ME-344 Clinical Trials

Size	Price	Qty
5mg	USD 290
25mg	USD 870

Clinical Trials

Multiple clinical trials have evaluated the therapeutic potential of ME-344 as monotherapy and in combination regimens across oncological indications, including advanced solid tumors, HER2-negative early-stage breast carcinoma, and metastatic colorectal cancer. Ranging from Early Phase 1 to Phase 1/2, these completed and terminated protocols have been spearheaded by both industry and academic sponsors, such as MEI Pharma, Inc. and Centro Nacional de Investigaciones Oncologicas CARLOS III.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05824559	TERMINATED	Colorectal Cancer	MEI Pharma, Inc.	2023-08-07	PHASE1
NCT02806817	COMPLETED	Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Early-Stage Breast Carcinoma	Centro Nacional de Investigaciones Oncologicas CARLOS III	2016-07	EARLY_PHASE1
NCT02100007	TERMINATED	Solid Tumors	MEI Pharma, Inc.	2014-04	PHASE1; PHASE2
NCT01544322	COMPLETED	Solid Tumors	MEI Pharma, Inc.	2012-05	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-11-21)

Check the ME-344 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ME-344 potently inhibits mitochondrial oxidative phosphorylation complex I while downregulating the AKT/mTOR pathway, thereby disrupting cellular ATP generation, suppressing oxygen consumption, and impairing cancer cell viability. By targeting energy production and survival signaling, this dual mechanism restricts tumor bioenergetics and growth in clinically relevant settings such as solid tumors, HER2-negative breast cancer, and colorectal 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>).