MI-3 (Menin-MLL Inhibitor) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

A clinical trial is currently recruiting participants to evaluate the safety and feasibility of rapid triage and discharge pathways for emergency department patients presenting with acute chest pain and suspected acute coronary syndrome utilizing point-of-care troponin monitoring systems. Classified under a phase designated as Not Applicable, the study involves collaboration among clinical and industrial sponsors, including Liverpool University Hospitals NHS Foundation Trust, Northwest Coast Academic Health Science Network, Quidel Corporation, Siemens Corporation Corporate Technology, and Abbott Diagnostics Division.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05322395	Recruiting	Acute Coronary Syndrome\|Troponin\|Chest Pain\|Point-of-care Systems	Liverpool University Hospitals NHS Foundation Trust\|northwest coast academic science network\|Quidel Corporation\|Siemens Corporation Corporate Technology\|Abbott Diagnostics Division	2021-12-10	Not Applicable

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

Check the MI-3 (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-3 selectively binds to the menin-MLL interaction interface with an IC50 of 648 nM, disrupting downstream histone methyltransferase complex activity and suppressing oncogenic gene transcription to inhibit cell proliferation. By blocking menin-dependent transcriptional machinery to impair aberrant cellular growth, this targeted mechanism establishes its therapeutic relevance, which is contextualized alongside clinical trial evaluations focusing on acute coronary syndrome, chest pain triage, and point-of-care troponin systems.

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>).