of alvimopan in treating post-operative ileus, bowel dysfunction, and constipation. Although a Phase IV clinical trial assessing post-operative dose efficacy was terminated, multiple Phase III clinical trials investigating bowel dysfunction and constipation have been completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03068975	Terminated	Post Operative Ileus	University of Puerto Rico\|Merck Sharp & Dohme LLC	2017-09-01	Phase 4
NCT00259922	Completed	Bowel Dysfunction\|Constipation	Cubist Pharmaceuticals LLC a subsidiary of Merck & Co. Inc. (Rahway New Jersey USA)\|GlaxoSmithKline	2005-08	Phase 3
NCT00256932	Completed	Bowel Dysfunction\|Constipation	Cubist Pharmaceuticals LLC a subsidiary of Merck & Co. Inc. (Rahway New Jersey USA)\|GlaxoSmithKline	2005-08	Phase 3
NCT00241722	Completed	Bowel Dysfunction\|Constipation	Cubist Pharmaceuticals LLC a subsidiary of Merck & Co. Inc. (Rahway New Jersey USA)\|GlaxoSmithKline	2005-08-01	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alvimopan functions as a potent peripherally acting opioid receptor antagonist, competitively binding to the μ-opioid receptor with high affinity (Ki = 0.77 nM) to block agonist-induced G-protein-coupled signaling and restore gastrointestinal cellular motility. By selectively inhibiting peripheral opioid receptors in the gastrointestinal tract without disrupting central analgesia, alvimopan prevents and alleviates post-operative ileus, bowel dysfunction, and constipation.

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>).