ML-9 HCl Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 390

Clinical Trials

A clinical trial evaluated local administration strategies for patients with symptomatic osteoarthritis of the knee by comparing intra-articular injections of corticosteroids, saline, and air placebo regimens. Sponsored by Rush University Medical Center, this Early Phase 1 investigation was withdrawn prior to participant enrollment. Consequently, clinical evaluation under this study protocol remains inactive.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02995083	WITHDRAWN	Symptomatic Osteoarthritis of the Knee	Rush University Medical Center	2017-06	EARLY_PHASE1

(data from https://clinicaltrials.gov, updated on 2017-12-18)

Check the ML-9 HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ML-9 HCl selectively inhibits Akt kinase, myosin light chain kinase (MLCK), and stromal interaction molecule 1 (STIM1), thereby disrupting calcium influx and downstream biochemical cascades essential for cellular survival and autophagic flux. By suppressing these enzymatic and calcium-channel signaling pathways, the compound modulates cellular stress and inflammatory responses that are relevant to joint tissue preservation in symptomatic osteoarthritis of the knee.

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>).