MI-2 (Menin-MLL Inhibitor) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 597

Clinical Trials

Multiple clinical trials without formal phase designations evaluate interventions for cardiorespiratory failure and acute ischemic stroke. A clinical trial sponsored by Istituti Clinici Scientifici Maugeri SpA is currently recruiting participants to examine an in-hospital motivational physical activity program for cardiorespiratory failure patients. Additionally, a completed clinical trial sponsored by the University of North Carolina in collaboration with Genentech Inc. assessed intravenous versus intra-arterial tissue plasminogen activator therapy in acute ischemic stroke patients with major vessel occlusion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05318482	Recruiting	Cardiorespiratory Failure	Istituti Clinici Scientifici Maugeri SpA	2022-03-23	Not Applicable
NCT00624000	Completed	Ischemic Stroke	University of North Carolina Chapel Hill\|Genentech Inc.	2004-03	Not Applicable

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

Check the MI-2 (Menin-MLL Inhibitor) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MI-2 is a potent menin-MLL interaction inhibitor with an IC50 of 446 nM that directly blocks target binding to inhibit downstream leukemogenic target gene transcription. This blockade suppresses cellular proliferation and promotes differentiation, underlying its potential therapeutic relevance in disease models such as cardiorespiratory failure and ischemic stroke.

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>).