methylnaltrexone bromide Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 297

Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the therapeutic efficacy and safety of methylnaltrexone bromide across conditions including opioid-induced constipation, intestinal obstruction, colonic inertia, esophageal sensitivity, and advanced pancreatic cancer. Sponsored by industry entities such as Bausch Health Americas, Inc. alongside academic centers like Universitaire Ziekenhuizen KU Leuven and University Medicine Greifswald, these studies vary in recruitment status. While many have been completed—including a Phase 3 study on opioid-induced constipation—others have reached withdrawn or unknown status, such as a Phase 2/3 trial in pancreatic cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04151719	WITHDRAWN	Pancreatic Cancer	Bausch Health Americas, Inc.	2020-02-03	PHASE3
NCT04083651	WITHDRAWN	Pancreatic Cancer	Bausch Health Americas, Inc.	2020-01-06	PHASE2; PHASE3
NCT03523520	COMPLETED	Constipation Drug Induced	University of Missouri-Columbia	2020-12-23	PHASE4
NCT02942550	COMPLETED	STEMI; Morphine; Ticagrelor; Methylnaltrexone	Karolinska University Hospital	2016-11	PHASE4
NCT03014843	COMPLETED	Endogenous and Esophageal Sensitivity	Universitaire Ziekenhuizen KU Leuven	2013-10
NCT01004393	COMPLETED	Neoplasms; Constipation; Opioid-Related Disorders	University of Vermont	2009-10	PHASE2
NCT00672139	COMPLETED	Opioid-Induced Constipation	Bausch Health Americas, Inc.	2008-07	PHASE4
NCT00949377	WITHDRAWN	Colonic Inertia	Beth Israel Medical Center	2009-09	PHASE4
NCT01596764	COMPLETED	Intestinal Obstruction	University Medicine Greifswald	2011-05	PHASE1
NCT01050595	UNKNOWN	Opioid-induced Constipation	St. John Health System, Michigan	2009-12	PHASE3
NCT00804141	COMPLETED	Constipation	Bausch Health Americas, Inc.	2008-12-03	PHASE3
NCT01366326	COMPLETED	Healthy Adult Subjects	Bausch Health Americas, Inc.	2010-07	PHASE1
NCT00640146	COMPLETED	Opioid-induced Constipation	Bausch Health Americas, Inc.	2007-10-19	PHASE2
NCT00529087	COMPLETED	Constipation	Bausch Health Americas, Inc.	2007-08	PHASE3
NCT00401375	COMPLETED	Post-Operative Ileus (POI)	Bausch Health Americas, Inc.	2006-10-31	PHASE3
NCT00547586	COMPLETED	Constipation	Bausch Health Americas, Inc.	2007-10	PHASE2
NCT01366365	COMPLETED	Healthy Adults	Bausch Health Americas, Inc.	2006-10	PHASE1

(data from https://clinicaltrials.gov, updated on 2021-05-07)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Methylnaltrexone bromide functions as a selective antagonist of the µ-opioid receptor, directly blocking receptor activation to inhibit downstream intracellular Src activation and reduce lung cancer cell viability. By peripherally targeting µ-opioid signaling to reverse gastrointestinal stasis and suppress receptor-mediated pathway activation, this mechanism directly addresses key clinical trial conditions including opioid-induced constipation and advanced pancreatic 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>).