Rimeporide Clinical Trials

Size	Price	Qty
5mg	USD 647
25mg	USD 1,949

Clinical Trials

A clinical trial sponsored by the EspeRare Foundation evaluated Rimeporide in patients with Duchenne muscular dystrophy. This completed Phase 1b investigation assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending oral doses of the compound. Overall, the data provide initial baseline evidence regarding the administration and biological activity of this investigational agent within the targeted patient cohort.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02710591	COMPLETED	Muscular Dystrophy, Duchenne	EspeRare Foundation	2016-03	PHASE1

(data from https://clinicaltrials.gov, updated on 2019-07-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rimeporide functions as a selective inhibitor of sodium-hydrogen exchanger 1 (NHE-1), preventing the electroneutral exchange of intracellular hydrogen ions for extracellular sodium ions across cellular membranes. By suppressing intracellular sodium influx and preventing secondary intracellular calcium overload, it reduces myofiber necrosis and tissue inflammation in Duchenne muscular dystrophy.

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>).