Lixumistat (IM156) Clinical Trials

Size	Price	Qty
5mg	USD 177
25mg	USD 517

Clinical Trials

Multiple clinical trials are currently evaluating the safety and therapeutic efficacy of Lixumistat (IM156). A completed Phase 1 trial sponsored by ImmunoMet Therapeutics, Inc. assessed the safety, tolerability, and preliminary efficacy of IM156 in patients with advanced solid tumors. Furthermore, M.D. Anderson Cancer Center is sponsoring an active, non-recruiting Phase 1b trial investigating IM156 in combination with gemcitabine and nab-paclitaxel for advanced pancreatic cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05497778	ACTIVE_NOT_RECRUITING	Pancreas Cancer	M.D. Anderson Cancer Center	2022-10-21	PHASE1
NCT03272256	COMPLETED	Advanced Solid Tumor	ImmunoMet Therapeutics, Inc.	2017-10-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-24)

Check the Lixumistat (IM156) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lixumistat (IM156) acts as a potent activator of AMP-activated protein kinase that increases AMPK phosphorylation and inhibits mitochondrial complex I, thereby disrupting cellular oxidative phosphorylation and promoting apoptosis. By suppressing mitochondrial respiration and metabolic pathways required for neoplastic survival, this compound targets bioenergetic dependencies in advanced solid tumors and pancreatic cancer to limit tumor growth.

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>).